Trieta Efavirenz 400 mg/300 mg Film-Coated Tablets

TRIETA film coated tablets is used in the treatment of acquired immune deficiency syndrome (AIDS) in adults over 18 years of age. TRIETA will not cure or prevent HIV infection or AIDS; however, it helps to keep the HIV virus from reproducing and to slow down the destruction of the immune system. TRIETA will not keep you from spreading HIV to other people.

Do not take TRIETA if you:

• are hypersensitive (allergic) to tenofovir disoproxil fumarate, lamivudine or efavirenz or to any of the other ingredients of TRIETA. (see section 6)
• have had liver problems when taking efavirenz previously
• have severe liver problems
• have moderate to severe kidney problems
• If you are pregnant or breastfeeding your baby
• If you are taking medicines containing any of the following: terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, ergot alkaloids, St John’s wort (Hypericum perforatum), zalcitabine or with elbasvir/grazoprevir

Warnings and precautions

Redistribution, accumulation or loss of body fat may occur. Contact your doctor if you notice changes in body fat.

Do not share medicines prescribed for you with any other person. Always take TRIETA exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is one TRIETA tablet once daily taken orally on an empty stomach.

Your doctor will tell you how long your treatment with TRIETA will last. If you have the impression that the effect of TRIETA is too strong or too weak, tell your doctor or pharmacist.

If you take more TRIETA 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 TRIETA

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

If you stop taking TRIETA

You should not stop treatment unless your doctor instructs you to. When your TRIETA supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to TRIETA and become harder to treat.

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

If any of the following happens, stop taking TRIETA 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 TRIETA. You may need urgent medical attention or hospitalisation.

The following are signs of serious liver problems (hepatitis):

• Yellow discolouration of the skin and the white part of your eyeballs
• Darkening of your urine
• Your bowel movements turn lighter in colour
• You feel sick to your stomach (nausea)
• You have stomach pain.

You may need urgent medical attention or hospitalisation.

The following are signs of a serious condition called lactic acidosis (build-up of acid in the blood). Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• You feel very weak or tired
• You have unusual (not normal) muscle pain
• You have trouble breathing
• You have stomach pain with nausea and vomiting
• You feel cold, especially in your arms and legs
• You feel dizzy or lightheaded
• You have a fast or irregular heartbeat.

This side effect can cause inflammation of the pancreas, liver and kidney failure, and has occasionally been fatal. Lactic acidosis also occurs more often in women, particularly if they are overweight. If you have liver disease, you may also be more at risk of getting this condition. While you are being treated with TRIETA, your doctor will monitor you closely for any signs that you may be developing lactic acidosis.

Tell your doctor if you notice any of the following:

• Frequent:
• dizziness
• diarrhoea, nausea, vomiting, flatulence (wind)
• headache, insomnia (difficulty sleeping)
• cough, nose symptoms
• stomach pain or cramps
• rash, loss of hair
• joint pain, muscle problems
• fatigue (weakness), malaise (feel unwell), fever
• anxiety, depression
• abnormal dreams, disturbance in attention
• sleepiness
• itching.

Less frequent:

• lactic acidosis (build-up of acid in the blood)
• shortness of breath
• inflammation of the pancreas, which causes severe pain in the abdomen and back

increases in enzymes produced by the liver, liver disease

kidney problems

asthenia (lack of energy)

low white blood cell count, low red blood cell count, increased bruising, or bleeding (thrombocytopenia), bone marrow stops making red blood cells (pure red cell aplasia)

peripheral neuropathy (when the nerves carrying messages to and from the brain are damaged)

rhabdomyolysis (muscle breaks down causing muscle pain, weakness, vomiting and confusion)

allergy

aggression, unrealistic feeling of wellbeing, false perceptions, mania, paranoia, suicide thoughts or attempts

agitation, memory loss, loss of muscle coordination, abnormal coordination, confusion, fits, abnormal thinking, blurred vision

erythema multiforme (skin eruption)

increased size of male breasts.

Frequency not known:

• myopathy (muscle weakness and wasting), osteomalacia (rickets)
• kidney inflammation.

Changes in body fat. Changes in body fat develop in some patients taking TRIETA. These changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), in the breasts and around the trunk. Loss of fat from the legs, arms and face may also happen. The cause and long-term health effects of these fat changes are not known.

Opportunistic infections. 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 an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately.

Osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). You must contact your doctor if you experience joint aches and pain, joint stiffness or difficulty in movement. 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 or to Cipla Medpro (Pty) Ltd. by e-mail: [email protected] or telephone 080 222 6662 (toll free). By reporting side effects, you can help provide more information on the safety of TRIETA.

Store all medicines out of reach of children. Store at or below 30 °C. Store in the original container. Do not remove from the carton until required for use. Keep the container tightly closed.