Komycitaf Film-Coated Tablets

KOMYCITAF 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 KOMYCITAF:

• If you are hypersensitive (allergic) to emtricitabine, tenofovir alafenamide or dolutegravir, or any of the other ingredients of KOMYCITAF (listed in section 6).
• If you take medicine containing dofetilide or pilsicainide, as taking them with KOMYCITAF 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.

Take special care with KOMYCITAF:

• If you have or have had liver problems, including hepatitis B or C virus infection.
• If you have kidney problems.
• If you are taking other medicines as taking them with KOMYCITAF can cause side effects (See Using other medicines with KOMYCITAF below).

Children and adolescents

Do not give KOMYCITAF to children who weigh less than 40 kg.

Other medicines and KOMYCITAF

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines). Medicines containing dofetilide should not be taken with KOMYCITAF as blood levels are raised and increased side effects can result. Metformin blood levels are increased by KOMYCITAF. You should not take KOMYCITAF if you are also taking metformin.

Blood levels of KOMYCITAF are decreased by the following medicines and should not be used:

• rifabutin, rifampin, rifapentine (medicines used to treat tuberculosis)
• St John’s wort

Blood levels of KOMYCITAF are decreased by the following medicines and your dosage will need to be adjusted or a different medicine may need to be prescribed: Carbamazepine, oxcarbazepine, phenytoin, phenobarbitone. Some antacids or laxatives containing magnesium or aluminium, sucralfate and oral calcium or iron supplements may be used if KOMYCITAF is taken 2 hours before or 6 hours after these medicines.

Do not share medicines prescribed for you with any other person. Always take KOMYCITAF 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 KOMYCITAF will last. Do not run out of KOMYCITAF 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 KOMYCITAF is too strong or too weak, tell your doctor or pharmacist.

If you take more KOMYCITAF 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 KOMYCITAF

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

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

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

Worsening of hepatitis B virus infection: KOMYCITAF tablets are not for use to treat chronic hepatitis B virus (HBV) infection. If you have hepatitis B virus (HBV) infection and take KOMYCITAF tablets, your HBV may get worse (flare-up) if you stop taking KOMYCITAF 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 KOMYCITAF.
• 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.

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