Entecavir Kabi

PACKAGE LEAFLET

Package leaflet: information for the user

Entecavir Kabi 0.5 mg film-coated tablets, 1.0 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 Kabi tablets are an antiviral medicine used in adults for the treatment of chronic
(long-term) hepatitis B virus (HBV) infection. Entecavir Kabi can be used in patients whose liver is
damaged but still functions properly (compensated liver disease) and in patients whose liver is
damaged and does not function properly (decompensated liver disease).
Entecavir Kabi tablets are also used for the treatment of chronic (long-term) hepatitis B virus
(HBV) infection in children and adolescents. Entecavir Kabi can be used in children whose liver is
damaged but still functions properly (compensated liver disease).
Hepatitis B virus infection can cause liver damage. Entecavir Kabi reduces the amount of virus in the
body and improves the condition of the liver.

2. What you need to know before taking Entecavir Kabi

Do not take Entecavir Kabi

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Entecavir Kabi.

• If you have had kidney problems, inform your doctor. This is important because Entecavir Kabi is eliminated from the body through the kidneys, and you may require a dose adjustment or modified dosing schedule.
• Do not stop taking Entecavir Kabi without consulting your doctor, as hepatitis may worsen after stopping treatment. If treatment with this medicine is discontinued, your doctor will continue to monitor you and perform blood tests for several months.
• Discuss with your doctor whether your liver is functioning properly, and, if not, how this may affect your treatment with Entecavir Kabi.
• If you are also infected with HIV (human immunodeficiency virus), inform your doctor. You should not take this medicine to treat hepatitis B infection unless you are already receiving medications for HIV, as the effectiveness of future HIV treatment may be reduced. Entecavir Kabi will not control your HIV infection.
• Taking Entecavir Kabi will not prevent you from transmitting hepatitis B virus (HBV) to others through sexual contact or bodily fluids (including blood contamination). Therefore, it is important to take precautions to avoid spreading the hepatitis B virus (HBV) to others. A vaccine is available to protect individuals at risk of contracting hepatitis B virus (HBV) infection.
• Entecavir Kabi belongs to a class of medicines that can cause lactic acidosis (excess lactic acid in the blood) and enlargement of the liver. Symptoms such as nausea, vomiting, and stomach pain may indicate the development of lactic acidosis. This rare but serious side effect has occasionally been fatal. Lactic acidosis occurs more frequently in women, especially those who are significantly overweight. Your doctor will monitor you regularly during treatment with Entecavir Kabi.
• If you have previously received treatment for chronic hepatitis B, inform your doctor.

Children and adolescents
Entecavir must not be given to children under 2 years of age or weighing less than 10 kg.
Other medicines and Entecavir Kabi
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Entecavir Kabi with food and drink
In most cases, you may take this medicine with or without food. However, if you have previously been treated with a medicine containing the active substance lamivudine, consider the following. If you have switched to treatment with Entecavir Kabi because lamivudine therapy was unsuccessful, you must take Entecavir Kabi once daily on an empty stomach. If your liver disease is very advanced, your doctor will instruct you to take Entecavir Kabi on an empty stomach. An empty stomach means at least 2 hours after a meal and at least 2 hours before the next meal.
Children and adolescents (from 2 to 18 years of age) may take Entecavir Kabi 0.5 mg tablets with or without food.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breast-feeding, consult your doctor or pharmacist before taking this medicine.
It has not been proven that entecavir is safe to use during pregnancy. Unless specifically indicated by your doctor, Entecavir Kabi must not be used during pregnancy. It is important that women of childbearing potential use an effective method of contraception during treatment with this medicine to avoid pregnancy.
You must not breast-feed during treatment with this medicine.
It is not known whether entecavir, the active substance in Entecavir Kabi, is excreted in human breast milk.
Driving and using machines
Dizziness, fatigue, and somnolence are common side effects that may impair your ability to drive or operate machinery. For any clarification, 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, contact him before taking this medicine.

3. How to take Entecavir Kabi

Not all patients need to take the same dose of Entecavir Kabi.
Always take this medicine exactly as your doctor has instructed you. If you have any doubts, consult
your doctor or pharmacist.
For adults, the recommended dose is 0.5 mg or 1 mg, taken once daily by mouth (orally).
Your dose will depend on:

• whether you have previously received treatment for hepatitis B virus (HBV) infection, and which medicine you were treated with.
• whether you have kidney problems. Your doctor may prescribe a lower dose or advise you to take it less than once daily.
• the condition of your liver.

For children and adolescents (from 2 to 18 years of age), your child's doctor will determine the appropriate dose based on your child's weight.
0.5 mg tablet: children weighing at least 32.6 kg may take the 0.5 mg tablet, or an oral solution of entecavir may be available. An oral solution of entecavir is recommended for patients weighing between 10 kg and 32.5 kg. Each dose will be administered once daily by mouth (orally). There are no recommendations for entecavir in children under 2 years of age or with body weight below 10 kg. The paediatrician will determine the appropriate dose based on your child's weight.
1 mg tablet: Entecavir Kabi 0.5 mg tablets are available, or an oral solution of entecavir may be available. Your child's doctor will determine the appropriate dose based on your child's weight.
To ensure the medicine is fully effective and to reduce the development of resistance to treatment, always take the dose prescribed by your doctor. Take Entecavir Kabi for the entire duration indicated by your doctor. Your doctor will inform you whether and when to stop treatment.
Some patients must take Entecavir Kabi on an empty stomach (see Entecavir Kabi with food and drink in section 2). If your doctor has told you to take this medicine on an empty stomach, this means at least 2 hours after a meal and at least 2 hours before the next meal.
If you take more Entecavir Kabi than you should
Contact your doctor immediately.
If you forget to take Entecavir Kabi
It is important that you do not miss any doses. If you forget a dose of Entecavir Kabi, take it as soon as possible, then continue with your next dose at the usual time. If it is almost time for your next dose, do not take the missed dose. Wait and take your next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Entecavir Kabi
Do not stop treatment with Entecavir Kabi without consulting your doctor. Many people experience very severe symptoms of hepatitis when they stop taking entecavir.
Inform your doctor immediately if you notice any changes in your symptoms after stopping treatment.
If you have any doubts about how to use this medicine, speak to 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:
Common (at least 1 in 100 patients):

• headache, insomnia (inability to sleep), fatigue (excessive tiredness), dizziness, drowsiness (somnolence),
• vomiting, diarrhoea, nausea, dyspepsia (indigestion),
• increased levels of liver enzymes in the blood.

Uncommon (at least 1 in 1,000 patients):

• skin rash,
• hair loss.

Rare (at least 1 in 10,000 patients):

• severe allergic reaction.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 bottle, blister pack, or carton after Exp.
The expiry date refers to the last day of that month.
After first opening the bottle, the tablets must be used within 30 days.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Entecavir Kabi contains

• The active substance is entecavir. Each film-coated tablet of Entecavir Kabi 0.5 mg contains entecavir monohydrate equivalent to 0.5 mg of entecavir. Each film-coated tablet of Entecavir Kabi 1.0 mg contains entecavir monohydrate equivalent to 1.0 mg of entecavir.

• The other components are:
  Entecavir Kabi 0.5 mg
  Tablet core: Monohydrate lactose, microcrystalline cellulose, crospovidone (type A), hydroxypropylcellulose (type L), and magnesium stearate.
  Film coating (white): Titanium dioxide (E171), monohydrate lactose, hypromellose, macrogol 4000.

  Entecavir Kabi 1 mg
  Tablet core: Monohydrate lactose, microcrystalline cellulose, crospovidone (type A),
  hydroxypropylcellulose (type L), and magnesium stearate.
  Film coating (pink): Hypromellose, titanium dioxide (E171), dextrin, talc,
  maltodextrin, medium-chain triglycerides, red iron oxide (E172), yellow iron oxide (E172).

Description of the appearance of Entecavir Kabi and pack contents

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

Entecavir Kabi 1 mg film-coated tablets are pink, triangular-shaped tablets, marked with "1" on one side, with average dimensions of 10.6 mm ± 0.2 mm and a thickness of 4.5 mm ± 0.3 mm.

Entecavir Kabi is available in cardboard cartons containing OPA/ALU/PVC blisters – aluminum foil or white HDPE bottles with child-resistant PP cap and induction seal.

Pack sizes:
30 tablets (blister)
90 tablets (blister)
30 tablets (bottle)

Not all pack sizes may be marketed.

Marketing Authorization Holder
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
37063 Isola della Scala - Verona
Italy

Manufacturers:
PHARMATHEN INTERNATIONAL S.A
Industrial Park Sapes, Rodopi Prefecture, Block No 5
Rodopi
69300 Greece
Pharmathen S.A.
6 Dervenakion Str.
Pallini, Attiki, 153 51 Greece
Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50
Nürnberg
90449 Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
Denmark Entecavir Pharmathen
United Kingdom Entecavir
Germany Entecavir Heumann 0.5 mg & 1 mg Filmtabletten
Italy Entecavir Kabi
Spain Entecavir Kabi 0.5 mg comprimidos recubiertos con película
EFG
Entecavir Kabi 1.0 mg comprimidos recubiertos con película
EFG
Romania Entecavir Pharmathen 0.5 mg comprimate filmate
Entecavir Pharmathen 1 mg comprimate filmate
Poland Entecavir Synoptis
France ENTECAVIR PHARMATHEN 0.5 mg, comprimé pelliculé
ENTECAVIR PHARMATHEN 1 mg, comprimé pelliculé

This patient information leaflet was last approved on