Kavmyl Film-Coated Tablets

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

Do not take KAVMYL:

• If you are allergic (hypersensitive) to abacavir, lamivudine or dolutegravir or any other medicine containing abacavir, lamivudine or dolutegravir or any other ingredients of KAVMYL (listed in section 6). Carefully read all the information about abacavir and dolutegravir hypersensitivity reactions in POSSIBLE SIDE EFFECTS and ‘Take special care with KAVMYL.
• If you’re taking another medicine called dofetilide or pilsicainide (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 kidney disease.

Warnings and precautions

Take special care with KAVMYL:

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

Do not share medicines prescribed for you with any other person. Always take KAVMYL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. The usual dose of KAVMYL in adults and in adolescents weighing more than 40 kg is one tablet (containing 50 mg dolutegravir, 600 mg abacavir, 300 mg lamivudine together in one tablet) once a day every day, at about the same time each day. Swallow the tablet with a sufficient quantity of liquid (e.g. one glass of water).

KAVMYL can be taken with or without food. If you weigh less than 40 kg, you cannot take KAVMYL. The dose of each component of this medicine cannot be adjusted to your weight. In this case your doctor might prescribe the components as separate medicine for you to take.

Antacid medicines:

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

Calcium and iron supplements:

Calcium or iron supplements can stop KAVMYL 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 KAVMYL, or for at least 2 hours after you take it. Your doctor will tell you how long your treatment with KAVMYL will last. Do not stop treatment unless your doctor advises you to.

KAVMYL can have side effects. Not all side effects reported for KAVMYL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking KAVMYL, 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 KAVMYL or other medicines you may be taking. If you get any of these effects, and if they are severe, your doctor may advise you to stop taking KAVMYL.

If any of the following happens, stop taking KAVMYL and tell your doctor immediately or go to the casualty department at your nearest hospital:

• a life-threatening allergic reaction referred to as anaphylaxis. Symptoms include, but are not limited to, fast or irregular breathing, puffiness or swelling around the face, shortness of breath, a sudden severe decrease in blood pressure, abdominal pain and cramping, anxiety, confusion, cough, diarrhoea, difficulty in swallowing, fainting, light-headedness, dizziness, hives, itchiness, wheezing and blocked nose.
• a severe skin rash (see below) OR
• one or more symptoms from at least TWO of the following groups:

• shortness of breath, sore throat or cough, swelling of the face, tongue or throat,
• nausea or vomiting or diarrhoea or abdominal (stomach) pain,
• severe tiredness or aches and pains or generally feeling ill.

• skin rash, which may form blisters and looks like small targets known as erythema multiforme (central dark spots surrounded by a paler area, with a dark ring around the edge).

• widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals known as Stevens-Johnson syndrome. As well as a more severe from causing skin peeling in more than 30 % of the body surface known as toxic epidermal necrosis. These are all very serious side effects. If you have them, you may have had a serious reaction to KAVMYL. You may need urgent medical attention or hospitalisation.

Store all medicines out of reach of children. Store at or below 25 o C. Store in the original package to protect from moisture. Keep the bottle tightly closed. Do not remove the desiccant. Do not use after the expiry date stated on the packaging. Do not store in the bathroom. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilet).