Vexabax Film-Coated Tablets

VEXABAX contains both abacavir and lamivudine. VEXABAX belongs to a group of antiretroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs) and is used in combination with other antiretrovirals to treat Human Immunodeficiency Virus (HIV) infection in adults and adolescents from 12 years of age, weighing at least 40 kg. VEXABAX reduces HIV viral load and keeps it at a low level. It also increases CD4 cell counts. Response to treatment with VEXABAX varies between patients. Your doctor will be monitoring the effectiveness of your treatment.

Do not take VEXABAX:

• if you are allergic to the active substances abacavir, lamivudine or any of the other ingredients in VEXABAX.
• if you have serious liver disease, VEXABAX may not be suitable for you.
• if you are pregnant, intend to become pregnant or if you are breastfeeding your baby. If you are not sure whether you should be taking VEXABAX, please discuss with your doctor before taking this medicine.

Warnings and precautions:

Take special care with VEXABAX:

Hypersensitivity reaction (serious allergic reaction): VEXABAX contains abacavir. Abacavir can cause a serious allergic reaction known as a hypersensitivity reaction, which can be life-threatening if treatment with abacavir containing products is not stopped.

Who gets these reactions? Anyone taking VEXABAX could develop a hypersensitivity reaction to abacavir, which could be life-threatening if they continue to take VEXABAX. Research has found that people with a gene called HLA-B (type 5701) are more likely to have a hypersensitivity reaction to abacavir. However, even if you do not have this gene type it is still possible for you to get this reaction. If you know you have this gene type, be sure to tell your doctor before you take abacavir.

What are the symptoms? The most common symptoms of this reaction are:

• high temperature (fever) and a skin rash.
• Other frequently observed signs or symptoms include:
• nausea (feeling sick), vomiting (being sick), diarrhoea, abdominal (stomach) pain, shortness of breath, cough, headache and severe tiredness.
• Other symptoms may include:
• joint or muscle pain, discomfort, swelling of the neck, serious breathing problems and sore throat. Occasionally inflammation of the eye (conjunctivitis), ulcers in the mouth, low blood pressure or tingling or numbness of the hands or feet may occur.

When do these reactions happen? The symptoms of this allergic reaction can occur at any time during treatment with VEXABAX. However, they usually occur in the first six weeks of treatment and get worse with continued treatment. If you are caring for a child who is being treated with VEXABAX, it is important that you understand the information about this hypersensitivity reaction. If your child gets the symptoms described below it is essential that you follow the instructions given. The hypersensitivity reaction can be life-threatening or fatal if treatment with VEXABAX is continued. You should contact your doctor immediately for advice on whether you should stop taking VEXABAX 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(stomach) pain
• severe tiredness or achiness or generally ill feeling.

Your doctor may advise you to stop taking VEXABAX.

Do not share medicines prescribed for you with any other person. Always take VEXABAX exactly as your doctor has instructed. You should check with your doctor or pharmacist if you are unsure.

Take VEXABAX for as long as your doctor recommends. Don’t stop unless your doctor advises you to. Take great care not to miss any doses if at all possible. Swallow the tablet whole with water. The usual dose in adults and adolescents from 12 years of age, who weigh at least 40 kg, is one tablet daily.

If you take more VEXABAX than you should: 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 VEXABAX: It is important to take VEXABAX as prescribed to ensure you get maximum benefit. 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. It is important to take VEXABAX regularly because irregular intake may increase the risk of hypersensitivity reactions.

If you stop taking VEXABAX: If you have stopped taking VEXABAX for any reason, particularly because you think you are having side effects or for other illness, it is important that you contact your doctor before restarting. In some cases, your doctor will ask you to restart VEXABAX under direct medical supervision. If your doctor thinks that there is a possibility that your symptoms were related to a hypersensitivity reaction, you may be told never to take VEXABAX or any other medicine containing abacavir again.

VEXABAX can have side effects. Not all side effects reported for VEXABAX are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VEXABAX, please consult your doctor, pharmacist or other health care professional for advice.

Conditions you need to look out for: VEXABAX may cause other conditions to develop during HIV treatment. Hypersensitivity reaction: VEXABAX can cause a serious allergic reaction known as a hypersensitivity reaction, see ‘Hypersensitivity reaction’ in ‘Take special care with VEXABAX’. It is important that you read and understand the information about this serious reaction.

Symptoms of infection and inflammation: Symptoms of infection and inflammation may develop and include:

• muscle weakness and/or muscle pain
• joint pain or swelling
• weakness beginning in the hands and feet and moving up towards the trunk of the body
• palpitations or tremor
• hyperactivity (excessive restlessness and movement).

If you get any symptoms of infection while you’re taking VEXABAX: Tell your doctor immediately. Don’t take other medicines for the infection without your doctor’s advice.

Your body shape may change: People taking combination therapy for HIV may find that their body shape changes, because of changes in fat distribution:

• fat may be lost from the legs, arms or face.
• extra fat may build up around the stomach, or on the breasts or internal organs.
• fatty lumps (sometimes called buffalo hump) may appear on the back of the neck.

If you notice changes in your body shape, tell your doctor.

Lactic acidosis is serious side effect: Some people taking VEXABAX or other medicines like it (NRTIs), develop a condition called lactic acidosis, together with an enlarged liver. Signs of lactic acidosis include:

• deep, rapid, difficult breathing
• drowsiness
• numbness or weakness in the limbs
• feeling sick (nausea), being sick (vomiting)
• stomach pain.

During your treatment, your doctor will monitor you for signs of lactic acidosis. If you have any of the symptoms listed above or any other symptoms that worry you: See your doctor as soon as possible.

Other effects may show up in blood tests: Combination therapy for HIV can also cause:

• increased levels of lactic acid in the blood, which on rare occasions can lead to lactic acidosis
• increased levels of sugar and fats (triglycerides and cholesterol) in the blood.

As VEXABAX contains both abacavir and lamivudine, the side effects reported for each of these have been combined.

Frequent side effects:

• headache
• feeling sick (nausea)
• hypersensitivity reaction (see ‘hypersensitivity reactions’ section above)
• being sick (vomiting)
• diarrhoea
• stomach pains
• loss of appetite
• tiredness, lack of energy
• high temperature (fever)
• general feeling of being unwell
• muscle pain and discomfort
• joint pain
• skin rash
• hair loss

Less frequent side effects: Side effects that may show up in blood tests are:

• a low red blood cell count (anaemia) or low white blood cell count (neutropenia or leucopenia)
• an increase in the level of liver enzymes
• a decrease in the number of cells involved in blood clotting (thrombocytopenia)
• lactic acidosis (see ‘Conditions you need to look out for’)
• inflammation of the pancreas (pancreatitis)
• breakdown of muscle tissue

Frequency unknown:

• tingling or numbness of the skin, arms or legs
• skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
• a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form causing skin peeling on large parts of your body surface (toxic epidermal necrolysis).

If you notice any of these symptoms contact a doctor urgently. Side effects that may show up in blood tests are:

• a failure of the bone marrow to produce new red blood cells (pure red cell aplasia). Symptoms include fatigue, shortness of breath with exertion, rapid or irregular heart rate, pale skin, frequent or prolonged infections, unexplained or easy bruising, nosebleeds and bleeding gums, prolonged bleeding from cuts, skin rash, dizziness and headache.

If you notice any side effects not mentioned in this leaflet, please inform your doctor of pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the ‘6.04 Adverse Drug Reaction Reporting Form’, found on-line under SAHPRA’S publications: htpp://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of VEXABAX.

Store all medicines out of reach of children. Store at or below 25 °C. Protect from moisture. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).