Tulodiv 600 mg/50 mg/300 mg Film-Coated Tablets

TULODIV is a medicine that contains three active ingredients used to treat HIV infection: abacavir, lamivudine and dolutegravir. Abacavir and lamivudine belong to a group of anti-retroviral medicines (medicines used to treat HIV infection) called nucleoside analogue reverse transcriptase inhibitors (NRTIs), and dolutegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs).

TULODIV is used to treat HIV (human immunodeficiency virus) infection in adults and adolescents aged 18 years and older. TULODIV 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 TULODIV in the same way. Your doctor will monitor the effectiveness of your treatment.

Do not take TULODIV:

• if you are allergic (hypersensitive) to abacavir, dolutegravir or lamivudine, or any of the other ingredients of TULODIV (listed in section 6). Carefully read all the information about hypersensitivity reactions in Warnings and precautions, and Section 4.
• if you have liver problems.
• if you have kidney problems.
• if you are taking another medicine called dofetilide or pilsicanide (to treat heart conditions) or metformin (to treat diabetes).
• if you are pregnant and are within your first trimester of pregnancy or are breastfeeding.

Warnings and precautions

Hypersensitivity to abacavir

TULODIV contains abacavir. About 5 in every 100 people who take abacavir develop a hypersensitivity reaction (a serious allergic reaction), which can be life-threatening if they continue to take abacavir.

Who gets these reactions?

Anyone taking TULODIV could develop a hypersensitivity reaction to abacavir. You are more likely to develop such a reaction if you have a gene called HLA-B*5701 (but you can get a reaction even if you don't have this gene). If possible, you will have been tested for this gene before TULODIV was prescribed for you. If you know you have this gene, tell your doctor before you take TULODIV.

Do not share medicines prescribed for you with any other person. Always take TULODIV exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is of TULODIV 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 TULODIV, 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.

TULODIV can be taken with or without food.

Antacid medicines

Antacids, to treat indigestion and heartburn, can stop TULODIV being absorbed into your body and make it less effective. Do not take an antacid during the 6 hours before you take TULODIV, 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 TULODIV. Talk to your doctor for further advice on taking acid-lowering medicines with TULODIV.

TULODIV can have side effects. Not all side effects reported for TULODIV are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TULODIV, please consult your healthcare provider for advice. If any of the following happens, stop taking TULODIV and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fever,
• shortness of breath,
• sore throat or cough,
• nausea, vomiting, diarrhoea, abdominal pain,
• severe tiredness, aches and pains, generally feeling ill,
• peeling and/or blistering of the skin.

These are all very serious side effects. If you have them, you may have had a serious reaction to TULODIV. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• unexplained bleeding or bruising, which may be due to changes in the numbers of certain cells in the blood which may affect blood clotting or lead to anaemia,
• changes in numbers of certain cells in the blood which may affect your ability to fight infection some signs of infection include: any fever, sore throat, mouth ulcers and tiredness,
• rapid or irregular heartbeat, tremor, excessive restlessness and movement, or weakness beginning in the hands and feet and moving up towards the trunk of the body,
• recurrent nausea or vomiting, abdominal pain or rapid breathing (lactic acidosis),
• suicidal thoughts or suicide attempt (particularly in patients who have had depression or mental health problems before),
• inflamed pancreas (pancreatitis) with symptoms such as stomach pain, nausea or vomiting,
• inflammation of the liver or liver failure with symptoms such as fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, yellowing of the skin or whites of the eyes,
• breakdown of muscle tissue with symptoms such as dark, reddish urine, a decreased amount of urine, weakness and muscle aches.

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any side effects not mentioned in this leaflet.

• Store all medicines out of reach of children.

• Store at or below 30 °C.

• Do not store in a bathroom.

• Do not use after the expiry date stated on the carton.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).