Trelavue Film-Coated Tablets

TRELAVUE is used to treat HIV (human immunodeficiency virus) infection in adults and adolescents aged 18 years and older. Dolutegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs). Abacavir and lamivudine belong to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs). TRELAVUE does not cure HIV infection; it reduces the amount of virus in your body and keeps it at a low level. Not everyone responds to treatment with TRELAVUE in the same way. Your doctor will monitor the effectiveness of your treatment.

Do not take TRELAVUE:

• if you are allergic (hypersensitive) to abacavir (or any other medicine containing abacavir, lamivudine, or dolutegravir, or any other ingredients of TRELAVUE. Carefully read all the information about abacavir hypersensitivity reactions in POSSIBLE SIDE EFFECTS and ‘Take special care with TRELAVUE’.
• if you’re taking another medicine called dofetilide or pilsicanide (to treat heart conditions) or metformin (to treat diabetes)
• if you have moderate to severe liver disease
• if you are pregnant, intend to become pregnant or if you are breastfeeding your baby
• if you have moderate to severe renal disease.

Take special care with TRELAVUE:

• if you have mild liver disease or have ever had liver disease, including hepatitis B or C. Talk to your doctor if this applies to you. You may need extra check-ups, including blood tests, while you’re taking your medication. See POSSIBLE SIDE EFFECTS for more information.

Do not share medicines prescribed for you with any other person. Always take TRELAVUE exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The usual dose of TRELAVUE in adults and in adolescents weighing more than 40 kg is one combined tablet (50 mg dolutegravir, 600 mg abacavir, 300 mg lamivudine) taken once a day. If you weigh less than 40 kg, you cannot take TRELAVUE, because the dose of each component of this medicine cannot be adjusted to your weight. Your doctor might prescribe the components separately for you. Swallow the tablet with some liquid. TRELAVUE can be taken with or without food.

Antacid medicines: Antacids, to treat indigestion and heartburn, can stop TRELAVUE being absorbed into your body and make it less effective. Do not take an antacid during the 6 hours before you take TRELAVUE, or for at least 2 hours after you take it. Other acid-lowering medicines like ranitidine and omeprazole can be taken at the same time as TRELAVUE. Talk to your doctor for further advice on taking acid-lowering medicines with TRELAVUE. Calcium or iron supplements: Calcium or iron supplements can stop TRELAVUE being absorbed into your body and make it less effective. Do not take a calcium or iron supplement during the 6 hours before you take TRELAVUE, or for at least 2 hours after you take it. If you take food with TRELAVUE, then you can take calcium and iron supplements at the same time as TRELAVUE.

TRELAVUE can have side effects. Not all side effects reported for TRELAVUE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TRELAVUE, please consult your doctor, pharmacist or other healthcare professional for advice. When you’re being treated for HIV, it can be hard to tell whether a symptom is a side effect of TRELAVUE or other medicines you are taking, or an effect of the HIV disease itself. So it is very important to talk to your doctor about any changes in your health. Some side effects may only be seen in your blood tests, and may not appear immediately after you start taking TRELAVUE. If you get any of these effects, and if they are severe, your doctor may advise you to stop taking TRELAVUE.

Conditions to look out for: Hypersensitivity reactions: If you notice any of these symptoms stop taking TRELAVUE and contact a doctor immediately or go to the casualty department of the nearest hospital. Hypersensitivity to abacavir: About 5 in every 100 people who take abacavir develop a hypersensitivity reaction (a serious allergic reaction) which can be life-threatening. It is very important that you read and understand the information about this serious reaction. See ‘Take special care with TRELAVUE’.

Store all medicines out of reach of children.

• Store at or below 30 °C
• Store in the original package to protect from moisture
• Keep the bottle tightly closed
• Do not remove the dessicant
• Do not use after the expiry date stated on the label and carton
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).