ENTECAVIR KABI 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Entecavir Kabi 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 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 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

• youareallergictoentecavirortoanyoftheotheringredientsofthismedicine(listedinsection6).

Warnings and precautions

Tell your doctor or pharmacist before you start taking entecavir

• Ifyouhaveeverhadkidneyproblems,tellyourdoctor.Thisisimportantbecauseentecavirisremovedfromthebodybythekidneysanditmaybenecessarytoadjustyourdoseortreatmentschedule.

• Donotstoptakingentecavirwithoutconsultingyourdoctor,asyourhepatitismayworsenwhentreatmentisinterrupted.Whenyourtreatmentwithentecavirisinterrupted,yourdoctorwillmonitoryoucloselyandperformbloodtestsforseveralmonths.

• Askyourdoctorifyourliverisworkingproperlyandifnot,aboutthepossibleeffectsthattreatmentwithentecavircouldhave.

• IfyouarealsoinfectedwithHIV(humanimmunodeficiencyvirus),makesuretotellyourdoctor.YoumustnottakeentecavirforthetreatmentofyourhepatitisBinfectionunlessyouarealsotakingmedicinesforthetreatmentofHIVinfection,asotherwisetheeffectivenessoffuturetreatmentsforHIVmaybereduced.EntecavirwillnotcontrolyourHIVinfection.

• TakingEntecavirwillnotpreventyoufrominfectingotherpeoplewithhepatitisBvirus(HBV)throughsexualcontactorbodyfluids(includingcontaminationofblood).Therefore,itisimportantthatyoutakeappropriateprecautionstopreventotherpeoplefromgettinginfectedwithHBV.AvaccineisavailabletoprotectpeopleatriskofinfectionwithHBV.

• Entecavirbelongstoaclassofmedicinesthatcancauselacticacidosis(excesslacticacidinyourblood)andenlargementoftheliver.Symptomssuchasnausea,vomitingandabdominalpaincouldindicatethedevelopmentoflacticacidosis.Onoccasion,thisrarebutserioussideeffecthasbeenfatal.Lacticacidosisoccursmorefrequentlyinwomen,especiallyinthosewhoareoverweight.Yourdoctorwillmonitoryouregularlywhileyouaretakingthismedicine.

• IfyouhavereceivedprevioustreatmentforchronichepatitisB,pleasetellyourdoctor.

Children and adolescents

Entecavir must 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 that contains 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.

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) can take entecavir with or without food.

Pregnancy, breast-feeding and fertility

Tell your doctor if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby. 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 prevent pregnancy.

You must not breast-feed while taking entecavir. If you are breast-feeding, tell your doctor. It is not known whether entecavir, the active ingredient of this medicine, is excreted in human 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 affected, do not drive or operate machines.

Entecavir Kabi contains lactose and maltodextrin

This medicine contains lactose and maltodextrin (which contains glucose). If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Entecavir Kabi

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

Follow exactly the instructions of your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

For adultsthe 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, and what medicine you received.
• whether you have kidney problems. Your doctor may prescribe a lower dose or tell you to take it less often than once a day.
• the condition of your liver.

For children and adolescents(from 2 to less than 18 years of age), your paediatrician will decide on the appropriate dose based on the child's body weight. 0.5 mg tablets are available and an oral solution of entecavir may also be available.

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 you should stop treatment.

Some patients must take this medicine on an empty stomach (see Entecavir Kabi with food and drinksin Section 2). If your doctor tells you to take this medicine on an empty stomach, an empty stomach means at least 2 hours after 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 a doctor or pharmacist immediately. If possible, show them the pack or this leaflet.

If you forget to take Entecavir Kabi

It is important that you do not 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 forgotten dose.

Do not stop taking Entecavir Kabi without consulting your doctor

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

If you have any further questions on the use of this product, 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, diarrhoea, nausea, dyspepsia (indigestion)
• increase in 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 that is important for fighting infections).

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 and Healthcare Products Agency (AEMPS) 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 that month.

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 substance is entecavir.

Each film-coated tablet of Entecavir Kabi 1.0 mg contains entecavir monohydrate equivalent to 1 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 (pink): hypromellose, titanium dioxide (E171), polydextrose, talc, maltodextrin, medium-chain triglycerides, red iron oxide (E172), yellow iron oxide (E172).

Appearance of the product and pack size

Entecavir Kabi 1.0 mg film-coated tablets are pink, triangular tablets, marked with “1” on one side, with a mean size of 10.6 mm ± 0.2 mm and 4.5 mm ± 0.3 mm in thickness.

Entecavir Kabi is available in cardboard boxes containing OPA/ALU/PVC-Aluminium blisters or a white high-density polyethylene (HDPE) bottle with a child-resistant polypropylene cap and an induction seal.

Pack sizes:

30 tablets

30 x 1 tablets

90 tablets

90 x 1 tablets

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: August 2020

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