ENTECAVIR SUN 1 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Entecavir SUN 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 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 experience 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 Sun and what is it used for
2. What you need to know before you take Entecavir Sun
3. How to take Entecavir Sun
4. Possible side effects
5. Storing Entecavir Sun
6. Contents of the pack and further information

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

Entecavirisan antiviral medicineusedtotreatchronic(long-term)hepatitisBvirus(HBV)infectioninadults.

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).

Entecavirisalsousedtotreatchronic(long-term)HBVinfectioninchildrenandadolescentsfrom2tolessthan18yearsofage.

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 the condition of your liver.

2. What you need to know before you take Entecavir Sun

Do not take Entecavir Sun

• 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 starting entecavir

• if you have ever had kidney problems, inform 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 monitor you 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 to treat your hepatitis B infection unless you are also taking medicines to treat your HIV infection, as the effectiveness of future HIV treatments may be reduced. Entecavir will not control your HIV infection.

• taking Entecavir will not prevent you from infecting others with the hepatitis B virus (HBV)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. 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 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 Sun with other medicines

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

Taking Entecavir Sun 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.

Empty stomach means at least 2 hours after and at least 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 contraceptive method to avoid becoming pregnant.

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 drowsiness are common side effects that may reduce your ability to drive and use machines. If you are unsure, talk to your doctor.

Entecavir Sun contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to take Entecavir Sun

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

Follow your doctor's instructions for taking this medicine exactly. If you are unsure, talk to your doctor or pharmacist.

For adults, the 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 tell you to 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.

Entecavir oral solution is recommended for patients weighing between 10 kg and 32.5 kg. Children weighing at least 32.6 kg may take the oral solution or the 0.5 mg tablets. 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 tells you. Your doctor will tell you when to stop treatment.

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

If you take more Entecavir Sun than you should

If you have taken more entecavir than you should, talk to your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Entecavir Sun

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 Sun without talking to your doctor

Some people develop severe hepatitis symptoms when they stop taking entecavir. Tell your doctor immediately if you notice any changes in your symptoms after stopping treatment.

If you have any further questions about 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 (inability to sleep),
  • fatigue (extreme tiredness),
  • dizziness, drowsiness (sleepiness),
  • vomiting, diarrhea, 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.

Children and adolescents

The side effects experienced by children and adolescents are similar to those experienced by 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).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Entecavir Sun

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

Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

Bottle: use within 30 days of opening the bottle.

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 Sun

The active ingredient is entecavir.

Entecavir Sun 1 mg: each film-coated tablet contains 1 mg of entecavir.

The other ingredients are:

Core of the tablet: lactose monohydrate, povidone K30, crospovidone, microcrystalline cellulose PH 102, and magnesium stearate.

Coating:

Opadry 13B84610 Pink (contains HPMC 2910/Hypromellose (E464), titanium dioxide (E171), Macrogol 400 (E1521), polysorbate 80 (E433), and red iron oxide (E172))

Appearance of Entecavir Sun and contents of the pack

Entecavir SUN 1 mg film-coated tablets

Pink or light pink, triangular tablet, 10.90 mm x 10.60 mm in size, marked with “RL2” on one side and plain on the other side.

The film-coated tablets are available in HDPE bottles, in blisters containing 30 or 90 film-coated tablets, and in unit-dose blisters containing 30 or 90 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Alkaloida Chemical Company Zrt

Kabay János u. 29

Tiszavasvári, H-4440

Hungary

S.C. Terapia S.A.

Str. Fabricii nr. 124

Cluj-Napoca, 400632

Romania

You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona

Spain

Tel.: +34 93 342 78 90

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany ENTECAVIR BASICS 1 mg, Filmtabletten

Italy Entecavir SUN 1 mg compresse rivestite con film

Poland Entecavir Ranbaxy

Romania Entecavir Terapia 1 mg comprimate filmate

Spain Entecavir SUN 1 mg comprimidos recubiertos con película EFG

United Kingdom Entecavir SUN 1 mg film-coated tablets

Date of last revision of this leaflet:January 2022