Emtricitabine/Rilpivirine/Tenofovir Alafenamide 200 mg/25 mg/25 mg – patient leaflet, side effects, dosage

1. What Emtricitabine/Rilpivirine/Tenofovir Alafenamide is and what it is used for

Emtricitabine/Rilpivirine/Tenofovir Alafenamide is an antiviral medicine used to treat infection by the Human Immunodeficiency Virus (HIV). It is a single tablet that contains a combination of three active substances: emtricitabine, rilpivirine and tenofovir alafenamide. Each of these active substances works by interfering with an enzyme called 'reverse transcriptase', which is essential for the HIV-1 virus to multiply.

Emtricitabine/Rilpivirine/Tenofovir Alafenamide reduces the amount of HIV in your body. This will improve your immune system and reduce the risk of developing illnesses linked to HIV infection.

Emtricitabine/Rilpivirine/Tenofovir Alafenamide is used in adults and adolescents aged 12 years and older, who weigh at least 35 kg.

2. What you need to know before you take Emtricitabine/Rilpivirine/ Tenofovir Alafenamide

Do not take Emtricitabine/Rilpivirine/Tenofovir Alafenamide

• If you are allergic to emtricitabine, rilpivirine, tenofovir alafenamide

  or any of the other ingredients of this medicine (listed in section 6).

• If you are currently taking any of the following medicines:

  • carbamazepine, oxcarbazepine, phenobarbital and phenytoin

    (used to treat epilepsy and prevent seizures)

  • rifabutin, rifampicin and rifapentine (used to treat some bacterial

    infections such as tuberculosis)

  • omeprazole, dexlansoprazole, lansoprazole, rabeprazole,

    pantoprazole and esomeprazole (used to prevent and treat stomach ulcers, heartburn, acid reflux disease)

  • dexamethasone (a corticosteroid medicine used to treat

    inflammation and suppress the immune system) when taken by mouth or injected (except as a single dose treatment)

  • products that contain St. John's wort (Hypericum perforatum) (a

    herbal remedy used for depression and anxiety)

è If this applies to you, do not take Emtricitabine/Rilpivirine/Tenofovir

Alafenamide and tell your doctor immediately.

Warnings and precautions

You must remain under the care of your doctor while taking Emtricitabine/ Rilpivirine/Tenofovir Alafenamide.

This medicine is not a cure for HIV infection. While taking Emtricitabine/ Rilpivirine/Tenofovir Alafenamide you may still develop infections or other illnesses associated with HIV infection.

Talk to your doctor before taking Emtricitabine/Rilpivirine/Tenofovir Alafenamide:

• If you have liver problems or a history of 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/Rilpivirine/Tenofovir Alafenamide. It is important not to stop taking Emtricitabine/Rilpivirine/Tenofovir Alafenamide without talking to your doctor: see section 3, Do not stop taking Emtricitabine/Rilpivirine/Tenofovir Alafenamide.

• If you are taking any medicines that may cause a life-threatening

  irregular heartbeat (Torsades de Pointes).

• 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/ Rilpivirine/Tenofovir Alafenamide.

While you are taking Emtricitabine/Rilpivirine/Tenofovir Alafenamide

Once you start taking Emtricitabine/Rilpivirine/Tenofovir Alafenamide, look out for:

• Signs of inflammation or infection
• Joint pain, stiffness or bone problems

è 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 Emtricitabine/Rilpivirine/Tenofovir Alafenamide 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 Emtricitabine/Rilpivirine/Tenofovir Alafenamide in children aged 11 years or under or weighing less than 35 kg has not yet been studied.

Other medicines and Emtricitabine/Rilpivirine/Tenofovir Alafenamide

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Emtricitabine/Rilpivirine/Tenofovir Alafenamide may interact with other medicines. As a result, the amounts of Emtricitabine/Rilpivirine/Tenofovir Alafenamide or other medicines in your blood may be affected. 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 that must never be taken with Emtricitabine/Rilpivirine/ Tenofovir Alafenamide:

• carbamazepine, oxcarbazepine, phenobarbital and phenytoin (used

  to treat epilepsy and prevent seizures)

• rifabutin, rifampicin and rifapentine (used to treat some bacterial

  infections such as tuberculosis)

  • omeprazole, dexlansoprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole (used to prevent and treat stomach ulcers, heartburn, acid reflux disease)
  • dexamethasone (a corticosteroid medicine used to treat inflammation and suppress the immune system) when taken by mouth or injected (except as a single dose treatment)
  • products that contain St. John's wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety)

è If you are taking any of these medicines, do not take Emtricitabine/

Rilpivirine/Tenofovir Alafenamide and tell your doctor immediately.

Other types of medicine:

Talk to your doctor if you are taking:

• Any medicines used for treating HIV

• Any medicines containing:

  • tenofovir alafenamide
  • tenofovir disoproxil
  • lamivudine
  • adefovir dipivoxil

• Antibiotics used to treat bacterial infections containing:

  • clarithromycin
  • erythromycin

These medicines can increase the amount of rilpivirine and tenofovir alafenamide (components of Emtricitabine/Rilpivirine/Tenofovir Alafenamide) in your blood. Your doctor will give you a different medicine.

• Antifungal medicines used to treat fungal infections:

  • ketoconazole
  • fluconazole
  • itraconazole
  • posaconazole
  • voriconazole

These medicines can increase the amount of rilpivirine and tenofovir alafenamide (components of Emtricitabine/Rilpivirine/Tenofovir Alafenamide) in your blood. Your doctor will give you a different medicine.

• Medicines for stomach ulcers, heartburn or acid reflux such as:

  • antacids (aluminium/magnesium hydroxide or calcium carbonate)

  • H -antagonists (famotidine, cimetidine, nizatidine or ranitidine)

    2

These medicines can decrease the amount of rilpivirine (a component of Emtricitabine/Rilpivirine/Tenofovir Alafenamide) in your blood. If you are taking one of these medicines your doctor will either give you a different medicine, or recommend how and when you take that medicine:

• If you are taking an antacid, take it at least 2 hours before or at least

  4 hours after Emtricitabine/Rilpivirine/Tenofovir Alafenamide. - If you are taking an H -antagonist, take it at least 12 hours before or

  2

  at least 4 hours after Emtricitabine/Rilpivirine/Tenofovir Alafenamide. H -antagonists can only be taken once a day if you take

  2

  Emtricitabine/Rilpivirine/Tenofovir Alafenamide. H -antagonists

  2 should not be taken in a twice a day regimen. Talk to your doctor about an alternative regimen (see How to take Emtricitabine/ Rilpivirine/Tenofovir Alafenamide).

• Ciclosporin, a medicine used to reduce the strength of the body's immune system:

  This medicine can increase the amount of rilpivirine and tenofovir alafenamide (components of Emtricitabine/Rilpivirine/Tenofovir Alafenamide) in your blood. Your doctor will give you a different medicine.

• Methadone, a medicine used to treat opiate addiction, as your doctor may need to change your methadone dose.
• Dabigatran etexilate, a medicine used to treat heart conditions, as your doctor may need to monitor the levels of this medicine in your blood.

è Tell your doctor if you are taking any of these 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 for advice before taking this medicine.

• Use effective contraception while taking Emtricitabine/Rilpivirine/

  Tenofovir Alafenamide.

Ask your doctor or pharmacist for advice before taking any medicine when pregnant.

If you have taken Emtricitabine/Rilpivirine/Tenofovir Alafenamide 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 nucleoside reverse transcriptase inhibitors (NRTIs) during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.

Do not breast-feed during treatment with Emtricitabine/Rilpivirine/ Tenofovir Alafenamide.

This is because some of the active substances in this medicine pass into human 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

Do not drive or operate machines if you feel tired, sleepy or dizzy after taking your medicine.

Emtricitabine/Rilpivirine/Tenofovir Alafenamide contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium- free'.

è If any of these applies to you, talk to your doctor before taking

Emtricitabine/Rilpivirine/Tenofovir Alafenamide.

3. How to take Emtricitabine/Rilpivirine/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 food

Adolescents 12 years of age and older, who weigh at least 35 kg: one tablet each day with food

It is important to take Emtricitabine/Rilpivirine/Tenofovir Alafenamide with food to get the right levels of active substance in your body. A nutritional drink alone does not replace food.

It is recommended not to chew, crush or split the tablet due to the bitter taste.

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If you are taking an antacid such as aluminium/magnesium hydroxide, or calcium carbonate, take it at least 2 hours before or at least 4 hours after Emtricitabine/Rilpivirine/Tenofovir Alafenamide.

If you are taking an H -antagonist such as famotidine, cimetidine, nizatidine

2

or ranitidine, take it at least 12 hours before or at least 4 hours after Emtricitabine/Rilpivirine/Tenofovir Alafenamide. H - antagonists can only be

2 taken once a day if you take Emtricitabine/Rilpivirine/Tenofovir Alafenamide. H -antagonists should not be taken twice a day. Talk to your doctor about an 2

alternative regimen.

If you are on dialysis, take your daily dose of Emtricitabine/Rilpivirine/ Tenofovir Alafenamide following completion of dialysis.

If you take more Emtricitabine/Rilpivirine/Tenofovir Alafenamide than you should

If you accidentally take more than the recommended dose of Emtricitabine/ Rilpivirine/Tenofovir Alafenamide you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).

Contact your doctor or nearest emergency department immediately for advice. Keep or take the tablet bottle with you so that you can easily describe what you have taken.

If you forget to take Emtricitabine/Rilpivirine/Tenofovir Alafenamide

It is important not to miss a dose of Emtricitabine/Rilpivirine/Tenofovir Alafenamide.

If you do miss a dose:

• If you notice within 12 hours of the time you usually take

  Emtricitabine/Rilpivirine/Tenofovir Alafenamide, you must take the tablet as soon as possible. Always take the tablet with food. Then take the next dose as usual.

• If you notice 12 hours or more after the time you usually take

  Emtricitabine/Rilpivirine/Tenofovir Alafenamide, then do not take the missed dose. Wait and take the next dose, with food, at your usual time.

If you vomit less than 4 hours after taking Emtricitabine/Rilpivirine/ Tenofovir Alafenamide, take another tablet with food. If you vomit more than 4 hours after taking Emtricitabine/Rilpivirine/Tenofovir Alafenamide

you do not need to take another tablet until your next regularly scheduled tablet.

Do not stop taking Emtricitabine/Rilpivirine/Tenofovir Alafenamide

Do not stop taking Emtricitabine/Rilpivirine/Tenofovir Alafenamide without talking to your doctor. Stopping Emtricitabine/Rilpivirine/Tenofovir Alafenamide can seriously affect your response to future treatment. If Emtricitabine/Rilpivirine/Tenofovir Alafenamide is stopped for any reason, speak to your doctor before you restart taking Emtricitabine/Rilpivirine/ Tenofovir Alafenamide tablets.

When your supply of Emtricitabine/Rilpivirine/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 short time. The disease may then become harder to treat.

If you have both HIV infection and hepatitis B, it is especially important not to stop your Emtricitabine/Rilpivirine/Tenofovir Alafenamide treatment 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 is not recommended as this may lead to worsening of your hepatitis, which may be life-threatening.

è 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 side effects: tell a doctor immediately

• Any signs of inflammation or infection. In some patients with advanced

  HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after HIV 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, when 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

è If you notice these or any symptoms of inflammation or infection, tell your doctor immediately.

Very common side effects

(may affect more than 1 in 10 people)

• difficulty sleeping (insomnia)
• headache
• dizziness
• feeling sick (nausea)

Tests may also show:

• increased levels of cholesterol and/or pancreatic amylase (a digestive

  enzyme) in the blood

• increased levels of liver enzymes in the blood

Common side effects

(may affect up to 1 in 10 people)

• decreased appetite
• depression
• abnormal dreams
• sleep disorders
• depressed mood
• feeling sleepy (somnolence)
• tiredness
• stomach pain or discomfort
• being sick (vomiting)
• feeling bloated
• dry mouth
• wind (flatulence)
• diarrhoea

• rash

  Tests may also show:

  • low white blood cell count (a reduced white blood cell count can make you more prone to infection)
  • low platelet count (a type of blood cell involved in clotting blood)
  • decrease in haemoglobin in your blood
  • increased fatty acids (triglycerides), bilirubin or lipase in the blood

Uncommon side effects

(may affect up to 1 in 100 people)

• signs or symptoms of inflammation or infection
• low red blood cell count (anaemia)
• severe skin reactions including rash accompanied by fever, swelling and liver problems
• problems with digestion resulting in discomfort after meals
• swelling of the face, lips, tongue or throat (angioedema)
• itching (pruritus)
• hives (urticaria)
• joint pain (arthralgia)

è 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 Emtricitabine/Rilpivirine/Tenofovir Alafenamide 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

è 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 life style, 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, Website: 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/Rilpivirine/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.

This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture. Keep the bottle tightly closed. Do not remove the desiccant. Do not swallow the desiccant.

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 protect the environment.

6. Contents of the pack and other information

What Emtricitabine/ Rilpivirine/Tenofovir Alafenamide contains

The active substances are emtricitabine, rilpivirine and tenofovir alafenamide. Each tablet contains 200 mg of emtricitabine, rilpivirine hydrochloride equivalent to 25 mg of rilpivirine and tenofovir alafenamide succinate equivalent to 25 mg of tenofovir alafenamide.

The other ingredients are

Tablet core:

Croscarmellose sodium, lactose monohydrate, povidone, polysorbate 20, anhydrous lactose, silicified microcrystalline cellulose, iron oxide yellow (E172), magnesium stearate, microcrystalline cellulose, sodium stearyl fumarate, purified water.

Film-coating:

Hypromellose, hydroxypropyl cellulose, talc, calcium carbonate, iron oxide yellow (E172), methylene chloride, isopropyl alcohol.

What Emtricitabine/Rilpivirine/Tenofovir Alafenamide looks like and contents of the pack

Emtricitabine/Rilpivirine/Tenofovir Alafenamide is a yellow coloured, capsule shaped, film coated tablet debossed with “L” on one side and “2” on the other side.

Emtricitabine/Rilpivirine/Tenofovir Alafenamide comes in bottles of 30 tablets and in packs made up of 3 bottles, each containing 30 tablets. Each bottle contains molecular sieve canister as desiccant that must be kept in the bottle to help protect your tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Lupin Healthcare (UK) Ltd.

The Urban Building, 2nd floor

3-9 Albert Street, Slough,

Berkshire SL1 2BE,

United Kingdom

This leaflet was last revised in April 2026.

Code No.: GO/DRUGS/654 ID#: 281070

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