Tivicay 50 mg Film-Coated Tablets

TIVICAY is used to treat HIV (human immunodeficiency virus) infections in adults in combination with other anti-retroviral medicines (combination therapy). The active ingredient in TIVICAY is dolutegravir. TIVICAY is a type of medicine known as an anti-retroviral. It belongs to a group of medicines called integrase inhibitors (INIs).

Do not take TIVICAY:

• if you are hypersensitive (allergic) to dolutegravir or any of the other ingredients of TIVICAY
• if you are taking another medicine called dofetilide or pilsicainide (to treat heart conditions)
• if you are taking a medicine called metformin (to treat diabetes)
• if you have moderate or severe liver disease
• if you are in your first trimester of pregnancy.

Take special care with TIVICAY:

• if you develop a rash. Some people taking TIVICAY have had allergic reactions.
• if you get any symptoms of infection while you are taking TIVICAY: People with advanced HIV infection (AIDS) have weak immune systems and are more likely to develop serious infections (opportunistic infections). When these people start treatment, they may find that old, hidden infections (such as tuberculosis) flare up, causing signs and symptoms of inflammation. These symptoms are probably caused by the body’s immune system becoming stronger, so that the body starts to fight these infections.

➔ Keep in touch with your doctor, and do not stop taking TIVICAY without your doctor’s advice. HIV can still be transmitted despite taking TIVICAY. TIVICAY does not cure HIV infection; it reduces the amount of virus in your body. While you are taking TIVICAY, you will need regular blood tests. For as long as you are taking TIVICAY, your doctor will arrange regular blood tests to check for side effects. There is more information about these side effects in this leaflet. See Possible Side Effects. Protect other people.

Do not share medicines prescribed for you with any other person. Always take TIVICAY exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The usual dose of TIVICAY is one 50 mg tablet, once a day. For people with HIV infection resistant to other medicines similar to TIVICAY, the usual dose of TIVICAY is one 50 mg tablet, twice a day.

Your doctor will decide on the correct dose of TIVICAY for you. Swallow the tablet with some liquid. TIVICAY can be taken with or without food. Your doctor will tell you how long your treatment with TIVICAY will last. Do not stop treatment unless your doctor advises you to. If you have the impression that the effect of TIVICAY is too strong or too weak for you, tell your doctor or pharmacist. If you take more TIVICAY than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre. If possible, show them the TIVICAY pack. If you forget to take or missed a dose of TIVICAY: 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. Effects when treatment with TIVICAY is stopped: Take TIVICAY for as long as your doctor recommends. Don’t stop unless your doctor advises you to. If you stop taking TIVICAY without your doctor’s recommendation, your HIV infection will flare up much stronger than before, and your HIV medicines might not work anymore.

TIVICAY can have side effects. Not all side effects reported for TIVICAY are included in this leaflet. Should your general health worsen while taking TIVICAY, please consult your doctor, pharmacist or other healthcare professional for advice.

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 TIVICAY. If you get any of these effects and if they are severe, your doctor may advise you to stop taking TIVICAY. As well as the effects listed below for TIVICAY, other conditions can develop during combination therapy for HIV (see Take special care with TIVICAY). If any of the following happens, see a doctor immediately: Allergic reactions: These appear less frequently in people taking TIVICAY. Signs 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.

➔ These are all very serious side effects. 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 TIVICAY. Frequent side effects:

• headache
• diarrhoea
• feeling sick (nausea)
• rash
• itching (pruritus)
• being sick (vomiting)
• stomach pain (upper abdominal pain)
• difficulty in sleeping (insomnia)
• dizziness
• abnormal dreams
• lack of energy (fatigue)
• wind (flatulence).

Less frequent side effects:

• inflammation of the liver (hepatitis)
• an inflammatory condition which may develop as the immune system becomes stronger (immune reconstitution syndrome or ‘IRIS’)
• allergic reaction (hypersensitivity) (see earlier in this section for more details)
• stomach (abdominal) discomfort.

Side effects that may show up in blood tests:

• increase in bilirubin (a substance produced by the liver) in the blood
• an increase in the level of enzymes produced in the muscles (creatine phosphokinase, creatinine)

➔ Tell your doctor or pharmacist if any of the side effects listed becomes severe or troublesome, or if you notice any side effects not listed in this leaflet.

Store all medicines out of reach of children.

• Store at or below 30 °C
• 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).