Entecavir Tarbis 0.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Entecavir Tarbis 0.5 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you must not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

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

Entecavir Tarbis tablets are also used to treat chronic (long-term) HBV infection 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 functions adequately (compensated liver disease).

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

2. What you need to know before taking Entecavir Tarbis

Do not take Entecavir Tarbis

• if you are allergic (hypersensitive) 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 starting entecavir

• if you have ever had kidney problems, inform your doctor. This is important because Entecavir Tarbis is eliminated from the body through the kidneys, and your dose or treatment schedule may need to be adjusted.

• do not stop taking entecavir without consulting your doctor, as your hepatitis may worsen if treatment is interrupted. When you stop treatment with entecavir, your doctor will continue to monitor you and perform blood tests for several months.

• ask your doctor if your liver is functioning properly, and if not, about the possible effects your treatment with entecavir might have.

• if you are also infected with HIV (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 medications for the treatment of HIV infection, as otherwise the effectiveness of future HIV treatments could be reduced. Entecavir will not control your HIV infection.

• taking Entecavir 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 that you take appropriate precautions to prevent others from becoming infected with HBV. A vaccine is available to protect people at risk of HBV infection.

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

• if you have previously received treatment for chronic hepatitis B, please inform your doctor.

Children and adolescents

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

Taking Entecavir Tarbis with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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 previously been treated with another medicine containing lamivudine as the active ingredient, consider the following. If you have switched to entecavir because lamivudine treatment was not successful, you must take entecavir on an empty stomach, once daily. If your liver disease is very advanced, your doctor will also instruct you to take 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) may take entecavir with or without food.

Pregnancy, breastfeeding and fertility

Inform your doctor if you are pregnant or intend to become pregnant. It has not been demonstrated that the use of entecavir is safe during pregnancy. Entecavir should not be used during pregnancy except when clearly necessary, as determined by your doctor. It is important that women of childbearing potential who are being treated with entecavir use an effective method of contraception to prevent pregnancy.

You must not breastfeed during treatment with entecavir. If you are currently breastfeeding, inform your doctor. It is unknown whether entecavir, the active substance in this medicine, is excreted in breast milk.

Driving and using machines

Dizziness, tiredness (fatigue), and numbness (somnolence) are common adverse reactions that could affect your ability to drive and use machines. If you have any doubts, 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 given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

For adults, the recommended dose is 0.5 mg or 1 mg once daily (orally).

Your dose will depend on:

• whether you have previously been treated for HBV infection, and which medication you received.
• whether you have kidney problems. Your doctor may prescribe a lower dose or advise you to take it less frequently than once daily.
• the condition of your liver.

For children and adolescents (from 2 to less than 18 years of age), your paediatrician will determine the appropriate dose based on the child's body weight. Oral solution is recommended for patients weighing between 10 kg and 32.5 kg. Children weighing at least 32.6 kg may take either the oral solution or the 0.5 mg tablets. All doses should be taken once daily (orally). There are no recommendations for entecavir use 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 the medicine is fully effective and to reduce the risk of developing treatment resistance. Take entecavir for the entire duration prescribed by your doctor. Your doctor will tell you when to stop treatment.

Some patients should take this medicine on an empty stomach (see Entecavir Tarbis with food and drink in Section 2). If your doctor instructs you to take this medicine on an empty stomach, this 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, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Entecavir Tarbis

It is important not to miss any doses. If you miss a dose of Entecavir, take it as soon as possible, then take the next 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 a missed dose.

Do not stop treatment with Entecavir Tarbis without consulting your doctor

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

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been reported in patients treated with entecavir:

Adults

• Common (at least 1 in 100 patients): headache, insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (drowsiness), vomiting, diarrhea, nausea, dyspepsia (indigestion), and increased levels of liver enzymes 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

Adverse effects experienced in children and adolescents are similar to those observed 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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This 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 components are:

Tablet core: calcium carbonate (E-170), pregelatinized corn starch, sodium carboxymethylcellulose, soy polysaccharides, citric acid monohydrate, sodium stearyl fumarate.

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

Nature of the product and pack contents

The film-coated tablets are white to off-white, biconvex, triangular in shape. They are marked with "J" on one side and "110" on the other. 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 single-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.

Additionally, film-coated tablets are available in bottles containing 30 or 90 film-coated tablets.

Only certain 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

The Netherlands

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

This medicinal product 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 Filmtabletten
Spain: Entecavir Tarbis 0.5 mg film-coated tablets EFG
The Netherlands: Entecavir Amarox 0.5 mg filmomhulde tabletten
United Kingdom: Entecavir 0.5 mg film-coated tablets
Sweden: Entecavir Amarox 0.5 mg Filmdragerad tablett

Date of the most recent revision of this leaflet: October 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)