Aurovirar 50 mg Film-Coated Tablets

AUROVIRAR is a type of medicine known as an anti-retroviral (ARV). It belongs to a group of medicines called integrase inhibitors (INIs). AUROVIRAR is used to treat HIV (human immunodeficiency virus) infection in adults aged 18 years and older. AUROVIRAR is also used in combination therapy (i.e., AUROVIRAR with other anti-retroviral medicines).

Do not take AUROVIRAR:

• If you are hypersensitive (allergic) to dolutegravir or any of the other ingredients of AUROVIRAR.
• If you are already treated by the medicines called dofetilide or pilsicainide (this medicines are used to treat abnormal rate of muscle contractions in the heart).
• If you are treated by a medicine called metformin (this medicine is used for diabetes - lowering of sugar levels in the body).
• If you have any liver disease (mild to moderate).

Take special care with AUROVIRAR:

Tell your doctor:

• If you get any rash as it may be an indication that you are having an allergic reaction. You should stop taking AUROVIRAR and contact your doctor immediately if you get other symptoms of an allergic reaction such as fever, fatigue, muscle or joint aches, blisters, sores in your mouth, swelling of your feet or face.
• If you get any other symptoms of other serious infections, usually due to your already weakened immune system. When you start treatment you may find that old, hidden infections (such as tuberculosis) flares 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 against these infections.
• If you notice that there is a change in the distribution of fat throughout your body e.g. a hump forming on your back, loss of fat from your face, collection of fat around your abdomen.
• If you experience joint aches and pains, stiffness in your joints or any difficulty with movement, it may be an indication that your bones are being damaged.
• If you are taking any other medicines even if they are non-prescription. However do not stop taking AUROVIRAR without your doctor’s advice.

AUROVIRAR does not cure HIV infection, it only reduces the amount of virus in your blood therefore HIV can still be transmitted while you are taking AUROVIRAR. You should therefore use condoms during intercourse.

Taking AUROVIRAR with food and drink: AUROVIRAR can be taken with or without food.

Pregnancy and Breastfeeding: If you are pregnant, or think you could be, or if you are planning to have a baby, don’t take AUROVIRAR without checking with your doctor. Your doctor will consider the benefit to you and the risk to your baby of taking AUROVIRAR while you're pregnant. If you could get pregnant while receiving AUROVIRAR, you need to use a reliable method of contraception, to prevent pregnancy. It is not recommended to breastfeed your baby if you are HIV positive as HIV infection may be transmitted through the breast milk. If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking AUROVIRAR.

Driving and using machinery: After taking AUROVIRAR you may get dizzy therefore do not drive or operate machinery unless you know what the effect of AUROVIRAR is on you.

Important information about some of the ingredients of AUROVIRAR: AUROVIRAR contains mannitol and may have a laxative effect.

Taking other medicines with AUROVIRAR: Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines).

Do not share medicines prescribed for you with any other person. Always take AUROVIRAR exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The usual dose of AUROVIRAR is one 50 mg tablet, once a day. Your doctor will however decide on the best dose of AUROVIRAR for you.

Your doctor will tell you how long your treatment with AUROVIRAR will last. If you have the impression that the effect of AUROVIRAR is too strong or too weak, tell your doctor or pharmacist.

If you take more AUROVIRAR than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take AUROVIRAR: If you forget to take a dose, take it as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for forgotten individual doses.

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

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

• skin rash,
• fever,
• lack of energy,
• swelling of the face and mouth causing difficulty in breathing,
• muscle or joint aches.
• IRIS (development of other inflammatory reactions or infections when you begin treatment with AUROVIRAR.

These are very serious side effects therefore you should see your doctor as soon as possible or go to your nearest hospital.

The following side effects occur frequently:

• insomnia (difficulty in sleeping),
• headache,
• dizziness,
• abnormal dreams,
• nausea,
• diarrhoea (frequent and watery bowel movements),
• vomiting,
• flatulence (excessive gas/wind),
• upper abdominal pain,
• pruritus (an intense itching sensation),
• fatigue (temporary loss of strength and energy),
• depression.

The following side effects occur less frequently:

• abdominal pain,
• abdominal discomfort.
• allergic reactions,
• inflammation of the liver usually noticed by yellowing of your skin and nails,
• suicide attempts or thoughts about suicide.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store at or below 30 °C. Keep HDPE containers tightly closed. Keep the HDPE container in the pre-printed carton which contains the professional information. STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).