Aurogra 50 mg Film-Coated Tablets

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

Do not take AUROGRA:

• If you are hypersensitive (allergic) to dolutegravir or any of the other ingredients of AUROGRA.
• 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 AUROGRA:

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 AUROGRA 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 AUROGRA without your doctor’s advice.

AUROGRA 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 AUROGRA. You should therefore use condoms during intercourse.

Taking AUROGRA with food and drink: AUROGRA 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 AUROGRA without checking with your doctor. Your doctor will consider the benefit to you and the risk to your baby of taking AUROGRA while you're pregnant. If you could get pregnant while receiving AUROGRA, 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 AUROGRA.

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

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

Taking other medicines with AUROGRA: 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 AUROGRA exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The usual dose of AUROGRA is one 50 mg tablet, once a day. Your doctor will however decide on the best dose of AUROGRA for you.

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

If you take more AUROGRA 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 AUROGRA: 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.

AUROGRA can have side effects. 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).