Entecavir Viatris

Package leaflet: Information for the user

Entecavir Viatris 0.5 mg film-coated tablets, 1 mg film-coated tablets

entecavir
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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Entecavir Viatris is and what it is used for

Entecavir Viatris tablets are an antiviral medicine used to treat chronic (long-term) hepatitis B virus (HBV) infection in adults. Entecavir Viatris can be used in people whose liver is damaged but still functions properly (compensated liver disease) and in people whose liver is damaged and does not function properly (decompensated liver disease).
Entecavir Viatris tablets are also used to treat chronic (long-term) hepatitis B virus (HBV) infection in children and adolescents from 2 years of age up to but below 18 years of age. Entecavir Viatris can be used in children whose liver is damaged but still functions properly (compensated liver disease).
Hepatitis B virus infection can cause liver damage. Entecavir Viatris reduces the amount of virus in the body and helps improve liver condition.

2. What you need to know before taking Entecavir Viatris

Do not take Entecavir Viatris

• if you are allergic to entecavir or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Entecavir Viatris

• if you have had kidney problems, inform your doctor. This is important because Entecavir Viatris is eliminated from the body through the kidneys, and you may need a dose adjustment or changes in your treatment schedule.
• do not stop taking Entecavir Viatris without consulting your doctor, as hepatitis may worsen after stopping treatment. If your treatment with Entecavir Viatris is discontinued, your doctor will continue to monitor you and perform blood tests for several months.

Ask your doctor whether your liver is functioning properly and, if not, what the possible

• effects of treatment with Entecavir Viatris might be.
• if you are also infected with HIV (human immunodeficiency virus), inform your doctor. You must not take Entecavir Viatris to treat hepatitis B infection unless you are also receiving HIV medications, as the effectiveness of future HIV treatment may be reduced. Entecavir Viatris does not control HIV infection.
• taking Entecavir Viatris will not prevent you from transmitting the hepatitis B virus (HBV) to others through sexual contact or bodily fluids (including blood contamination). Therefore, it is important to take precautions to avoid spreading the hepatitis B virus (HBV) to others. A vaccine is available to protect individuals at risk of contracting hepatitis B virus (HBV) infection.
• Entecavir Viatris belongs to a class of medicines that can cause excessive lactic acid in the blood (lactic acidosis) and liver enlargement. Symptoms such as nausea, vomiting, and stomach pain may indicate the development of lactic acidosis. This rare but serious side effect has occasionally been fatal. Lactic acidosis occurs more frequently in women, especially those who are significantly overweight. Your doctor will monitor you regularly during treatment with Entecavir Viatris.
• if you have previously undergone treatment for chronic hepatitis B, inform your doctor.

Children and adolescents
Entecavir Viatris must not be used in children under 2 years of age or weighing less than 10 kg.
Other medicines and Entecavir Viatris
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Entecavir Viatris with food and drink
In most cases, you can take Entecavir Viatris with or without food. However, if you have previously been treated with a medicine containing the active substance lamivudine, the following applies. If you have switched to treatment with Entecavir Viatris because lamivudine treatment was not successful, you must take Entecavir Viatris once daily on an empty stomach. If your liver disease (hepatic condition) is very advanced, your doctor will instruct you to take Entecavir Viatris on an empty stomach. An empty stomach means at least 2 hours after a meal and at least 2 hours before the next meal.
Children and adolescents (from 2 years of age up to, but not including, 18 years) may take Entecavir Viatris with or without food.
Pregnancy, breastfeeding and fertility
Inform your doctor if you are pregnant or planning to become pregnant. It has not been established that the use of Entecavir Viatris during pregnancy is safe. Entecavir Viatris must not be used during pregnancy unless specifically instructed by your doctor. It is important that women of childbearing potential use an effective method of contraception during treatment with Entecavir Viatris to avoid pregnancy.
You must not breastfeed while taking Entecavir Viatris. Inform your doctor if you are breastfeeding. It is not known whether entecavir, the active substance in Entecavir Viatris, is excreted in human breast milk.
Driving and using machines
Dizziness, fatigue, and drowsiness are common side effects that may impair your ability to drive or operate machinery. For any clarification, consult your doctor.
Entecavir Viatris contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Entecavir Viatris

Not all patients need to take the same dose of Entecavir Viatris.
Always take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
For adults, the recommended dose is 0.5 mg or 1 mg taken once daily by mouth (orally).
Your dose will depend on:

• whether you have previously received treatment for hepatitis B virus (HBV) infection, and which medicine you were treated with.
• whether you have kidney problems. Your doctor may prescribe a lower dose or advise you to take it less than once daily.
• the condition of your liver.

For children and adolescents (from 2 years of age up to below 18 years), your child's doctor will determine the appropriate dose based on your child's body weight. Children weighing more than 32.6 kg may take the 0.5 mg tablet or may be given an oral solution of entecavir. For patients weighing between 10 kg and 32.5 kg, use of the oral solution is recommended. Each dose should be administered once daily by mouth (orally). There is no information available on the use of Entecavir Viatris in children below 2 years of age or weighing less than 10 kg.
For children and adolescents (from 2 years of age up to below 18 years), Entecavir Viatris 0.5 mg film-coated tablets or an oral solution are available. Your child's doctor will decide the correct dosage according to your child's body weight.
Your doctor will inform you about the correct dosage.
To ensure the medicine is fully effective and to reduce the risk of developing resistance to treatment, always take the dose recommended by your doctor. Take Entecavir Viatris for the entire duration prescribed by your doctor. Your doctor will advise you whether and when to stop treatment.
Some patients need to take Entecavir Viatris on an empty stomach (see Entecavir Viatris with food and drink in section 2). If your doctor tells you to take Entecavir Viatris on an empty stomach, this means you should take it at least 2 hours after a meal and at least 2 hours before the next meal.
If you take more Entecavir Viatris than you should
Contact your doctor immediately.
If you forget to take Entecavir Viatris
It is important that you do not miss any doses. If you forget a dose of Entecavir Viatris, take it as soon as possible, then take the next dose at the scheduled time. If it is almost time for the next dose, do not take the missed dose. Wait and take the next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose.
Do not stop treatment with Entecavir Viatris without consulting your doctor
Some people experience very severe hepatitis symptoms when they stop taking entecavir. Inform your doctor immediately if you notice any changes in your symptoms after stopping treatment.
If you have any doubts 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 everybody gets them.
Patients treated with entecavir have reported the following side effects:

Adults

• Common (affects at least 1 in 100 patients): headache (cephalalgia), inability to sleep (insomnia), fatigue, dizziness, drowsiness (somnolence), vomiting, diarrhoea, nausea, indigestion (dyspepsia), and increased levels of liver enzymes in the blood.
• Uncommon (affects at least 1 in 1,000 patients): rash, hair loss.
• Rare (affects at least 1 in 10,000 patients): severe allergic reaction.

Children and adolescents
Side effects observed in children and adolescents are similar to those observed in adults as described above, with the following difference:
Very common (affects at least 1 in 10 patients): low levels of neutrophils (a type of white blood cells, important in fighting infections).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Entecavir 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 bottle, blister pack or carton
after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Entecavir Viatris contains
Entecavir Viatris 0.5 mg film-coated tablets
The active substance is entecavir. Each film-coated tablet contains entecavir monohydrate equivalent to 0.5 mg of entecavir.
Entecavir Viatris 1 mg film-coated tablets
The active substance is entecavir. Each film-coated tablet contains entecavir monohydrate equivalent to 1 mg of entecavir.
The other components are:
Tablet core: microcrystalline cellulose, crospovidone, monohydrate lactose (see section 2, "Entecavir Viatris contains lactose"), magnesium stearate.
Tablet coating: titanium dioxide (E171), hypromellose, macrogol 400, polysorbate 80.

Description of the appearance of Entecavir Viatris and contents of the pack
Entecavir Viatris 0.5 mg film-coated tablets
The film-coated tablets (tablets) are white, film-coated, round, biconvex, with bevelled edges, marked with "M" on one side and "EA" on the other side.
Entecavir Viatris 1 mg film-coated tablets
The film-coated tablets (tablets) are white, film-coated, round, biconvex, with bevelled edges, marked with "M" on one side and "EB" on the other side.
Entecavir Viatris film-coated tablets are supplied in blister packs containing 30 tablets, in perforated blister packs containing 30 × 1 or 90 × 1 tablets, and in bottles containing 30 or 90 tablets.
Not all pack sizes may be marketed.

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

Manufacturer
McDermott Laboratories Limited t/a Gerard Laboratories
Unit 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13
Ireland
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
(Sverige)

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

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

Ελλάδα Österreich
Viatris Hellas Ltd Arcana Arzneimittel GmbH
Τηλ: +30 2100 100 02 Tel: +43 1 416 2418

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
Mylan Ireland 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
GPA Pharmaceuticals Ltd Viatris AB
Τηλ: +357 22863100 Tel: +46 (0)8 630 19 00

Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 Tel: +353 18711600

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