Triovir 600 mg/200 mg/245 mg Film-Coated Tablets

• TRIOVIR contains efavirenz, emtricitabine and tenofovir belonging to a group of antiviral medicines, called as non-nucleoside reverse transcriptase inhibitors (NNRTIs), nucleoside reverse transcriptase inhibitors (NRTIs) and nucleotide reverse transcriptase inhibitors (NtRTIs) respectively and also known as antiretrovirals. They work by interfering with an enzyme (reverse transcriptase) that is essential for the virus to multiply.

• It is used to treat Human Immunodeficiency Virus (HIV-1) infection in adults aged 18 years and over. TRIOVIR can be given alone or in combination with other antiretrovirals.

Do not take TRIOVIR:

• if you are allergic to efavirenz, emtricitabine, tenofovir, tenofovir disoproxil or any of the other ingredients of TRIOVIR (listed in section 6).
• if you have severe liver disease.
• If you had a liver disorder or liver failure attributed to treatment with TRIOVIR.
• 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 your doctor has told you that you have high or low levels of electrolytes such as potassium or magnesium in your blood.
• If you have moderate to severe kidney problem or are undergoing kidney dialysis treatment.
• If you are pregnant or planning to become pregnant.
• If you are breastfeeding your baby.
• If you are younger than 18 years of age.
• if you are currently taking any of the following medicines (see also “Other Medicines and TRIOVIR”):
• astemizole or terfenadine (used to treat hay fever or other allergies)
• bepridil (used to treat heart disease)
• cisapride (used to increase emptying of stomach)
• elbasvir/grazoprevir (used to treat hepatitis C)
• ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraines and cluster headaches)
• midazolam or triazolam (used to help you sleep)
• pimozide, imipramine, amitriptyline or clomipramine (used to treat certain mental conditions)
• St. John’s wort (Hypericum perforatum) (a herbal preparation used for depression and anxiety)
• voriconazole (used to treat fungal infections)
• flecainide, metoprolol (used to treat irregular heartbeat)
• certain antibiotics (macrolides, fluoroquinolones, imidazole)
• triazole antifungal agents
• certain antimalarial agents
• methadone (used to treat opiate addiction)

Do not take TRIOVIR if you are already taking lamivudine/zidovudine, lamivudine, abacavir sulphate/lamivudine, abacavir sulphate/lamivudine/zidovudine, tenofovir disoproxil fumarate, efavirenz, emtricitabine or adefovir dipivoxil because these medicines contain the same or similar active ingredients. Discuss with your doctor if you are unsure whether the above applies to you.

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

• The usual dose of TRIOVIR is: one tablet once a day taken orally at about the same time each day.

• You should take TRIOVIR on an empty stomach.

• Swallow the TRIOVIR tablet whole with water.

• Taking TRIOVIR at bedtime may make some side effects less bothersome. Your doctor will tell you how long your treatment with TRIOVIR will last. Do not stop treatment early. If you have the impression that the effect of TRIOVIR is too strong or too weak, tell your doctor or pharmacist.

TRIOVIR is not recommended for patients less than 18 years of age.

If you take more TRIOVIR than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Take this leaflet and the rest of the remaining TRIOVIR with you so the doctor will know what you have taken.

If you accidentally take too many TRIOVIR tablets you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).

If you forget to take TRIOVIR It is important not to miss a dose of TRIOVIR. If you do miss a dose of TRIOVIR within 12 hours of when it is usually taken, take it as soon as you can, and then take your next dose at its regular time. If it is almost time (less than 12 hours) for your next dose anyway, do not take the missed dose. Wait and take the next dose at the regular time. Do not take a double dose to make up for a forgotten tablet.

If you throw up the tablet (within 1 hour after taking TRIOVIR), you should take another tablet. Do not wait until your next dose is due. You do not need to take another tablet if you were sick more than 1 hour after taking TRIOVIR.

Don’t stop taking TRIOVIR without talking to your doctor. Stopping TRIOVIR can seriously affect your response to future treatment. If TRIOVIR is stopped, speak to your doctor before you restart taking TRIOVIR tablets. Your doctor may consider giving you the components of TRIOVIR separately if you are having problems or need your dose adjusted. When your supply of TRIOVIR starts to run low, get more from your doctor or pharmacist. This is very important because the amount of virus may start to increase if the medicine is stopped for even a short time. The virus may then become harder to treat.

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

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

• Lactic acidosis (build-up of lactic acid in the blood). Lactic acidosis can be a medical emergency and may need to be treated in the hospital. Call your healthcare professional right away if you get the following signs of lactic acidosis:
• weakness and tiredness
• muscle pain
• stomach pain with nausea and vomiting
• fast, shallow breathing
• dizzy and lightheaded
• a fast and irregular heartbeat

• Allergic reaction (hypersensitivity) to TRIOVIR which include:

• severe skin reactions (including red spots or blotches sometimes with blistering and swelling of the skin)
• swelling of the face, lips, tongue or throat

• Serious psychiatric problems. Some patients may experience severe depression, strange thoughts, thoughts of suicide or angry behaviour, paranoia, unable to think clearly, mood being affected, seeing or hearing things that are not really there (hallucinations), personality change (psychosis), catatonia (a condition in which the patient is rendered motionless and speechless for a period), while taking TRIOVIR. Contact your doctor right away if you think you are having these psychiatric symptoms. These are all very serious side effects. If you have them, you may have had a serious reaction to TRIOVIR. 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:

• Serious liver problems (hepatotoxicity) with liver enlargement (hepatomegaly) and fat in the liver (Steatosis). Call your healthcare professional right away if you get any of the following signs of liver problems:
• yellow discolouration of your skin and the white part of your eyeballs
• darkening of your urine
• bowl movements turn lighter in colour
• nauseous
• stomach 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:
• dizziness, headache, diarrhoea, feeling sick (nausea), being sick (vomiting)
• feeling weak
• decreases in phosphate levels in the blood
• increased levels of creatine kinase in the blood that may result in muscle pain and weakness
• disturbances of coordination and balance
• feeling worried or depressed
• difficulty sleeping, abnormal dreams, difficulty concentrating, drowsiness
• pain, stomach pain
• problems with digestion resulting in discomfort after meals, feeling bloated, wind (flatulence)
• loss of appetite
• tiredness
• itching
• changes in skin colour including darkening of the skin in patches often starting on hands and soles of feet
• low white blood cell count (a reduced white blood cell count can make you more prone to infection)
• liver and pancreas problems
• increased fatty acids (triglycerides), bilirubin or sugar levels in the blood

Less frequent side effects:

• breakdown of muscle, muscle pain or weakness
• anaemia (low red blood cell count)
• a feeling of spinning or tilting (vertigo), whistling, ringing or other persistent noise in the ears
• blurred vision
• chills
• breast enlargement in males
• decreased sexual drive
• flushing
• dry mouth
• increased appetite
• decreases in potassium in the blood
• increases in creatinine in the blood
• proteins in urine
• increased cholesterol in the blood
• The breakdown of muscle, softening of the bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood may occur due to damage to kidney tubule cells.
• itchy rash to the skin caused by a reaction to sunlight

Side effects with unknown frequencies include:

• accumulation of body fat
• skin discolouration
• itchy skin
• flushing
• nail disorders
• lack of energy and strength
• excessive urination
• muscle pain and weakness
• constipation, improper absorption of food.
• increase in Amylase (enzyme in body that breaks down starch)
• breathing difficulty
• palpitations
• loss of sensation
• loss of position sense resulting in improper movement.
• Impaired coordination
• excessive sleepiness
• fat accumulation
• brain disease
• coma
• anxiousness
• increased urination and renal disease

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 or 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 TRIOVIR.

• TRIOVIR tablets should be stored at or below 30 °C.

• The bottle should be kept tightly closed and the silica gel sachet should not be removed from the bottle after opening.

• Protect from moisture and light.

• Keep well closed.

• Keep out of reach of children.

• Any unused medicine or waste material should be returned to the pharmacy for destruction.

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

• Do not store in bathrooms.

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