ENTECAVIR STADA 0.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

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

Entecavirisanantiviralmedicineusedtotreatchronic(long-term)hepatitisBvirus(HBV)infectioninadults.

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).

Entecavirisalsousedtotreatchronic(long-term)HBVinfectioninchildrenandadolescentsfrom2tolessthan18yearsofage.

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 Stada

Do not take Entecavir Stada

• 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

• , tell your doctor. This is important because entecavir 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 you stop treatment. When you stop treatment with 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 treatment with entecavir may have.

• (human immunodeficiency virus), make sure to tell your doctor. You should not take entecavir to treat your hepatitis B infection unless you are also taking medicines to treat your HIV infection, as otherwise the effectiveness of future HIV treatments 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 those who are overweight. Your doctor will monitor you regularly 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.

Other medicines and Entecavir Stada

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

Taking Entecavir Stada 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.

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 it is clearly necessary, according to your doctor. It is important that women of childbearing age who are being treated with 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, talk to your doctor.

Entecavir Stada contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to take Entecavir Stada

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

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, talk to your doctor or pharmacist again.

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

Your dose will depend on:

• if you have been treated before for a hepatitis B infection, as well as the medicine you received.
• if you have kidney problems. Your doctor may prescribe a lower dose or tell you to 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. Children with a weight of at least 32.6 kg may take the oral solution or the 0.5 mg tablets. Entecavir oral solution is recommended for patients with a weight between 10 kg and 32.5 kg. 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 pediatrician will decide on the appropriate dose based on the child's body weight.

Your doctor will advise you on what dose is right 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 need to take this medicine on an empty stomach (see Taking Entecavir Stada with food and drinksin Section 2). If your doctor tells you to take this medicine on an empty stomach, empty stomach means at least 2 hours after a meal and 2 hours before the next meal.

If you take more Entecavir Stada 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 Stada

It is important that you do not miss any dose. If you miss a dose of entecavir, you should 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 treatment with Entecavir Stada without talking to your doctor

Some people develop 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 other 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.

Adults

Patients treated with entecavir have reported the following side effects:

Common(may affect up to 1 in 10 people)

• headache
• insomnia (inability to sleep)
• fatigue (extreme tiredness)
• dizziness
• drowsiness
• vomiting
• diarrhea
• nausea
• indigestion
• increase in liver enzyme levels in 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

The side effects experienced in children and adolescents are similar to those experienced 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)

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get 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 via the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Entecavir Stada

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.

Do not store above 30°C. Store in the original package.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Entecavir Stada

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

Core of the tablet: lactose monohydrate, microcrystalline cellulose, pregelatinized maize starch, crospovidone (type IA) (E1202), and magnesium stearate.

Coating: titanium dioxide (E171), hypromellose (E464), macrogol 400, and polysorbate 80 (E433).

Appearance and packaging

The film-coated tablets are white, oval, and scored on both sides.

Entecavir Stada 0.5 mg film-coated tablets are supplied in boxes containing 30 x 1 or 90 x 1 film-coated tablets (in unit dose blisters).

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorio Stada, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Medis International a.s.

výrobní závod Bolatice

Prumyslová 961/16, 747 23 Bolatice

Czech Republic

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

Netherlands

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

Date of last revision of this leaflet:September 2021

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