Entecavir Normon 0.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Entecavir Normon 0.5 mg film-coated tablets EFG

entecavir

Read the entire leaflet carefully before you start taking this medicine, as 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 should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Entecavir is an antiviral medicine used to treat long-term (chronic) infection with 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 properly (decompensated liver disease).

Entecavir is also used to treat chronic (long-term) HBV infection in children and adolescents from 2 years up to but not including 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 taking Entecavir Normon

Do not take Entecavir Normon

• if you are allergic (hypersensitive) 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 after stopping treatment. 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 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 HIV infection, because otherwise the effectiveness of future HIV treatments could be reduced. Entecavir will not control your HIV infection.

• taking Entecavir Normon will not prevent you from transmitting the hepatitis B virus (HBV) to others through sexual contact or bodily fluids (including blood contamination). Therefore, it is important to take appropriate precautions to prevent others from becoming infected with HBV. A vaccine is available to protect people at risk of HBV infection.

• Entecavir Normon 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 entecavir.

• 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 Normon 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 Normon with food and drinks

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 substance, 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 safety of entecavir use during pregnancy has not been established. 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 prevent pregnancy.

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 numbness (somnolence) are common side effects that could affect your ability to drive or operate machinery. If you have any doubts, consult your doctor.

Entecavir Normon 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 Normon

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

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, 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 medicine you received.
• whether you have kidney problems. Your doctor may prescribe a lower dose or instruct 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. 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 daily (orally). There are no recommendations for entecavir use 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 must 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, 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 immediately at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Entecavir Normon

It is important not to miss any doses. If you forget a dose of Entecavir, take it as soon as possible, 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 Normon 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 may 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 gets them.

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

Adults

• Common (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 (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

Adverse effects experienced in children and adolescents are similar to those observed 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 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 type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater 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 Normon

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

Appearance of the product and contents of the container

Entecavir Normon is available in packages with blisters containing 30 tablets.

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

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
C/ Ronda de Valdecarrizo, 6
28760 Tres Cantos, Madrid
Spain

Date of the most recent review of this leaflet: June 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/

You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/82134/P_82134.html