Kavideza Film-Coated Tablets

KAVIDEZA 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). KAVIDEZA 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 KAVIDEZA in the same way. Your doctor or healthcare provider will monitor the effectiveness of your treatment.

Do not take KAVIDEZA:

• If you are allergic (hypersensitive) to abacavir, lamivudine or dolutegravir or any other medicine containing abacavir, lamivudine or dolutegravir or any other ingredients of KAVIDEZA (listed in section 6). Carefully read all the information about abacavir and dolutegravir hypersensitivity reactions in POSSIBLE SIDE EFFECTS and ‘Take special care with KAVIDEZA.
• 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 KAVIDEZA:

• 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 KAVIDEZA exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. The usual dose of KAVIDEZA 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).

KAVIDEZA can be taken with or without food.

If you weigh less than 40 kg, you cannot take KAVIDEZA. 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 KAVIDEZA being absorbed into your body and make it less effective. Do not take antacid during the 6 hours before you take KAVIDEZA, 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 KAVIDEZA. Talk to your doctor or health care provider for further advice on taking acid-lowering medicines with KAVIDEZA.

Calcium and iron supplements:

Calcium or iron supplements can stop KAVIDEZA 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 KAVIDEZA, or for at least 2 hours after you take it.

Your doctor will tell you how long your treatment with KAVIDEZA will last. Do not stop treatment unless your doctor advises you to.

If you have the impression that the effect of KAVIDEZA is too strong or too weak, tell your doctor or pharmacist.

If you take more KAVIDEZA than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. If possible, show them the KAVIDEZA pack.

If you forget to take KAVIDEZA or missed a dose of KAVIDEZA: If you miss a dose, take it as soon as you remember, but if it is within 4 hours of your next dose, skip the dose you missed and take the next one at the usual time. Then continue your treatment as before. Do not take a double dose to make up for a missed dose.

If you stop taking KAVIDEZA: Take KAVIDEZA for as long as your doctor recommends. Don’t stop unless your doctor advises you to. If you have stopped taking KAVIDEZA for any reason, particularly because you think you are having side effect or for other illness, it is important that you contact your doctor before restarting. In some cases, your doctor will ask you to restart KAVIDEZA in a place where you will be able to get ready access to medical care if needed. If you have hepatitis B infection, don’t stop KAVIDEZA without your doctor’s advice, as your hepatitis may come back.

KAVIDEZA can have side effects. Not all side effects reported for KAVIDEZA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking KAVIDEZA, 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 KAVIDEZA 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 KAVIDEZA.

If any of the following happens, stop taking KAVIDEZA 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 KAVIDEZA. You may need urgent medical attention or hospitalisation.

Very serious condition to look out for: Hypersensitivity reactions: If you notice any of these symptoms stop taking KAVIDEZA 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 KAVIDEZA’. Hypersensitivity to dolutegravir: KAVIDEZA contains dolutegravir, some people taking dolutegravir have allergic reactions. Signs of a hypersensitivity reaction include:

• skin rash,
• a high temperature (fever),
• lack of energy (fatigue),
• swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing,
• muscle or joint aches.

See a doctor as soon as possible. Your doctor may decide to carry out tests on your liver, kidneys or blood, and may tell you to stop taking KAVIDEZA. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following: Symptoms of infection and inflammation: Symptoms of infection and inflammation may develop and include:

• muscle weakness and/or muscle pain,
• joint pain or swelling,
• weakness beginning in the hands and feet and moving up towards the trunk of the body,
• palpitations and/or tremor,
• hyperactivity (excessive restlessness and movement).

If you get any symptoms of infection while you’re taking KAVIDEZA: Tell your doctor immediately. Don’t take other medicines for the infection without your doctor’s advice. See ‘Take special care with KAVIDEZA. Your body shape may change: People taking combination therapy for HIV may find that their body shape changes, because of changes in fat distribution:

• Fat may be lost from the legs, arms or face.
• Extra fat may build up around the stomach, on the breasts or internal organs.
• Fatty lumps (sometimes called buffalo hump) may appear on the back of the neck.

If you notice change in your body shape, tell your doctor immediately. Lactic acidosis is a serious side effect: Some people taking KAVIDEZA, develop a condition called lactic acidosis, together with an enlarged liver. Signs of lactic acidosis include:

• deep, rapid, difficult breathing,
• drowsiness,
• numbness or weakness in the limbs,
• feeling sick (nausea), being sick (vomiting),
• stomach pain.

During your treatment, your doctor will monitor you for signs of lactic acidosis. If you have any of the symptoms listed above or any other symptoms that worry you: See your doctor immediately. As well as the conditions listed above, other side effects can develop:

Tell your doctor if you notice any of the following:

Frequent side effects:

• abacavir hypersensitivity reaction (see ‘Take special care with KAVIDEZA),
• high temperature (fever),
• skin rash, itching (pruritus),
• joint pain, muscle pain and/or discomfort,
• headache,
• diarrhoea, feeling sick (nausea), being sick (vomiting), stomach pains (abdominal pain) and bloating (abdominal distention), stomach (abdominal) discomfort, wind (flatulence), indigestion (dyspepsia), gastro-oesophageal reflux disease, loss of appetite,
• feeling drowsy, tiredness, lack of energy, general feeling of being unwell,
• dizziness,
• nightmares and abnormal dreams, sleep disorder, difficulty in sleeping (insomnia), depression,
• hair loss,
• weight gain.

Frequent side effects that may show up in blood tests are:

• increase in triglycerides (type of fat) shown in blood tests,
• increase in glucose(sugar) shown in blood tests.

Less frequent side effects:

• dolutegravir allergic reaction (see ‘Hypersensitivity reactions’ earlier in this section),
• inflammation of the liver (hepatitis),
• lactic acidosis (see ‘Lactic acidosis is a serious side effect’ earlier in this section),
• inflammation of the pancreas (pancreatitis),
• breakdown of muscle tissue,
• tingling and/or numbness of the hands and/or feet (paraesthesia),
• numbness, tingling and/or weakness of the arms and/or legs (peripheral neuropathy),
• suicide (particularly in patients who have had depression or mental health problems before).

If you notice any of these symptoms contact a doctor immediately.

Store all medicines out of reach of children. Store at or below 25 °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).