Emtricitabine 200 mg/25 mg Tablets

Emtritaf 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)

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

Warnings and precautions

Too much lactic acid 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 Emtritaf 200/25. It is important not to stop taking Emtritaf 200/25 without talking to your doctor. You must remain under the care of your doctor while taking Emtritaf 200/25.

You can still pass on HIV when taking Emtritaf 200/25. Discuss with your doctor the precautions needed to avoid infecting other people. Emtritaf 200/25 is not a cure for HIV infection. While taking Emtritaf 200/25 you may still develop infections or other illnesses associated with HIV infection.

During HIV therapy such as with Emtritaf 200/25 there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

Autoimmune disorders (the immune system attacks healthy body tissue), may also occur after you start taking medicines for HIV infection such as Emtritaf 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

Do not share medicines prescribed for you with any other person. Always take Emtritaf 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 Emtritaf 200/25 following completion of dialysis.

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

If you take more Emtritaf 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.

If you forget to take Emtritaf 200/25

It is important to take your Emtritaf 200/25 regularly at the same time each day. It is important not to miss a dose of Emtritaf 200/25. If you do miss a dose:

• If you notice within 18 hours of the time you usually take Emtritaf 200/25, you must take the tablet as soon as possible. Then take the next dose as usual.
• If you notice 18 hours or more after the time you usually take Emtritaf 200/25, then do not take the missed dose. Wait and take the next dose at your usual time.
• If you vomit less than 1 hour after taking Emtritaf 200/25, take another tablet.

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

If any of the following happens, stop taking Emtritaf 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 Emtritaf 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 Emtritaf 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 Emtritaf 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 Emtritaf 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).