Mylamba 600 mg/300 mg Film-Coated Tablets

MYLAMBA belongs to a group of antiviral medicines, also known as antiretrovirals, called nucleoside analogue reverse transcriptase inhibitors (NRTIs). These are used to treat Human Immunodeficiency Virus (HIV) infection.

What it is used for: MYLAMBA is used in combination with other antiretroviral medicines for the treatment of HIV infection in adults and adolescents from 12 years of age. MYLAMBA is always used with other anti-HIV-1 medicines.

Do not take MYLAMBA:

• if you are allergic (hypersensitive) to any of the active ingredients abacavir, lamivudine or any of the other ingredients of MYLAMBA (listed in section 6);
• if you have liver disease;
• if you have kidney disease;
• if you are taking emtricitabine (a medicine to treat HIV infection);
• if you are a child below 12 years of age, an adult or adolescent, weighing less than 40 kg, as the necessary dose adjustment cannot be made.

If you are not sure whether you should be taking MYLAMBA, please discuss with your doctor before taking this medicine.

Warnings and precautions

Hypersensitivity reaction (serious allergic reaction): The most important symptoms of this reaction are high temperature (fever) and a skin rash. Other frequently seen signs or symptoms are nausea, vomiting, diarrhoea, abdominal pain, shortness of breath, cough, headache, and severe tiredness. Other symptoms may be joint or muscle pain, swelling of the neck and sore throat. Occasionally swelling of the eye, ulcers in the mouth or low blood pressure may occur. The symptoms of this allergic reaction can occur at any time during treatment with MYLAMBA. However, they usually occur in the first six weeks of treatment and get worse with continued treatment.

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

The usual dose is:

• The usual dose in adults and adolescents from 12 years of age, who weigh at least 40 kg, is one tablet daily.
• Treatment should be prescribed and initiated by a medical practitioner experienced in the management of HIV infection.
• Take MYLAMBA 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.
• MYLAMBA tablets can be taken with or without food.
• Your doctor will tell you how long your treatment with MYLAMBA will last.
• If you have the impression that the effect of MYLAMBA is too strong or too weak, tell your doctor or pharmacist.

If you take more MYLAMBA than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take MYLAMBA

It is important to take MYLAMBA 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.

If you stop taking MYLAMBA

If you have stopped taking MYLAMBA for any reason, especially if you think you are having side effects, or for other illness, it is important that you contact your doctor before restarting. In some cases, you doctor will ask you to restart MYLAMBA under direct medical supervision or where medical care can be easily accessed by yourself or others. If your doctor thinks that there is a possibility your symptoms were related to hypersensitivity reaction, you may be told never to take MYLAMBA or any other medicine containing abacavir again.

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

If any of the following happens, stop taking MYLAMBA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Some patients treated with MYLAMBA and did not have a gene called HLA- B*5701 developed a serious allergic reaction. The hypersensitivity reaction can be life-threatening or fatal if treatment with MYLAMBA is continued. You should contact your doctor immediately for advice on whether you should stop taking MYLAMBA if:
• you get a skin rash OR
• you get one or more symptom 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 aches and pains or generally feeling ill.
• Lactic acidosis (is more likely to develop in people who have liver disease or in very overweight people, especially women). It can be life-threatening, causing failure of internal organs.
• Liver disorders, such as jaundice, enlarged liver or fatty liver, hepatitis (inflammation of the liver).
• 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 in more than 30 % of the body surface (toxic epidermal necrolysis).
• Inflammation of the pancreas (pancreatitis).

These are all very serious side effects. If you have them, you may have had a serious reaction to MYLAMBA. 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:

• swelling of the eye,
• mouth ulcers,
• low blood pressure,
• headache.

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

The following side effects have been reported frequently:

• anorexia,
• difficulty in sleeping,
• cough,
• irritated or runny nose,
• skin rash,
• hair loss,
• joint pains,
• muscle pain and discomfort.

The following side effects have been reported less frequently:

• a low red blood cell count (anaemia) or low white blood cell count (neutropenia),
• redistribution/accumulation of body fat (fat may be lost from the legs, arms or face; extra fat may build up around the tummy or on the breasts; fatty lumps (sometimes called buffalo hump) may appear on the back of the neck),
• sensation of weakness in the limbs,
• increase in an enzyme called amylase,
• breakdown of muscle tissue.

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

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 MYLAMBA.

• Store all medicines out of reach of children.
• Do not store above 30 °C.
• Protect from light.
• Store the tablets in the original container.
• Keep the blisters in the outer carton until required for use.
• Keep the container tightly closed.
• Do not store in bathrooms.
• Do not use after the expiry date stated on the label/carton/bottle.
• Return all unused medicines to your pharmacist.
• Do not dispose of unused medicines in drains or sewerage systems (e.g., toilets).