Entecavir Kabi 0.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Entecavir Kabi 0.5 mg film-coated tablets EFG

entecavir

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

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

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

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).

Entecavir is also used to treat chronic (long-term) HBV infection in children and adolescents aged 2 to less than 18 years.

Entecavir may be used in children whose liver is damaged but 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 starting to take Entecavir Kabi

Do not take Entecavir Kabi

• 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 to take 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 you interrupt treatment. When treatment with entecavir is stopped, your doctor will continue to monitor you and perform blood tests for several months.

• Ask your doctor if your liver is functioning properly, and if not, about the possible effects that your treatment with entecavir 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 your hepatitis B infection unless you are also taking medications for the treatment of HIV infection, as otherwise the effectiveness of future HIV treatments could be reduced. Entecavir will not control your HIV infection.

• Taking Entecavir will not prevent you from infecting other people with the hepatitis B virus (HBV) through sexual contact or bodily fluids (including blood contamination). Therefore, it is important that you take appropriate precautions to prevent others from becoming infected with HBV. A vaccine is available to protect people at risk of HBV infection.

• Entecavir belongs to a class of medicines that can cause lactic acidosis (excess lactic acid in your blood) and enlargement of the liver. Symptoms such as nausea, vomiting, and stomach pain could indicate the development of lactic acidosis. This rare but serious adverse 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 weighing less than 10 kg.

Taking Entecavir Kabi 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 Kabi with food and drinks

In most cases, you can take entecavir with or without food. However, if you have previously been treated with another medicine containing lamivudine as the active substance, consider the following. If you have switched to entecavir because treatment with lamivudine was not successful, 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, breast-feeding and fertility

Inform your doctor if you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant. The use of entecavir has not been shown to be safe during pregnancy. It should not be used during pregnancy unless clearly necessary, as determined by your doctor. It is important that women of childbearing potential who are being treated with entecavir use an effective method of contraception to avoid becoming pregnant.

You must not breast-feed during treatment with entecavir. If you are currently breast-feeding, inform your doctor. It is not known whether entecavir, the active substance of this medicine, is excreted in breast milk.

Driving and using machines

Dizziness, tiredness (fatigue), and numbness (somnolence) are common adverse reactions that could affect your ability to drive and use machines. If you have any doubts, consult your doctor.

Entecavir Kabi contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Entecavir Kabi

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

Always follow exactly your doctor's instructions for taking this medicine. If you are unsure, 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 medicine you received.
• whether you have kidney problems. Your doctor may prescribe a lower dose or instruct you to take it less frequently than once daily.
• the condition of your liver.

For children and adolescents (aged 2 to less than 18 years), your pediatrician will determine 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 weighing between 10 kg and 32.5 kg. All doses should be taken once daily (orally). There are no recommendations for entecavir use in children under 2 years of age or weighing less than 10 kg.

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 must 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 Kabi than you should

If you have taken more entecavir than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Entecavir Kabi

It is important not to miss any doses. If you miss 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 Kabi 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 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 everybody gets them.

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

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)
• 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

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 cells, which are important for fighting infections).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Entecavir Kabi

Content of Entecavir Kabi

• The active substance is entecavir.

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

• The other components are:

Tablet core: Monohydrate lactose, microcrystalline cellulose, crospovidone (type A), hydroxypropyl cellulose (type L), magnesium stearate.

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

Appearance of the product and contents of the pack

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

Entecavir Kabi is available in cardboard boxes containing OPA/ALU/PVC-Aluminum blisters or white high-density polyethylene (HDPE) 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)

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Fresenius Kabi España, S.A.U.

Marina 16-18

08005 Barcelona

Spain

Manufacturers:

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

Date of the last revision of this leaflet: January 2022

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