Bricanyl Tablets 5mg

Bricanyl Tablets 5 mg

terbutaline sulphate

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Bricanyl Tablets are and what they are used for


• 2. Before you take Bricanyl Tablets


• 3. How to take Bricanyl Tablets


• 4. Possible side effects


• 5. How to store Bricanyl Tablets


• 6. Further information

What Bricanyl Tablets are and what they are used for

Bricanyl Tablets contain a medicine called terbutaline sulphate. This belongs to a group of medicines called beta-agonists. These work by relaxing certain muscles. For example, they open up the airways in the lungs or relax the muscles of the womb (uterus) during pregnancy.

• Bricanyl Tablets are used for the regular treatment of breathing disorders such as asthma. They help to relieve tightening of the chest and difficulty breathing (bronchospasm).


• They are also used in pregnancy to prevent early delivery of the baby (premature labour).

Before you take Bricanyl Tablets

Do not take Bricanyl Tablets if:

• You are allergic (hypersensitive) to terbutaline sulphate or any of the other ingredients of Bricanyl Tablets (listed in Section 6: Further information).

Take special care with Bricanyl Tablets

Check with your doctor or pharmacist before using Bricanyl Tablets if:

• You are pregnant and you have had problems with your pregnancy.


• You are diabetic. If so, you may need some additional blood sugar tests when you start taking Bricanyl Tablets.


• You have a history of heart disease, irregular heart rhythm or angina.


• You have an overactive thyroid gland.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Bricanyl Tablets.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes medicines that you buy without a prescription and herbal medicines. Bricanyl Tablets can affect the way that some medicines work and some medicines can have an effect on Bricanyl Tablets.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• Steroid medicines (such as prednisolone).


• Xanthine medicines (such as theophylline or aminophylline).


• Beta-blocker medicines (such as atenolol or propranolol), including eye drops (such as timolol).


• Water tablets, also known as diuretics (such as frusemide).

Pregnancy and breast-feeding

Talk to your doctor before taking Bricanyl Tablets if you are pregnant, might become pregnant or are breast-feeding.

Driving and using tools and machines

Bricanyl Tablets are not likely to affect you being able to drive or use any tools or machines.

Important information about some of the ingredients of Bricanyl Tablets

Bricanyl Tablets contain lactose which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.

How to take Bricanyl Tablets

Always take Bricanyl Tablets exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure. The instructions on the label should remind you of what the doctor said. Do not stop taking your medicine without first discussing it with your doctor.

For asthma and breathing problems

Adults and young people over 16 years

• The usual starting dose is half a tablet three times in 24 hours. This dose is usually taken for the first 1 to 2 weeks.


• Your doctor may increase the dose to one tablet three times a day.

Children (7 to 15 years)

• The usual starting dose is half a tablet twice a day.


• The doctor may increase the dose to half a tablet three times a day.

Contact your doctor straight away if:

• 
  Your breathing is getting worse.
  


• 
  You often wake up at night with asthma.
  


• 
  You start getting chest tightness.
  


• 
  You are not getting relief from your current dose.
  

These signs could mean your asthma is not being controlled and you may need different or additional treatment straight away.

For prevention of premature labour

The dose is one tablet three times in 24 hours. Your doctor will ask you to start taking Bricanyl Tablets after your contractions have been controlled with injections. The doctor will want you to continue taking Bricanyl Tablets for as long as is needed to prolong your pregnancy.

If you take more Bricanyl Tablets than you should

If you have accidentally taken too much of this medicine, contact your doctor or pharmacist for advice.

If you forget to take Bricanyl Tablets

If you forget to have a dose, have it as soon as you remember. However, if it is almost time for the next dose, wait until then and take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

Possible side effects

Like all medicines, Bricanyl Tablets can cause side effects, although not everybody gets them.

Important side effects to look out for:

• Allergic reactions. The signs may include a swollen face, skin rash, breathing problems, low blood pressure (feeling faint) and collapse. It is not known exactly how often this happens. If this happens to you, stop taking Bricanyl Tablets and see a doctor straight away.


• Sudden wheezing soon after taking Bricanyl Tablets. It is not known exactly how often this happens. If this happens to you, stop taking Bricanyl Tablets and see a doctor straight away.

Other possible side effects:

Very common (affects more than 1 in 10 people)

• Trembling or shaking.


• Headache.

Common (affects less than 1 in 10 people)

• Fast heart beats.


• Pounding heart beats (palpitations).


• Cramp or feeling tense.


• Low levels of potassium in your blood which may cause muscle weakness, thirst, or ‘pins and needles’.

The following effects have sometimes been seen but it is not known exactly how often they happen:

• Unusual or irregular heart beats.


• Chest pain (due to heart problems such as angina). Tell your doctor if you develop this symptom whilst receiving treatment with Bricanyl Tablets, but do not stop using this medicine unless told to.


• Feeling sick (nausea).


• Mouth and throat irritation.


• Changes in sleeping patterns and changes in behaviour, such as feeling agitated, restless or “hyperactive”.

Do not be concerned by this list of side effects. You may not get any of them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Bricanyl Tablets

• Keep in a safe place, out of the reach and sight of children.


• Do not store above 25°C.


• Do not take Bricanyl Tablets after the expiry date printed on the packaging. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

Further information

What Bricanyl Tablets contain

The active substance is terbutaline sulphate. Each Bricanyl Tablet contains 5 mg of terbutaline sulphate.

The other ingredients are lactose monohydrate, maize starch, povidone, microcrystalline cellulose and magnesium stearate.

What Bricanyl Tablets look like and the contents of the pack

Bricanyl Tablets are off-white. They have ‘A/BT’ and a score on one side and the symbol ‘5’ on the other side.

Bricanyl Tablets are available in glass bottles or securitainers of 100 tablets.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Bricanyl Tablets is held by

AstraZeneca UK Ltd

600 Capability Green

Luton

LU1 3LU

UK

Bricanyl Tablets are manufactured by

AstraZeneca UK Ltd

Silk Road Business Park

Macclesfield

Cheshire

SK10 2NA

UK

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name
Bricanyl Tablets

Reference number 17901/0116

This is a service provided by the Royal National Institute of Blind People.

Leaflet prepared: December 2008

Bricanyl is a trademark of the AstraZeneca group of companies.

© AstraZeneca 2008

RSP 08 0083a

P024565

haloprogin topical

Generic Name: haloprogin topical (ha low PROE gin)

Brand Names: Halotex

What is haloprogin topical?

Haloprogin topical is an antifungal medication. It prevents fungus from growing on your skin.

Haloprogin topical is used to treat skin infections such as athlete's foot, jock itch, ringworm, and tinea versicolor (a fungus that discolors the skin).

Haloprogin topical is not commercially available in the United States.

Haloprogin topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about haloprogin topical?

Haloprogin topical is not commercially available in the United States.

Use this medication for the full amount of time prescribed by your doctor even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

After applying haloprogin topical, do not cover the affected area with bandages or dressings that do not allow air to circulate unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Avoid getting this medication in your eyes, nose, or mouth.

Who should not use haloprogin topical?

Do not use haloprogin topical if you have had an allergic reaction to it in the past.

It is not known whether haloprogin topical will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. It is not known whether haloprogin topical passes into breast milk. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.

How should I use haloprogin topical?

Use haloprogin topical exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply the cream or solution twice daily as directed for 2 to 4 weeks. Use this medication for the full amount of time prescribed by your doctor or as recommended in the package, even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

If the infection does not clear up in 4 weeks, or if it appears to get worse, see your doctor.

After applying haloprogin topical, do not cover the affected area with bandages or dressings that do not allow air to circulate unless otherwise directed by your doctor. A light cotton-gauze dressing may be used to protect clothing.

Avoid getting this medication in your eyes, nose or mouth. Store haloprogin topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the dose you missed and apply only the regular amount of haloprogin topical. Do not use a double dose unless otherwise directed by your doctor.

What happens if I overdose?

An overdose of haloprogin topical is unlikely. If you do suspect that a much larger than normal dose has been used or that haloprogin topical has been ingested, contact an emergency room or a poison control center.

What should I avoid while using haloprogin topical?

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Haloprogin topical side effects

Serious side effects from haloprogin topical use are not expected. Stop using the medication and see your doctor if you experience unusual blistering, itching, redness, peeling, dryness, or irritation of the skin.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Haloprogin topical Dosing Information

Usual Adult Dose for Taenia saginata (beef tapeworm):

Apply liberally to the affected area twice daily for 2 to 3 weeks.

Usual Adult Dose for Tinea Corporis:

Apply liberally to the affected area twice daily for 2 to 3 weeks.

Usual Adult Dose for Tinea Cruris:

Apply liberally to the affected area twice daily for 2 to 3 weeks.

What other drugs will affect haloprogin topical?

Other skin medications may affect the absorption or effectiveness of haloprogin topical. Avoid using other topical medications at the same time unless your doctor approves.

More haloprogin topical resources

• Haloprogin topical Dosage
• Haloprogin topical Support Group
• 0 Reviews for Haloprogin - Add your own review/rating

Compare haloprogin topical with other medications

• Taenia saginata, beef tapeworm
• Tinea Corporis
• Tinea Cruris

Where can I get more information?

• Your pharmacist has additional information about haloprogin topical written for health professionals that you may read.

What does my medication look like?

Haloprogin topical is available with a prescription under the brand name Halotex in 1% cream and solution formulations. Other brand and generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Lipoféine

Lipoféine may be available in the countries listed below.

Ingredient matches for Lipoféine

Caffeine

Caffeine is reported as an ingredient of Lipoféine in the following countries:

• France

International Drug Name Search

Amlodipine-Teva

Amlodipine-Teva may be available in the countries listed below.

Ingredient matches for Amlodipine-Teva

Amlodipine

Amlodipine besilate (a derivative of Amlodipine) is reported as an ingredient of Amlodipine-Teva in the following countries:

• France


• Sweden

Amlodipine maleate (a derivative of Amlodipine) is reported as an ingredient of Amlodipine-Teva in the following countries:

• Israel

International Drug Name Search

rabies vaccine, human diploid cell

Generic Name: rabies vaccine, human diploid cell (RAY beez vax EEN, HUE man DYE ploid sel)

Brand Names: Imovax Rabies

What is rabies vaccine?

Rabies is a serious disease caused by a virus. Rabies is mainly a disease of animals. Humans get rabies when they are bitten by an infected animal. There may be no symptoms at first, but weeks or even years after a bite from an infected animal, rabies can cause pain, fatigue, headaches, irritability, fever, seizures, hallucinations, and paralysis. Rabies can be fatal.

You are more likely to be exposed to the rabies virus if you are a veterinarian, animal handler, rabies laboratory worker, or may otherwise come into contact with animals that could possibly carry the virus (including cats, dogs, foxes, skunks, raccoons, bobcats, coyotes, and bats). Travel to certain countries may also increase your risk of exposure to rabies.

Rabies human diploid cell vaccine is used to prevent rabies in people who have been bitten by an animal or otherwise exposed to the rabies virus.

What is the most important information I should know about rabies vaccine?

Keep track of any and all side effects you have after receiving this vaccine. When you receive another vaccine in the future, you will need to tell the doctor if the first shot caused any side effects. Getting rabies disease is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects. The risk of serious side effects is extremely low.

You can still receive a rabies vaccine if you have a cold or other minor illness. If you have a more severe illness with a fever, wait until you recover before receiving this vaccine. However, if you have been bitten by an infected animal or otherwise exposed to the rabies virus, you should receive the rabies vaccine regardless of having another illness.

What should I discuss with my healthcare provider before receiving rabies vaccine?

Do not receive this vaccine if you have ever had an allergic reaction to a rabies vaccine.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely receive this vaccine:

• 
  

  any type of infection or severe illness;

  
  


• 
  

  human immunodeficiency virus (HIV) infection;

  
  


• 
  

  a weak immune system caused by disease or by taking certain medicines or receiving cancer treatments; or

  
  


• 
  

  if you are taking medicine to treat or prevent malaria.

  
  

You can still receive a rabies vaccine if you have a cold or other minor illness. If you have a more severe illness with a fever, wait until you recover before receiving this vaccine. However, if you have been bitten by an infected animal or otherwise exposed to the rabies virus, you should receive the rabies vaccine regardless of having another illness.

FDA pregnancy category C. It is not known whether this vaccine is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether rabies vaccine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is rabies vaccine given?

Rabies human diploid cell vaccine is given as an injection into a muscle. You will receive this injection in your doctor's office or other clinic setting. A doctor, nurse, or other healthcare provider will give you this injection.

For preventing rabies if you are at risk of exposure, you will need to receive a total of 3 injections. The second injection is usually given 7 days after the first, followed by a third injection 2 or 3 weeks later.

Depending on your risk of exposure to rabies, you may need to receive the rabies vaccine series every 2 years. If you work around live rabies virus, such as in a laboratory or a vaccine production area, you may need to receive a booster rabies vaccine every 6 months.

For treating rabies after you have been bitten or exposed, you will need to receive a total of 6 injections. The injections are usually given on Days 0, 3, 7, 14, 30, and 90. At the beginning of your treatment you may also receive a second injection with a rabies anti-serum or immune globulin (im-YOON GLOB-yoo-lin). This medicine is sometimes injected into or near the bite wound or injury where the rabies virus is likely to have entered your body.

Follow your doctor's instructions for your injection schedule.

What happens if I miss a dose?

Contact your doctor if you miss an appointment to receive your rabies vaccine.

What happens if I overdose?

An overdose of rabies vaccine is unlikely to occur.

What should I avoid before or after getting rabies vaccine?

There are no restrictions on food, beverages, or activity before or after receiving rabies vaccine.

Rabies vaccine side effects

Keep track of any and all side effects you have after receiving this vaccine. When you receive another vaccine in the future, you will need to tell the doctor if the first shot caused any side effects. Getting rabies disease is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects. The risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• 
  

  fever, chills, weakness, body aches, flu symptoms;

  
  


• 
  

  joint pain; or

  
  


• 
  

  vomiting.

  
  

Less serious side effects are more likely to occur, such as:

• 
  

  pain, swelling, itching, or redness where the shot was given;

  
  


• 
  

  headache;

  
  


• 
  

  dizziness;

  
  


• 
  

  muscle pain; or

  
  


• 
  

  nausea, stomach pain.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Rabies vaccine, human diploid cell Dosing Information

Usual Adult Dose for Rabies Prophylaxis:

Preexposure Prophylaxis:
1 mL IM for a total of 3 doses on days 0, 7, and 21 or 28.

Postexposure prophylaxis:
Not previously vaccinated:
1 mL IM for a total of 5 doses on days 0, 3, 7, 14, and 28. ( ACIP Provisional Recommendations, 2009,: 1 mL/dose for 4 doses, on days 0, 3, 7, 14 with immunocompromised patients to receive a fifth dose on day 28). Rabies immune globulin should also be administered on day 0 at 20 units/kg (half of this is infiltrated at bite site if possible, and the remainder is administered IM).

Previously vaccinated:
1 mL IM for a total of 2 doses on days 0 and 3. Do not administer rabies immune globulin.

Booster:
1 mL IM every 2 years or as indicated by antibody titers. People with continuing high risk of exposure such as certain veterinarians, should have their serum tested for rabies antibodies every 2 years; others working with live rabies in laboratories or vaccine production facilities and who are at risk of inapparent exposure should be tested every 6 months.

Usual Pediatric Dose for Rabies Prophylaxis:

Preexposure Prophylaxis:
1 mL IM for a total of 3 doses on days 0, 7, and 21 or 28.

Postexposure prophylaxis:
Not previously vaccinated:
1 mL IM for a total of 5 doses on days 0, 3, 7, 14, and 28. ( ACIP Provisional Recommendations, 2009,: 1 mL/dose for 4 doses, on days 0, 3, 7, 14 with immunocompromised patients to receive a fifth dose on day 28). Rabies immune globulin should also be administered on day 0 at 20 units/kg (half of this is infiltrated at bite site if possible, and the remainder is administered IM).

Previously vaccinated:
1 mL IM for a total of 2 doses on days 0 and 3. Do not administer rabies immune globulin.

Booster:
1 mL IM every 2 years or as indicated by antibody titers. People with continuing high risk of exposure such as certain veterinarians, should have their serum tested for rabies antibodies every 2 years; others working with live rabies in laboratories or vaccine production facilities and who are at risk of inapparent exposure should be tested every 6 months.

What other drugs will affect rabies vaccine?

Before receiving this vaccine, tell your doctor if you are using any of the following drugs:

• 
  

  chemotherapy or radiation cancer treatments;

  
  


• 
  

  cyclosporine (Neoral, Sandimmune, Gengraf);

  
  


• 
  

  sirolimus (Rapamune), tacrolimus (Prograf);

  
  


• 
  

  basiliximab (Simulect), efalizumab (Raptiva), muromonab-CD3 (Orthoclone);

  
  


• 
  

  mycophenolate mofetil (CellCept);

  
  


• 
  

  azathioprine (Imuran), leflunomide (Arava), etanercept (Enbrel);

  
  


• 
  

  a steroid medicine such as betamethasone (Celestone), cortisone (Cortone), dexamethasone (Decadron, Dexone), hydrocortisone (Cortef, Hydrocortone), methylprednisolone (Medrol), prednisolone (Prelone, Pediapred), prednisone (Orasone, Deltasone, others), or triamcinolone (Aristocort); or

  
  


• 
  

  an inhaled or nasal steroid such as beclomethasone (Qvar, Beclovent, Beconase, Vanceril, Vancenase), budesonide (Pulmicort, Rhinocort), flunisolide (Aerobid, Nasalide, Nasarel), fluticasone (Flovent, Flonase), mometasone (Nasonex), or triamcinolone (Azmacort, Nasacort).

  
  

If you are using any of these drugs, you may not be able to receive rabies vaccine, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect rabies vaccine. Tell your doctor about all the prescription and over-the-counter medications you use, and other vaccines you receive. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More rabies vaccine, human diploid cell resources

• Rabies vaccine, human diploid cell Side Effects (in more detail)
• Rabies vaccine, human diploid cell Use in Pregnancy & Breastfeeding
• Rabies vaccine, human diploid cell Drug Interactions
• Rabies vaccine, human diploid cell Support Group
• 0 Reviews for Rabies vaccine, human diploid cell - Add your own review/rating

• Imovax Rabies Advanced Consumer (Micromedex) - Includes Dosage Information


• Rabies Vaccine Monograph (AHFS DI)

Compare rabies vaccine, human diploid cell with other medications

• Rabies Prophylaxis

Where can I get more information?

• Your doctor or pharmacist may have additional information about rabies vaccine. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.

See also: rabies vaccine, human diploid cell side effects (in more detail)

hydralazine and isosorbide dinitrate

Generic Name: hydralazine and isosorbide dinitrate (hi dral LA zeen and I so zor bi da din eye treyt)

Brand Names: BiDil

What is hydralazine and isosorbide dinitrate?

Hydralazine is a vasodilator. It relaxes (widens) veins and arteries, which makes it easier for your heart to pump.

Isosorbide dinitrate is in a class of drugs called nitrates. Isosorbide dinitrate dilates (widens or relaxes) blood vessels (arteries and veins). When blood vessels are dilated, it is easier for the heart to pump. Also, more blood, which is rich in oxygen, can flow to the heart.

Hydralazine and isosorbide dinitrate is used to treat heart failure.

Hydralazine and isosorbide dinitrate may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about hydralazine and isosorbide dinitrate?

You may develop a headache because of this medicine, but do not stop taking it. Take aspirin or acetaminophen to treat the headache. Ask your doctor which is best for you. This side effect usually goes away with continued hydralazine and isosorbide dinitrate treatment.

Do not stop taking hydralazine and isosorbide dinitrate suddenly. Talk to your doctor before you stop taking the drug completely. Do not drink alcohol while taking this medication. Use caution when driving, operating machinery, or performing other hazardous activities. Hydralazine and isosorbide dinitrate may cause dizziness. If you experience dizziness, avoid these activities.

What should I discuss with my healthcare provider before taking hydralazine and isosorbide dinitrate?

Before taking this medication, tell your doctor if you

• 
  

  have low blood pressure;

  
  


• 
  

  have had a stroke, a transient ischemic attack (TIA, or mini-stroke), or a serious head injury;

  
  


• 
  

  have anemia;

  
  


• 
  

  have an allergy to nitrates;

  
  


• 
  

  have closed-angle glaucoma;

  
  


• 
  

  suffer from migraines;

  
  


• 
  

  have systemic lupus erythematosus;

  
  


• 
  

  have high levels of cholesterol or triglycerides (types of fat) in your blood;

  
  


• 
  

  have pulmonary hypertension;

  
  


• have kidney disease; or


• have liver disease.

You may not be able to take hydralazine and isosorbide dinitrate, or you may require a dosage adjustment or special monitoring during therapy.

Hydralazine and isosorbide dinitrate is in the FDA pregnancy category C. This means that it is not known whether hydralazine and isosorbide dinitrate will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. It is also not known whether hydralazine or isosorbide dinitrate pass into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 60 years of age, you may be more likely to experience dizziness from hydralazine. You may require a lower dose or special monitoring during therapy.

How should I take hydralazine and isosorbide dinitrate?

Take hydralazine and isosorbide dinitrate exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Do not stop taking hydralazine and isosorbide dinitrate suddenly. Talk to your doctor before you stop taking the drug completely. Store this medication at room temperature away from moisture and heat.

See also: Hydralazine and isosorbide dinitrate dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If your next regularly scheduled dose is within 2 hours, skip the dose you missed and take only the next dose. Do Not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of an hydralazine and isosorbide dinitrate overdose include a severe throbbing headache, difficult or slow breathing, muscle cramps, nausea, vomiting, diarrhea, fever, dizziness, fainting, an irregular or slow heart beat, changes in vision, confusion, flushing, and seizures.

What should I avoid while taking hydralazine and isosorbide dinitrate?

Use caution when driving, operating machinery, or performing other hazardous activities. Hydralazine and isosorbide dinitrate may cause dizziness. If you experience dizziness, avoid these activities. Also, stand up slowly from a lying or sitting position. Avoid alcohol. Alcohol also widens your blood vessels, and it can cause very low blood pressure, dizziness, and drowsiness. If you consume alcohol, you could endanger yourself or others. Do not stop taking hydralazine and isosorbide dinitrate suddenly. Talk to your doctor before you stop taking the drug completely.

Hydralazine and isosorbide dinitrate side effects

If you experience any of the following serious side effects, stop taking hydralazine and isosorbide dinitrate and seek emergency medical attention:

• 
  

  an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

  
  


• 
  

  blurred vision and dry mouth;

  
  


• 
  

  irregular heartbeat; or

  
  


• 
  

  blood in your urine or stools;

  
  


• 
  

  numbness, tingling, pain, or weakness of your arms or legs;

  
  


• 
  

  fainting.

  
  

Other, less serious side effects may be more likely to occur. If you experience any of the following side effects, continue to take isosorbide and talk to your doctor:

• 
  

  headache or dizziness;

  
  


• 
  

  flushing (redness of the face, neck and chest);

  
  


• 
  

  nausea or vomiting;

  
  


• 
  

  fast heartbeat;

  
  


• 
  

  swollen ankles; or

  
  


• 
  

  weakness.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Hydralazine and isosorbide dinitrate Dosing Information

Usual Adult Dose for Congestive Heart Failure:

Initial: 1 tablet (37.5 mg-20 mg) orally three times a day.

The initial dose may be titrated to a maximum tolerated dose not to exceed two tablets three times a day. Although titration can be rapid (3 to 5 days), some patients experience side effects and may take longer to reach their maximum tolerated dose.

What other drugs will affect hydralazine and isosorbide dinitrate?

Do not use sildenafil (Viagra, Revatio), vardenafil (Levitra), or tadalafil (Cialis) while taking hydralazine and isosorbide dinitrate. The combination could cause severe or life-threatening low blood pressure.

Before taking hydralazine and isosorbide dinitrate, tell your doctor if you are taking any of the following medicines:

• 
  

  dihydroergotamine (D.H.E. 45); or

  
  


• 
  

  any other heart medicines, especially those used to treat high blood pressure or irregular heartbeats.

  
  

You may require a dosage adjustment or special monitoring during your treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with hydralazine and isosorbide dinitrate or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More hydralazine and isosorbide dinitrate resources

• Hydralazine and isosorbide dinitrate Dosage
• Hydralazine and isosorbide dinitrate Use in Pregnancy & Breastfeeding
• Hydralazine and isosorbide dinitrate Drug Interactions
• Hydralazine and isosorbide dinitrate Support Group
• 0 Reviews for Hydralazine and isosorbide dinitrate - Add your own review/rating

Compare hydralazine and isosorbide dinitrate with other medications

• Heart Failure

Where can I get more information?

• Your pharmacist has additional information about hydralazine and isosorbide dinitrate written for health professionals that you may read.

Hydro-PC II

Generic Name: chlorpheniramine, hydrocodone, and phenylephrine (KLOR fe NEER a meen, HYE droe KOE done, FEN il EFF rin)

Brand Names: B-Tuss, Coughtuss, Cytuss HC, De-Chlor HC, DroTuss-CP, Ed-TLC, Ed-Tuss HC, Endal-HD Plus, H-C Tussive, Histussin-HC, Hydro-PC II, Hydro-PC II Plus, Hydron CP, Liquicough HC, Maxi-Tuss HCX, Mintuss MS, Neo HC, Poly-Tussin, Poly-Tussin HD, Relacon-HC, Relacon-HC NR, Relasin-HC, Rindal HD Plus, Rindal-HD, Triant-HC, Tusana-D, Z-Cof HC

What is Hydro-PC II (chlorpheniramine, hydrocodone, and phenylephrine)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Hydrocodone is a narcotic cough medicine.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of chlorpheniramine, hydrocodone, and phenylephrine is used to treat runny or stuffy nose, sinus congestion, and cough caused by the common cold or flu.

Chlorpheniramine, hydrocodone, and phenylephrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Hydro-PC II (chlorpheniramine, hydrocodone, and phenylephrine)?

Do not take this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use chlorpheniramine, hydrocodone, and phenylephrine before the MAO inhibitor has cleared from your body. Chlorpheniramine, hydrocodone, and phenylephrine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine, hydrocodone, and phenylephrine. Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine, hydrocodone, and phenylephrine. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Never share hydrocodone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

What should I discuss with my healthcare provider before taking Hydro-PC II (chlorpheniramine, hydrocodone, and phenylephrine)?

Do not take this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use chlorpheniramine, hydrocodone, and phenylephrine before the MAO inhibitor has cleared from your body. You should not use chlorpheniramine, hydrocodone, and phenylephrine if you are allergic to it.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

• 
  

  asthma, COPD, sleep apnea, or other breathing disorder;

  
  


• liver or kidney disease;


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  diabetes;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  curvature of the spine;

  
  


• 
  

  a history of head injury or brain tumor;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  low blood pressure;

  
  


• 
  

  glaucoma;

  
  


• 
  

  gallbladder disease;

  
  


• 
  

  Addison's disease or other adrenal gland disorders;

  
  


• 
  

  enlarged prostate, urination problems;

  
  


• 
  

  mental illness; or

  
  


• 
  

  a history of drug or alcohol addiction.

  
  

Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Never share hydrocodone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. FDA pregnancy category C. It is not known whether chlorpheniramine, hydrocodone, and phenylephrine will harm an unborn baby. Hydrocodone may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using chlorpheniramine, hydrocodone, and phenylephrine. It is not known whether chlorpheniramine, hydrocodone, and phenylephrine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Hydro-PC II (chlorpheniramine, hydrocodone, and phenylephrine)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

You may take this medication with or without food.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Store at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Hydrocodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of hydrocodone can be fatal.

Overdose symptoms may include extreme drowsiness, feeling restless or nervous, vomiting, stomach pain, warmth or tingly feeling, seizure (convulsions), pinpoint pupils, confusion, cold and clammy skin, weak pulse, shallow breathing, fainting, or breathing that stops.

What should I avoid while taking Hydro-PC II (chlorpheniramine, hydrocodone, and phenylephrine)?

Chlorpheniramine, hydrocodone, and phenylephrine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine, hydrocodone, and phenylephrine.

Hydro-PC II (chlorpheniramine, hydrocodone, and phenylephrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  fast, pounding, or uneven heartbeats;

  
  


• 
  

  shallow breathing, slow heartbeat;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, chest pain, shortness of breath, seizure); or

  
  


• 
  

  upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  nausea, vomiting, upset stomach, constipation;

  
  


• 
  

  dry mouth;

  
  


• 
  

  blurred vision;

  
  


• 
  

  dizziness, drowsiness;

  
  


• 
  

  problems with memory or concentration;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  ringing in your ears;

  
  


• 
  

  warmth, tingling, or redness under your skin; or

  
  


• 
  

  skin rash or itching.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Hydro-PC II (chlorpheniramine, hydrocodone, and phenylephrine)?

Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine, hydrocodone, and phenylephrine.

Tell your doctor about all other medications you use, especially:

• 
  

  blood pressure medication;

  
  


• 
  

  cimetidine (Tagamet);

  
  


• 
  

  rifampin (Rifadin, Rifater, Rifamate, Rimactane);

  
  


• 
  

  zidovudine (Retrovir, AZT);

  
  


• 
  

  an antidepressant;

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  medication to treat irritable bowel syndrome;

  
  


• 
  

  bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

  
  


• 
  

  aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);

  
  


• 
  

  seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or

  
  


• 
  

  medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), pimozide (Orap), or thioridazine (Mellaril).

  
  

This list is not complete and other drugs may interact with chlorpheniramine, hydrocodone, and phenylephrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Hydro-PC II resources

• Hydro-PC II Side Effects (in more detail)
• Hydro-PC II Use in Pregnancy & Breastfeeding
• Hydro-PC II Drug Interactions
• Hydro-PC II Support Group
• 0 Reviews for Hydro-PC II - Add your own review/rating

• Chlorpheniramine/Hydrocodone/Phenylephrine Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Hydro-PC II with other medications

• Cough and Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about chlorpheniramine, hydrocodone, and phenylephrine.

See also: Hydro-PC II side effects (in more detail)

Boots Cold & Flu Max Relief Sachets Blackcurrant Flavour

1. Name Of The Medicinal Product

Paramed Max Strength Cold and Flu Relief Blackcurrant

Boots Cold & Flu Max Relief Sachets Blackcurrant Flavour

Superdrug Max Strength Cold & Flu Relief Sachets Blackcurrant

Asda Max Strength Cold & Flu Relief Sachets Blackcurrant

Tesco Max Strength Cold & Flu Relief Sachets Blackcurrant

2. Qualitative And Quantitative Composition

Each sachet contains; 1000 mg Paracetamol,

Phenylephrine hydrochloride 12.2 mg.

For excipients, see 6.1.

3. Pharmaceutical Form

Powder for oral solution.

Blackcurrant powder.

4. Clinical Particulars

4.1 Therapeutic Indications

For relief of symptoms of colds and influenza, including the relief of headaches, aches and pains, sore throat, nasal congestion and lowering of temperature.

4.2 Posology And Method Of Administration

Adults and elderly: For oral administration after dissolution in water.

Contents of one sachet dissolved in hot water. May be repeated after 4 – 6 hours.

Maximum of 4 sachets in 24 hours.

Children: Not recommended for children under 12 years of age.

4.3 Contraindications

Hypersensitivity to any of the ingredients. Avoid in patients with cardiovascular disease, high blood pressure, diabetes mellitus, closed angle glaucoma, hyperthyroidism, prostatic enlargement and phaeochromocytoma. Patients being treated with monoamine oxidase inhibitors or within 14 days of ceasing such treatment (See section 4.5).

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

This medicine should be used with caution in patients with occlusive vascular disease including Raynaud's Phenomenon.

Do not take for longer than 7 days, unless your doctor agrees.

Contains aspartame (E951) a source of phenylalanine equivalent to 14 mg/dosage unit. May be harmful for people with phenylketonuria. The content of sucrose on a daily basis of four doses is 7.75 g.

(Label) Immediate medical advice should be sought in the event of an overdose, even if you feel well.

(Leaflet) Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

Do not exceed the stated dose. Do not take with other paracetamol containing products. If symptoms persist consult your doctor. Keep out of the sight and reach of children. If you are pregnant or are being prescribed medicine by your doctor, seek his advice before taking this product.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

These interactions are considered to be of unlikely clinical significance in acute use at the dosage regimen proposed.

This medicine may increase the possibility of arrhythmias in digitalised patients. May enhance the cardiovascular effects of other sympathomimetic amines (e.g. decongestants). This medicine should not be taken together with vasodilators, Beta-blockers or enzyme inducers such as alcohol. Drugs which induce hepatic microsomal enzymes, such as barbiturates and tricyclic antidepressants, may increase the hepatotoxicity of paracetamol, particularly after overdosage. Should not be given to patients being treated with monoamine oxidase inhibitors or within 14 days of stopping such treatment.

4.6 Pregnancy And Lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

Phenylephrine hydrochloride: Due to the vasoconstrictive properties of phenylephrine the product should be used with caution in patients with history of pre-eclampsia. Phenylephrine may reduce placental perfusion and the product should be used in pregnancy only if the benefits outweigh this risk. There is no information on use in lactation.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Adverse effects of paracetamol are rare (< 1/1000) but hypersensitivity including skin rash may occur. There have been a few reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.

Adverse effects of phenylephrine hydrochloride include raised blood pressure, tachycardia and occasionally bradycardia, insomnia, restlessness, tremor and anxiety have occasionally occurred, as have urinary retention and hallucinations.

4.9 Overdose

PARACETAMOL

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk factors

If the patient

a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

Or

b, Regularly consumes ethanol in excess of recommended amounts.

Or

c, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

PHENYLEPHRINE HYDROCHLORIDE:

Features of severe overdosage of phenylephrine include haemodynamic changes and cardiovascular collapse with respiratory depression. Treatment includes early gastric lavage and symptomatic and supportive measures. Hypertensive effects may be treated with an IV α-receptor blocking agent.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC N02BG51

Paracetamol: Paracetamol has both analgesic and antipyretic activity which is believed to be mediated principally through its inhibition of prostaglandin synthesis in the central nervous system.

Phenylephrine hydrochloride: Phenylephrine is a post-synaptic α-receptor agonist with low cardioselective β-receptor affinity and minimal central stimulant activity. It is a recognised decongestant and acts by vasoconstriction to reduce oedema and nasal swelling.

5.2 Pharmacokinetic Properties

Paracetamol is absorbed rapidly and completely mainly from the small intestine, producing peak plasma levels after 15- 20 minutes following oral dosing. The systemic availability is subject to first-pass metabolism and varies with dose between 70% and 90%. The drug is rapidly and widely distributed throughout the body and is eliminated from plasma with a half-life of approximately 2 hours. The major metabolites are glucuronide and sulphate conjugates (> 80%) which are excreted in the urine.

Ascorbic acid is readily absorbed from the gastro-intestinal tract and is widely distributed in the body tissues, 25% bound to plasma proteins. Ascorbic acid in excess of the body's needs is eliminated in the urine as metabolites.

Phenylephrine hydrochloride is readily and rapidly absorbed from the gastro-intestinal tract. Presystemic metabolism is high at about 60%, resulting in systemic bioavailability of about 40%. Peak plasma levels occur between 1 and 2 hours and the plasma half-life ranges from 2 – 3 hours. When taken by mouth as a nasal decongestant phenylephrine is usually given at intervals of 4 – 6 hours.

5.3 Preclinical Safety Data

No preclinical findings of relevance have been reported.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sucrose

Sodium Citrate

Citric Acid

Ascorbic Acid

Acesulfame Potassium (E950)

Aspartame (E951)

Blackcurrant Flavour Permaseal S- 133747

Blackcurrant Flavour 1007348

Euroblend Blackcurrant Shade *

* Contains Carmoisine (E122)

Brilliant Blue (E133)

6.2 Incompatibilities

None known.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

This product is packed in laminate sachets comprising paper/polyethylene/aluminium foil/ polyethylene or paper/polyethylene/aluminium foil/Surlyn.

Five or ten sachets are contained in a boxboard carton.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Wrafton Laboratories Limited

Wrafton

Braunton

North Devon

EX33 2DL.

8. Marketing Authorisation Number(S)

PL 12063/0070

9. Date Of First Authorisation/Renewal Of The Authorisation

31^st March 2006

10. Date Of Revision Of The Text

14 July 2010

Aseptochrome

Aseptochrome may be available in the countries listed below.

Ingredient matches for Aseptochrome

Merbromin

Merbromin is reported as an ingredient of Aseptochrome in the following countries:

• Luxembourg

International Drug Name Search

Thioproperazine Mesilate

Thioproperazine Mesilate may be available in the countries listed below.

Ingredient matches for Thioproperazine Mesilate

Thioproperazine

Thioproperazine Mesilate (BANM) is also known as Thioproperazine (Rec.INN)

International Drug Name Search

Glossary

BANM	British Approved Name (Modified)
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Loseca

Loseca may be available in the countries listed below.

Ingredient matches for Loseca

Omeprazole

Omeprazole is reported as an ingredient of Loseca in the following countries:

• Mexico

International Drug Name Search

Edrigard

Edrigard may be available in the countries listed below.

Ingredient matches for Edrigard

Cefpodoxime

Cefpodoxime proxetil (a derivative of Cefpodoxime) is reported as an ingredient of Edrigard in the following countries:

• India

International Drug Name Search

Benlysta

Pronunciation: be-LIM-ue-mab
Generic Name: Belimumab
Brand Name: Benlysta

Benlysta is used for:

Treating certain patients with systemic lupus erythematosus (SLE). It may also be used for other conditions as determined by your doctor.

Benlysta is a B-lymphocyte stimulator (BLyS)-specific inhibitor. Patients with lupus often have high levels of a certain protein in their blood. Benlysta works by limiting the activity of that protein.

Do NOT use Benlysta if:

• you are allergic to any ingredient in Benlysta


• you have severe, active central nervous system lupus


• you have certain severe kidney problems associated with lupus (severe, active lupus nephritis)


• you are using another biologic medicine (eg, etanercept, infliximab, immune globulin)


• you are receiving cyclophosphamide as an injection into your vein (intravenous [IV])

Contact your doctor or health care provider right away if any of these apply to you.

Before using Benlysta:

Some medical conditions may interact with Benlysta. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of a long-term infection, an infection that keeps coming back, tuberculosis (TB) infection or a positive TB skin test, or hepatitis B infection


• if you have an infection, open cuts or sores on your body, flu-like symptoms or other signs of infection (eg, fever; chills; cough; warm, red, or painful skin), or are using medicine to treat an infection


• if you have a history of cancer or heart problems


• if you have a history of mental or mood problems (eg, depression), or suicidal thoughts or actions


• if you have recently received a vaccine or are scheduled to receive a vaccine

Some MEDICINES MAY INTERACT with Benlysta. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Other biologic medicines (eg, etanercept, infliximab, immune globulin), IV cyclophosphamide, or monoclonal antibodies (eg, certolizumab, denosumab) because the risk of their side effects may be increased by Benlysta

This may not be a complete list of all interactions that may occur. Ask your health care provider if Benlysta may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Benlysta:

Use Benlysta as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Benlysta comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Benlysta refilled.


• Benlysta is usually given as an injection into the vein at your doctor's office, hospital, or clinic.


• You may receive another medicine before each treatment with Benlysta to decrease the chance of an allergic reaction. Discuss any questions with your doctor.


• Do not use Benlysta if it contains particles, is cloudy or discolored, or if the syringe or pen is cracked or damaged.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Benlysta, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Benlysta.

Important safety information:

• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Benlysta may lower the ability of your body to fight infection and may increase the risk of severe or fatal infection. Avoid contact with people who have colds, flu, shingles, or other infections. Tell your doctor right away if you notice signs of infection like fever, sore throat, rash, or chills.


• Treatment with medicines similar to Benlysta may increase in the risk of developing cancer. It is possible that treatment with Benlysta may also increase this risk. Discuss any questions or concerns with your doctor.


• Some patients using Benlysta reported mental or mood changes (eg, anxiety, depression) and suicidal thoughts or actions. The majority of these patients had a history of depression or other serious mental or mood problems. It is unknown if Benlysta is associated with an increased risk of these events. Tell your doctor right away if you develop anxiety, depression, severe or persistent trouble sleeping, suicidal thoughts or actions, or any other mental or mood changes.


• Tell your doctor or dentist that you take Benlysta before you receive any medical or dental care, emergency care, or surgery.


• Do not receive a live vaccine (eg, measles, mumps) while you are using Benlysta or for 30 days before you begin using it. Talk with your doctor before you receive any vaccine.


• Benlysta may not work as well in black patients. Contact your doctor if your symptoms do not improve or if they become worse.


• Women who may become pregnant should use effective birth control while using Benlysta and for 4 months after the last treatment. Check with your doctor if you have questions about effective birth control.


• Benlysta should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Benlysta while you are pregnant. It is not known if Benlysta is found in breast milk. Do not breast-feed while using Benlysta.

Possible side effects of Benlysta:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; nausea; pain in the arm or leg; sinus inflammation; stomach pain; stuffy or runny nose; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; wheezing; unusual hoarseness); fainting; mental or mood changes (eg, anxiety, depression); muscle pain or weakness; severe or persistent headache or dizziness; severe or persistent trouble sleeping; suicidal thoughts or actions; symptoms of heart problems (eg, chest pain or discomfort, shortness of breath, slow heartbeat, dizziness, cold sweats); symptoms of infection (eg, fever, chills, or persistent sore throat; persistent cough; flu-like symptoms; warm, red, or painful skin; open sore that does not heal; increased or painful urination).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Benlysta side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Benlysta:

Benlysta is usually handled and stored by a health care provider. If you are using Benlysta at home, store Benlysta as directed by your pharmacist or health care provider. Keep Benlysta out of the reach of children and away from pets.

General information:

• If you have any questions about Benlysta, please talk with your doctor, pharmacist, or other health care provider.


• Benlysta is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Benlysta. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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Calpol Sugar Free Infant Suspension (100ml GSL bottle)

1. Name Of The Medicinal Product

CALPOL Sugar Free Infant Suspension

2. Qualitative And Quantitative Composition

CALPOL Sugar Free Infant Suspension contains 120 mg Paracetamol in each 5 ml.

Excipients: maltitol liquid (E965), sorbitol liquid (E420), methyl parahydroxybenzoate (E218), ethyl parahydroxybenzoate (E214), propyl parahydroxybenzoate (E216) and carmoisine (E122). See section 4.4 for further information.

For full list of excipients, see section 6.1.

3. Pharmaceutical Form

Oral Suspension.

A pink strawberry flavoured suspension.

4. Clinical Particulars

4.1 Therapeutic Indications

CALPOL Sugar Free Infant Suspension is indicated for the treatment of mild to moderate pain and as an antipyretic. It can be used in many conditions including headache, toothache, earache, teething, sore throat, colds & influenza, aches and pains and post-immunisation fever.

4.2 Posology And Method Of Administration

Age : 2 – 3 months	Dose
1. Post-vaccination fever	2.5 ml (small end of spoon) If necessary, after 4-6 hours, give a second 2.5 ml dose
2. Other causes of Pain and Fever - if your baby weighs over 4 kg and was born after 37 weeks
• Do not give to babies less than 2 months of age. • Do not give more than 2 doses. • Leave at least 4 hours between doses. • If further doses are needed, talk to your doctor or pharmacist.

Children aged 3 months- 6 years:

Child's Age	How Much	How often (in 24 hours)
3 – 6 months	One 2.5 ml spoonful (small end)	4 times
6 – 24 months	One 5 ml spoonful (large end)	4 times
2 – 4 years	One 5 ml spoonful (large end) and one 2.5 ml spoonful (small end)	4 times
4 – 6 years	Two 5 ml spoonfuls (large end)	4 times
• Do not give more than 4 doses in any 24 hour period • Leave at least 4 hours between doses • Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist

It is important to shake the bottle for at least 10 seconds before use.

The Elderly:

In the elderly, the rate and extent of paracetamol absorption is normal but plasma half-life is longer and paracetamol clearance is lower than in young adults.

4.3 Contraindications

CALPOL Sugar Free Infant suspension is contra-indicated in patients with known hypersensitivity to paracetamol, or any of the other components.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with severe renal impairment or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Concomitant use of other paracetamol-containing products should be avoided.

Due to the presence of maltitol liquid (E965) and sorbitol liquid (E420), patients with rare hereditary problems of fructose intolerance should not take this medicine.

Ethyl (E214), Propyl (E216) and Methyl (E218) parahydroxybenzoate may cause allergic reactions (possibly delayed).

Carmoisine (E122) may cause allergic reactions.

The label contains the following statements:

Contains paracetamol.

Do not give this medicine with any other paracetamol containing products.

For oral use only

Never give more medicine than shown in the table.

Do not overfill the spoon.

Always use the spoon supplied with the pack.

Do not give to babies less than 2 months of age.

For infants 2-3 months no more than 2 doses should be given.

Do not give more than 4 doses in any 24 hour period.

Leave at least 4 hours between doses.

Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist

As with all medicines, if your child is currently taking any other medicine consult your doctor or pharmacist before using this product.

Keep out of the reach and sight of children.

Do not store above 25°C. Keep bottle in the outer carton

Shake the bottle for at least 10 seconds before use.

Do not exceed the stated dose.

If symptoms persist consult your doctor.

Immediate medical advice should be sought in the event of an overdose, even if the child seems well. (label)

Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage. (leaflet)

Talk to your doctor: If your child has an inherited intolerance to fructose or been diagnosed with an intolerance to some other sugars. (leaflet)

The sorbitol (E420) and maltitol (E965) content of this product means that this product is unsuitable for people with inherited intolerance to fructose. (leaflet)

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Chronic alcohol intake can increase the hepatotoxicity of paracetamol overdose and may have contributed to the acute pancreatitis reported in one patient who had taken an overdose of paracetamol. Acute alcohol intake may diminish an individual's ability to metabolise large doses of paracetamol, the plasma half-life of which can be prolonged.

The use of drugs that induce hepatic microsomal enzymes, such as anticonvulsants and oral contraceptives, may increase the extent of metabolism of paracetamol, resulting in reduced plasma concentrations of the drug and a faster elimination rate.

4.6 Pregnancy And Lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of the doctor regarding its use.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Adverse effects of paracetamol are rare. Very rarely hypersensitivity and anaphylatic reactions including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.

Most reports of adverse reactions to paracetamol relate to overdose with the drug.

Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year and liver damage has been reported after daily ingestion of excessive amounts for shorter periods. A review of a group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those who were long-term users of paracetamol nor was the control of their disease improved after paracetamol withdrawal.

Nephrotoxicity following therapeutic doses of paracetamol is uncommon, but papillary necrosis has been reported after prolonged administration.

4.9 Overdose

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below)

Risk Factors:

If the patient

a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes

OR

b) Regularly consumes ethanol in excess of recommended amounts

OR

c) Is likely to be glutathione deplete e.g, eating disorders, cystic fibrosis, HIV infection, starvation, cachexia

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia,and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of the overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentrations should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patient who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol has analgesic and antipyretic effects similar to those of aspirin and is useful in the treatment of mild to moderate pain. It has only weak anti-inflammatory effects.

5.2 Pharmacokinetic Properties

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are reached 30-90 minutes post dose and the plasma half-life is in the range of 1 to 3 hours after therapeutic doses. Drug is widely distributed throughout most body fluids. Following therapeutic doses 90-100% of the drug is recovered in the urine within 24 hours almost entirely following hepatic conjugation with glucuronic acid (about 60%), sulphuric acid (about 35%) or cysteine (about 3%). Small amounts of hydroxylated and deacetylated metabolites have also been detected. Children have less capacity for glucuronidation of the drug than do adults. In overdosage there is increased N-hydroxylation followed by glutathione conjugation. When the latter is exhausted, reaction with hepatic proteins is increased leading to necrosis.

5.3 Preclinical Safety Data

Mutagenicity

There are no studies relating to the mutagenic potential of Calpol Sugar Free Infant Suspension Sachets.

In vivo mutagenicity tests of paracetamol in mammals are limited and show conflicting results. Therefore, there is insufficient information to determine whether paracetamol poses a mutagenic risk to man.

Paracetamol has been found to be non-mutagenic in bacterial mutagenicity assays, although a clear clastogenic effect has been observed in mammalian cells in vitro following exposure to paracetamol (3 and 10 mM for 2h).

Carcinogenicity

There are no studies to the carcinogenic potential of Calpol Sugar Free Infant Suspension Sachets.

There is inadequate evidence to determine the carcinogenic potential of paracetamol in humans. A positive association between the use of paracetamol and cancer of the ureter (but not of other sites in the urinary tract) was observed in a case-control study in which approximate lifetime consumption of paracetamol (whether acute or chronic) was estimated. However, other similar studies have failed to demonstrate a statistically significant association between paracetamol and cancer of the urinary tract, or paracetamol and renal cell carcinoma.

There is limited evidence for the carcinogenicity of paracetamol in experimental animals. Liver cell tumours can be detected in rats following chronic feeding of 500 mg/kg/day paracetamol.

Teratogenicity

There is no information relating to the teratogenic potential of Calpol Sugar Free Infant Suspension Sachets. In humans, paracetamol crosses the placenta and attains concentrations in the foetal circulation similar to those in the maternal circulation. Intermittent maternal ingestion of therapeutic doses of paracetamol are not associated with teratogenic effects in humans.

Paracetamol has been found to be foetotoxic to cultured rat embryo.

Fertility

There is no information relating to the effects of Calpol Sugar Free Infant Suspension Sachets on fertility. A significant decrease in testicular weight was observed when male Sprague-Dawley rats were given daily high doses of paracetamol (500 mg/kg/body weight/day) orally for 70 days.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Maltitol liquid

Sorbitol liquid (non crystallising) (E420)

Glycerol

Dispersible cellulose

Xanthan gum

Ethyl parahydroxybenzoate (E214)

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Polysorbate 80

Strawberry flavour

Carmoisine (E122)

Purified water

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Do not store above 25°C. Keep bottle in the outer carton.

6.5 Nature And Contents Of Container

Amber glass bottle with a two-piece plastic child resistant, tamper evident closure fitted with a polyethylene or polyvinylidene chloride (PVDC) laminate faced wad.

or

Amber glass bottle with a three-piece plastic child resistant, tamper evident closure fitted with a polyethylene or polyvinylidene chloride (PVDC) laminate faced wad.

Pack sizes

70ml and 100ml. A spoon with a 5 ml and 2.5 ml measure is supplied with this pack.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

UK

8. Marketing Authorisation Number(S)

PL 15513/0123

9. Date Of First Authorisation/Renewal Of The Authorisation

3^rd June 2005/ 25 February 2009

10. Date Of Revision Of The Text

6^th June 2011

LEGAL STATUS

GSL for bottles of 100ml or less