Entecavir Sun 0.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Leaflet contents

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

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

Entecavir Sun 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 functions adequately (compensated liver disease) and in patients whose liver is damaged and does not function properly (decompensated liver disease).

Entecavirisalso usedtotreatchronic(long-term)HBVinfectioninchildrenandadolescentsaged2tolessthan18years.

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

HBV 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 taking Entecavir Sun

Do not take Entecavir Sun

• 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 potential effects 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 your hepatitis B infection unless you are also taking medications for the treatment of HIV infection, as 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 other people 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 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. Occasionally, 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.

• 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 Sun 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 Sun with food and drink

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 ingredient, consider the following: If you have switched to entecavir because treatment with lamivudine was unsuccessful, 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 at least 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

Inform your doctor if you are pregnant or intend to become pregnant. The safety of using entecavir during pregnancy has not been established. Entecavir should not be used during pregnancy unless 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 breast-feed while being treated with entecavir. If you are currently breast-feeding, inform your doctor. It is unknown whether entecavir, the active substance of this medicine, is excreted in breast milk.

Driving and using machines

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

Entecavir Sun 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 Sun

Not all patients require the same dose of Entecavir.

Always follow your doctor's instructions for taking this medicine exactly. 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), your pediatrician will determine 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 either the oral solution or the 0.5 mg tablets. 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 the entire duration prescribed by your doctor. Your doctor will tell you when to stop treatment.

Some patients should take this medicine on an empty stomach (see Entecavir tablets with food and drink in Section 2). If your doctor instructs 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 Sun 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, stating the medicine and the amount taken.

If you forget to take Entecavir Sun

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 Sun 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 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, diarrhoea, nausea, dyspepsia (indigestion),
  • 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 observed 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).

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 may also report them directly via 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 Sun

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the label and on the packaging 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 following opening of the bottle.

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

6. Contents of the container and other information

Composition of Entecavir Sun

The active substance is entecavir.

Entecavir Sun 0.5 mg: each film-coated tablet contains 0.5 mg of entecavir.

The other components are:

Tablet core: lactose monohydrate, povidone K30, crospovidone, microcrystalline cellulose PH 102 and magnesium stearate.

Film coating:

Opadry 13B58802 White (contains HPMC 2910/Hypromellose (E464), titanium dioxide (E171), Macrogol 400 (E1521) and polysorbate 80 (E433))

Appearance of Entecavir Sun and contents of the container

Entecavir SUN 0.5 mg film-coated tablets

White or almost white triangular-shaped tablet, 8.60 mm x 8.30 mm in size, marked with “RL1” on one side and plain on the other.

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.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona

Spain

Tel.: +34 93 342 78 90

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany ENTECAVIR BASICS 0.5 mg, Filmtabletten

Italy Entecavir SUN 0.5 mg compresse rivestite con film

Poland Entecavir Ranbaxy

Romania Entecavir Terapia 0.5 mg comprimate filmate

Spain Entecavir SUN 0.5 mg comprimidos recubiertos con película EFG

United Kingdom Entecavir SUN 0.5 mg film coated tablets

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