Package Leaflet: Information for the User

Entecavir Aurovitas 1 mg Film-Coated Tablets

Read this 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. Do not pass it on to others even if they have similar symptoms, as it may harm them.

-If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Entecavir Aurovitas

3.How to take Entecavir Aurovitas

4.Possible side effects

5.Storage of Entecavir Aurovitas

6.Contents of the pack and additional information

Entecavir is an antiviral medication used to treat chronic (long-term) infection by the 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 adequately (decompensated liver disease).

Entecavir is also used to treatchronic (long-term)infection by the HBV in children and adolescentsfrom 2 to less than 18 years old.

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

The infection by the hepatitis B virus may damage the liver. Entecavir reduces the amount of virus in your body and improves the state of the liver.

Do not take Entecavir Aurovitas

•If you areallergicto entecavir or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor orpharmacist before starting to take Entecavir Aurovitas:

•If you have ever had problems with your kidneys, inform your doctor. This is important because entecavir is eliminated from the body through the kidneys and it may be necessary to adjust your dose or treatment regimen.

•Do not stop taking entecavir without consulting your doctor, as your hepatitis may worsen by interrupting treatment. When your treatment with entecavir is interrupted, your doctor will continue to monitor you and perform blood tests for several months.

•Ask your doctor if your liver is functioning properlyand if not, about the possible effects that your treatment with entecavir could 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 otherwise, the effectiveness of future HIV treatments could be reduced. Entecavir will not control your HIV infection.

•Taking entecavir will not prevent you from infecting others with the hepatitis B virus (HBV)through sexual contact or bodily fluids (including blood contamination). Therefore, it is essential to take the necessary precautions to prevent others from becoming infected with HBV. There is a vaccine available to protect individuals at risk of HBV infection.

•Entecavir belongs to a class of medications that can cause lactic acidosis(excess of lactic acid in your blood) and liver enlargement. Symptoms such as nausea, vomiting, and abdominal pain may indicate the development of lactic acidosis. In some cases, this rare but severe 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 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 medications and Entecavir Aurovitas

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

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 medication containing lamivudine as the active ingredient, consider the following. If you have switched to entecavir because lamivudine treatment was unsuccessful, take entecavir on an empty stomach, once a day. If your liver disease is 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 (2 to less than 18 years of age) can take entecavir with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Entecavir use has not been proven to be safe during pregnancy. Do not use entecavir during pregnancy except when clearly necessary, according to your doctor. It is essential for women of childbearing age who are being treated with entecavir to use an effective contraceptive method to avoid becoming pregnant.

Do not breastfeed during treatment with entecavir. If you are breastfeeding, inform your doctor. It is unknown whether entecavir, the active ingredient in this medication, is excreted in breast milk.

Driving and operating machines

Dizziness, fatigue, and drowsiness are common side effects that may impair your ability to drive and operate machines. If you have any doubts, consult your doctor.

Entecavir Aurovitas contains lactose

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with thembefore taking this medication.

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

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

For adultsthe recommended dose is 0.5 mg or 1 mg once a day (oral administration).

Your dose will depend on:

-whether you have been previously treated for a hepatitis B infection, as well as the medication you have received.

-if you have kidney problems. Your doctor may prescribe a lower dose or indicate that you take it less frequently than once a day.

-your liver condition.

For children and adolescents(from 2 to less than 18 years of age), your pediatrician will decide on the appropriate dose according to the child's body weight. Children weighing at least 32.6 kg can take 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 (oral administration). 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 according to the child's body weight.

Your doctor will advise you on what dose is correct for you. Always take the dose recommended by your doctor to ensure the medication is fully effective and to reduce the development of treatment resistance. Take entecavir for the entire time your doctor has indicated. Your doctor will tell you when to stop treatment

Some patients must take this medication on an empty stomach (seeEntecavir Aurovitas with food and drinksin Section 2). If your doctor tells you to take this medication 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forgot to take Entecavir Aurovitas

It is essential not to forget any dose. 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 compensate for the missed doses.

Do not interrupt treatment with Entecavir Aurovitas without consulting your doctor

Some people develop severe hepatitis symptoms when stopping entecavir. Inform your doctor immediately of any changes in symptoms you observe after stopping treatment.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Patients treated with entecavir have reported the following adverse effects:

Adults

?Common (may affect up to 1 in 10 people): headache, insomnia (inability to sleep), extreme fatigue, dizziness, drowsiness, vomiting, diarrhea, nausea, indigestion, 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this prospectus.

Children and Adolescents

The adverse effects experienced by children and adolescents are similar to those experienced by 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 that is important in fighting infection).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the label, in the box, and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Blister Pack: Store below 30°C.

HDPE Bottle: No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Entecavir Aurovitas

-The active ingredient is entecavir. Each film-coated tablet contains 1 mg of entecavir (as monohydrate).

-The other components are:

Core of the tablet:lactose monohydrate, microcrystalline cellulose (E460), crospovidone (E1202) and magnesium stearate.

Coating of the tablet:hypromellose (E464), macrogol 400 and titanium dioxide (E171).

Appearance of the product and contents of the package

Film-coated tablets of white color, round, biconvex, with the mark “ET” on one face and “1” on the other.

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

Package sizes:

Blister packs:30 and 90 film-coated tablets.

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

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Arrow Génériques

26 Avenue Tony Garnier

69007 Lyon

France

O

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 with the following names:

Last review date 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/).