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ABACAVIR/ LAMIVUDINE VIATRIS Consumer Medicine Information (CMI) summary The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. Why am I using ABACAVIR/LAMIVUDINE VIATRIS? ABACAVIR/LAMIVUDINE VIATRIS contains the active ingredients abacavir and lamivudine. ABACAVIR/LAMIVUDINE VIATRIS is used together with other antiretrovirals to slow down the progression of human immunodeficiency virus (HIV) infection, which can lead to Acquired Immune Deficiency Syndrome (AIDS) and other related illnesses (e.g. AIDS-related Complex or ARC). For more information, see Section 1. Why am I using ABACAVIR/ LAMIVUDINE VIATRIS? in the full CMI. 2. What should I know before I use ABACAVIR/LAMIVUDINE VIATRIS? Do not use if you have ever had an allergic reaction to abacavir or lamivudine or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use ABACAVIR/LAMIVUDINE VIATRIS? in the full CMI. 3. What if I am taking other medicines? Some medicines may interfere with ABACAVIR/LAMIVUDINE VIATRIS and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. How do I use ABACAVIR/LAMIVUDINE VIATRIS? The normal dose for adults and adolescents is one tablet once a day. ABACAVIR/LAMIVUDINE VIATRIS tablets should be swallowed whole with water and do not have to be taken with food. More instructions can be found in Section 4. How do I use ABACAVIR/LAMIVUDINE VIATRIS? in the full CMI. 5. What should I know while using ABACAVIR/ LAMIVUDINE VIATRIS? Things you should do Remind any doctor, dentist or pharmacist you visit that you are using ABACAVIR/LAMIVUDINE VIATRIS. If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. For as long as you're taking ABACAVIR/LAMIVUDINE VIATRIS, your doctor will arrange regular blood tests to check for side effects. Keep in contact with your doctor, and don't stop taking KIVEXA without your doctor's advice. Things you should not do Do not take ABACAVIR/LAMIVUDINE VIATRIS to treat any other complaints unless your doctor tells you to. Do not stop taking ABACAVIR/LAMIVUDINE VIATRIS tablets or change the dose without first talking to your doctor. Driving or using machines Don't drive or operate machinery unless you are sure you are not affected. Looking after your medicine Keep your tablets in cool, dry place where it stays below 25°C Keep your ABACAVIR/LAMIVUDINE VIATRIS tablets in their pack until you take them. For more information, see Section 5. What should I know while using ABACAVIR/ LAMIVUDINE VIATRIS? in the full CMI. 6. Are there any side effects? The most common side effects are feeling sick (nausea), diarrhoea, being sick (vomiting), stomach pain (abdominal pain), headache and rash. Tell your doctor or pharmacist if you notice anything that is making you feel unwell. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI. PATIENTS TAKING ABACAVIR/LAMIVUDINE VIATRIS, WHICH CONTAINS ABACAVIR, MAY DEVELOP A HYPERSENSITIVITY REACTION (SERIOUS ALLERGIC REACTION) WHICH CAN BE LIFE-THREATENING IF TREATMENT WITH ABACAVIR/LAMIVUDINE VIATRIS IS CONTINUED. CONTACT YOUR DOCTOR IMMEDIATELY FOR ADVICE ON WHETHER YOU SHOULD STOP TAKING ABACAVIR/LAMIVUDINE VIATRIS 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 ILL FEELING IF YOU HAVE HAD A HYPERSENSITIVITY (ALLERGIC) REACTION TO ABACAVIR/LAMIVUDINE VIATRIS TABLETS, NEVER TAKE ABACAVIR/LAMIVUDINE VIATRIS, OR ANY OTHER MEDICINAL PRODUCT CONTAINING ABACAVIR AGAIN AS YOU MAY DEVELOP A LIFE THREATENING REACTION WHICH CAN BE FATAL. THERE IS AN ALERT CARD INCLUDED IN THE ABACAVIR/LAMIVUDINE VIATRIS PACK, TO REMIND YOU AND MEDICAL STAFF ABOUT ABACAVIR HYPERSENSITIVITY. THIS CARD SHOULD BE REMOVED FROM THE PACK AND KEPT WITH YOU AT ALL TIMES. SEE MORE DETAILS UNDER BEFORE YOU TAKE ABACAVIR/LAMIVUDINE VIATRIS. Active ingredient(s): abacavir (as sulfate) and lamivudine Full Consumer Medicine Information (CMI) This leaflet provides important information about using ABACAVIR/LAMIVUDINE VIATRIS. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using ABACAVIR/LAMIVUDINE VIATRIS. Where to find information in this leaflet: 1. Why am I using ABACAVIR/LAMIVUDINE VIATRIS? 2. What should I know before I use ABACAVIR/ LAMIVUDINE VIATRIS? 3. What if I am taking other medicines? 4. How do I use ABACAVIR/LAMIVUDINE VIATRIS? 5. What should I know while using ABACAVIR/ LAMIVUDINE VIATRIS? 6. Are there any side effects? 7. Product details 1. Why am I using ABACAVIR/ LAMIVUDINE VIATRIS? ABACAVIR/LAMIVUDINE VIATRIS contains the active ingredients abacavir and lamivudine. ABACAVIR/ LAMIVUDINE VIATRIS belong to a group of medicines called antiretrovirals. These are also available as separate medicinal products. ABACAVIR/LAMIVUDINE VIATRIS is used to treat human immunodeficiency virus (HIV) infection. ABACAVIR/LAMIVUDINE VIATRIS tablets do not cure AIDS or kill the HIV virus, but delays further damage to the immune system by stopping production of new viruses. You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. You will still be able to pass on the HIV virus by sexual activity or by contamination with infected blood. You should still use proper precautions to prevent this. Discuss with your doctor the precautions needed to avoid infecting other people. ABACAVIR/LAMIVUDINE VIATRIS tablets are used together with other antiretrovirals to slow down the progression of human immunodeficiency virus (HIV) infection, which can lead to Acquired Immune Deficiency Syndrome (AIDS) and other related illnesses (e.g. AIDS-related Complex or ARC). 2. What should I know before I use ABACAVIR/LAMIVUDINE VIATRIS? Warnings Do not use ABACAVIR/LAMIVUDINE VIATRIS if: you have ever had an allergic reaction to abacavir. you are allergic to the active ingredient lamivudine, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine. you have a serious liver disease ABACAVIR/ LAMIVUDINE VIATRIS may not be suitable for you. you have severe kidney disease. Check with your doctor if you: have any other medical conditions take any medicines for any other condition have allergies to any other medicines, foods, preservatives or dyes . During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects ? Pregnancy and breastfeeding Check with your doctor if you are pregnant or intend to become pregnant. Talk to your doctor if you are breastfeeding or intend to breastfeed. You must not take ABACAVIR/LAMIVUDINE VIATRIS tablets if you are pregnant, think you may be pregnant or are breastfeeding, unless your doctor tells you to. Symptoms of infection and inflammation People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections). When these people start treatment, the immune system becomes stronger, so that the body starts to fight these infections. Symptoms of infection and inflammation may develop, caused by either: old, hidden infections flaring up against as the body fights them the immune system attacking healthy body tissue (autoimmune disorders). The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection. Symptoms may include: muscle weakness and/or muscle pain joint pain or swelling weakness beginning in the hands feet and moving towards the trunk of the body palpitations or tremor hyperactivity (excessive restlessness and movement). If you get any symptoms of infection or if you notice any of the symptoms above tell your doctor immediately. Don’t take other medicines for the infection without your doctors' advice. 3. What if I am taking other medicines? Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop. Abacavir or lamivudine in ABACAVIR/LAMIVUDINE VIATRIS tablets may interact with certain other medicines. ABACAVIR/LAMIVUDINE VIATRIS tablets should not be taken with emtricitabine. Some medicines may interfere with ABACAVIR/ LAMIVUDINE VIATRIS and affect how it works. sorbitol-containing medicines (usually liquids) used regularly trimethoprim-sulphamethoxazole (also known as co-trimoxazole), (an antibiotic used to treat PCP - Pneumocystis jiroveci pneumonia (often referred to as PCP) or toxoplasmosis). If you are taking methadone, your doctor may need to adjust your methadone dose, as abacavir increases the rate at which methadone leaves your body. This is unlikely to affect most methadone users. Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect ABACAVIR/ LAMIVUDINE VIATRIS. 4. How do I use ABACAVIR/ LAMIVUDINE VIATRIS? How much to take The normal dose for adults and adolescents is one tablet once a day. Follow the instructions provided and use ABACAVIR/ LAMIVUDINE VIATRIS until your doctor tells you to stop. When to take ABACAVIR/LAMIVUDINE VIATRIS ABACAVIR/ LAMIVUDINE VIATRIS should be used swallowed whole with water. ABACAVIR/LAMIVUDINE VIATRIS tablets do not have to be taken with food. If you forget to take ABACAVIR/LAMIVUDINE VIATRIS ABACAVIR/LAMIVUDINE VIATRIS should be used regularly at the same time each day. If you miss your dose at the usual time, take it as soon as you remember, and then continue as before. If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Do not take a double dose to make up for the dose you missed. If you take too much ABACAVIR/LAMIVUDINE VIATRIS If you think that you have used too much ABACAVIR/ LAMIVUDINE VIATRIS, you may need urgent medical attention. You should immediately: phone the Poisons Information Centre (Australia telephone 13 11 26) for advice, or contact your doctor, or go to the Emergency Department at your nearest hospital. You should do this even if there are no signs of discomfort or poisoning. 5. What should I know while using ABACAVIR/LAMIVUDINE VIATRIS? Things you should do If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking ABACAVIR/LAMIVUDINE VIATRIS tablets. Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine. If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery. If you become pregnant while taking this medicine, tell your doctor immediately. Keep all of your doctor's appointments so that your progress can be checked. If you have stopped taking ABACAVIR/LAMIVUDINE VIATRIS 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 or have another illness. In some cases your doctor will ask you to restart ABACAVIR/LAMIVUDINE VIATRIS tablets where medical care can be readily accessed by yourself or others. You will need regular blood tests For as long as you're taking ABACAVIR/LAMIVUDINE VIATRIS, your doctor will arrange regular blood tests to check for side effects. Stay in regular contact with your doctor ABACAVIR/LAMIVUDINE VIATRIS helps to control your condition, but does not cure HIV infection, you will need to take the tablets every day to stop your illness from getting worse. While taking ABACAVIR/LAMIVUDINE VIATRIS tablets and/or any other therapy for HIV disease, you may continue to develop other infections and other complications of HIV infection. You should keep in regular contact with the doctor who is looking after you. Do not stop taking ABACAVIR/LAMIVUDINE VIATRIS tablets or change the dose without first talking to your doctor. Things you should not do Do not give this medicine to anyone else, even if their symptoms seem similar to yours. Do not use ABACAVIR/LAMIVUDINE VIATRIS tablets to treat any other complaints unless your doctor tells you to. If you have hepatitis B infection, you should not stop ABACAVIR/LAMIVUDINE VIATRIS tablets without instructions from your doctor, as you may have a recurrence of your hepatitis. This may occur due to you suddenly stopping lamivudine. Hypersensitivity reaction ABACAVIR/LAMIVUDINE VIATRIS 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 VIATRIS 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 VIATRIS 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 VIATRIS tablets, NEVER take ABACAVIR/LAMIVUDINE VIATRIS 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 VIATRIS 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 VIATRIS tablets were restarted in patients who had no symptoms of hypersensitivity before stopping. If you have stopped taking ABACAVIR/LAMIVUDINE VIATRIS 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 VIATRIS tablets again. It is important that you follow this advice. If you are hypersensitive to ABACAVIR/LAMIVUDINE VIATRIS tablets you should return all of your unused ABACAVIR/LAMIVUDINE VIATRIS tablets to your doctor or pharmacist for proper disposal. Kidney disease If you have moderate kidney disease you should be monitored as you are at higher risk of some side effects. See additional information under Section 6. Are there any side effects ? Driving or using machines Be careful before you drive or use any machines or tools until you know how ABACAVIR/