Triploco 600 mg/200 mg/300 mg Film-Coated Tablets

TRIPLOCO contains three active substances that are used to treat human immunodeficiency virus (HIV) infection: efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI), emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and tenofovir is a nucleotide reverse transcriptase inhibitor (NRTI).

Each of these active substances, also known as antiretroviral medicines, work by interfering with an enzyme (reverse transcriptase) that is essential for the virus to multiply.

TRIPLOCO can be used alone as a complete regimen or in combination with other anti- retroviral medicines for the treatment of HIV-1 infection in adults.

Do not take TRIPLOCO:

• If you are hypersensitive (allergic) to efavirenz, emtricitabine and/or tenofovir disoproxil fumarate or any of the other ingredients of TRIPLOCO (listed in section 6).
• You had a liver disorder or liver failure attributed to treatment with TRIPLOCO.
• If you have moderate to severe kidney failure.
• If you are pregnant or breastfeeding.
• If you have a heart condition, such as an abnormal electrical signal called prolongation of the QT interval that puts you at high risk for severe heart rhythm problems (Torsade de Pointes).
• If any member of your family (parents, grandparents, brothers or sisters) has died suddenly due to a heart problem or was born with heart problems.
• If your doctor has told you that you have high or low levels of electrolytes such as low potassium or low magnesium in your blood.
• If you are also taking the following medicines: antiarrhythmics of classes IA and III, neuroleptics, antidepressants, terfenadine, astemizole, bepridil, cisapride, ergot derivatives, midazolam, pimozide, triazolam, voriconazole, St. John’s wort, flecainide, certain antibiotics (macrolides, fluoroquinolones, imidazole), triazole antifungals, certain antimalarial medicines and methadone.

Do not take TRIPLOCO with the following related medicines:

• Medicines containing the same active ingredients as TRIPLOCO such as emtricitabine, tenofovir disoproxil fumarate, emtricitabine/tenofovir disoproxil fumarate and efavirenz.
• Medicines containing lamivudine, which is similar to emtricitabine including lamivudine/zidovudine, lamivudine, abacavir sulphate/lamivudine or abacavir sulphate/lamivudine/zidovudine (see Other medicines and TRIPLOCO).

Do not share medicines prescribed for you with any other person. Always take TRIPLOCO exactly as your doctor or pharmacist has instructed you. You should check with your doctor or pharmacist if you are unsure.

Take one tablet daily on an empty stomach. Taking TRIPLOCO at bedtime may improve the tolerability of nervous system symptoms. Take your dose with water. Do not stop taking TRIPLOCO unless your doctor has told you so. Taking your dose at the same time each day will have the best effect in controlling your viral load and will help you remember when to take the tablets. Always get more tablets before your current supply is finished in order to avoid ever skipping a dose.

Children

TRIPLOCO is not recommended for use in patients under the age of 18 years.

Kidney failure

TRIPLOCO should not be used by patients who need dose adjustment because it is a fixed dose tablet. If your creatinine clearance is less than 50 ml/min you may not use TRIPLOCO.

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

If you take more TRIPLOCO 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 TRIPLOCO

Take a missed dose as soon as you remember it. However, if it is almost time for your next dose rather leave it and continue with your normal schedule. Do not take a double dose to make up for forgotten individual doses. If you miss more than one dose, rather leave those doses and resume with the normal schedule when the time comes to take your normal dose. Please consult your doctor or pharmacist if you are not sure about your dosing.

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

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

• Allergic reaction, e.g. skin rash, itching.
• Erythema multiforme (skin disorder occurring due to allergic reaction and its symptoms may include fever, itching, joint aches and multiple skin lesions).
• Stevens-Johnson syndrome (life-threatening skin disorder whereby the outmost part of skin peels off).

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to TRIPLOCO. 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:

• Suicidal thoughts or attempts.
• Increased susceptibility to infection, for example, coughing, flu-like symptoms, pneumonia.
• Diarrhoea.
• Shortness of breath.
• Irregular heartbeat.
• Seizures or fits.
• Bone pain.
• Loss of bone mass.

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

Tell your doctor if you notice any of the following:

• Anorexia (severely resisting food due to irrational fear of gaining weight).
• Aggressive behaviour.
• Impaired concentration.
• Anxiety.
• Nervousness.
• Sleeplessness.
• Euphoria (intense feeling of happiness and excitement for no apparent reason).
• Confusion.
• Depersonalisation.
• Hallucination.
• Agitation.
• Being paranoid.
• Partial loss of sensation and drowsiness.
• Forgetfulness.
• Abnormal thoughts or dreams.
• Headache.
• Fatigue.
• Increased sweating.
• Mild to severe depression, or mania.
• Feeling of tingling or prickling, or numbness.
• Vomiting.
• Flatulence.
• Breast growth in men and females.
• Indigestion.
• Constipation.
• Bloatedness.
• Abdominal pain.
• Abnormal vision.
• Back pain.
• Joint pain and muscle pain.
• Dizziness.
• Feeling weak or sickly.
• Sensation of ringing in the ears.
• Frequent urination.
• Lack of voluntary coordination of movements, speech and movements such as walking may be affected.
• Tremors.
• Changes in body fat resulting in formation of buffalo hump-like structure on the trunk, weight gain in and around the stomach area, loss of weight on the limbs and face.
• Skin discolouration.
• Photoallergic skin reactions.

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 Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who- umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of TRIPLOCO.

• Store all medicines out of the reach of children.

• Store at or below 25 °C.

• Store TRIPLOCO in the original container.

• Keep the container tightly closed in order to protect the medicine from light and moisture.

• Do not store in a bathroom.

• Do not use after the expiry date stated on the label/carton /bottle.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).