ENTECAVIR KABI 0.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Entecavir Kabi 0.5 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 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 Package Leaflet

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

1. What is Entecavir Kabi 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 Kabi

Do not take Entecavir Kabi

• 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 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 if 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.

• If you are also infected with HIV(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.

• If you have received previous treatment for chronic hepatitis B, 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 Kabi with other medicines

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

Taking Entecavir Kabi 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 breastfeeding, think you may be pregnant, or are planning to have a baby. 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 avoid becoming pregnant.

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 somnolence are common side effects that may affect your ability to drive and use machines. If you are unsure, talk to your doctor.

Entecavir Kabi 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 Kabi

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

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

For adults, the 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 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 weighing 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.

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 tablets 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 Kabi 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 Kabi

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 Kabi 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.

Patients treated with entecavir have reported the following side effects:

Adults

Common(may affect up to 1 in 10 people)

• headache, insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (drowsiness)
• vomiting, diarrhea, nausea, dyspepsia (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, which is 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 and Healthcare Products Agency (AEMPS) via 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 Kabi

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.

Once the bottle is opened, the tablets should be used within 30 days.

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 Kabi

Contents of Entecavir Kabi

• The active ingredient is entecavir.

Each Entecavir Kabi 0.5 mg film-coated tablet contains entecavir monohydrate equivalent to 0.5 mg of entecavir.

• The other ingredients are:

Core of the tablet: Lactose monohydrate, microcrystalline cellulose, crospovidone (type A), hydroxypropyl cellulose (type L), magnesium stearate.

Film coating (white): Titanium dioxide (E171), lactose monohydrate, hypromellose, macrogol 4000.

Appearance and packaging of the product

Entecavir Kabi 0.5 mg film-coated tablets are white to off-white triangular tablets, marked with “0.5” on one side, with a medium size of 8.4 mm ± 0.2 mm and 3.7 mm ± 0.3 mm in thickness.

Entecavir Kabi is available in cardboard boxes containing OPA/ALU/PVC-Aluminum or high-density polyethylene (HDPE) white bottles with child-resistant polypropylene caps and induction seals.

Pack sizes:

30 tablets

30 x 1 tablets (perforated blister)

60 tablets

90 tablets

90 x 1 tablets (perforated blister)

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Fresenius Kabi España, S.A.U.

Marina 16-18

08005 Barcelona

Spain

Manufacturer:

Pharmathen S.A.

6 Dervenakion Str

15351 Pallini (Athens)

Greece

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

Nürnberg 90449

Germany

Pharmathen International S.A.

Industrial Park Sapes, Rodopi Prefecture, Block No 5

Rodopi 69300

Greece

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

Date of last revision of this leaflet: January 2022

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