Emtricitabine/tenofovir alafenamide Viatri

Package leaflet: Information for the user

Emtricitabine/Tenofovir alafenamide Viatris 200 mg/10 mg film-coated tablets, mg/25 mg film-coated tablets

emtricitabine/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 yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Emtricitabine/Tenofovir alafenamide Viatris is and what it is used for
2. What you need to know before taking Emtricitabine/Tenofovir alafenamide Viatris
3. How to take Emtricitabine/Tenofovir alafenamide Viatris
4. Possible side effects
5. How to store Emtricitabine/Tenofovir alafenamide Viatris
6. Contents of the pack and other information

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

Emtricitabine/Tenofovir alafenamide Viatris contains two active substances:

• emtricitabine, an antiretroviral medicine belonging to the class of nucleoside reverse transcriptase inhibitors (NRTIs)
• tenofovir alafenamide, an antiretroviral medicine belonging to the class of nucleotide reverse transcriptase inhibitors (NtRTIs)

Emtricitabine/Tenofovir alafenamide Viatris blocks the action of the reverse transcriptase enzyme, which is essential for the virus to replicate. Emtricitabine/Tenofovir alafenamide Viatris therefore reduces the amount of HIV in your body.
Emtricitabine/Tenofovir alafenamide Viatris, in combination with other medicines, is used for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents aged 12 years and older with a body weight of at least 35 kg.

2. What you need to know before taking Emtricitabine/Tenofovir alafenamide Viatris

Do not take Emtricitabine/Tenofovir alafenamide Viatris

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

Warnings and precautions
While taking Emtricitabine/Tenofovir alafenamide Viatris, you must continue to be monitored by your doctor.
This medicine does not cure HIV infection. While taking Emtricitabine/Tenofovir alafenamide Viatris, you may still develop infections or other illnesses associated with HIV infection.
Talk to your doctor before taking Emtricitabine/Tenofovir alafenamide Viatris:

• If you have or have had liver problems, including hepatitis. Patients with liver problems, including chronic hepatitis B or C, treated with antiretrovirals, have a higher risk of serious liver complications that may lead to death. 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/Tenofovir alafenamide Viatris. Do not stop treatment with Emtricitabine/Tenofovir alafenamide Viatris without speaking to your doctor: see section 3, Do not stop treatment with Emtricitabine/Tenofovir alafenamide Viatris.

• Your doctor may decide not to prescribe Emtricitabine/Tenofovir alafenamide Viatris if your virus has a specific resistance mutation, as Emtricitabine/Tenofovir alafenamide Viatris may not effectively reduce the amount of HIV in your body.
• If you have kidney disease or if tests have shown kidney problems. Your doctor may request blood tests to monitor how well your kidneys are functioning at the beginning and during treatment with Emtricitabine/Tenofovir alafenamide Viatris.

While taking Emtricitabine/Tenofovir alafenamide Viatris
When you start taking Emtricitabine/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 Emtricitabine/Tenofovir alafenamide Viatris (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/Tenofovir alafenamide Viatris in children aged 11 years or younger has not yet been studied.

Other medicines and Emtricitabine/Tenofovir alafenamide Viatris
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Emtricitabine/Tenofovir alafenamide Viatris may interact with other medicines. As a result, blood levels of Emtricitabine/Tenofovir alafenamide Viatris or other medicines may change. This could prevent the medicines from working properly or may worsen side effects. In some cases, your doctor may need to adjust the dose or monitor blood levels.
Medicines used to treat hepatitis B:
You must not take Emtricitabine/Tenofovir alafenamide Viatris together with medicines containing:

• tenofovir alafenamide
• tenofovir disoproxil
• lamivudine
• adefovir dipivoxil

→ Tell your doctor if you are taking any of these medicines.
Other types of medicines:
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 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, consult your doctor or pharmacist before taking this medicine.
• If you become pregnant, inform your doctor immediately and discuss the potential benefits and risks of antiretroviral therapy for you and your baby.

If you have already taken Emtricitabine/Tenofovir alafenamide Viatris during pregnancy, your doctor may request regular blood tests and other diagnostic examinations to monitor your baby’s development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV has outweighed the risk of side effects.
Do not breastfeed while taking Emtricitabine/Tenofovir alafenamide Viatris. One of the active substances in this medicine is excreted in breast milk.
Breastfeeding is not recommended for HIV-positive women, as HIV infection can be transmitted to the baby through breast milk.
If you are breastfeeding or considering breastfeeding, you must discuss this with your doctor as soon as possible.

Driving and using machines
Emtricitabine/Tenofovir alafenamide Viatris may cause dizziness. If you experience dizziness while taking Emtricitabine/Tenofovir alafenamide Viatris, do not drive and do not operate tools or machinery.

Emtricitabine/Tenofovir alafenamide Viatris contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Emtricitabine/Tenofovir alafenamide Viatris

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Recommended dose:
Adults: One tablet daily, taken with or without food.
Adolescents aged 12 years and older, weighing at least 35 kg: One tablet daily, taken with or without food.
Due to its bitter taste, it is recommended not to chew or crush the tablet.
If you have difficulty swallowing the tablet whole, you may split it in half. Take both halves of the tablet one after the other to ensure the full dose is taken. Do not store the split tablet.
Always take the dose prescribed by your doctor. This is important to ensure that your medicine remains fully effective and to reduce the risk of developing resistance to treatment. Do not change the dose unless your doctor tells you to do so.
If you are undergoing dialysis, take your daily dose of Emtricitabine/Tenofovir alafenamide Viatris after completion of dialysis.
If you take more Emtricitabine/Tenofovir alafenamide Viatris than you should
If you take more Emtricitabine/Tenofovir alafenamide Viatris than the recommended dose, you may have an increased risk of side effects from this medicine (see section 4, Possible side effects).
Contact your doctor or nearest emergency department immediately. Take the medicine container with you so you can show what you have taken.
If you forget to take Emtricitabine/Tenofovir alafenamide Viatris
It is important that you do not miss any doses of Emtricitabine/Tenofovir alafenamide Viatris.
If you miss a dose:

• If you remember within 18 hours of your usual dosing time for Emtricitabine/Tenofovir alafenamide Viatris, take the tablet as soon as possible. Then take your next dose at the usual time.
• If you remember 18 hours or more after your usual dosing time for Emtricitabine/Tenofovir alafenamide Viatris, do not take the missed dose. Wait and take your next dose at the usual time.

If you vomit within 1 hour after taking Emtricitabine/Tenofovir alafenamide Viatris, take another tablet.
Do not stop treatment with Emtricitabine/Tenofovir alafenamide Viatris
Do not stop treatment with Emtricitabine/Tenofovir alafenamide Viatris without speaking to your doctor. Stopping treatment with Emtricitabine/Tenofovir alafenamide Viatris may seriously affect the effectiveness of subsequent treatment. If treatment with Emtricitabine/Tenofovir alafenamide Viatris is stopped for any reason, talk to your doctor before restarting the tablets.
When your supply of Emtricitabine/Tenofovir alafenamide Viatris starts to run low, obtain a new supply from your doctor or pharmacist. This is very important because the amount of virus may start to increase if the medicine is interrupted, even for a few days. The disease may become more difficult to treat.
If you have both HIV infection and hepatitis B, it is very important not to stop treatment with Emtricitabine/Tenofovir alafenamide Viatris without first contacting 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 may lead to worsening of hepatitis, which can be potentially fatal.
→ Immediately inform your doctor of any new or unusual symptoms occurring after stopping treatment, particularly symptoms typically associated with hepatitis B infection.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• Signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) who have previously had opportunistic infections (infections occurring in people with a very weak immune system), signs and symptoms of inflammation from prior infections may occur soon after starting antiretroviral therapy. 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 (the immune system attacks healthy body tissues) may also occur when you start taking medicines for HIV infection. Autoimmune disorders may appear several 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 experience any of the above side effects, inform your doctor immediately.
Very common side effects
(may affect more than 1 in 10 people)

• feeling unwell (nausea)

Common side effects
(may affect up to 1 in 10 people)

• abnormal dreams
• headache
• dizziness
• diarrhoea
• vomiting
• stomach ache
• intestinal gas (flatulence)
• rash
• tiredness (fatigue)

Uncommon side effects
(may affect up to 1 in 100 people)

• low red blood cell count (anaemia)
• digestive problems causing discomfort after meals (dyspepsia)
• swelling of the face, lips, tongue or throat (angioedema)
• itching
• hives
• joint pain (arthralgia)

→ If any of these side effects worsens, inform your doctor.
Other possible side effects observed 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/Tenofovir alafenamide Viatris may develop a bone disease called osteonecrosis (death of bone tissue due to reduced blood supply to the bone). Long-term use of these medicines, use of corticosteroids, alcohol consumption, having a weakened immune system, and being overweight may be some of the many risk factors for developing this condition. Signs of osteonecrosis include:
  • joint stiffness
  • discomfort and pain in the joints (especially in the hips, knees, and shoulders)
  • difficulty moving
    → If you notice any of these symptoms, inform your doctor.

During HIV therapy, an increase in weight and in blood lipid and glucose levels may occur. This is partly related to improved 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system mentioned in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Emtricitabine/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.
Blister: do not store above 30 °C.
Bottles: this medicine does not require any special storage temperature.
Do not dispose of medicines 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/Tenofovir alafenamide Viatris contains
The active substances are emtricitabine and tenofovir alafenamide.
Each film-coated tablet of Emtricitabine/Tenofovir alafenamide Viatris contains 200 mg of
emtricitabine and tenofovir alafenamide monofumarate equivalent to 10 mg of tenofovir alafenamide, or
200 mg of emtricitabine and tenofovir alafenamide monofumarate equivalent to 25 mg of tenofovir
alafenamide.
The other components are
Tablet core:
Microcrystalline cellulose, croscarmellose sodium, magnesium stearate.
Film coating:
Partially hydrolysed poly(vinyl alcohol), titanium dioxide (E171), iron oxide black (E172) (only in
200 mg/10 mg film-coated tablets), macrogol, talc, indigo carmine aluminium lake (E132) (only in
200 mg/25 mg film-coated tablets).

Description of the appearance of Emtricitabine/Tenofovir alafenamide Viatris and contents of the
pack
The film-coated tablets (tablets) of Emtricitabine/Tenofovir alafenamide Viatris 200 mg/10 mg are
grey, film-coated, rectangular, with bevelled edges, biconvex (approximately 15 mm x 7 mm),
imprinted with 'ET 1' on one side of the tablet and 'V' on the other side.
The film-coated tablets (tablets) of Emtricitabine/Tenofovir alafenamide Viatris 200 mg/25 mg are
blue, film-coated, rectangular, with bevelled edges, biconvex (approximately 15 mm x 7 mm),
imprinted with 'ET 2' on one side of the tablet and 'V' on the other side.
Emtricitabine/Tenofovir alafenamide Viatris is supplied in bottles containing 30 and 90 film-coated
tablets (with a silica gel desiccant, which must remain in the bottle to protect the tablets). The silica gel
is contained in a separate sachet or container and must not be swallowed.
Available pack sizes: outer packaging containing 1 bottle with 30 and 90 film-coated tablets.
The 200 mg/25 mg film-coated tablets are also available in outer packaging containing blisters of 30 and 90 film-coated tablets, and perforated, divisible unit-dose blisters of 30 x 1 and 90 x 1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Viatris Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland

Manufacturer:
Mylan Hungary Kft.
Mylan utca. 1, H-2900 Komárom,
Hungary

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation 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: + 386 123 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 Limited Viatris AB
Τηλ: + 357 22863100 Tel: + 46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: + 371 676 055 80

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