Entecavir Kern Pharma 0.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Entecavir Kern Pharma 0.5 mg film-coated tablets EFG

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Entecavir Kern Pharma is and what it is used for

Entecavir is an antiviral medicine used to treat chronic (long-term) 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 properly (decompensated liver disease).

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

2. What you need to know before taking Entecavir Kern Pharma

Do not take Entecavir Kern Pharma

• if you are allergic (hypersensitive) to entecavir or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting 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 to treat your hepatitis B infection unless you are also taking medications for HIV infection, because otherwise the effectiveness of future HIV treatments could be reduced. Entecavir will not control your HIV infection.

• Taking entecavir will not prevent you from transmitting the hepatitis B virus (HBV) to others 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 individuals at risk of HBV infection.

• Entecavir belongs to a class of medicines that may 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 Kern Pharma 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 Kern Pharma with food and drinks

In most cases, you may 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 lamivudine treatment 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 (aged 2 to under 18 years) may take entecavir with or without food.

Pregnancy, breastfeeding, and fertility

Inform your doctor if you are pregnant or intend to become pregnant. The safety of entecavir use during pregnancy has not been established. Entecavir should not be used during pregnancy except if 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 breastfeed while being treated with entecavir. If you are currently breastfeeding, inform your doctor. It is unknown whether entecavir, the active substance in this medicine, 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.

Entecavir Kern Pharma 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 Kern Pharma

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

Always follow exactly the instructions provided by your doctor for taking this medicine. If in doubt, please 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 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 tablet. 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 doctor will advise you on the correct 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 Entecavir 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 Kern Pharma than you should

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

If you forget to take Entecavir Kern Pharma

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 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 Kern Pharma 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 everyone will experience them.

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

Adults

• Common (at least 1 in 100 patients): headache, insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (drowsiness), vomiting, diarrhea, nausea, dyspepsia (indigestion), and 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.

Children and adolescents

Adverse effects experienced in children and adolescents are similar to those in adults as described above, with the following difference:

• Very common (at least 1 in 10 patients): low levels of neutrophils (a type of white blood cell important for fighting infections).

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Entecavir Kern Pharma

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.

Blister: This medicine does not require any special storage conditions.

Bottle: This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Entecavir Kern Pharma

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

Tablet core: lactose monohydrate, microcrystalline cellulose, crospovidone (type A) (E1202), anhydrous ethanol and magnesium stearate.

Film coating: Opadry II white 85F28751 containing polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol/PEG 3000 (E1521) and talc (E553b).

Appearance of the product and contents of the pack

Entecavir Kern Pharma 0.5 mg film-coated tablets are white or almost white, triangular-shaped tablets. They are marked with “ENT” on one side and “0.5” on the other.

The medicine is supplied in boxes containing 30 or 30 x 1 film-coated tablets in Alu/Alu blisters or in single-dose Alu/Alu blisters, respectively, and in bottles containing 30 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer:

PHARMASCIENCE INTERNATIONAL LIMITED

1st floor Iacovides Tower

81-83 Griva Digeni Avenue,

1090 Nicosia, Cyprus

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

Spain: Entecavir Kern Pharma 0.5 mg film-coated tablets

Bulgaria: ????????? Pharmascience International Ltd 0.5 mg ????????? ????????

Hungary: Entecavir Pharmascience International Ltd 0.5 mg filmtabletta

Date of the most recent review of this leaflet: July 2022

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