ENTECAVIR DR. REDDYS 0.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

ENTECAVIR DR. REDDYS 0.5 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 Dr. Reddys and what is it used for
2. What you need to know before you take Entecavir Dr. Reddys
3. How to take Entecavir Dr. Reddys
4. Possible side effects
5. Storing Entecavir Dr. Reddys
6. Contents of the pack and further information

1. What is Entecavir Dr. Reddys and what is it used for

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

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).

Entecavir is also used to treat long-term (chronic) 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 works adequately (compensated liver disease).

Hepatitis B virus infection can damage your liver. Entecavir reduces the amount of virus in your body and improves liver condition.

2. What you need to know before you take Entecavir Dr. Reddys

Do not take Entecavir Dr. Reddys

• if you are allergicto entecavir or 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, tell your doctor. This is important because entecavir is removed from the body by the kidneys and it may be necessary to adjust your dose or treatment schedule.

• do not stop taking entecavir without talking to your doctor, as your hepatitis may get worse when treatment is stopped. When you stop your treatment with entecavir, your doctor will follow you up and perform blood tests for several months.

• ask your doctor if your liver is working properlyand, if not, about the possible effects that your treatment with entecavir may have.

• (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 medicines for the treatment of your HIV infection, as otherwise the effectiveness of future HIV treatments may be reduced. Entecavir will not control your HIV infection.

• taking Entecavir will not prevent you from infecting other people with hepatitis B virus (HBV)through sexual contact or body fluids (including blood contamination). Therefore, it is important that you take appropriate precautions to prevent other people from getting infected with HBV. There is a vaccine to protect people at risk of HBV infection.

• Entecavir belongs to a class of medicines that can cause lactic acidosis(excess of lactic acid in your blood) and liver enlargement. Symptoms such as nausea, vomiting, and stomach pain could indicate the development of lactic acidosis. On rare occasions, this rare but serious side effect has been fatal. Lactic acidosis occurs more frequently in women, especially in those who are overweight. Your doctor will monitor you periodically while you are taking this medicine.

• , please inform your doctor.

Children and adolescents

Entecavir should not be used in children under 2 years of age or weighing less than 10 kg.

Taking Entecavir Dr. Reddys with other medicines

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

Taking Entecavir Dr. Reddys 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 containing lamivudine as the active ingredient, you should consider the following. If you have switched to entecavir because lamivudine treatment 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, breastfeeding, and fertility

Tell your doctor if you are pregnant or planning to become pregnant. 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 should not breastfeed during treatment with entecavir. If you are breastfeeding, tell your doctor. It is not known whether entecavir, the active ingredient of this medicine, is excreted in breast 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 unsure, consult your doctor.

Entecavir Dr. Reddys contains lactose

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

3. How to take Entecavir Dr Reddys

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

Follow exactly the instructions of administration of this medicine given by your doctor. 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, as well as the medicine you received.
• whether you have kidney problems. Your doctor may prescribe a lower dose or indicate that you take it less frequently than once a day.
• the condition of your liver.

For children and adolescents(from 2 to less than 18 years of age), your pediatrician will decide the appropriate dose based on the child's body weight. Children weighing at least 32.6 kg can take the oral solution or the 0.5 mg tablets. Entecavir oral solution is recommended for patients with a weight between 10 kg and 32.5 kg. All doses should be taken once a day (by mouth). There are no recommendations for 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 that the medicine is fully effective and to reduce the development of resistance to treatment. Take entecavir for as long as your doctor has told you. Your doctor will tell you when to stop treatment.

Some patients must take entecavir on an empty stomach (see Entecavir Dr. Reddys with food and drinksin Section 2). If your doctor tells you to take entecavir on an empty stomach, an empty stomach means at least 2 hours after a meal and 2 hours before the next meal.

If you take more Entecavir Dr. Reddys than you should

Contact your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Entecavir Dr. Reddys

It is important that you do not miss any dose. 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 missed doses.

Do not stop taking Entecavir Dr. Reddys without talking to your doctor

Some people develop very 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 medicine, 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 (at least 1 in 100 patients): headache, insomnia, fatigue, dizziness, somnolence, vomiting, diarrhea, nausea, dyspepsia, and increased liver enzyme levels in 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

The side effects experienced in children and adolescents are similar to those experienced 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 in fighting infection).

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Information System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Entecavir Dr. Reddys

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 the month shown.

Do not store above 30°C. Store in the original package.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Entecavir Dr. Reddys

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

The other ingredients are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose (E460), pregelatinized corn starch, crospovidone (Type A) (E1202), and magnesium stearate.

Coating of the tablet: titanium dioxide (E171), hypromellose (E464), macrogol 400 (E1521), and polysorbate 80 (E433).

Appearance of the product and pack contents

Entecavir Dr. Reddys 0.5 mg film-coated tablets are white, oval-shaped, and have a score line on both sides.

Entecavir Dr. Reddys 0.5 mg is supplied in boxes containing 10 x 1, 30 x 1, 60 x 1, or 90 x 1 film-coated tablets in unit dose blisters.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Reddy Pharma Iberia, S.A.

Avda Josep Tarradellas, nº 38

08029 Barcelona

Spain

Phone: 93 355 49 16

Fax: 93 355 49 61

Manufacturer:

Medis International a.s

výrobní závod Bolatice

Prumyslová 961/16, 747 23 Bolatice

Czech Republic

This medicine is authorised in the Member States of the EU under the following names:

Holada: Entecavir Dr. Reddy’s 0.5 mg Filmomhulde tabletten

Germany: Entecavir beta 0.5 mg Filmtabletten

Spain: Entecavir Dr. Reddys 0.5 mg comprimidos recubiertos con película EFG

Italy: Entecavir Dr. Reddy’s

Romania: Entecavir Dr. Reddy’s 0.5 mg comprimate filmate

United Kingdom: Entecavir Dr. Reddy’s 0.5 mg film-coated tablets

Date of last revision of this leaflet:December 2020

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