Do not take if:

You must not take ABACAVIR/LAMIVUDINE MYLAN tablets if:

you have ever had an allergic reaction to abacavir

you are allergic to the active ingredient lamivudine or any of the other ingredients listed toward the end of this leaflet.

you have a serious liver disease ABACAVIR/LAMIVUDINE MYLAN may not be suitable for you.

Special Warning

ABACAVIR/LAMIVUDINE MYLAN 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.

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.

The most common symptoms of this reaction include high temperature (fever) and a skin rash. Other most frequently seen symptoms include nausea, vomiting, diarrhoea or abdominal pain; severe tiredness or body aches or generally feeling ill; headache; shortness of breath, sore throat or cough. If you develop any of these symptoms call your doctor IMMEDIATELY WHO WILL ADVISE YOU WHETHER YOU SHOULD STOP TAKING ABACAVIR/LAMIVUDINE MYLAN tablets. If your doctor is not available you must urgently seek other medical advice (e.g. the Accident and Emergency unit of the nearest hospital) before taking the next dose.

Other symptoms may include joint or muscle pain, swelling of the neck or itchy skin. Occasionally inflammation of the eye (conjunctivitis), ulcers in the mouth, tingling or numbness of the hands or feet or low blood pressure may occur. The symptoms of this allergic reaction can occur at any time during treatment with ABACAVIR/LAMIVUDINE MYLAN tablets. However they usually occur in the first six weeks of treatment, and get worse with continued treatment.

If you have had this serious reaction to ABACAVIR/LAMIVUDINE MYLAN tablets, NEVER take ABACAVIR/LAMIVUDINE MYLAN or any other medicinal product containing abacavir again as within hours you may experience a life-threatening lowering of your blood pressure or death.

Occasionally life threatening hypersensitivity reactions have occurred when ABACAVIR/LAMIVUDINE MYLAN tablets was restarted in patients who reported only one of the symptoms on the Alert Card before stopping.

On very rare occasions, hypersensitivity has been reported when ABACAVIR/LAMIVUDINE MYLAN tablets were restarted in patients who had no symptoms of hypersensitivity before stopping.

If you have stopped taking ABACAVIR/LAMIVUDINE MYLAN tablets for any reason it is important that you contact your doctor before restarting. This is especially so if you think you are having side-effects from other medicines or have another illness. Your doctor will check whether any symptoms you had before stopping may be related to this hypersensitivity reaction. If your doctor thinks there is a possibility that they were related, you may be told never to take ABACAVIR/LAMIVUDINE MYLAN tablets again. It is important that you follow this advice.

If you are hypersensitive to ABACAVIR/LAMIVUDINE MYLAN tablets you should return all of your unused ABACAVIR/LAMIVUDINE MYLAN tablets to your doctor or pharmacist for proper disposal.

You must not take ABACAVIR/LAMIVUDINE MYLAN tablets if:

you had a previous allergic reaction to ABACAVIR/LAMIVUDINE MYLAN tablets or other abacavir containing products

you are pregnant, think you may be pregnant or are breastfeeding, unless your doctor tells you to

the expiry date (EXP.) printed on the pack has passed

the packaging is torn or shows signs of tampering.