Entecavir Sandoz 0.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Entecavir Sandoz 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Entecavir Sandoz is an antiviral medicine used to treat long-term (chronic) infection with the 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 from 2 years up to but not including 18 years of age.

Entecavir may be used in children whose liver is damaged but still functions adequately (compensated liver disease).

Infection with the hepatitis B virus can damage the liver. Entecavir reduces the amount of virus in the body and improves liver condition.

2. What you need to know before taking Entecavir Sandoz

Do not take Entecavir Sandoz

• 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 taking 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 treatment is interrupted. When your treatment with entecavir is stopped, your doctor will continue to monitor you and perform blood tests for several months,
• ask your doctor whether your liver is functioning properly and, if not, about the possible effects your treatment with entecavir might have,
• if you are also infected with HIV (human immunodeficiency virus), make sure to inform your doctor. You must not take entecavir for the treatment of your hepatitis B infection unless you are also taking medicines for the treatment of HIV infection, because otherwise the effectiveness of future HIV treatments may be reduced. Entecavir will not control your HIV infection,
• taking entecavir will not prevent you from transmitting the hepatitis B virus (HBV) to other people 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 entecavir,
• 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 who weigh less than 10 kg.

Taking Entecavir Sandoz with other medicines

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

Taking Entecavir Sandoz with food and drink

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

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. It has not been proven that the use of entecavir is safe during pregnancy. Entecavir must not be used during pregnancy except when 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 prevent pregnancy.

You must not breast-feed during treatment with entecavir. If you are currently breast-feeding, inform your doctor. It is unknown whether entecavir, the active substance in Entecavir Sandoz, is excreted in human milk.

Driving and using machines

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

This medicine contains lactose

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

3. How to take Entecavir Sandoz

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

Always follow exactly the instructions given by your doctor for taking this medicine. If in doubt, 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 hepatitis B virus (HBV) infection, and which medication you received.
• whether you have kidney problems. Your doctor may prescribe a lower dose or advise 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 paediatrician 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 the use of entecavir in children under 2 years of age or weighing less than 10 kg. Your child's doctor will determine the correct dose based on your child's weight.

Your doctor will advise you on the appropriate dose for you. 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 should take this medicine on an empty stomach (see Taking Entecavir Sandoz 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 Sandoz 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, indicating the medicine and the amount taken.

If you forget to take Entecavir Sandoz

It is important not to miss any doses. If you forget a dose of Entecavir, take it as soon as you remember, 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 a missed dose.

Do not stop treatment with Entecavir Sandoz without consulting your doctor

Some people develop very severe hepatitis symptoms when stopping entecavir. Inform your doctor immediately of any changes in symptoms you may notice after stopping treatment.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adults

Patients treated with entecavir have reported the following adverse effects:

• 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), and 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 observed 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 adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via 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 Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the bottle, packaging, and blister after EXP.

The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

After opening the bottle, use within 6 months.

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

6. Contents of the container and other information

Composition of Entecavir Sandoz

• The active substance is entecavir (as monohydrate).
  • Each film-coated tablet contains 0.5 mg of entecavir (as monohydrate).
• The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose, crospovidone (Type A), and magnesium stearate.

Film coating: hypromellose 2910, macrogol 6000, titanium dioxide (E171), talc.

Appearance of the product and contents of the container

Film-coated tablet, white in colour, round, marked on both sides with "SZ" on one side and "108" on the other, with a diameter of approximately 8.0 mm.

The film-coated tablets are packaged in blisters made of OPA/Aluminium/PVC-Aluminium or in HDPE bottles with child-resistant polypropylene caps, placed in an outer carton.

Pack sizes:

Blister: 30 and 90 film-coated tablets.

Bottle: 30 film-coated tablets.

Only certain 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 medicinal product is authorised in the Member States of the European Economic Area under the following names

Netherlands: Entecavir Sandoz 0.5 mg, filmomhulde tabletten

Italy: Entecavir Sandoz

Norway: Entecavir Sandoz 0.5 mg, filmomhulde tabletten

Poland: Entecavir Sandoz, 0.5 mg, tabletki powlekane

Romania: Entecavir Sandoz 0.5 mg comprimate filmate

Sweden: Entecavir Sandoz 0.5 mg filmdragerade tabletter

Date of the most recent review of this leaflet: February 2021.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/