Ivatebi 200 mg/25 mg Film-Coated Tablets

IVATEBI contains two active substances:

• emtricitabine, an antiretroviral medicine of a type known as a nucleoside reverse transcriptase inhibitor (NRTI)
• tenofovir alafenamide, an antiretroviral medicine of a type known as a nucleotide reverse transcriptase inhibitor (NtRTI)

IVATEBI blocks the action of the reverse transcriptase enzyme, which is essential for the virus to multiply. IVATEBI therefore reduces the amount of HIV in your body. IVATEBI in combination with other medicines is for the treatment of human immunodeficiency virus 1 (HIV - 1) infection in adults and adolescents 12 years of age and older, who weigh at least 35 kg.

Do not take IVATEBI:

• If you are allergic to emtricitabine, tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6 of this leaflet).

Warnings and precautions

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 get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or 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 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 IVATEBI. It is important not to stop taking IVATEBI without talking to your doctor. You must remain under the care of your doctor while taking IVATEBI.

Do not share medicines prescribed for you with any other person. Always take IVATEBI exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

• Adults: one tablet each day, with or without food
• Adolescents 12 years of age and older, who weigh at least 35 kg: one tablet each day with or without food.

Do not chew, crush or split the tablet. Always take the dose recommended by your doctor. This is to make sure that your medicine is fully effective, and to reduce the risk of developing resistance to the treatment. Do not change the dose unless your doctor tells you to.

If you are on dialysis, take your daily dose of IVATEBI following completion of dialysis.

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

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

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• Rash or itching
• Fainting.

These are all very serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects

• Abnormal dreams
• Headache
• Dizziness
• Nausea
• Diarrhoea
• Vomiting
• Abdominal pain
• Flatulence (passing of wind (air or gas) from the intestine and through the anus)
• Fatigue.

Less frequent side effects

• Anaemia (decreased red blood cell count)
• Dyspepsia (indigestion or heartburn)
• Arthralgia (joint pain).

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. Do not use this medicine after the expiry date, which is stated on the carton, label, bottle. The expiry date refers to the last day of that month. Store in the original package in order to protect from moisture. Keep the bottle tightly closed. Store at or below 30 °C. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).