Trifalda 25 mg Film-Coated Tablets

TRIFALDA is a combination antiretroviral medicine and is used to treat Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and children weighing at least 40 kg. Limitation of Use: TRIFALDA alone is not recommended in patients with resistance-associated integrase substitutions or clinically suspected integrase strand transfer inhibitor resistance because the dose of TRIFALDA is insufficient in these subpopulations. See the full prescribing information for dolutegravir.

Do not take TRIFALDA if you:

• are hypersensitive (allergic) to dolutegravir, lamivudine, tenofovir alafenamide or any of the other ingredients of TRIFALDA (listed in Section 6 ).
• take dofetilide. Taking TRIFALDA and dofetilide can cause side effects that may be serious or life-threatening.
• If you have been diagnosed with severe liver disease.
• Co-administration with metformin, adefovir, pisicainide or didanosie.
• are pregnant or breast feeding your baby.
• are woman of childbearing age.
• a patient younger than 18 years.
• You have moderate or severe liver function.
• Uncontrolled kidney disease.

Warnings and Precautions

Take special care with TRIFALDA:

• If you have too much lactic acid in your blood (lactic acidosis) is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away If you experience symptoms such as weakness or being more tired than usual, unusual muscle pain, being short of breath of fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat.
• If you have an abnormal distribution of fat in the body including central obesity; buffalo hump (a build-up of fat between the shoulder blades); muscle and facial wasting and breast enlargement in HIV patients.
• Immune reconstitution inflammatory syndrome (IRIS): the worsening of a recognised or unrecognised pre-existing infection of improved immunologic function.
• If you suffer from Osteonecrosis, when blood flow to part of a bone is reduced.
• If you suffer from mitochondrial dysfunction (when the mitochondria, which is present in cells and function is to produce energy, fail to produce enough energy for the body to function properly).
• If you have been diagnosed with hepatitis B infection, your doctor will carefully consider the best treatment regimen for you. If you have hepatitis B infection, liver problems may become worse after you stop taking TRIFALDA. It is important not to stop taking TRIFALDA without talking to your doctor.

Do not share medicines prescribed for you with any other person. Always take TRIFALDA exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. TRIFALDA therapy should be initiated by a healthcare professional experienced in the management of HIV infections. Take TRIFALDA at the same time every day. Take TRIFALDA each day with or without food. If you take antacids, laxatives, or other medicines that contain aluminum, magnesium, or buffered medicines, TRIFALDA should be taken at least 2 hours before or 6 hours after you take these medicines. If you need to take iron or calcium supplements by mouth during treatment with TRIFALDA: If you take TRIFALDA with food, you may take these supplements at the same time that you take TRIFALDA. If you do not take TRIFALDA with food, take TRIFALDA at least 2 hours before or 6 hours after you take these supplements.

For adults and children weighing at least 40 kg, the usual dose of TRIFALDA is one tablet each day. Stay under the care of a healthcare provider during treatment with TRIFALDA. Do not run out of TRIFALDA. The virus in your blood may increase and the virus may become harder to treat. When your supply starts to run low, get more from your healthcare provider or pharmacy. Your healthcare professional will tell you how long your treatment with TRIFALDA will last. If you have an impression that the effect of TRIFALDA is too strong or too weak tell your healthcare professional or pharmacist. If you take more TRIFALDA 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 for help. If you forget to take TRIFALDA: If you forget to take a dose of TRIFALDA, take it as soon as you remember and then continue as before. Do not take a double dose to make up for missed individual doses. Effects when treatment with TRIFALDA is stopped: Do not stop treatment early because this may worsen your condition and make your body resistant to TRIFALDA.

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

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

• Swelling of the hands, feet, face, lips or throat which may cause difficulty swallowing or breathing, These are all very serious side effects. If you have them, you may have had a serious reaction to TRIFALDA . 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:

• Risk of inflammation of the pancreas (pancreatitis) . Children may be at risk for developing pancreatitis during treatment with TRIFALDA if they:
• have taken nucleoside analogue medicines in the past
• have a history of pancreatitis
• have other risk factors for pancreatitis
• Call your healthcare provider right away if your child develops signs and symptoms of pancreatitis including severe upper stomach-area pain, with or without nausea and vomiting . Your healthcare provider may tell you to stop giving TRIFALDA to your child if their symptoms and blood test results show that your child may have pancreatitis.
• New or worse kidney problems, including kidney failure . Your healthcare provider may do blood and urine tests to check your kidneys before and during treatment with TRIFALDA. Tell your healthcare provider if you get signs and symptoms of kidney problems, including bone pain that does not go away or worsening bone pain, pain in your arms, hands, legs or feet, broken (fractured) bones, muscle pain or weakness.
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time.
• Too much lactic acid in your blood (lactic acidosis) . Lactic acidosis is a serious medical emergency that can lead to death. Tell your healthcare provider right away if you get any of the following symptoms that could be signs of lactic acidosis:
• feel very weak or tired
• unusual (not normal) muscle pain
• trouble breathing
• stomach pain with nausea and vomiting
• feel cold, especially in your arms and legs
• feel dizzy or light-headed
• have a fast or irregular heartbeat

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:
• trouble sleeping,
• nausea,
• diarrhoea,
• tiredness,
• headache,
• dizziness,
• abnormal dreams,
• depression.
• Less frequent side effects:
• abdominal pain,
• abdominal discomfort,
• winds,
• stomach pain,
• vomiting,
• inflammation of the liver,
• inflammation of the muscle tissue,
• suicidal thoughts and behaviour,
• kidney problems,
• itching,
• increase in liver enzymes in the blood.
• Frequency unknown:
• increased weight,
• painful joints and muscles,
• liver failure,
• anxiety,
• accumulation of body fat,
• increase in blood sugar,
• weakness.

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. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the “ 6.04 Adverse Drug Reaction Reporting Form ”, found online under SAHPRA’s publications: http://www.sahpra.org.za/publications/index/8 . By reporting side effects, you can help provide more information on the safety of TRIFALDA .

Store all medicines out of reach of children. Store at or below 30 °C. Do not refrigerate. Store in the original packaging. Do not store in a bathroom. Keep the container tightly closed. Protect from moisture. Do not use TRIFALDA after the expiry date stated on the carton. Return all unused medicines to your pharmacist. Do not dispose unused medicines in drains or sewage systems. (e.g. Toilets)