Label: Information for the User

Entecavir Stada 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 only for you, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

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

2.What you need to know before starting to take Entecavir Stada

3.How to take Entecavir Stada

4.Possible side effects

5.Storage of Entecavir Stada

6.Contents of the pack and additional information

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

Entecavir maybeusedinpatientswhoseliverisdamagedbutstillfunctionsadequately(compensatedliverdisease)andinpatientswhoseliverisdamagedanddoesnotfunctionadequately(decompensatedliverdisease).

Entecavirisalsousedtotreatchronic(long-term)infectioncausedbyVHBinchildrenandadolescentsfrom2yearstolessthan18yearsold.

Entecavir maybeusedinchildrenwhoseliverisdamagedbutstillfunctionsadequately(compensatedliverdisease).

TheinfectioncausedbythehepatitisBvirusmaydamagetheliver.Entecavir reducestheamountofvirusinthebodyandimprovestheconditionoftheliver.

Do not take Entecavir Stada

• 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 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. 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 individuals 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.

Other medicines and Entecavir Stada

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

Taking Entecavir Stada 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 treatment with entecavir. If you are breastfeeding, inform your doctor. It is unknown whether entecavir, the active ingredient of this medicine, 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 Stada contains lactose

This medicine contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them 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 route).

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 oral solution or 0.5 mg tablets. Entecavir oral solution is recommended for patients weighing between 10 kg and 32.5 kg. All doses should be taken once a day (oral route). 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 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 Stada 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 Stada 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 Stada

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 Stada 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 all people may experience them.

Adults

Patients treated with entecavir have reported the following adverse effects:

Frequent(may affect up to 1 in 10 people)

• Headache
• Insomnia (inability to sleep)
• Extreme fatigue
• Dizziness
• Drowsiness (drowsiness)
• Vomiting
• Diarrhea
• Nausea
• Indigestion (dyspepsia)
• Increased levels of liver enzymes in the blood

Infrequent(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 earlier, with the following exception:

Very frequent (may affect more than 1 in 10 people)

• 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 possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://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 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.

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

Composition of Entecavir Stada

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

Tablet core: lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, crospovidone (type IA) (E1202) and magnesium stearate.

Coating: titanium dioxide (E171), hypromellose (E464), macrogol 400 and polisorbate 80 (E433).

Appearance of the product and contents of the package

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

Entecavir Stada 0.5 mg tablets are supplied in boxes containing 30 x 1 or 90 x 1 film-coated tablets (in blister packs).

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio Stada, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Medis International a.s.

výrobní závod Bolatice

Prumyslová 961/16, 747 23 Bolatice

Republic of Czech

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

Netherlands

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

Last review date of this leaflet:September 2021

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