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

TEERENZ contains three active ingredients that are used to treat HIV-infection:

• Efavirenz is a non-nucleotide reverse transcriptase inhibitor (NNRTI)
• Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI)
• Tenofovir is nucleotide reverse transcriptase inhibitor (NtRTI)

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

TEERENZ is a treatment for HIV infection in adults aged 18 years and older. TEERENZ may be given alone or with other anti-retroviral medicines.

Do not take TEERENZ:

• if you are hypersensitive (allergic) to efavirenz, emtricitabine, tenofovir or any of the other ingredients of TEERENZ (listed in section 6);
• if you have a severe kidney disease;
• if you had a liver disorder or liver failure attributed to treatment with TEERENZ.
• if you have a heart condition; or
• if you are currently taking any of the following medicines:

• terfenadine, astemizole (used to treat hay fever or other allergies);
• bepridil (used to treat heart disease);
• cisapride (used to treat heartburn);
• 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 (used to treat certain mental conditions);
• St. John’s wort (Hypericum perforatum) (an herbal preparation used for depression and anxiety);
• voriconazole (used to treat fungal infections);

If you are taking any of the above medicines, tell your doctor immediately. Taking these medicines with TEERENZ could cause serious or life-threatening side effects or stop these medicines from working properly.

Warnings and precautions

Take special care with TEERENZ

• if you have or have had kidney disease, or if tests have shown problems with your kidneys. TEERENZ is not recommended if you have moderate to severe kidney disease. TEERENZ may affect your kidneys. Before starting treatment, your doctor may order blood tests to assess kidney function. Your doctor may also order blood tests during treatment to monitor your kidneys.
• if you have a history of mental illness, including depression, or of substance or alcohol abuse. Tell your doctor immediately if you feel depressed, have suicidal thoughts or have strange thoughts (see section 4, Possible side effects);
• if you have a history of convulsions (fits or seizures) or if you are being treated with anticonvulsant therapy such as carbamazepine, phenobarbital and phenytoin. If you are taking any of these medicines, your doctor may need to check the level of anticonvulsant medicine in your blood to ensure that it is not affected while taking TEERENZ. Your doctor may give you a different anticonvulsant;
• if you have a history of liver disease, including chronic active hepatitis. Patients with liver disease including chronic hepatitis B or C, who are treated with combination antiretrovirals, have a higher risk of severe and potentially life-threatening liver problems. Your doctor may conduct blood tests in order to check how well your liver is working or may switch you to another medicine. If you have severe liver disease, do not take TEERENZ;
• if you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you. Tenofovir disoproxil and emtricitabine, two of the active substances in TEERENZ, show some activity against hepatitis B virus although emtricitabine is not approved for the treatment of hepatitis B infection. Symptoms of your hepatitis may become worse after discontinuation of TEERENZ. Your doctor may then conduct blood tests at regular intervals in order to check how well your liver is working (see section 3, If you stop taking TEERENZ);
• if you have a liver problem or independent of a history of liver disease, your doctor will consider regular blood tests to check how your liver is working;
• if you are over 65. Insufficient numbers of patients over 65 years of age have been studied. If you are over 65 years of age and are prescribed TEERENZ, your doctor will monitor you carefully;
• if you are younger than 18 years old.

Tell your doctor, pharmacist or healthcare professional before taking TEERENZ:

• If you have a history of kidney problems, more frequent monitoring may be needed, as your kidney function and serum phosphate should be checked before and during treatment.
• If a skin rash occur. These may appear within the first 2 weeks of starting and may resolve within a month of continued treatment. TEERENZ treatment should be stopped if a severe skin rash, with blistering, scaling, mucosal involvement, or fever, develops.
• TEERENZ may cause lowering of your bone density, therefore you should be checked for bone abnormalities; especially if you have a history of bone fractures or are at risk of low bone mass.
• If you notice any of the following: redistribution/accumulation of body fat including increased body fat, “buffalo hump” - lump of fat on the back of the neck, bodily swelling, facial swelling, breast enlargement, and "cushingoid appearance” (a disease with moon face appearance) may occur.
• If you notice any signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
• 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.
• Continue to use appropriate precautions as TEERENZ does not prevent transmission of HIV to others through sexual contact or blood contamination.
• Some medicines may interact with TEERENZ (see Other medicines and TEERENZ).

Do not share medicines prescribed for you with any other person. Always take TEERENZ exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The usual dose for adults is one tablet taken each day by mouth. TEERENZ should be taken on an empty stomach preferably at bedtime. Dosing at bedtime may help to make some side effects (for example, dizziness, drowsiness) less troublesome. Swallow the tablet whole with water. Your doctor will tell you how long your treatment with TEERENZ will last. If you have the impression that the effect of TEERENZ is too strong or too weak, tell your doctor or pharmacist.

If you take more TEERENZ 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 any remaining tablets with you, so that the doctor knows what you have taken. You may experience an increase in side effects and their frequency. You might get symptoms caused by TEERENZ such as nervous system side effects, including e.g. agitation, memory loss, confusion, dizziness, abnormal sense of well-being, headache, sleeplessness or sleepiness, impaired concentration, abnormal thinking or dreaming, convulsions, feeling of not being part of your body or surroundings, and seeing, hearing or feeling things that are not there.

If you forget to take TEERENZ

Do not miss a dose of TEERENZ. If you forget to take a tablet, take the missed dose right away, unless it is almost time for your next dose. Do not take a double dose to make up for forgotten individual doses.

If you stop taking TEERENZ

Don’t stop taking TEERENZ without talking to your doctor. Stopping TEERENZ can seriously affect your response to future treatment. If TEERENZ is stopped, speak to your doctor before you restart taking TEERENZ tablets. Your doctor may consider giving you the components of TEERENZ separately if you are having problems or need your dose adjusted.

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

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

• if you develop rapid breathing, drowsiness and /or feeling sick (nausea), being sick (vomiting) and stomach pain. This is a rare but serious side effect called lactic acidosis that can be fatal.
• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,

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

• allergic reaction (hypersensitivity) that may cause severe skin reactions (Stevens-Johnson syndrome, erythema multiforme),
• angry behaviour, suicidal thoughts, strange thoughts, paranoia, unable to think clearly, mood being affected, seeing or hearing things that are not really there (hallucinations), suicide attempts, personality change (psychosis),
• pain in the abdomen (stomach), caused by inflammation of the pancreas,
• forgetfulness, confusion, fitting (seizures), incoherent speech, tremor (shaking),
• yellow skin or eyes, itching, or pain in the abdomen (stomach) caused by inflammation of the liver,
• liver failure, in some cases leading to death or liver transplant,
• inflammation of the kidney, passing a lot of urine and feeling thirsty, damage to kidney tubules,
• back pain caused by kidney problems, including kidney failure.
• Your doctor may do blood tests to see if your kidneys are working properly,
• softening of the bones (with bone pain and sometimes resulting in fractures) which may occur due to damage to the kidney tubule cells,
• Combination antiretroviral therapy (such as TEERENZ) may change your body shape, by changing the way body fat is distributed. You may lose fat from your legs, arms and face; gain fat around the abdomen (tummy) and internal organs; get larger breasts or fatty lumps on the back of the neck. The cause and the long-term effects of these changes are not yet known.

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:

• feeling down, feeling anxious, abnormal dreams, struggle to sleep,
• being unbalanced, having trouble with coordination, having trouble to focus, dizziness, headache,
• diarrhoea, feeling sick (nausea), being sick (vomiting), stomach pain, indigestion, feeling windy and bloated after a meal,
• rashes (including red spots or blotches sometimes with blistering and swelling of the skin) which may be allergic reactions, change in skin colour, dry skin patches,
• feeling weak, pain, abnormal physical weakness or lack of energy.

Less frequent side effects

• blurred vision,
• a feeling of spinning or tilting (vertigo), whistling, ringing or other persistent noise in the ears,
• reddening of the skin,
• itchy rash to the skin caused by a reaction to sunlight,
• breast enlargement in males,
• breakdown of muscle, muscle pain.

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 TEERENZ.

Store all medicines out of reach of children.

Store at or below 25 °C.

Store in the original package. Keep the bottle tightly closed and the silica gel should not be removed from the bottle after opening.

Do not store your medicine in the bathroom.

Do not use TEERENZ after the expiry date stated on the label or container. Return any expired or unused medicine to your pharmacist for safe disposal.

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