Sonke Efavirenz Capsules

SONKE EFAVIRENZ is used in combination with other medicines (antiretrovirals) for the treatment of HIV infection in adults, adolescents and children weighing 13 kg and above, and/or 3 years and above.

Do not take SONKE EFAVIRENZ

• If you are hypersensitive (allergic) to efavirenz or any of the other ingredients of SONKE EFAVIRENZ (listed in section 6).
• If you are pregnant or planning to become pregnant or are breastfeeding.
• If you had a liver disorder or liver failure attributed to treatment with SONKE EFAVIRENZ.
• If you are taking any of the following medicines:
• Ergot derivatives such as ergotamine tablets – used for treatment of migraine.
• Terfenadine or astemizole – used for treatment of allergies.
• Cisapride – used for treatment of digestive problems.
• Midazolam or triazolam – used as tranquilizers/sedatives.
• Bepridil – used to treat heart disease.
• Pimozide – used to treat certain mental conditions.
• SONKE EFAVIRENZ 200 capsules: Children less than 3 years or weighing less than 13 kg and adults weighing less than 13 kg.
• SONKE EFAVIRENZ 600 tablets: Adults and children who weigh less than 40 kg.

Warnings and precautions

• SONKE EFAVIRENZ must not be used as a single medicine to treat HIV. It must always be used in combination with other medicines (antiretrovirals).
• This medicine helps to control your condition, but it is not a cure for the HIV infection. You may continue to develop other infections or other illnesses associated with the HIV disease.

Take special care with SONKE EFAVIRENZ:

• If you have problems with your liver.
• If you develop a severe rash associated with blistering, fever, etc.
• If you have a history of mental illness (e.g. severe depression) or substance abuse.
• If you have a history of convulsions (fits or seizures).
• If you have a heart disorder, such as abnormal electrical signal called prolongation of the QT interval.

Do not share medicines prescribed for you with any other person. Always take SONKE EFAVIRENZ exactly as your doctor or pharmacist has told you. Check with your doctor, pharmacist or nurse if you are not sure.

The usual adult dosage for patients weighing more than 40 kg is 3 SONKE EFAVIRENZ 200 capsules or 1 SONKE EFAVIRENZ 600 tablet once daily in combination with other anti-retroviral medicines. For children under 17 years, the dose will be decided by the doctor based on the child’s weight. For children weighing more than 40 kg, the dose is the same as the adult dose. SONKE EFAVIRENZ 200 must not be used in children less than 3 years of age or less than 13 kg weight. SONKE EFAVIRENZ 600 tablets can only be used in adults and children who weigh greater than or equal to 40 kg.

Swallow the capsule or tablet whole with a glass of water. SONKE EFAVIRENZ may be taken with or without food. You should avoid taking SONKE EFAVIRENZ with fatty meals. For best results, you may take this medicine at bedtime.

To help you remember to take your medicine, try to get into the habit of taking it at the same time each day. Your doctor will tell you how long your treatment with SONKE EFAVIRENZ will last.

If you have the impression that the effect of SONKE EFAVIRENZ is too strong or too weak, tell your doctor or pharmacist.

If you take more SONKE EFAVIRENZ 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. Take this leaflet or some capsules or tablets with you so your doctor will know what you have taken.

If you forget to take SONKE EFAVIRENZ

Do not take a double dose to make up for forgotten individual doses.

If you stop taking SONKE EFAVIRENZ

Take your capsules/tablets as directed and for as long as directed. Do not stop them, even if you feel better, as the symptoms may return.

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

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

• Rashes, hives, itching, chest constriction, shortness of breath or swelling of the face, lips, hands/feet, fainting, high temperature.
• Severe skin reactions with blisters, sores or ulceration. These are all very serious side effects. If you have them, you may have had a serious reaction to SONKE EFAVIRENZ. 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:

• Depressed mood, strange thoughts, hallucinations.
• Fast or irregular heartbeat.
• Yellowing of skin and whites of eyes with decreased appetite, abdominal pain. 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:

• Increased triglycerides (fatty acids) in the blood.
• Rapid or exaggerated changes in mood, seeing or hearing things (hallucination).
• Dizziness, impaired concentration, headache, excessive sleepiness, difficulty in sleeping.
• Nausea, vomiting, loose stools.
• Increased sweating.
• Tiredness, abnormal physical weakness or lack of energy.

Less frequent side effects:

• Increased cholesterol in the blood.
• Mania, paranoia, suicidal thoughts, suicide attempt or completed suicide, delusion, neurosis.
• Abnormal dreams, loss of appetite, numbness, problems with balance or coordination, seizures, pins and needles sensation or nerve pain especially in the hands and feet, uncontrolled shaking (tremor), agitation, memory loss, anxiety, indifference, increased appetite, confusion, decreased or increased sexual desire or ability, speech disorder, a feeling of spinning or tilting (vertigo).
• Blurred vision.
• Ringing in ears.
• Flushing.
• Heartburn, pain in the abdomen (stomach) caused by inflammation of the pancreas.
• Inflammation of the liver, increased liver enzymes in the blood.
• Hair loss, skin problems.
• Joint and muscle pain.
• Breast enlargement in males.
• Altered sense of taste, a general sense of being unwell, fainting.

Frequency unknown:

• Weight gain or weight loss.
• Sinusitis, difficulty in breathing, respiratory infection.
• Gastrointestinal disturbances, acid reflux, constipation.
• Liver failure.
• Acne, oily skin, nail disorders, discolouration of the skin.
• Muscle disorders.
• Intolerance to alcohol, hot flushes, flu-like symptoms, pain, redistribution/accumulation of body fat.

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 SONKE EFAVIRENZ.

• Store all medicines out of reach of children.
• Store at or below 25 °C in the original package, protected from moisture. Do not remove the blister strip from the carton until required for use. Keep the bottle tightly closed.
• Do not store in a bathroom.
• Do not use after the expiry date stated on the label/ bottle.
• Return all unused medicines to your pharmacist.
• Do not dispose of unused medicines in drains or sewerage systems (e.g. toilets).