Label: information for the user

ENTECAVIR TEVA 0.5 MG FILM-COATED TABLETS

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What isEntecavirTeva and what it is used for

2. What you need to know before starting to takeEntecavirTeva

3. How to takeEntecavirTeva

4. Possible side effects

5. Storage ofEntecavirTeva

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 functioning properly (compensated liver disease) and in patients whose liver is damaged and not functioning properly (decompensated liver disease).

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

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

Hepatitis B infection can damage the liver. Entecavir reduces the amount of virus in the body and improves liver condition.

Do not take Entecavir Teva

• if you are allergicto entecavir or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take entecavir

• 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 schedule.

• do not stop taking entecavir without consulting your doctor,as your hepatitis may worsen if you interrupt treatment. When you stop taking entecavir, 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 may have.

• if you are also infected with HIV(human immunodeficiency virus), make sure to inform your doctor. Do 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 may 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 to protect individuals at risk of HBV infection.

• Entecavir belongs to a class of medicines that can cause lactic acidosis(excess 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 serious 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 this medicine.

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

Children and adolescents

Entecavir should not be used in children under 2 years of age or weighing less than 32.6 kg.

Entecavir Teva with other medicines

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

Entecavir Teva 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, 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.

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, breastfeeding, and fertility

Inform your doctor if you are pregnant or plan to become pregnant. Entecavir use has not been proven to be safe during pregnancy. Do not use entecavir during pregnancy unless it is 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 entecavir treatment. If you are doing so, inform your doctor. It is unknown whether entecavir, the active ingredient of this medicine, is excreted in breast milk.

Driving and operating machinery

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

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 based on the child's body weight. Children weighing at least 32.6 kg can take the 0.5 mg tablet or a oral solution may be available. It is recommended to use the oral solution of entecavir for patients weighing between 10 kg and 32.5 kg. All doses should be taken once a day by 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 correct dose based on the child's 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 (see Entecavir tablets with food and drinksin theSection 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 Teva 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 Teva

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 Teva without consulting your doctor

Some people develop severe hepatitis symptoms when stopping entecavir treatment. 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 all people may experience them.

Patients treated with entecavir have reported the following adverse effects:

Common (may affect up to 1 in 10 people):

• Headache
• Difficulty sleeping (insomnia)
• Extreme fatigue
• Dizziness
• Drowsiness
• Vomiting
• Diarrhea
• Nausea
• Indigestion (dyspepsia)
• 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.

Children and Adolescents

Adverse effects experienced by children and adolescents are similar to those experienced by adults as described above, with the following exception:

Very common (may affect more than 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 that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthecontainer, blister, orpackageafter CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and

medicines that you no longer need at the SIGREdrop-off point at the pharmacy. If in doubt, ask your pharmacisthow to dispose ofthecontainers and themedicines that you no longerneed. By doing so, you will help protect the environment.

Composition of Entecavir Teva

• The active ingredient is entecavir.
• Each film-coated tablet contains 0.5 mg of entecavir.
• The other components are:

Core of the tablet:mannitol (E421), microcrystalline cellulose (E460), pregelatinized maize starch, crospovidone type A (E1202), magnesium stearate.

Film coating:partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (polyethylene glycol), talc (E553b).

Appearance of the product and contents of the package

Round, white to off-white tablet, marked with “05” on one face of the tablet and with “E” on the other face, with a diameter of approximately 5.96- 6.26 mm.

The film-coated tablets are supplied in:

• PVC/PVdC – Aluminum blisters in packs containing 10, 30, 60 or 90 tablets.
• Single-dose PVC/PVdC – Aluminum blisters in packs containing 30x1 tablets.
• Aluminum/OPA/PVC – Aluminum blisters in packs containing 10, 30, 60 or 90 tablets.
• Single-dose Aluminum/OPA/PVC – Aluminum blisters in packs containing 30x1 tablets.
• HDPE bottles with polypropylene child-resistant closures in packs containing 30 or 100 tablets.
• HDPE bottles with polypropylene child-resistant closures and silica gel desiccant in packs containing 30 or 100 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1st floor.

28108 Alcobendas, Madrid

Spain

Manufacturer responsible

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80

31-546 Cracovia

Poland

or

Merckle GmbH

Ludwig-Merckle-Strasse 3, Blaubeuren

89143 Baden-Wuerttemberg

Germany

or

PLIVA Croatia Ltd.

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

This medicinal product is authorized in the member states of the European Economic Area with the following names:

AustriaEntecavir ratiopharm 0.5 mg Filmtabletten

DenmarkEntecavir Teva

SpainEntecavir Teva 0.5 mg film-coated tablets EFG

FranceEntecavir Teva 0.5mg, film-coated tablet

HungaryEntecavir Teva 0.5 mg filmtabletta

CroatiaEntekavir Pliva 0.5 mg filmom obložene tablete

IrelandEntecavir Teva 0.5 mg Film-coated Tablets

NetherlandsEntecavir Teva 0.5 mg, filmomhulde tablets

NorwayEntecavir Teva

PolandEntecavir Teva

PortugalEntecavir Teva

SwedenEntecavir Teva

SloveniaEntekavir Teva 0.5 mg filmsko obložene tablete

Last review date of this leaflet: June 2022

The 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/)