Label: information for the user

Entecavir Kabi 0.5 mg film-coated tablets

entecavir

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 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What isEntecavirKabi and what it is used for

2. What you need to know before starting to takeEntecavirKabi

3. How to takeEntecavirKabi

4. Possible side effects

5. Storage ofEntecavirKabi

6. Contents of the pack and additional information

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

Entecavirmaybeusedinpatientswhoseliverisdamagedbutstillfunctionsadequately(compensatedliverdisease)andinpatientswhoseliverisdamagedanddoesnotfunctionadequately(decompensatedliverdisease).

Entecavirisalsousedtotreatchronic(long-term)infectioncausedbyVHBinchildrenandadolescentsfrom2yearstolessthan18yearsold.

Entecavirmaybeusedinchildrenwhoseliverisdamagedbutstillfunctionsadequately(compensatedliverdisease).

TheinfectioncausedbythehepatitisBviruscandamagetheliverEntecavirreducestheamountofvirusinthebodyandimprovestheconditionoftheliver.

Do not take Entecavir Kabi

• 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.

Entecavir Kabi with other medicines

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

Entecavir Kabi 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 breastfeeding, think you may be pregnant, or intend 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 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 Kabi 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 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 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 administration). There are no recommendations for entecavir in children under 2 years of age or weighing less than 10 kg.

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 Kabi 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 Kabi

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 Kabi 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 will experience them.

Patients treated with entecavir have reported the following adverse effects:

Adults

Frequent(may affect up to 1 in 10 people)

• headache, insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (drowsiness)
• vomiting, diarrhea, nausea, dyspepsia (indigestion)
• 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

The side 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 neutrophil levels (a type of white blood cell, which is important for fighting infections).

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 Medicines 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.

This medication does not require special storage conditions.

Once the bottle is opened, the tablets must be used within the next 30 days.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and unused medications at the SIGRE point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the containers and unused medications. By doing so, you will help protect the environment.

Composition of Entecavir Kabi

Content of Entecavir Kabi

• The active ingredient is entecavir.

Each film-coated tablet of Entecavir Kabi 0.5 mg contains entecavir monohydrate equivalent to 0.5 mg of entecavir.

• The other components are:

Core of the tablet: Lactose monohydrate, microcrystalline cellulose, crospovidone (type A), hydroxypropyl cellulose (type L), magnesium stearate.

Film coating (white): Titanium dioxide (E171), lactose monohydrate, hypromellose, macrogol 4000.

Appearance of the product and contents of the package

Entecavir Kabi 0.5 mg film-coated tablets are white to off-white triangular tablets, marked with “0.5” on one side, with a medium size of 8.4 mm ± 0.2 mm and 3.7 mm ± 0.3 mm in thickness.

Entecavir Kabi is presented in cartons of cardboard, containing OPA/ALU/PVC-Aluminum blisters or a high-density polyethylene (HDPE) white bottle with a child-resistant polypropylene closure and induction-sealed.

Package sizes:

30 tablets

30 x 1 tablet (perforated blister)

60 tablets

90 tablets

90 x 1 tablet (perforated blister)

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Fresenius Kabi España, S.A.U.

Marina 16-18

08005 Barcelona

Spain

Manufacturer responsible:

Pharmathen S.A.

6 Dervenakion Str

15351 Pallini (Athens)

Greece

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

90449 Nürnberg

Germany

Pharmathen International S.A.

Industrial Park Sapes, Rodopi Prefecture, Block No 5

Rodopi 69300

Greece

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

Last review date of this leaflet: January 2022

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