EMTRICITABINA 200 mg/10 mg Film-Coated Tablet

Содержание инструкции

1. Emtricitabina/Tenofovir alafenamide Viatris 200 mg/10 mg film-coated tablets, 200 mg/25 mg film-coated tablets
   1. What is Emtricitabina/Tenofovir alafenamide Viatris and what is it used for
   2. What you need to know before taking Emtricitabine/Tenofovir alafenamide Viatris
   3. How to take Emtricitabina/Tenofovir alafenamide Viatris
   4. Possible side effects
   5. How to store Emtricitabina/Tenofovir alafenamide Viatris
   6. Package contents and other information

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

emtricitabina/tenofovir alafenamide

Read 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Emtricitabina/Tenofovir alafenamide Viatris contains two active ingredients:

• 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)

Emtricitabina/Tenofovir alafenamide Viatris blocks the action of the reverse transcriptase enzyme, which is
essential for the virus to multiply. Emtricitabina/Tenofovir alafenamide Viatris therefore reduces
the amount of HIV in your body.
Emtricitabina/Tenofovir alafenamide Viatris in combination with other medicines is used for the

treatment of human immunodeficiency virus type 1 (HIV-1) infectionin adults and
adolescents aged 12 years or 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 allergicto emtricitabine, to tenofovir alafenamideor 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 diseases 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 and potentially life-threatening liver complications. If you have hepatitis B, your doctor will carefully assess the best treatment regimen for you.

If you have hepatitis B, liver problems may worsen when you stop the
treatment with Emtricitabine/Tenofovir alafenamide Viatris. Do not stop treatment with
Emtricitabine/Tenofovir alafenamide Viatris without talking 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 certain resistance mutation, as Emtricitabine/Tenofovir alafenamide Viatris may not be able to reduce the amount of HIV in your body effectively.
• If you have kidney disease or if tests have shown problems with your kidneys. Your doctor may request blood tests to monitor how your kidneys are functioning at the beginning and during treatment with Emtricitabine/Tenofovir alafenamide Viatris.

While taking Emtricitabina/Tenofovir alafenamide Viatris
When you start taking Emtricitabine/Tenofovir alafenamide Viatris, be careful to:

• 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.
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 childrenaged 11 years or under or with a body weight of less than
35 kg. The use of Emtricitabine/Tenofovir alafenamide Viatris in children aged 11 years or
under 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 can interact with
other medicines. As a result, the amount of Emtricitabine/Tenofovir alafenamide Viatris or of
the other medicines in the blood may vary. This may prevent the medicines from working correctly or
may worsen their side effects. In some cases, your doctor may need to adjust the dose or
check blood levels.

Medicines used for the treatment of hepatitis B:
You must not take Emtricitabine/Tenofovir alafenamide Viatris together with medicines containing:

• tenofovir alafenamide
• tenofovir disoproxil
• lamivudine
• adefovir dipivoxil

→ Tell your doctorif you are taking any of these medicines.

Other types of medicines:
Talk to your doctor if you are taking:

• antibioticsused 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 remediesused to treat depression and anxiety containing:
• St John's wort ( Hypericum perforatum)

→ Tell your doctor if you are taking these or other medicines.Do not stop treatment without
contacting your doctor.

Pregnancy and breastfeeding

• If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
• If you become pregnant, tell your doctor immediately and ask about 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 tests to monitor your baby's development. In children whose mothers have taken NRTIs during pregnancy, the benefit of
protection against HIV has outweighed the risk of side effects.

Do not breastfeed during treatment with Emtricitabine/Tenofovir alafenamide Viatris.The reason is
that one of the active ingredients of 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 are thinking about breastfeeding you should talk to your doctor as soon as possible.

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

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 Emtricitabina/Tenofovir alafenamide Viatris

Take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor or pharmacist.

The recommended dose is:
Adults:one tablet a day, to be taken with or without food.

Adolescents aged 12 years or older, with a body weight of at least 35 kg:one tablet a day, to be taken with or without food.
Due to the bitter taste, it is recommended not to chew or crush the tablet.
If you have difficulty swallowing the tablet whole, you can divide it in half. Take both halves of the tablet one after the other, so as to take the entire dose. Do not store the divided tablet.

Always take the dose recommended by your doctor.This is to ensure that your medicine is fully effective and to reduce the risk of developing resistance to treatment. Do not change the dose unless your doctor tells you to.

If you are undergoing dialysis, take your daily dose of Emtricitabina/Tenofovir alafenamide Viatris after completion of the dialysis.

If you take more Emtricitabina/Tenofovir alafenamide Viatris than you should
If you take a dose of Emtricitabina/Tenofovir alafenamide Viatris higher than that recommended, you may have a higher risk of side effects of this medicine (see section 4,

Possible side effects).
Contact your doctor or the nearest emergency center immediately. Bring the bottle of tablets with you so you can show what you have taken.

If you forget to take Emtricitabina/Tenofovir alafenamide Viatris
It is important that you do not forget any dose of Emtricitabina/Tenofovir alafenamide Viatris.
If you forget a dose :

• if you realise this within 18 hoursof the usual time of taking Emtricitabina/Tenofovir alafenamide Viatris, you should take the tablet as soon as possible. Then take the next dose as usual.
• if you realise this after 18 hours or moreof the usual time of taking Emtricitabina/Tenofovir alafenamide Viatris, do not take the forgotten dose. Wait and take the next dose at the usual time.

In case of vomiting occurring within 1 hour of taking Emtricitabina/Tenofovir
alafenamide Viatris, take another tablet.

Do not stop treatment with Emtricitabina/Tenofovir alafenamide Viatris
Do not stop treatment with Emtricitabina/Tenofovir alafenamide Viatris without talking to your doctor.Stopping treatment with Emtricitabina/Tenofovir alafenamide Viatris can seriously affect the effectiveness of subsequent treatment. If treatment with Emtricitabina/Tenofovir alafenamide Viatris is interrupted for any reason, talk to your doctor before starting to take Emtricitabina/Tenofovir alafenamide Viatris tablets again.

When your supply of Emtricitabina/Tenofovir alafenamide Viatris begins to run low, ask your doctor or pharmacist for another supply. It is very important because the amount of virus can start to increase if the medicine is stopped even for a few days. The disease may become more difficult to treat.

If you have both an HIV infection and hepatitis B, it is very important not to stop treatment with Emtricitabina/Tenofovir alafenamide Viatris without contacting your doctor first. It may be necessary to repeat blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment may lead to a worsening of hepatitis, which can be potentially fatal.
→ Immediately tell your doctorabout any new or unusual symptoms observed after stopping treatment, especially symptoms that are normally associated with hepatitis B infection.
If you have any questions about 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.

Serious possible side effects: inform your doctor immediately

• 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 very weak immune system), signs and symptoms of inflammation from previous infections may occur shortly after starting antiretroviral treatment. These symptoms are thought to be due to an improvement in the body's immune response, which allows it to fight infections that may be present without obvious symptoms.
• Autoimmune diseases(the immune system attacks healthy tissue in the body) may also develop when you start taking medicines for HIV infection. Autoimmune diseases can develop many months after starting treatment. Pay attention to any symptoms 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 the side effects described above, 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 pain
• intestinal gas ( flatulence)
• skin 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 get worse, tell your doctor.
Other possible side effects observed during HIV treatment
The frequency of the following side effects is not known (frequency cannot be estimated on the
basis of available data).

• Bone problems.Some patients taking combination antiretroviral medicines such as Emtricitabine/Tenofovir alafenamide Viatris may develop a bone disease called osteonecrosis(bone tissue death caused by reduced blood supply to the bone). Taking this type of medicine for a prolonged period, taking corticosteroids, drinking alcohol, having a weakened immune system and being overweight may be some of the many risk factors for developing this disease. Signs of osteonecrosis are:
• joint stiffness
• discomfort and pain in the joints (especially in the hips, knees and shoulders)
• difficulty moving → If you notice any of these symptoms, tell your doctor.

During HIV therapy, weight and levels of lipids and glucose may increase
in the blood. This is partly related to the restoration of health and lifestyle and, in the case of
blood lipids, sometimes can be related to the HIV medicines themselves. Your doctor will check
these changes.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system as detailed in Annex V. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Emtricitabina/Tenofovir alafenamide Viatris

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 pack and bottle after
“Exp.”. The expiry date refers to the last day of that month.
Blisters: do not store at a temperature above 30 °C.
Bottles: this medicine does not require any particular storage temperature.
Do not dispose of any medicine in waste water 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 Emtricitabina/Tenofovir alafenamide Viatris contains
The active ingredients areemtricitabine and tenofovir alafenamide.
Each film-coated tablet of Emtricitabina/Tenofovir alafenamide Viatris contains 200 mg of
emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide or
200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir
alafenamide.

The other ingredients are

Tablet core:
Microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Film coating:
Partially hydrolyzed poly(vinyl alcohol), titanium dioxide (E171), black iron oxide (E172) (only
200 mg/10 mg film-coated tablets), macrogol, talc, aluminum carmine indigo (E132) (only
200 mg/25 mg film-coated tablets).

Description of the appearance of Emtricitabina/Tenofovir alafenamide Viatris and contents of the
pack
The film-coated tablets (tablets) of Emtricitabina/Tenofovir alafenamide Viatris
200 mg/10 mg are grey, film-coated, rectangular, with chamfered edges, biconvex (approximately
15 mm x 7 mm), imprinted with ‘ET 1’ on one side of the tablet and with ‘V’ on the other side.
The film-coated tablets (tablets) of Emtricitabina/Tenofovir alafenamide Viatris
200 mg/25 mg are blue, film-coated, rectangular, with chamfered edges, biconvex (approximately 15 mm x
7 mm), imprinted with ‘ET 2’ on one side of the tablet and with ‘V’ on the other side.
Emtricitabina/Tenofovir alafenamide Viatris is supplied in bottles of 30 and 90 film-coated
tablets (with the desiccant silica gel, which must remain in the bottle to protect the tablets). The silica
gel is contained in a sachet or a separate jar and must not be swallowed.
The following pack sizes are available: outer packaging containing 1 bottle of 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 blisters for unit dose 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 on this medicinal product, contact the local representative of the marketing
authorisation holder.

België/Belgique/Belgien
Viatris
Tél/Tel: + 32 (0) 2 658 61 00

Lietuva
Viatris UAB
Tel: +370 5 205 1288

България
Майлан ЕООД
Тел.: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZ s.r.o.
Tel: + 420 222 004 400

Magyarország
Viatris Healthcare Kft.
Tel.: + 36 1 465 2100

Danmark
Viatris ApS
Tlf.: + 45 28 11 69 32

Malta
V.J. Salomone Pharma Ltd
Tel: + 356 21 22 01 74

Deutschland
Viatris Healthcare GmbH
Tel: + 49 800 0700 800

Nederland
Mylan BV
Tel: + 31 (0)20 426 3300

Eesti
Viatris OÜ
Tel: + 372 6363 052

Norge
Viatris AS
Tlf: + 47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: + 30 2100 100 002

Österreich
Viatris Austria GmbH
Tel: + 43 1 86390

España
Viatris Pharmaceuticals, S.L.
Tel: + 34 900 102 712

Polska
Viatris Healthcare Sp. Z o.o.
Tel.: +48 22 546 64 00

France
Viatris Santé
Tél: + 33 4 37 25 75 00

Portugal
Mylan, Lda.
Tel: + 351 214 127 200

Hrvatska
Viatris Hrvatska d.o.o.
Tel: + 385 1 23 50 599

România
BGP Products SRL
Tel: + 40 372 579 000

Ireland
Viatris Limited
Tel: + 353 1 8711600

Slovenija
Viatris d.o.o.
Tel: + 386 123 63 180

Ísland
Icepharma hf.
Sími: + 354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: + 421 2 32 199 100

Italia
Viatris Italia S.r.l.
Tel: + 39 (0) 2 612 46921

Suomi/Finland
Viatris Oy
Puh/Tel: + 358 20 720 9555

Κύπρος
CPO Pharmaceuticals Limited
Τηλ: + 357 22863100

Sverige
Viatris AB
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 .