ENTECAVIR NORMON 0.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

1. What is Entecavir Normon 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 functions properly (compensated liver disease) and in patients whose liver is damaged and does not function properly (decompensated liver disease).

Entecavirisalsousedtotreatchronic(long-term)HBVinfectioninchildrenandadolescentsfrom2tolessthan18yearsofage.

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

Hepatitis B virus infection can damage the 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 Normon

Do not take Entecavir Normon

• to entecavir or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell your doctor or pharmacist before you start taking entecavir

• , 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 if you stop treatment. 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 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 Normon 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 Normon 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 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 entecavir.

• , 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 Normon with other medicines

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

Taking Entecavir Normon 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. It has not been shown that the use of entecavir is 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 affect your ability to drive and use machines. If you are unsure, consult your doctor.

Entecavir Normon contains lactose

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

3. How to take Entecavir Normon

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, consult your doctor or pharmacist again.

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

Some patients must 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, an empty stomach means at least 2 hours after a meal and 2 hours before the next meal.

If you take more Entecavir Normon than you should, contact your doctor immediately

If you have taken more entecavir than you should, consult 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 Normon

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 treatment with Entecavir Normon without consulting 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 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, fatigue, dizziness, drowsiness, vomiting, diarrhea, nausea, dyspepsia, 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

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 side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet.

Reporting of side effects

If you get 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 through the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Entecavir Normon

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.

No special storage conditions are required.

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

6. Contents of the pack and further information

Composition of Entecavir Normon

The active ingredient of Entecavir Normon is entecavir. The film-coated tablets of Entecavir Normon contain entecavir monohydrate equivalent to 0.5 mg of entecavir. The other ingredients of the tablet core are: lactose monohydrate, microcrystalline cellulose, crospovidone, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, and vegetable magnesium stearate. The film coating contains: hypromellose, titanium dioxide (E171), macrogol 6000, and talc.

Appearance and packaging

Entecavir Normon is available in blister packs of 30 tablets.

Entecavir Normon 0.5 mg film-coated tablets are white, round, and biconvex.

Marketing authorisation holder and manufacturer

LABORATORIOS NORMON, S.A.

C/ Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Date of last revision of this leaflet:June 2025

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