Entecavir Teva 0.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ENTECAVIR TEVA 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 should not give it to other people, 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 Teva is and what it is used for
2. What you need to know before taking Entecavir Teva
3. How to take Entecavir Teva
4. Possible side effects
5. How to store Entecavir Teva
6. Contents of the pack and other information

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

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

Entecavir may be used in patients who have liver damage but whose liver still functions adequately (compensated liver disease) and in patients who have liver damage and whose liver does not function properly (decompensated liver disease).

Entecavir is 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 who have liver damage but whose liver 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 Teva

Do not take Entecavir Teva

• 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 starting entecavir

• if you have ever had kidney problems – inform your doctor. This is important because entecavir 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 whether your liver is functioning properly, and if not, about the possible effects your entecavir treatment 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 hepatitis B infection unless you are also taking medications for HIV infection, as otherwise the effectiveness of future HIV treatments could be reduced. Entecavir will not control your HIV infection.

• taking Entecavir does 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 appropriate precautions to prevent others from becoming infected with HBV. A vaccine is available to protect individuals at risk of HBV infection.

• Entecavir belongs to a class of medicines that may cause lactic acidosis (excess lactic acid in the blood) and enlargement of the liver. 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 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 in those weighing less than 32.6 kg.

Taking Entecavir Teva 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 Teva with food and drinks

In most cases, entecavir may be taken with or without food. However, if you have previously been treated with a medicine containing lamivudine as the active ingredient, the following applies. If you have switched to entecavir because lamivudine treatment was not effective, 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 planning to become pregnant. The use of entecavir during pregnancy has not been shown to be safe. Entecavir should not be used during pregnancy unless clearly necessary, as determined by your doctor. It is important that women of childbearing age receiving entecavir treatment use an effective method of contraception to avoid becoming pregnant.

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 human milk.

Driving and using machines

Dizziness, tiredness (fatigue), and drowsiness (somnolence) are common side effects that may affect your ability to drive or operate machinery. If you have any doubts, consult your doctor.

3. How to take Entecavir Teva

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

Always 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. Children weighing at least 32.6 kg may take the 0.5 mg tablet, or an oral solution may be available. The entecavir oral solution is recommended for patients weighing between 10 kg and 32.5 kg. All doses should be taken once daily by mouth. There are no recommendations for entecavir use in children under 2 years of age or weighing less than 10 kg.

Your paediatrician will decide the correct dose based on the child's weight.

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 as long as your doctor has instructed. Your doctor will tell you when to stop treatment.

Some patients should take this medicine on an empty stomach (see Entecavir tablets with food and drink in Section 2). If your doctor tells 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 Teva 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: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Entecavir Teva

It is important not to miss any doses. If you forget 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 a missed dose.

Do not stop treatment with Entecavir Teva 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 may notice after stopping treatment.

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

4. Possible adverse effects

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

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

Common (may affect up to 1 in 10 people):

• headache
• inability to sleep (insomnia)
• extreme tiredness (fatigue)
• dizziness
• drowsiness (somnolence)
• vomiting
• diarrhoea
• nausea
• indigestion (dyspepsia)
• increased levels of liver enzymes in the blood

Uncommon (may affect up to 1 in 100 people):

• skin rash
• hair loss

Rare (may affect up to 1 in 1,000 people):

• 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 (may affect more than 1 in 10 people): low levels of neutrophils (a type of white blood cell important in fighting infection).

Reporting of adverse effects

If you experience any 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Entecavir Teva

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you have any doubts, 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 Teva

• The active substance is entecavir.
• Each film-coated tablet contains 0.5 mg of entecavir.
• The other components are:

Tablet core: mannitol (E421), microcrystalline cellulose (E460), pregelatinized corn starch, crospovidone type A (E1202), magnesium stearate.

Film coating: partially hydrolysed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (polyethylene glycol), talc (E553b).

Appearance of the product and contents of the pack

Round, white to off-white film-coated tablet, marked with "05" on one side and "E" on the other, with a diameter of approximately 5.96–6.26 mm.

The film-coated tablets are supplied in:

• PVC/PVdC – Aluminium blisters in packs containing 10, 30, 60 or 90 tablets.
• PVC/PVdC – Aluminium unit dose blisters in packs containing 30x1 tablets.
• Aluminium/OPA/PVC – Aluminium blisters in packs containing 10, 30, 60 or 90 tablets.
• Aluminium/OPA/PVC – Aluminium unit dose blisters in packs containing 30x1 tablets.
• HDPE bottles with child-resistant polypropylene caps in packs containing 30 or 100 tablets.
• HDPE bottles with child-resistant polypropylene caps and silica gel desiccant in packs containing 30 or 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1st floor.

28108 Alcobendas, Madrid

Spain

Manufacturer

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80

31-546 Kraków

Poland

or

Merckle GmbH

Ludwig-Merckle-Strasse 3, Blaubeuren

89143 Baden-Württemberg

Germany

or

PLIVA Croatia Ltd.

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Austria Entecavir ratiopharm 0.5 mg Filmtabletten

Denmark Entecavir Teva

Spain Entecavir Teva 0.5 mg film-coated tablets EFG

France Entecavir Teva 0.5 mg, comprimé pelliculé

Hungary Entecavir Teva 0.5 mg filmtabletta

Croatia Entekavir Pliva 0.5 mg filmom obložene tablete

Ireland Entecavir Teva 0.5 mg Film-coated Tablets

Netherlands Entecavir Teva 0.5 mg, filmomhulde tabletten

Norway Entecavir Teva

Poland Entecavir Teva

Portugal Entecavir Teva

Sweden Entecavir Teva

Slovenia Entekavir Teva 0.5 mg filmsko obložene tablete

Date of the most recent revision of this leaflet: June 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)