ENTECAVIR SANDOZ 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Entecavir Sandoz 1 mg Film-Coated Tablets EFG

entecavir

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 experience 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 Package Leaflet

1. What is Entecavir Sandoz and what is it used for
2. What you need to know before you take Entecavir Sandoz
3. How to take Entecavir Sandoz
4. Possible side effects
5. Storage of Entecavir Sandoz
6. Package Contents and Further Information

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

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

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).

Entecavirisalsousedtotreatchronic(long-term)HBVinfectioninchildrenandadolescentsfrom2tolessthan18yearsofage.

Entecavir may be used in children whose liver is damaged but still functions 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 Sandoz

Do not take Entecavir Sandoz

• 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 your dose or treatment schedule may need to be adjusted,
• do not stop taking entecavir without talking to your doctor, as your hepatitis may worsen if treatment is stopped. When your treatment with entecavir is stopped, 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 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 others with the hepatitis B virus (HBV)through sexual contact or body fluids (including blood contamination). Therefore, it is important that you take appropriate precautions to prevent others 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 periodically while you are taking entecavir,
• , 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.

Using Entecavir Sandoz with other medicines

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

Taking Entecavir Sandoz 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.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The use of entecavir has not been shown to be 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 avoid becoming pregnant.

You should not breastfeed while taking entecavir. If you are breastfeeding, tell your doctor. It is not known whether entecavir, the active ingredient in Entecavir Sandoz, 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.

This medicine contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Entecavir Sandoz

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 (orally).

Your dose will depend on:

• if you have been previously treated for HBV infection, as well as the medicine you received,
• if 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). Entecavir 0.5 mg tablets or entecavir oral solution are available. Your child's doctor will decide the correct dose based on your 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 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 Taking Entecavir Sandoz 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 Sandoz 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 Sandoz

It is important that you do not miss any dose. If you forget a dose of entecavir, you should take it as soon as possible and 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 missed doses.

Do not stop taking Entecavir Sandoz without talking to your doctor

Some people develop severe hepatitis symptoms when they stop taking entecavir. Tell your doctor immediately if you notice any change in 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.

Adults

Patients treated with entecavir have reported the following side effects:

• common (may affect up to 1 in 10 people): headache, insomnia, fatigue, dizziness, drowsiness, vomiting, diarrhea, nausea, dyspepsia, and increased liver enzyme levels 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

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 for fighting infections).

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 Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Entecavir Sandoz

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, bottle, and blister after EXP.

The expiry date is the last day of the month stated.

No special storage conditions are required.

After opening the bottle, use within 6 months.

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. Package Contents and Further Information

Composition of Entecavir Sandoz

• The active substance is entecavir (as monohydrate).
• • Each film-coated tablet contains 1 mg of entecavir (as monohydrate)
• The other ingredients are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose, crospovidone (Type A), and magnesium stearate.

Film coating: hypromellose 2910, macrogol 6000, titanium dioxide (E171), talc, iron oxide red (E172), and iron oxide yellow (E172).

Appearance of the Product and Package Contents

Film-coated tablet, pink, round, marked on both sides with "SZ" on one face and "109" on the other, with a diameter of approximately 10.0 mm.

The film-coated tablets are packaged in OPA/Aluminum/PVC-Aluminum blisters or in an HDPE bottle with a child-resistant polypropylene cap, inserted in a carton.

Package size:

Blister: 30 and 90 film-coated tablets.

Bottle: 30 film-coated tablets.

Not all pack sizes may be marketed in your country.

Marketing Authorization Holder and Manufacturer

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova ulica 57

1526 Ljubljana

Slovenia

or

Lek Pharmaceuticals d.d.

Trimlini 2d

9220 Lendava

Slovenia

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

Netherlands: Entecavir Sandoz 1 mg, filmomhulde tabletten

Italy: Entecavir Sandoz

Norway: Entecavir Sandoz 1 mg filmdrasjerte tabletter

Poland: Entecavir Sandoz, 1 mg, tabletki powlekane

Romania: Entecavir Sandoz 1 mg comprimate filmate

Sweden: Entecavir Sandoz 1 mg filmdragerade tabletter

Date of last revision of this leaflet:February 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/