Bavir Oral 20 mg Oral Solution

BAVIR is an antiretroviral medicine. It belongs to a group called nucleoside reverse transcriptase inhibitors (NRTIs). BAVIR is a prescription medicine used in combination with other medicines to treat adults and children who are infected with HIV (the human immunodeficiency virus), the virus that causes AIDS. BAVIR reduces the growth of HIV, which helps your body maintain its supply of CD4 cells, which are important for fighting HIV and other infections. BAVIR will not cure your HIV infection, and does not prevent a patient infected with HIV from passing the virus to other people.

Do not take BAVIR TABLETS:

• If you are hypersensitive (allergic) to abacavir or any of the other ingredients of BAVIR.
• If you have liver disease.
• If you are pregnant or breast-feeding.
• BAVIR must not be given to infants under 3 months of age.

Warnings and precautions

Take special care with BAVIR:

HYPERSENSITIVITY REACTION (SERIOUS ALLERGIC REACTION): About 4% of patients, who are treated with abacavir, develop a hypersensitivity reaction. The most common symptoms of this reaction are high temperature (fever) and a skin rash. Other frequently observed signs are nausea, vomiting, diarrhoea, abdominal pain and severe tiredness. Other symptoms may include joint or muscle pain, swelling of the neck, shortness of breath, sore throat, cough and headache. Inflammation of the eye (conjunctivitis), mouth ulcers or low blood pressure may occur. The symptoms of this allergic reaction can occur at any time during treatment with abacavir. However they usually occur in the first six weeks of treatment. The symptoms worsen with continued treatment and may be life-threatening if treatment is continued.

CONTACT YOUR DOCTOR IMMEDIATELY for advice on whether you should stop taking BAVIR if:

1. you get a skin rash OR
2. you get one or more symptoms from at least TWO of the following groups:

• fever
• shortness of breath, sore throat or cough
• nausea or vomiting or diarrhoea or abdominal pain
• severe tiredness or achiness or generally feeling ill

If you have discontinued BAVIR due to a hypersensitivity (allergic) reaction, YOU MUST NEVER TAKE BAVIR, or any other medicine containing abacavir again as you may experience a life-threatening lowering of your blood pressure or death. If you stop taking BAVIR for any other reason, do not start taking it again without first talking to your doctor. If you are hypersensitive (allergic) to abacavir you should return all your unused BAVIR for disposal. Ask your doctor or pharmacist for advice.

Do not share medicines prescribed for you with any other person. Always take BAVIR exactly as your doctor has instructed you. Your doctor will tell you how long your treatment with BAVIR will last. You should check with your doctor or pharmacist if you are unsure.

The usual daily dose of BAVIR in adults and adolescents over 12 years of age is one tablet of 300 mg or 15 mL of oral solution twice a day.

In children three months to 12 years of age the dose given depends on the body weight of your child. The recommended dose is 8 mg/kg twice a day up to a maximum of 600 mg daily.

Use the oral dosing syringe supplied with the oral solution pack to measure the dose accurately.

If you take more BAVIR than you should: Seek emergency medical attention if you think you have used too much of this medicine. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take BAVIR: If you forget to take a dose, take it as soon as you remember, and then continue as before. Do not take a double dose to make up for forgotten individual doses.

BAVIR can have side effects. If any of the following happens, stop taking BAVIR and tell your doctor immediately or go to the casualty department at your nearest hospital:

• You develop a skin rash OR
• You get one or more symptoms from at least TWO of the following groups:

• Fever (high temperature),
• Shortness of breath, sore throat or cough,
• Nausea, vomiting, diarrhoea or abdominal pain,
• Severe tiredness, achiness or generally feeling ill.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to BAVIR. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Lactic acidosis (severe increase of lactic acid in the blood) - nausea, vomiting, abdominal pain, shortness of breath, feeling very weak and tired, or weight loss.
• Severe liver enlargement.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Loss of appetite,
• Raised sugar in the blood,
• Increased fats in the blood,
• Headache,
• Diarrhoea,
• Nausea,
• Vomiting,
• Skin rash (without any other illness),
• Serious skin reactions,
• Lethargy,
• Fatigue,
• Fever,
• Inflammation of the pancreas,
• Joint or muscle pain,
• Swelling of the neck,
• Inflammation of the eye (conjunctivitis),
• Mouth ulcers,
• Low blood pressure.

Tell your doctor if any of the above side effects are severe, bothersome, do not go away or about any concerns you have while taking BAVIR. Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of BAVIR.

BAVIR TABLETS 300 mg: Store at or below 30 ºC. KEEP OUT OF REACH OF CHILDREN.

BAVIR ORAL SOLUTION 20 mg/ml: Store at or below 30 ºC. Keep well closed. Discard oral solution two months after first opening. KEEP OUT OF REACH OF CHILDREN. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).