Entecavir Aurovitas 1 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Entecavir Aurovitas 1 mg film-coated tablets EFG

Read the entire 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, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Entecavir Aurovitas 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 can be used in patients who have liver damage but whose liver still functions adequately (compensated liver disease) and in patients who have liver damage and whose liver does not function adequately (decompensated liver disease).

Entecavir is also used to treat chronic (long-term) HBV infection in children and adolescents from 2 up to but less than 18 years of age.

Entecavir can be used in children who have liver damage but whose liver 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 Aurovitas

Do not take Entecavir Aurovitas

• 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 Aurovitas:

• 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 your treatment with entecavir might have.

• If you are also infected with HIV (human immunodeficiency virus), make sure to inform your doctor. You must not take entecavir for the treatment of hepatitis B infection unless you are also taking medications for the treatment of HIV infection, as 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 bodily 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 individuals at risk of HBV infection.

• Entecavir belongs to a class of medicines that can cause lactic acidosis (excess lactic acid in the blood) and hepatomegaly (enlarged liver). Symptoms such as nausea, vomiting, and stomach pain could indicate the development of lactic acidosis. This rare but serious adverse 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, inform your doctor.

Children and adolescents

Entecavir must not be used in children under 2 years of age or weighing less than 10 kg.

Other medicines and Entecavir Aurovitas

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

Taking Entecavir Aurovitas 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 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 under 18 years of age) may take entecavir with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The safety of entecavir use 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 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, fatigue, and somnolence are common adverse effects that could affect your ability to drive or operate machinery. If you have any doubts, consult your doctor.

Entecavir Aurovitas contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Entecavir Aurovitas

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 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 hepatitis B virus (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 paediatrician will determine the appropriate dose based on the child's body weight. Children weighing at least 32.6 kg may take the 0.5 mg tablets, or an oral solution may be available. For patients weighing between 10 kg and 32.5 kg, entecavir oral solution is recommended. 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.

The paediatrician will determine the appropriate dose according to 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 must take this medicine on an empty stomach (see Taking Entecavir Aurovitas with food and drink in Section 2). If your doctor has told 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 Aurovitas than you should

If you have taken more entecavir than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Entecavir Aurovitas

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 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 Aurovitas 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 can cause adverse effects, although not everyone experiences them.

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

Adults

? Common (may affect up to 1 in 10 people): 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 (may affect up to 1 in 100 people): skin rash, hair loss.

? Rare (may affect up to 1 in 1,000 people): severe allergic reaction.

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

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 (may affect up to 1 in 10 people): low levels of neutrophils (a type of white blood cell important in fighting infection).

Reporting of adverse effects

If you experience any adverse reaction, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Entecavir Aurovitas

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

Do not use this medicine after the expiry date stated on the label, the carton, and the blister after EXP. The expiry date is the last day of the month indicated.

Blister: Store below 30 ºC.

HDPE bottle: No special storage conditions required.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point in your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Entecavir Aurovitas

• The active substance is entecavir. Each film-coated tablet contains 1 mg of entecavir (as monohydrate).
• The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose (E460), crospovidone (E1202) and magnesium stearate.

Tablet coating: hypromellose (E464), macrogol 400 and titanium dioxide (E171).

Appearance of the product and contents of the pack

Film-coated white, round, biconvex tablets marked “ET” on one side and “1” on the other.

Entecavir Aurovitas film-coated tablets are available in blister packs and HDPE bottles.

Pack sizes:

Blister packs: 30 and 90 film-coated tablets.

HDPE bottles: 30, 100 and 250 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: July 2021

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