Emtricitabine/rilpivirine/tenofovir alafenamide Viatri: detailed information

Package leaflet: Information for the user

Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris 200 mg/25 mg/25 mg film-coated tablets

Emtricitabine/rilpivirine/tenofovir alafenamide
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris is and what it is used for
What you need to know before taking Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris
How to take Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris
Possible side effects
How to store Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris
Contents of the pack and other information

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

Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris is an antiviral medicine used to treat
infection with the human immunodeficiency virus (HIV). It is a single tablet containing three
active substances: emtricitabine, rilpivirine, and tenofovir alafenamide. Each of these components
inhibits an enzyme called "reverse transcriptase", which is essential for the replication of HIV-1 virus.
Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris reduces the amount of HIV in your body. This
improves your immune system and reduces the risk of developing HIV-related illnesses.
Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris is used in adults and adolescents aged 12 years
and older, weighing at least 35 kg.

2. What you should know before taking Emtricitabine/Rilpivirine/Tenofovir Alafenamide

Viatris
Do not take Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris

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 (medicines used to treat epilepsy and prevent seizures)
- rifabutin, rifampicin and rifapentine (used to treat certain bacterial infections, such as tuberculosis)
- omeprazole, dexlansoprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole (used to prevent and treat stomach ulcers, heartburn and acid reflux)
dexamethasone (a corticosteroid used to treat inflammation and suppress the immune system) taken orally or by injection (except for treatment with a single dose)
products containing St. John’s wort ( Hypericum perforatum ) (a herbal remedy used for depression and anxiety)

→ If any of these conditions apply to you, do not take
Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris and inform your doctor
immediately.
Warnings and precautions
While taking Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris, you must continue to be monitored by your doctor.
This medicine does not cure HIV infection. While taking Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris, you may still develop infections or other illnesses associated with HIV infection.
Talk to your doctor before taking Emtricitabine/Rilpivirine/Tenofovir Alafenamide
Viatris:

If you have or have previously had liver problems, including hepatitis. Patients with liver problems, including chronic hepatitis B or C, treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications. If you have hepatitis B, your doctor will carefully evaluate the most appropriate treatment regimen for you.
If you have hepatitis B, liver problems may worsen when you stop treatment with Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris. Do not stop treatment with this medicine without first discussing it with your doctor: see section 3, Do not stop treatment with Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris.
If you are taking medicines that may cause potentially life-threatening arrhythmias ( torsades de pointes ).
If you have kidney disease or if tests have shown problems with your kidneys. Your doctor may request blood tests to monitor how well your kidneys are functioning, both at the beginning and during treatment with Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris. While taking Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris

When starting Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris, be alert for:

signs of inflammation or infection
joint pain, stiffness or bone problems

→ If you notice any of these symptoms, inform your doctor immediately. For more information,
see section 4, Possible side effects.
Kidney problems may occur during long-term use of this medicine (see Warnings and precautions).
Children and adolescents
Do not give this medicine to children aged 11 years or younger or weighing less than 35 kg. The use of Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris in children aged 11 years or younger has not yet been studied.
Other medicines and Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris may interact with other medicines. As a result, the levels of emtricitabine/rilpivirine/tenofovir alafenamide or of other medicines in the blood may be altered. This may prevent the medicines from working properly or may worsen their side effects. In some cases, your doctor may need to adjust the dose or monitor blood levels.
Medicines that must never be taken with Emtricitabine/Rilpivirine/Tenofovir
Alafenamide Viatris:

carbamazepine, oxcarbazepine, phenobarbital and phenytoin (used to treat epilepsy and prevent seizures)
rifabutin, rifampicin and rifapentine (used to treat certain bacterial infections, such as tuberculosis)
omeprazole, dexlansoprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole (used to prevent and treat stomach ulcers, heartburn and acid reflux)
dexamethasone (a corticosteroid used to treat inflammation and suppress the immune system) taken orally or by injection (except for treatment with a single dose)
products containing St. John’s wort ( Hypericum perforatum ) (a herbal remedy used for depression and anxiety)

→ If you are taking any of these medicines, do not take
Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris and inform your doctor immediately.
Other types of medicines:
Talk to your doctor if you are taking:

Any medicine for the treatment of HIV infection
Any other medicine containing:
- tenofovir alafenamide
- tenofovir disoproxil
- lamivudine
- adefovir dipivoxil
Antibiotics used to treat bacterial infections, containing:
- clarithromycin
- erythromycin These medicines may increase the levels of rilpivirine and tenofovir alafenamide (components of Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris) in the blood. Your doctor will prescribe a different medicine.
Antifungals, used to treat fungal infections:
- ketoconazole
- fluconazole
- itraconazole
- posaconazole
- voriconazole These medicines may increase the levels of rilpivirine and tenofovir alafenamide (a component of Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris) in the blood. Your doctor will prescribe a different medicine.
Medicines for stomach ulcers, heartburn and acid reflux, such as:
- antacids (aluminium/magnesium hydroxide or calcium carbonate)
- H2-receptor antagonists (famotidine, cimetidine, nizatidine or ranitidine) These medicines may reduce the levels of rilpivirine (a component of Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris) in the blood. If you are taking any of these medicines, your doctor will advise you on how and when to take them, or will prescribe a different medicine:
- If you are taking an antacid, take it at least 2 hours before or at least 4 hours after Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris.
- If you are taking an H2-receptor antagonist, take it at least 12 hours before or at least 4 hours after Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris. H2-receptor antagonists may only be taken once daily if you are taking Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris. H2-receptor antagonists must not be taken twice daily. Consult your doctor regarding an alternative regimen (see How to take Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris).
Ciclosporin, a medicine used to reduce immune system activity: This medicine may increase the levels of rilpivirine and tenofovir alafenamide (components of Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris) in the blood. Your doctor will prescribe a different medicine.
Methadone, a medicine used to treat opioid dependence; your doctor may consider adjusting the methadone dose.
Dabigatran etexilate, a medicine used to treat heart problems; your doctor may consider monitoring medicine levels in the blood.

→ Inform your doctor if you are taking any of these medicines. Do not stop treatment without
contacting your doctor.
Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
Use an effective method of contraception during treatment with Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant.
If you have taken Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris during pregnancy, your
doctor may request periodic blood tests and other diagnostic examinations to monitor the child’s
development. In children whose mothers took a nucleoside reverse transcriptase inhibitor (NRTI) during
pregnancy, the benefit of protection against HIV infection outweighs the risk of side effects.
Do not breastfeed during treatment with Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris.
The reason is that some active substances of this medicine are excreted in human breast milk.
Breastfeeding is not recommended for HIV-positive women, as HIV infection can be transmitted to the
child through breast milk.
If you are breastfeeding or are considering breastfeeding, you must discuss this with your doctor as soon as possible.
Driving and using machines
Do not drive and do not operate machinery if you feel tired, sleepy or dizzy after taking the medicine.
Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially ‘sodium-free’.
→ If any of these conditions apply to you, talk to your doctor before taking
Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris.

3. How to take Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
Adults: One tablet daily, taken with food.
Adolescents aged 12 years and older, weighing at least 35 kg: One tablet daily, taken with food.

It is important to take Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris with food to ensure the correct amount of active substance is absorbed into the body. A nutritional drink alone does not replace food.

Due to the bitter taste, it is recommended not to chew, split, or crush the tablet.

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 taking Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris.

If you are taking an H-_2 receptor antagonist such as famotidine, cimetidine, nizatidine, or ranitidine, take it at least 12 hours before or at least 4 hours after Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris. H-_2 receptor antagonists should be taken only once daily if you are also taking Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris. H-_2 receptor antagonists must not be taken twice daily. Please consult your doctor about an alternative regimen.

If you are undergoing dialysis, take your daily dose of Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris after completion of dialysis.

If you take more Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris than you should
If you accidentally take more Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris than the recommended dose, you may have an increased risk of experiencing possible side effects of this medicine (see section 4, Possible side effects).
Contact your doctor or the nearest emergency centre immediately. Take the bottle of tablets with you so that you can clearly describe what has been taken.

If you forget to take Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris
It is important that you do not miss any doses of Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris.
If you miss a dose:

If you remember within 12 hours of your usual dosing time for Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris, take the tablet as soon as possible. Always take the tablet with food. Then take your next dose at the usual time.
If you remember after 12 hours (or more) from your usual dosing time for Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris, do not take the missed dose. Wait and take your next dose with food at the usual time.

If you vomit within 4 hours after taking Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris, take another tablet with food. If you vomit more than 4 hours (or later) after taking Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris, do not take another tablet until your next scheduled dose.

Do not stop taking Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris
Do not stop taking Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris
without talking to your doctor first. Stopping treatment with this medicine may seriously affect your response to future treatment. If treatment with this medicine is stopped for any reason, discuss with your doctor before restarting Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris tablets.

When your supply of Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris is running low, get a new supply from your doctor or pharmacist. This is very important because the amount of virus may begin to increase if the medicine is stopped, even for a short time. The disease may become more difficult to treat.

If you have both HIV infection and hepatitis B, it is especially important not to stop treatment with Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris without first consulting your doctor. Blood tests may need to be repeated for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended, as it may lead to worsening of hepatitis, which could be potentially fatal.
→ Contact your doctor immediately if you notice any new or unusual symptoms after stopping treatment, particularly symptoms normally associated with hepatitis B infection.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Possible side effects: inform your doctor immediately

Signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) and a history of prior opportunistic infections (infections occurring in people with a weakened immune system), signs and symptoms of inflammation from previous infections may occur shortly after starting anti-HIV treatment. These symptoms are believed to result from an improved immune response, which enables the body to fight infections that may have been present without obvious symptoms.
Autoimmune disorders may also occur, in which the immune system attacks healthy body tissues, when you start taking medicines for HIV infection. Autoimmune disorders may appear many months after starting treatment. Be alert for any signs of infection or other symptoms such as:
- muscle weakness
- weakness starting in the hands and feet and progressing towards the trunk
- palpitations, tremor, or hyperactivity → If you notice any of these symptoms, or any signs of inflammation or infection, inform your doctor immediately.

Very common side effects
(may affect more than 1 in 10 people)

difficulty sleeping ( insomnia )
headache
dizziness
feeling unwell ( nausea )

Blood 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 more than 1 in 10 people)

reduced appetite
depression
abnormal dreams
sleep disorders
depression and depressed mood
drowsiness
fatigue
stomach discomfort and pain
nausea ( vomiting )
abdominal bloating
dry mouth
intestinal gas ( flatulence )
diarrhoea
rash

Blood tests may also show:

decreased white blood cell count (this may make you more susceptible to infection)
reduced platelet count (a type of blood cell involved in blood clotting)
reduced haemoglobin levels in the blood
increased levels of 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
digestive problems causing discomfort after meals
swelling of the face, lips, tongue, or throat ( angioedema )
itching sensation ( pruritus )
hives
joint pain ( arthralgia )

→ If any of these side effects worsen, inform your doctor.
Other effects that may occur during HIV treatment
The frequency of the following side effects is unknown (frequency cannot be estimated from the available data).

Bone problems. Some patients taking combination antiretroviral medicines such as Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris may develop a bone disease called osteonecrosis (death of bone tissue caused by reduced blood supply to the bone). Taking this type of medicine for a prolonged period, use of corticosteroids, alcohol consumption, having a weakened immune system, and being overweight may all be among the many risk factors for developing this condition. Signs of osteonecrosis include:
- joint stiffness
- joint aches and pains (particularly in the hips, knees, and shoulders)
- difficulty moving → If you notice any of these symptoms, inform your doctor.

During HIV treatment, an increase in body weight and in blood levels of lipids and glucose may occur. This is partly related to the recovery of health status and lifestyle, and, in the case of blood lipids, may sometimes be related to the HIV medicines themselves. Your doctor will monitor these changes.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after {Exp.}. The expiry date refers to the last day of that month.
Do not store above 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris contains

The active substances are emtricitabine, rilpivirine and tenofovir alafenamide.
The other ingredients are croscarmellose sodium, magnesium stearate, povidone (K-30), maize starch, lactose monohydrate, polyvinyl alcohol, calcium carbonate, macrogol (MW 3350), talc and microcrystalline cellulose.

Description of the appearance of Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris and package contents

Film-coated tablet, white to off-white, capsule-shaped, biconvex, 15 mm x 7 mm in size, printed with “T7” on one side of the tablet and smooth on the other side.

Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris is supplied in blister packs of 30 and 90 film-coated tablets and in unit dose divisible blisters (BUD) of 30 x 1 and 90 x 1 film-coated tablets.

Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris is also supplied in bottles of 30 and 90 film-coated tablets. Each bottle contains a silica desiccant drying agent, which should remain in the bottle to protect the tablets. The desiccant is contained in a separate sachet or container and must not be swallowed.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer

Mylan Hungary Kft
Mylan utca 1, Komárom, 2900,
Hungary

Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe,
Benzstrasse 1, Bad Homburg v. d. Hoehe, Hessen, 61352,
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: + 32 (0) 2 658 61 00 Tel: + 370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: + 359 2 44 55 400 Tél/Tel: + 32 (0) 2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: + 420 222 004 400 Tel.: + 36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf.: + 45 28 11 69 32 Tel: + 356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: + 49 800 0700 800 Tel: + 31 (0) 20 426 3300

Eesti Norge
Viatris OÜ Viatris AS
Tel: + 372 6363 052 Tlf: + 47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: + 30 2100 100 002 Tel: + 43 1 86390

España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél: + 33 4 37 25 75 00 Tel: + 351 214 127 200

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: + 385 1 23 50 599 Tel: + 40 372 579 000

Ireland Slovenija
Viatris Limited Viatris d.o.o
Tel: + 353 1 8711600 Tel: + 386 1 23 63 180

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: + 354 540 8000 Tel: + 421 2 32 199 100

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel.: + 39 (0) 2 612 46921 Puh/Tel: + 358 20 720 9555

Κύπρος Sverige
CPO Pharmaceuticals Ltd Viatris AB
Τηλ: + 357 22863100 Tel: + 46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: + 371 676 055 80

More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu