ENTECAVIR AUROVITAS 1 mg FILM-COATED TABLETS

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

Do not take Entecavir Aurovitas

• If you are allergic 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 Aurovitas:

• If you have ever had problems with your kidneys, 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 consulting your doctor, as your hepatitis may get worse when you stop treatment. When you stop treatment with entecavir, your doctor will monitor you and perform blood tests for several months.

• Ask your doctor if your liver is working properly and, if not, about the possible effects that treatment with entecavir may have.

• If you are also infected with HIV (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 otherwise the effectiveness of future treatments for HIV may be reduced. Entecavir will not control your HIV infection.

• Taking entecavir will not prevent you from infecting other people with hepatitis B virus (HBV) through sexual contact or body fluids (including blood contamination). Therefore, it is important that you take appropriate precautions to prevent other people 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 the blood) and liver enlargement. Symptoms such as nausea, vomiting, and stomach pain could indicate the development of lactic acidosis. In some cases, this rare but 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.

• If you have received previous treatment for chronic hepatitis B, inform your doctor.

Children and adolescents

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

Other medicines and Entecavir Aurovitas

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

Taking Entecavir Aurovitas 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 substance, you should consider the following. If you have switched to entecavir because treatment with lamivudine 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 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 and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 method of contraception 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 substance 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 Aurovitas contains lactose

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

3. How to take Entecavir Aurovitas

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

Follow exactly the instructions of your doctor for taking this medicine. If you are unsure, consult 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 previously treated for HBV infection, 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 on the appropriate dose based on the child's body weight. Children weighing at least 32.6 kg can 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 a day (by mouth). There are no recommendations for entecavir in children under 2 years of age or weighing less than 10 kg.

Your pediatrician will decide on the appropriate dose based on 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 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 to. 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 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 Aurovitas than you should

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 Aurovitas

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 Aurovitas without consulting your doctor

Some people develop 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 on 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 (may affect up to 1 in 10 people): headache, insomnia, fatigue, dizziness, drowsiness, vomiting, diarrhea, nausea, dyspepsia, and increased levels of liver enzymes in the 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 side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

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

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 to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaram.es. By reporting side 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 which is stated on the label, carton, and blister after EXP. The expiry date is the last day of the month stated.

Blister: Store below 30°C.

HDPE bottle: 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 other information

Composition of Entecavir Aurovitas

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

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

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

Appearance and packaging of the product

White, round, biconvex film-coated tablets with "ET" on one side and "1" on the other.

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

Package sizes:

Blister:30 and 90 film-coated tablets.

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

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

Date of last revision of this leaflet:July 2021

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