Mylataf Film-Coated Tablets

MYLATAF is used to treat Human Immunodeficiency Virus (HIV - 1) infection in adults and children who weigh at least 40 kg. HIV - 1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

Do not take MYLATAF:

• If you are hypersensitive (allergic) to emtricitabine, tenofovir alafenamide or dolutegravir, or any of the other ingredients of MYLATAF (listed in section 6).
• If you take medicine containing dofetilide or pilsicainide, as taking them with MYLATAF can cause serious or life-threatening side effects.
• If you are taking medicine containing metformin.
• If you have moderate or severe hepatic impairment.
• If you have severe renal disease.
• If your doctor has told you that your HIV - 1 has the K65R mutation.
• If you are pregnant or breastfeeding.

Warnings and precautions

Lactic acid build up in the body (causes nausea, vomiting, rapid deep breathing, and generalised weakness) and enlarged liver and fatty liver, have been reported with the use of some medicines for HIV alone or in combination with other antiretrovirals.

Do not share medicines prescribed for you with any other person. Always take MYLATAF exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is one tablet taken once daily with or without food. Your doctor will tell you how long your treatment with MYLATAF will last.

Do not run out of MYLATAF tablets. The virus in your blood may increase and the virus may become harder to treat. If you have the impression that the effect of MYLATAF is too strong or too weak, tell your doctor or pharmacist.

If you take more MYLATAF 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 MYLATAF

Do not take a double dose to make up for forgotten individual doses. Do not miss a dose of MYLATAF. If you miss a dose of MYLATAF take it as soon as you remember.

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

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

• Fever
• Generally ill feeling
• Tiredness
• Muscle or joint aches
• Blisters or sores in the mouth
• Blisters or peeling of the skin
• Redness or swelling of the eyes
• Swelling of the mouth, face, lips or tongue
• Difficulty in swallowing or breathing

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to MYLATAF. You may need urgent medical attention or hospitalisation.

Worsening of hepatitis B virus infection: MYLATAF tablets are not for use to treat chronic hepatitis B virus (HBV) infection. If you have hepatitis B virus (HBV) infection and take MYLATAF tablets, your HBV may get worse (flare-up) if you stop taking MYLATAF tablets. A “flare-up” is when your HBV infection suddenly returns in a worse way than before.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following signs or symptoms of liver problems:

• Your skin or the white part of your eyes turns yellow (jaundice)
• Dark or “tea-coloured” urine
• Light coloured stools
• Nausea or vomiting
• Loss of appetite
• Pain, aching or tenderness on the right side of your stomach area.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following signs or symptoms of too much lactic acid in your blood:

• Weakness or being more tired than usual, unusual muscle pain
• Short of breath or fast breathing
• Stomach pain with nausea and vomiting
• Cold or blue hands and feet
• Feeling dizzy or lightheaded
• Fast or abnormal heartbeat

Too much lactic acid is a serious medical emergency that can lead to death.

Frequent side effects:

• Neutropenia (low levels of white blood cells). Symptoms are infections of the skin and other areas of the body, swollen gums, and sore mouth.
• Allergic reactions
• Inability to sleep, abnormal dreams
• Suicide
• Headache, dizziness
• Difficulty breathing
• Nausea, diarrhoea, vomiting, gas, stomach pain, indigestion
• Rash, itch, hives, skin discolouration
• Kidney problems
• Fatigue (mental or physical weakness), pain, lack of energy

Less frequent side effects:

• Changes in your immune system can happen as your immune system may get stronger and begin to fight infections in your body. Tell your healthcare provider if you start having new symptoms after you start taking MYLATAF
• Stomach pain or discomfort
• Liver problems

The following side effects are reported but the frequency is not known:

• Anaemia (low red blood cells)
• Inflammation of the pancreas
• Myopathy (muscle weakness)
• Osteomalacia (bone pain and muscle weakness)
• Rhabdomyolysis (breakdown of muscle tissue)

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. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reactions & Quality Problem Reporting Form”, found online under SAHPRA’s publications: https://sahpra.org.za/wp-content/uploads/2020/01/6.04_ARF1_v5.1_27Jan2020.pdf By reporting side effects, you can help provide more information on the safety of MYLATAF.

Store all medicines out of reach of children. Store at or below 30 °C in original container.