Entecavir Dr. Reddy's 1 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ENTECAVIR DR. REDDYS 1 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 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Entecavir Dr. Reddys 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 adequately (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 the condition of the liver.

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

Do not take Entecavir Dr. Reddys

• 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 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 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 hepatitis B infection unless you are also taking medications for the treatment of 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 body 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 side 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 Dr. Reddys 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 Dr. Reddys 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 ingredient, 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 (from 2 to less than 18 years of age) may take entecavir with or without food.

Pregnancy, breastfeeding, and fertility

Inform your doctor if you are pregnant or intend to become pregnant. The use of entecavir during pregnancy has not been proven to be safe. Entecavir should 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 avoid becoming pregnant.

You must not breastfeed during treatment with entecavir. If you are currently breastfeeding, inform your doctor. It is unknown whether entecavir, the active substance of this medicine, is excreted in human milk.

Driving and using machines

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

Entecavir Dr. Reddys 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 Dr. Reddys

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 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 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), with a body weight of at least 32.6 kg and who require a 0.5 mg dose (half of a 1 mg tablet), entecavir 0.5 mg may be administered.

All doses should be taken once daily (orally).

For children and adolescents weighing less than 32.6 kg and for doses lower than 0.5 mg, entecavir oral solution may be used.

Your paediatrician will determine the appropriate dose based on the child's body weight.

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 entecavir on an empty stomach (see Entecavir Dr. Reddys with food and drink in Section 2). If your doctor has told you to take entecavir on an empty stomach, this means at least 2 hours after a meal and 2 hours before the next meal.

The tablet may be divided into equal doses.

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 at: 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take Entecavir Dr. Reddys

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 your 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 Dr. Reddys without consulting your doctor

Some people develop very severe hepatitis symptoms when stopping 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 may cause adverse effects, although not everyone experiences them.

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

Adults

• Common (affects 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 blood.
• Uncommon (affects at least 1 in 1,000 patients): skin rash, hair loss.
• Rare (affects 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 (affects at least 1 in 10 patients): low levels of neutrophils (a type of white blood cells important in fighting infection).

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Entecavir Dr. Reddys

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.

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

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

6. Contents of the pack and other information

Composition of Entecavir Dr. Reddys

The active substance is entecavir. Each film-coated tablet contains entecavir monohydrate equivalent to 1 mg of entecavir.

The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose (E460), pregelatinized maize starch, crospovidone (Type A) (E1202) and magnesium stearate.

Film coating: titanium dioxide (E171), hypromellose (E464), macrogol 400 (E1521), polysorbate 80 (E433) and red iron oxide (E172).

Appearance of the medicine and contents of the pack

Entecavir Dr. Reddys 1 mg film-coated tablets are white, oval-shaped tablets, with a notch on both sides.

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

Only certain 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

Telephone: 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 EU Member States under the following names:

Netherlands: Entecavir Dr. Reddy’s 1 mg Filmomhulde tabletten

Germany: Entecavir beta 1 mg Filmtabletten

Spain: Entecavir Dr. Reddys 1 mg comprimidos recubiertos con película EFG

Italy: Entecavir Dr. Reddy’s

Romania: Entecavir Dr. Reddy’s 1 mg comprimate filmate

United Kingdom: Entecavir Dr. Reddy’s 1 mg film-coated tablets

Date of the most recent revision of this leaflet: December 2020

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