Olegra 50 mg Film-Coated Tablets

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

Do not take OLEGRA:

• If you are hypersensitive (allergic) to dolutegravir or any of the other ingredients of OLEGRA (listed in section 6),
• If you are already treated by the medicines called dofetilide or pilsicainide (these 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).

Warnings and precautions

Take special care with OLEGRA:

• 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 OLEGRA 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 OLEGRA without your doctor’s advice.

OLEGRA 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 OLEGRA. You should therefore use condoms during intercourse.

Children and adolescents

Consult your health care practitioner as OLEGRA is not recommended for use in children under 18 years of age.

Taking OLEGRA with food and drink:

OLEGRA 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 OLEGRA without checking with your doctor. Your doctor will consider the benefit to you and the risk to your baby of taking OLEGRA while you're pregnant. If you could get pregnant while receiving OLEGRA, 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 breast milk. If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking OLEGRA.

Driving and using machinery:

It is not always possible to predict to what extent OLEGRA may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which OLEGRA affects them. After taking OLEGRA you may get dizzy therefore do not drive or operate machinery unless you know what the effect of OLEGRA is on you.

Important information about some of the ingredients of OLEGRA:

OLEGRA contains mannitol and may have a laxative effect.

Taking other medicines with OLEGRA:

Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines) Do not take OLEGRA with the following medicines:

• Dofetilide or pilsicainide used to treat heart conditions,
• Metformin, which is used to treat diabetes.

OLEGRA may have an effect on other medicines or other medicines may have an effect on OLEGRA thus causing you to have side effects.

Tell your doctor if you are taking any of the following medicines:

• Medicines used to treat indigestion and heartburn called antacids should only be taken at least 6 hours before you take OLEGRA or 2 hours after taking OLEGRA.
• Calcium and iron supplements should also only be taken at least 6 hours before you take OLEGRA or 2 hours after taking OLEGRA.
• Etravirine, efavirenz, nevirapine, tipranavir/ritonavir, fosamprenavir/ritonavir which are all used in the treatment of HIV infection.
• Rifampicin which is used to treat tuberculosis.
• Phenytoin and phenobarbital which is used to treat epilepsy.
• Oxcarbamazepine and carbamazepine used to treat epilepsy and bipolar disorder.
• St. John’s wort, a herbal remedy for depression.

You should tell your doctor or pharmacist if you are taking any of these medicines. Your doctor will then decide to adjust your dose if required.

Do not share medicines prescribed for you with any other person. Always take OLEGRA exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The usual dose of OLEGRA is one 50 mg tablet, once a day. Your doctor will however decide on the best dose of OLEGRA for you. Your doctor will tell you how long your treatment with OLEGRA will last. If you have the impression that the effect of OLEGRA is too strong or too weak, tell your doctor or pharmacist.

If you take more OLEGRA 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 OLEGRA:

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.

If you stop taking OLEGRA

Consult your doctor if you stop or intend to stop taking OLEGRA.

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

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.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of OLEGRA.

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).