Teralavid 50 mg Film-Coated Tablets

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

Do not take TERALAVID:

• If you are hypersensitive (allergic) to dolutegravir or any of the other ingredients of TERALAVID (listed in section 6).
• If you are also taking medication for irregular heart beat containing dofetilide or pilsicainide.
• If you have moderate or severe liver disease.
• If you are taking metformin for the treatment of diabetes.
• If you are in your first trimester of pregnancy.

Warnings and precautions

Take special care with TERALAVID: Tell your doctor

• If you develop changes in body fat, which may include increased fat in the upper back and neck areas (“buffalo hump”), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also happen.
• If you show any symptoms of infection while you are taking TERALAVID. Patients with advanced HIV infection (AIDS) have weak immune systems and are more likely to develop serious infections (opportunistic infections). When these patients start with the treatment, they may find that old hidden infections (such as tuberculosis, pneumonia) flare up, causing signs and symptoms of inflammation (such as localised swelling, area appears red and hot, painful). These symptoms are probably caused by the body’s immune system becoming stronger, so that the body starts to fight these infections.
• If you experience joint aches and pain, joint stiffness or difficulty in movement or bone fractures, you may suffer from condition called osteonecrosis for which you may need treatment.
• If you have or have had problems with your liver, including hepatitis B and/or C. Your doctor may evaluate how severe your liver disease is before deciding if you can take TERALAVID and you may need regular liver function tests.

Special care should be taken with TERALAVID: TERALAVID does not reduce the risk of passing HIV on to other people through sexual contact or blood contamination. Therefore, it is important to continue to take appropriate precautions to prevent passing HIV on to others. Even if you are receiving treatment for HIV, you are still at risk of contracting other infections and other complications of the HIV infection. Therefore, you should remain under close observation by your doctor.

Children and adolescents

TERALAVID should not be used in children under the age of 18 years, as safety has not been established.

Other medicines and TERALAVID

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

• Dofetilide or pilsicainide (used to treat irregular heart beat).
• Metformin (used for the treatment of diabetes).

TERALAVID may have an effect on other medicines or other medicines may have an effect on TERALAVID thus causing you to have side effects. Tell your doctor if you are taking any of the following medicines:

Do not share medicines prescribed for you with any other person. Always TERALAVID exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose of TERALAVID is one 50 mg film-coated tablet, taken orally, once a day, with or without food. Film-coated tablets must be swallowed whole with water and must not be crushed or chewed.

For HIV that is resistant to other medicines similar to TERALAVID, the usual dose is 50 mg, twice a day. TERALAVID should only be used by adults and should not be taken by patients younger than 18 years of age. Your doctor will decide on the correct dose of TERALAVID for you.

If you take more TERALAVID 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 you forget to take TERALAVID

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 TERALAVID

Your doctor will tell you how long your treatment with TERALAVID will last. Do not stop treatment early because this may worsen your condition and make your body resistant to the medicine.

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

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

• Swelling of the hands, feet ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to TERALAVID. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• IRS (Immune reconstitution syndrome): 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 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. In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
• Swelling (inflammation) of the liver (hepatitis), that may include the following symptoms: Fatigue (tiredness). Nausea and vomiting. Stomach pain or discomfort, especially in the area of your liver on your right side beneath your lower ribs. Clay-coloured bowel movements. Loss of appetite. Fever. Dark urine. Joint pain. Yellowing of the skin and eyes (jaundice).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects

• Insomnia (difficulty in sleeping).
• Headache.
• Dizziness.
• Abnormal dreams.
• Nausea and vomiting.
• Diarrhoea.
• Flatulence (excessive gas/ wind).
• Upper abdominal pain.
• Fatigue (feeling tired).

Less frequent side effects

• Abdominal pain or discomfort.

The following side effects have also been reported (frequency not known)

• Anxiety.
• Damage to the liver or liver failure (signs may include yellowing of the skin and the whites of the eyes or unusually dark urine).
• Muscle pain.
• Inflammation and sore joints.
• Increase in weight.

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 TERALAVID.

Store at or below 30 °C in the original container. Keep the container tightly closed. After first opening, store at or below 25 °C in the original container and use within 30 days (28’s and 30’s tablets) or 90 days (84’s and 90’s tablets) after first opening. STORE ALL MEDICINES OUT OF REACH AND SIGHT OF CHILDREN. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).