Makovy

MAKOVY 200/25 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)

MAKOVY 200/25 blocks the action of the reverse transcriptase enzyme, which is essential for the virus to multiply. MAKOVY 200/25 therefore reduces the amount of HIV in your body. MAKOVY 200/25 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 MAKOVY 200/25:

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

Do not share medicines prescribed for you with any other person. Always take MAKOVY 200/25 exactly as your doctor has instructed you. You should 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 MAKOVY 200/25 following completion of dialysis.

If you have the impression that the effect of MAKOVY 200/25 is too strong or too weak, talk to your doctor or pharmacist.

If you take more MAKOVY 200/25 than you should

In the event of over dosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

MAKOVY 200/25 can have side effects. Not all side effects reported for MAKOVY 200/25 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MAKOVY 200/25, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking MAKOVY 200/25 and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Any signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) and who have had opportunistic infections in the past (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after antiretroviral treatment such as with MAKOVY 200/25 is started. It is thought 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.
• Autoimmune disorders (the immune system attacks healthy body tissue), may also occur after you start taking medicines for HIV infection such as MAKOVY 200/25. Autoimmune disorders may occur many months after the start of treatment. Look out for any symptoms of infection or other symptoms such as:
• muscle weakness
• weakness beginning in the hands and feet and moving up towards the trunk of the body
• palpitations, tremor or hyperactivity

If you notice the side effects described above, tell your doctor immediately.

Swelling of the face, lips or throat with difficult breathing (angioedema) These are all very serious side effects. If you have them, you may have had a serious reaction to MAKOVY 200/25. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

• Frequent Feeling sick (nausea)
• Abnormal dreams
• Headache
• Dizziness
• Diarrhoea
• Vomiting
• Stomach pain
• Wind (flatulence)
• Rash

Tiredness (fatigue)

Less frequent:

• Itching (pruritus)
• Hives (urticaria)
• Low red blood cell count (anaemia)
• Problems with digestion resulting in discomfort after meals (dyspepsia)
• Joint pain (arthralgia)

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist. Should your general health worsen or if you experience any untoward effects while taking MAKOVY 200/25, please consult your healthcare provider for advice.

Store at or below 25 °C. KEEP OUT OF THE REACH OF CHILDREN. Store in the original package / container. Keep the HDPE container tightly closed.

Do not store in a bathroom. Do not use after the expiry date stated on the blister / label / carton bottle. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).