Details for: APO-ABACAVIR-LAMIVUDINE

Important Information on Hypersensitivity Reactions

If you get two or more of the following groups of symptoms while taking APO-ABACAVIR-LAMIVUDINE contact your doctor immediately to find out if you should stop taking APO-ABACAVIR-LAMIVUDINE:

A list of these symptoms is on the Warning Card provided by your pharmacist. You should carry this Warning Card with you at all times. If you notice these symptoms while taking APO-ABACAVIR-LAMIVUDINE, call your doctor immediately. Your doctor may advise you to stop taking APO-ABACAVIR-LAMIVUDINE.

If you stop APO-ABACAVIR-LAMIVUDINE because of a serious allergic reaction, never take APO-ABACAVIR-LAMIVUDINE or any other medicine containing abacavir (such as abacavir sulfate, abacavir sulfate/ lamivudine/ zidovudine or dolutegravir/ abacavir/ lamivudine) again, regardless of whether you have the HLA-B*5701 gene variation or not. Within hours you may experience a life threatening lowering of your blood pressure or death. If you stop APO-ABACAVIR-LAMIVUDINE for any other reason, even for a few days, and you are not allergic to APO-ABACAVIR-LAMIVUDINE, talk with your doctor before taking it again. Taking APO-ABACAVIR-LAMIVUDINE again may cause a serious allergic or life-threatening reaction, even if you never had an allergic reaction to it before.

If your healthcare provider tells you that you can take APO-ABACAVIR-LAMIVUDINE, again, start taking it when you are around medical help or people who can call a doctor if you need one.

Occasionally, reactions have developed in people who start taking abacavir again, and had only one symptom on the Warning Card before they stopped taking it.

If you are hypersensitive to APO-ABACAVIR-LAMIVUDINE, return all your unused APO-ABACAVIR-LAMIVUDINE tablets for safe disposal. Ask your doctor or pharmacist for advice.

Before you use APO-ABACAVIR-LAMIVUDINE, talk to your doctor or pharmacist:

• About all your medicines and medical conditions
• If you have kidney or liver disease (including hepatitis B or C)
• If you have had previous use of any NRTI class medicine
• If you have been tested and know whether or not you have a gene variation called HLA-B*5701
• If you are pregnant, or planning to become pregnant, breastfeeding or planning to breastfeed
• About all the medicines you are taking including vitamins, herbal supplements and nonprescription drugs

Other special warnings

Your blood sugar levels (glucose) or levels of fats (lipids) in your blood may increase with HIV treatment. Your doctor may order blood tests for you.

The class of medicines to which APO-ABACAVIR-LAMIVUDINE belongs (NRTIs) can cause a condition called lactic acidosis (excess of lactic acid in your blood), together with an enlarged liver. Symptoms of lactic acidosis include feeling of weakness, loss of appetite, sudden unexplained weight loss, upset stomach and difficulty breathing or rapid breathing. This rare but serious side effect occurs more often in women. If you have liver disease you may also be more at risk of getting this condition. While you are being treated with APO-ABACAVIR-LAMIVUDINE your doctor will monitor you closely for any signs that you may be developing lactic acidosis.

If you have hepatitis B infection, you should not stop APO-ABACAVIR-LAMIVUDINE without instructions from your doctor, as you may have recurrence of your hepatitis. This may occur due to you suddenly stopping the active ingredient lamivudine in APO-ABACAVIR-LAMIVUDIN

Some HIV medicines including abacavir may increase your risk of heart attack. If you have heart problems, smoke or suffer from diseases that increase your risk of heart disease such as high blood pressure and diabetes, tell your doctor. Do not stop taking your medication unless you are advised to do so by your doctor.

You may continue to develop other infections and other illnesses associated with HIV disease. You should therefore keep in regular contact with your doctor while taking APO-ABACAVIR-LAMIVUDINE.

APO-ABACAVIR-LAMIVUDINE helps to control your condition but is not a cure for HIV infection. You will need to take it every day. Unless you suspect you are having an allergic reaction with APO-ABACAVIR-LAMIVUDINE, do not stop taking your medicine without first talking to your doctor.

Treatment with APO-ABACAVIR-LAMIVUDINE has not been shown to reduce the risk of passing HIV infection on to others by sexual contact or by blood transfer. You should continue to use appropriate precautions to prevent this.

Use of this medicine during pregnancy and breastfeeding:

If you are pregnant, or planning to become pregnant soon, you must inform your doctor before taking any medicine.

The safe use of abacavir sulfate/ lamivudine in pregnancy has not been established. Your doctor will decide whether you should continue to be treated with APO-ABACAVIR-LAMIVUDINE if you are pregnant. If you take APO-ABACAVIR-LAMIVUDINE while you are pregnant, talk to your doctor about how you can be included in the Antiretroviral Pregnancy Registry.

Babies and infants exposed to Nucleoside Reverse Transcriptase Inhibitors (NRTIs) during pregnancy or labour show minor temporary increases in blood levels of lactate. The clinical importance of these temporary increases is unknow.

These findings do not affect current recommendations to use antiretroviral therapy in pregnant women to prevent transmission of HIV to their babies. There have been very rare reports of disease that affect the neonatal (babies) nervous system such as delayed development and seizures. The long term effects of abacavir sulfate/ lamivudine are not known.

It is recommended that HIV infected women do not breastfeed their infants under any circumstances in order to avoid transmission of HIV from mother to child. Both of the active substances in APO-ABACAVIR-LAMIVUDINE are likely to be found in breast milk.

You are recommended not to breastfeed your baby while taking APO-ABACAVIR-LAMIVUDINE.

Remember: This medicine is for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours.