Label: information for the user

Entecavir Glenmark 1 mg film-coated tablets EFG

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 doubts, 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 isEntecavirGlenmark and what it is used for

2. What you need to know before starting to takeEntecavirGlenmark

3. How to takeEntecavirGlenmark

4. Possible adverse effects

5. Storage ofEntecavirGlenmark

6. Contents of the pack and additional information

Entecavirisamedicationthatisusedtotreatchronic(long-term)infectioncausedbythehepatitisBvirus(VHB)inadults.

Entecavirmaybeusedinpatientswhoseliverisdamagedbutstillfunctionsadequately(compensatedliverdisease)andinpatientswhoseliverisdamagedanddoesnotfunctionadequately(decompensatedliverdisease).

Entecavirisalsousedtotreatchronic(long-term)infectioncausedbyVHBinchildrenandadolescentsfrom2yearstolessthan18yearsold.

Entecavirmaybeusedinchildrenwhoseliverisdamagedbutstillfunctionsadequately(compensatedliverdisease).

TheinfectioncausedbythehepatitisBviruscandamagetheliver.Entecavirreducestheamountofvirusinthebodyandimprovestheconditionoftheliver.

Do not take Entecavir Glenmark

• 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 by interrupting treatment. When your treatment with entecavir is interrupted, your doctor will continue to monitor you and make 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. 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 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 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 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 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 10 kg.

Entecavir Glenmark with other medicines

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

Entecavir Glenmark 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 that women of childbearing age who are being treated with entecavir use an effective contraceptive method to avoid becoming pregnant.

Do not breastfeed during treatment with entecavir. 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.

Entecavir Glenmark contains lactose

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

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) with a weight of at least 32.6 kg and who require a dose of 0.5 mg (= half of a 1 mg tablet) the 0.5 mg dose is available. All doses should be taken once a day (oral administration).

For children and adolescents weighing less than 32.6 kg and for doses below 0.5 mg, the oral solution is available.

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.

The tablet can be divided into equal doses,

If you take more Entecavir Glenmark 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 forget to take Entecavir Glenmark

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 Glenmark without consulting your doctor

Some people develop severe hepatitis symptoms when stopping entecavir treatment. Inform your doctor immediately of any change 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:

Adults

• Common (in at least 1 in 100 patients): headache, insomnia (inability to sleep), extreme fatigue, dizziness, somnolence (drowsiness), vomiting, diarrhea, nausea, indigestion, and increased levels of liver enzymes in the blood.
• Uncommon (in at least 1 in 1,000 patients): skin rash, hair loss.
• Rare (in at least 1 in 10,000 patients): severe allergic reaction.

Children and Adolescents

The adverse effects experienced by children and adolescents are similar to those experienced by adults as described earlier, with the following exception:

• Very common (in at least 1 in 10 patients): low levels of neutrophils (a type of white blood cell that is important in fighting infection).

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus.

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 about 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 packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C. Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications.This will help protect the environment.

Composition of Entecavir Glenmark

• The active ingredient is entecavir. Each film-coated tablet contains the equivalent of 1 mg of entecavir monohydrate.
• The other components are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, crospovidone (Type A) (E1202) and magnesium stearate.

Film coating: titanium dioxide (E171), hypromellose (E464), macrogol 400 (E1521) and polysorbate 80 (E433) and iron oxide red (E172).

Appearance of the product and contents of the package

The film-coated tablets are pink, oval-shaped, and have a notch on both sides.

Entecavir 1 mg film-coated tablets are presented in packages containing 30 x 1 or 90 x 1 film-coated tablets in single-dose blisters.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31,

82194 Gröbenzell,

Germany

Responsible manufacturer:

Medis International a.s.

Výrobní závod Bolatice

Prumyslová 961/16, 747 23 Bolatice

Czech Republic

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7ª Planta,

28045 Madrid,

Spain

This medication is authorized in the EEA member states with the following names:

Last review date of this leaflet: February 2021

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