ENTECAVIR TARBIS 0.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Entecavir Tarbis 0.5 mg film-coated tablets EFG

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Entecavir Tarbis tablets are an antiviral medicine used to treat long-term (chronic) infection with hepatitis B virus (HBV) in adults.

Entecavir may be used in patients whose liver is damaged but still works adequately (compensated liver disease) and in patients whose liver is damaged and does not work adequately (decompensated liver disease).

Entecavir Tarbis tablets are also used to treat long-term (chronic) infection with HBV in children and adolescents from 2 to less than 18 years of age.

Entecavir may be used in children whose liver is damaged but still works adequately (compensated liver disease).

Hepatitis B virus infection can damage your liver. Entecavir reduces the amount of virus in your body and improves the condition of your liver.

2. What you need to know before you take Entecavir Tarbis

Do not take Entecavir Tarbis

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

Warnings and precautions

Talk to your doctor or pharmacist before taking entecavir

• if you have ever had problems with your kidneys, tell your doctor. This is important because Entecavir Tarbis is removed from the body by the kidneys and it may be necessary to adjust your dose or treatment schedule.

• do not stop taking entecavir without talking to your doctor, as your hepatitis may get worse when treatment is stopped. When you stop taking entecavir, your doctor will monitor you and perform blood tests for several months.

• ask your doctor if your liver is working properlyand, if not, about the possible effects that your treatment with entecavir may have.

• (human immunodeficiency virus), make sure to inform your doctor. You should not take entecavir for the treatment of your hepatitis B infection unless you are also taking medicines for the treatment of your HIV infection, as otherwise the effectiveness of future treatments for HIV may be reduced. Entecavir will not control your HIV infection.

• taking Entecavir will not prevent you from infecting other people with hepatitis B virus (HBV)through sexual contact or body fluids (including blood contamination). Therefore, it is important that you take appropriate precautions to prevent other people from becoming infected with HBV. There is a vaccine to protect people at risk of HBV infection.

• Entecavir belongs to a class of medicines that can cause lactic acidosis(excess of lactic acid in your blood) and liver enlargement. Symptoms such as nausea, vomiting, and stomach pain could indicate the development of lactic acidosis. On rare occasions, this rare but serious side effect has been fatal. Lactic acidosis occurs more frequently in women, especially in those who are overweight. Your doctor will monitor you periodically while you are taking this medicine.

• , please inform your doctor.

Children and adolescents

Entecavir should not be used in children under 2 years of age or weighing less than 10 kg.

Taking Entecavir Tarbis with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking Entecavir Tarbis with food and drinks

In most cases, you can take entecavir with or without food. However, if you have received previous treatment with another medicine containing lamivudine as the active ingredient, you should consider the following. If you have switched to entecavir because treatment with lamivudine was not successful, you should take entecavir on an empty stomach, once a day. If your liver disease is very advanced, your doctor will also instruct you on taking entecavir on an empty stomach.

An empty stomach means at least 2 hours after and 2 hours before the next meal.

Children and adolescents (from 2 to less than 18 years of age) can take entecavir with or without food.

Pregnancy, breastfeeding, and fertility

Tell your doctor if you are pregnant or planning to become pregnant. It has not been shown that the use of entecavir is safe during pregnancy. Entecavir should not be used during pregnancy unless clearly necessary, as determined by your doctor. It is important that women of childbearing age using entecavir use an effective method of contraception to prevent pregnancy.

You should not breastfeed during treatment with entecavir. If you are breastfeeding, tell your doctor. It is not known whether entecavir, the active ingredient of this medicine, is excreted in breast milk.

Driving and using machines

Dizziness, fatigue, and drowsiness are common side effects that may affect your ability to drive and use machines. If you are unsure, consult your doctor.

Entecavir Tarbis contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

Entecavir Tarbis contains soy polysaccharides

This medicine contains soy polysaccharides. If you are allergic to soy, do not use this medicine.

3. How to take Entecavir Tarbis

Not all patients need to take the same dose of Entecavir.

Follow exactly the instructions of your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

For adultsthe recommended dose is 0.5 mg or 1 mg once a day (by mouth).

Your dose will depend on:

• whether you have been treated for HBV infection before, as well as the medicine you received.
• whether you have kidney problems. Your doctor may prescribe a lower dose or indicate that you take it less frequently than once a day.
• the condition of your liver.

For children and adolescents(from 2 to less than 18 years of age), your pediatrician will decide on the appropriate dose based on the child's body weight. Entecavir oral solution is recommended for patients weighing between 10 kg and 32.5 kg. Children weighing at least 32.6 kg may take the oral solution or the 0.5 mg tablets. All doses should be taken once a day (by mouth). There are no recommendations for entecavir in children under 2 years of age or weighing less than 10 kg.

Your doctor will advise you on the correct dose for you. Always take the dose recommended by your doctor to ensure that the medicine is fully effective and to reduce the development of resistance to treatment. Take entecavir for as long as your doctor tells you. Your doctor will tell you when to stop treatment.

Some patients must take this medicine on an empty stomach (see Entecavir Tarbis with food and drinksin Section 2). If your doctor tells you to take this medicine on an empty stomach, an empty stomach means at least 2 hours after a meal and 2 hours before the next meal.

If you take more Entecavir Tarbis than you should

If you have taken more entecavir than you should, talk to your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Entecavir Tarbis

It is important that you do not miss any dose. If you miss a dose of Entecavir, take it as soon as possible and then take the next scheduled dose at the usual time. If it is almost time for your next dose, do not take the missed dose. Wait and take the next dose at the usual time. Do not take a double dose to make up for missed doses.

Do not stop taking Entecavir Tarbis without talking to your doctor

Some people develop very severe hepatitis symptoms when they stop taking entecavir. Tell your doctor immediately if you notice any changes in your symptoms after stopping treatment.

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.

Patients treated with entecavir have reported the following side effects:

Adults

• common (at least 1 in 100 patients): headache, insomnia, fatigue, dizziness, drowsiness, vomiting, diarrhea, nausea, dyspepsia, and increased liver enzyme levels in blood.
• uncommon (at least 1 in 1,000 patients): skin rash, hair loss.
• rare (at least 1 in 10,000 patients): severe allergic reaction.

Children and adolescents

The side effects experienced in children and adolescents are similar to those experienced in adults as described above, with the following difference:

Very common (at least 1 in 10 patients): low levels of neutrophils (a type of white blood cell important in fighting infection).

Reporting of side effects

If you experience 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 to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Entecavir Tarbis

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 after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Entecavir Tarbis

The active substance is entecavir. Each film-coated tablet contains 0.5 mg of entecavir (as monohydrate).

The other ingredients are:

Core of the tablet: calcium carbonate (E-170), maize starch pregelatinized, sodium carmellose, soy polysaccharides, citric acid monohydrate, sodium stearyl fumarate.

Coating: hypromellose, titanium dioxide (E-171), macrogol 400, polysorbate 80.

Appearance and packaging

The film-coated tablets are white to off-white, biconvex, and triangular in shape. They are marked with “J” on one side and “110” on the other side. Entecavir Tarbis 0.5 mg tablets are supplied in boxes containing 7 x 1, 10 x 1, 14 x 1, 20 x 1, 28 x 1, 30 x 1, 50 x 1, 56 x 1, 60 x 1, 80 x 1, 84 x 1, 90 x 1, 100 x 1, 112 x 1, 120 x 1, 200 x 1, or 500 x 1 film-coated tablets (in unit-dose blisters) and in blisters containing 7, 10, 14, 20, 28, 30, 50, 56, 60, 80, 84, 90, 100, 112, 120, 200, or 500 film-coated tablets.

In addition, the film-coated tablets are available in bottles containing 30 or 90 film-coated tablets.

Not all pack sizes may be marketed in your country.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer:

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany: Entecavir Amarox 0.5 mg film-coated tablets

Spain: Entecavir Tarbis 0.5 mg film-coated tablets EFG

Netherlands: Entecavir Amarox 0.5 mg film-coated tablets

United Kingdom: Entecavir 0.5 mg film-coated tablets

Sweden: Entecavir Amarox 0.5 mg film-coated tablets

Date of last revision of this leaflet:October 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/)