Patient leaflet - Emtricitabine/tenofovir Alafenamide 200 mg/10 mg film-coated tablets
1. What Emtricitabine/Tenofovir alafenamide is and what it is used for
The name of this medicine is
Emtricitabine/Tenofovir alafenamide 200 mg/10 mg film-coated tablets (called Emtricitabine/Tenofovir alafenamide throughout this leaflet). This medicine 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) This medicine blocks the action of the reverse transcriptase enzyme, which is essential for the virus to multiply. This medicine, therefore, reduces the amount of HIV in your body.
Emtricitabine/Tenofovir alafenamide in combination with other medicines is used 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.
2. What you need to know before you take Emtricitabine/Tenofovir alafenamide
Do not take Emtricitabine/Tenofovir alafenamide
- 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
You must remain under the care of your doctor while taking Emtricitabine/ Tenofovir alafenamide.
This medicine is not a cure for HIV infection. While taking Emtricitabine/ Tenofovir alafenamide you may still develop infections or other illnesses associated with HIV infection. Talk to your doctor before taking Emtricitabine/Tenofovir alafenamide:
If you have liver problems or have suffered liver disease, including hepatitis. Patients with liver disease including chronic hepatitis B or C, who are treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications. 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 Emtricitabine/ Tenofovir alafenamide. Do not stop taking Emtricitabine/Tenofovir alafenamide without talking to your doctor: see section 3, Do not stop taking Emtricitabine/Tenofovir alafenamide.
- Your doctor may choose to not prescribe Emtricitabine/Tenofovir alafenamide to you if your virus has a certain resistance mutation, as Emtricitabine/Tenofovir alafenamide may not be able to reduce the amount of HIV in your body as effectively.
- If you have had kidney disease or if tests have shown problems with your kidneys. Your doctor may order blood tests to monitor how your kidneys work when starting and during treatment with Emtricitabine/ Tenofovir alafenamide.
While you are taking Emtricitabine/ Tenofovir alafenamide
Once you start taking this medicine, look out for:
- Signs of inflammation or infection
- Joint pain, stiffness or bone problems
➔ If you notice any of these symptoms, tell your doctor
immediately. For more information see section 4, Possible side effects. There is a possibility that you may experience kidney problems when taking this medicine over a long period of time (see Warnings and precautions). Children and adolescents
Do not give this medicine to children aged 11 years or under, or weighing less than 35 kg. The use of this medicine in children aged 11 years or under has not yet been studied. Other medicines and Emtricitabine/ Tenofovir alafenamide
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This medicine may interact with other medicines. As a result, the amounts of this or other medicines in your blood may change. This may stop your medicines from working properly, or may make any side effects worse. In some cases, your doctor may need to adjust your dose or check your blood levels.
Medicines used in treating hepatitis B infection:
You should not take this medicine with medicines containing:
- tenofovir alafenamide
- tenofovir disoproxil
- lamivudine
- adefovir dipivoxil
➔ Tell your doctor if you are taking any of these medicines.
Other types of medicine:
Talk to your doctor if you are taking:
antibiotics, used to treat
bacterial infections including tuberculosis, containing:
- rifabutin, rifampicin, and rifapentine
antiviral medicines used to treat HIV:
- emtricitabine and tipranavir
anticonvulsants, used to treat epilepsy, such as:
- carbamazepine, oxcarbazepine, phenobarbital and phenytoin
herbal remedies used to treat depression and anxiety containing:
- St. John’s wort (Hypericum perforatum)
➔ Tell your doctor if you are taking these or any other medicines. Do not stop your treatment without contacting your doctor.
Pregnancy and breast-feeding
- If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
- Tell your doctor immediately if you become pregnant and ask about the potential benefits and risks of your antiretroviral therapy to you and your child.
If you have taken this medicine during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the
development of your child. In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Do not breast-feed during treatment with Emtricitabine/Tenofovir alafenamide. This is because one of the active substances in this medicine passes into breast milk.
Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk.
If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.
Driving and using machines This medicine can cause dizziness. If you feel dizzy when taking it, do not drive and do not use any tools or machines.
Emtricitabine/Tenofovir alafenamide contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Emtricitabine/ Tenofovir alafenamide
Always take this medicine 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 It is recommended not to chew or crush the tablet due to the bitter taste. 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 this medicine following completion of dialysis.
If you take more Emtricitabine/ Tenofovir alafenamide than you should
If you take more than the
recommended dose of this medicine you may be at higher risk of side effects of this medicine (see section 4, Possible side effects).
Contact your doctor or nearest emergency department immediately for advice. Keep the tablet bottle with you so that you can show what you have taken.
If you forget to take Emtricitabine/ Tenofovir alafenamide
It is important not to miss a dose of this medicine.
If you do miss a dose:
- If you notice within 18 hours of the time you usually take this medicine, 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 this medicine, 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 Emtricitabine/Tenofovir alafenamide, take another tablet. Do not stop taking Emtricitabine/ Tenofovir alafenamide
Do not stop taking this medicine without talking to your doctor. Stopping it can seriously affect how well future treatment works. If this medicine is stopped for any reason, speak to your doctor before you restart taking it.
When your supply of Emtricitabine/ Tenofovir alafenamide starts to run low, get more from your doctor or pharmacist. This is very important because the amount of virus may start to increase if the medicine is stopped for even a few days. The disease may then become harder to treat.
If you have both HIV infection and hepatitis B, it is very important not to stop taking this medicine without talking to your doctor first. You may require blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment may lead to worsening of hepatitis, which may be life-threatening.
➔ Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible serious side effects: tell a doctor immediately
- 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 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. 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.
Very common side effects
(may affect more than 1 in 10 people)
- feeling sick (nausea)
Common side effects
(may affect up to 1 in 10 people)
- abnormal dreams
- headache
- dizziness
- diarrhoea
- vomiting
- stomach pain
- wind (flatulence)
- rash
- tiredness (fatigue)
Uncommon side effects
(may affect up to 1 in 100 people)
- low red blood cell count (anaemia)
- problems with digestion resulting in discomfort after meals (dyspepsia)
- swelling of the face, lips, tongue or throat (angioedema)
- itching (pruritus)
- hives (urticaria)
- joint pain (arthralgia)
➔ If any of the side effects get serious tell your doctor.
Other effects that may be seen during HIV treatment
The frequency of the following side effects is not known (frequency cannot be estimated from the available data).
Bone problems. Some patients taking combination antiretroviral medicines such as this may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). Taking this type of medicine for a long time, taking corticosteroids, drinking alcohol, having a very weak immune system, and being overweight, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are:
- joint stiffness
- joint aches and pains (especially of the hip, knee and shoulder)
- difficulty with movement
➔ If you notice any of these symptoms tell your doctor.
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and lifestyle, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Emtricitabine/ Tenofovir alafenamide
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle after “EXP”. The expiry date refers to the last day of that month.
Store below 30 °C. Store in the original package in order to protect from moisture.
After first opening store below 25 °C and use this medicine within 30 days. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Emtricitabine/Tenofovir alafenamide contains
The active substances
are emtricitabine and
tenofovir alafenamide.
Each Emtricitabine/Tenofovir
alafenamide film-coated tablet contains 200 mg of emtricitabine and 10 mg of tenofovir alafenamide.
The other ingredients are
Tablet core:
Microcrystalline cellulose,
croscarmellose sodium, magnesium stearate, hypromellose.
Tablet coating:
Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc and iron oxide black (E172).
What Emtricitabine/Tenofovir alafenamide looks like and contents of the pack
Emtricitabine/Tenofovir alafenamide 200 mg/10 mg film-coated tablets are gray oval tablets. The length of the tablet is about 12.5 mm and its width is about 6.4 mm.
Emtricitabine/Tenofovir alafenamide 200 mg/10 mg come in white plastic bottles, which are closed with a child-resistant plastic screw cap with a desiccant attached to the cap. The following pack sizes are available: 30, 60 or 90 tablets (outer carton containing one product information leaflet and one, two or three bottle(s) of 30 tablets).
Not all pack sizes may be marketed. Marketing Authorisation Holder Zentiva Pharma UK Limited
12 New Fetter Lane
London
EC4A 1JP
United Kingdom
Manufacturer
Zentiva, k.s.
U kabelovny 130
102 37, Prague 10 - Dolní Měcholupy Czech Republic
This leaflet was last revised in October 2025.
ZV/747 65