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TRIUMEQ Film-Coated Tablets 50 Mg Dolutegravir (As Dolutegravir Sodium) / 600 Mg Abacavir (As Abacavir Sulfate) / 300Mg Lamivudine Consumer Medicine Information

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TRIUMEQ Film-Coated Tablets 50 Mg Dolutegravir (As Dolutegravir Sodium) / 600 Mg Abacavir (As Abacavir Sulfate) / 300Mg Lamivudine Consumer Medicine Information TRIUMEQ Film-coated tablets 50 mg dolutegravir (as dolutegravir sodium) / 600 mg abacavir (as abacavir sulfate) / 300mg lamivudine Consumer Medicine Information PATIENTS TAKING TRIUMEQ, WHICH CONTAINS ABACAVIR, MAY DEVELOP A HYPERSENSITIVITY REACTION (SERIOUS ALLERGIC REACTION) WHICH CAN BE LIFE-THREATENING IF TREATMENT WITH TRIUMEQ IS CONTINUED. CONTACT YOUR DOCTOR IMMEDIATELY FOR ADVICE ON WHETHER YOU SHOULD STOP TAKING TRIUMEQ 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 TRIUMEQ TABLETS, NEVER TAKE TRIUMEQ, OR ANY OTHER MEDICINAL PRODUCT CONTAINING ABACAVIR (KIVEXA, TRIZIVIR & ZIAGEN) AGAIN AS YOU MAY DEVELOP A LIFE THREATENING REACTION WHICH CAN BE FATAL. THERE IS AN ALERT CARD INCLUDED IN THE TRIUMEQ 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 TRIUMEQ. What is in this leaflet? cells that are important in helping your body to fight infection. Please read this leaflet carefully To control your HIV infection, and to before you take TRIUMEQ. This What is TRIUMEQ stop your illness from getting worse, leaflet answers some common used for? you must keep taking all your questions about TRIUMEQ medicines, unless your doctor tells TRIUMEQ contains three active (dolutegravir/abacavir/lamivudine). It you to stop taking any. ingredients that are used to treat HIV does not contain all of the available infection in adults and children over Ask your doctor if you have any information. It does not take the 12 years old: dolutegravir, abacavir, questions about why this medicine place of talking to your doctor or and lamivudine. Dolutegravir has been prescribed for you. pharmacist. belongs to a group of anti-retroviral TRIUMEQ is not addictive. All medicines have risks and medicines called integrase inhibitors TRIUMEQ is not recommended for benefits. Your doctor has weighed (INIs). Abacavir and lamivudine children under the age of 12 years as the expected benefits of you taking belong to a group of anti-retroviral the dosage cannot be modified. TRIUMEQ against the risks this medicines called nucleoside analogue medicine could have for you. reverse transcriptase inhibitors This medicine is available only with a doctor's prescription. If you have any concerns about (NRTIs). taking this medicine, ask your TRIUMEQ does not cure HIV doctor or pharmacist. infection; it reduces the amount of Keep this leaflet with the medicine. virus in your body, and keeps it at a low level. TRIUMEQ also increases You may need to read it again. the CD4 cell count in your blood. CD4 cells are a type of white blood TRIUMEQ 1 Before you take gene type, be sure to tell your who had no symptoms of TRIUMEQ doctor before you take abacavir. hypersensitivity before stopping. The most common symptoms of If you have stopped taking When you must not take it this reaction include high TRIUMEQ tablets for any reason temperature (fever) and a skin it is important that you contact You must not take TRIUMEQ if: rash. Other most frequently seen your doctor before restarting. This • you have ever had an allergic symptoms include nausea, is especially so if you think you are reaction to abacavir, which is vomiting, diarrhoea or abdominal having side-effects from other also included in medicines pain; severe tiredness or body medicines or have another illness. called KIVEXA, TRIZIVIR aches or generally feeling ill; Your doctor will check whether and ZIAGEN headache; shortness of breath, sore any symptoms you had before throat or cough. If you develop any stopping may be related to this • if you are allergic to the active of these symptoms call your doctor hypersensitivity reaction. If your ingredients dolutegravir or IMMEDIATELY WHO WILL doctor thinks there is a possibility lamivudine, or any of the other ADVISE YOU WHETHER YOU that they were related, you may be ingredients listed toward the SHOULD STOP TAKING told never to take TRIUMEQ end of this leaflet. TRIUMEQ TABLETS. If your tablets again. It is important that • if you're taking another doctor is not available you must you follow this advice. medicine called dofetilide, urgently seek other medical advice If you are hypersensitive to pilsicainide (to treat heart (e.g. the Accident and Emergency TRIUMEQ tablets you should conditions) or fampridine (used unit of the nearest hospital) before return all of your unused in multiple sclerosis) taking the next dose. TRIUMEQ tablets to your doctor • if you have a serious liver Other symptoms may include joint or pharmacist for proper disposal. disease TRIUMEQ may not be or muscle pain, swelling of the The TRIUMEQ pack includes an suitable for you. neck or itchy skin. Occasionally Alert Card, to remind you and Do not take this medicine after the inflammation of the eye medical staff about abacavir expiry date printed on the pack or if (conjunctivitis), ulcers in the hypersensitivity. Detach this card and the packaging is torn or shows signs mouth or low blood pressure may keep it with you at all times. of tampering. occur. The symptoms of this If it has expired or is damaged, return allergic reaction can occur at any Before you start to take it it to your pharmacist for disposal. time during treatment with TRIUMEQ tablets. However they Some other conditions may develop If you are not sure whether you usually occur in the first six weeks during HIV treatment. should start taking this medicine, talk of treatment, and get worse with Old infections may flare up to your doctor. continued treatment. People with advanced HIV infection Special Warning - If you have had this serious (AIDS) have weak immune systems, reaction to TRIUMEQ tablets, Hypersensitivity Reactions and are more likely to develop NEVER take TRIUMEQ or any serious infections (opportunistic TRIUMEQ contains abacavir and other medicinal product containing infections). When these people start dolutegravir. Both of these active abacavir (ZIAGEN, KIVEXA, treatment, they may find that old, substances can cause a serious TRIZIVIR) again as within hours hidden infections flare up, causing allergic reaction known as a you may experience a life- signs and symptoms of inflammation. hypersensitivity reaction. threatening lowering of your blood These symptoms are probably caused Abacavir hypersensitivity reactions pressure or death. by the body's immune system can be life-threatening if treatment Occasionally life threatening becoming stronger, so that the body with abacavir containing products is hypersensitivity reactions have starts to fight these infections. not stopped. occurred when medicine If you get any symptoms of Research has found that people containing abacavir was restarted infection while you're taking with a gene called HLA-B (type in patients who reported only one TRIUMEQ: 5701) are more likely to have a of the symptoms on the Alert Card Tell your doctor immediately. Don't hypersensitivity reaction to before stopping. take other medicines for the infection abacavir. However, even if you do On very rare occasions, without your doctor's advice. not have this gene type it is still hypersensitivity has been reported Tell your doctor if you have allergies possible for you to get this when treatment containing to any other medicines, foods, reaction. If you know you have this abacavir was re-started in patients preservatives or dyes. TRIUMEQ 2 If you are pregnant, or think you Taking other medicines or iron supplement at the same could be, or if you are planning to time as TRIUMEQ. have a baby, don’t take TRIUMEQ Tell your doctor or pharmacist if without checking with your doctor. you are taking any other • etravirine, efavirenz, medicines, including any that you fosamprenavir/ritonavir, Your doctor will consider the get without a prescription from nevirapine or tipranavir/ritonavir, benefit to you and the risk to your your pharmacy, supermarket or to treat HIV infection baby of taking TRIUMEQ while you're pregnant health food shop. • rifampicin, to treat tuberculosis Don't take TRIUMEQ with these (TB) and other bacterial If you could get pregnant while medicines: infections taking TRIUMEQ, you need to use • co-trimoxazole, an antibiotic used a reliable method of contraception • dofetilide or pilsicainide, to to prevent pregnancy. treat heart conditions to treat Pneumocystis jiroveci pneumonia (often referred to as • fampridine, used in multiple Taking dolutegravir (one of the PCP) or toxoplasmosis components of TRIUMEQ) at the sclerosis • phenytoin and phenobarbital, to time of becoming pregnant, or during These medicines should not be treat epilepsy the first twelve weeks of pregnancy, used with TRIUMEQ: may increase the risk of a type of • carbamazepine, to treat epilepsy • emtricitabine, to treat HIV birth defect, called neural tube and bipolar disorder defect, such as spina bifida infection • St. John's wort, (Hypericum (malformed spinal cord). • sorbitol-containing medicines perforatum), a herbal remedy to Your doctor can discuss with you the (usually liquids) used regularly risks and benefits involved. treat depression Tell your doctor if you're being Tell your doctor or pharmacist if you Abacavir and lamivudine belong to a treated with any of these. group of anti-retroviral medicines are taking any of these. Your doctor called nucleoside analogue reverse Methadone and TRIUMEQ may decide to adjust your dose or transcriptase inhibitors (NRTIs). In If you are taking methadone, your that you need extra checkups. babies and infants exposed to NRTIs doctor may need to adjust your Your doctor and pharmacist have during pregnancy or labour small methadone dose, as abacavir (one of more information on medicines to be temporary increases in blood levels the active substances in TRIUMEQ) careful with or avoid while taking of a substance called lactate have increases the rate at which this medicine.
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