Label: information for the user

Entecavir Tarbis 1 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 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 isEntecavirTarbisand what it is used for

2. What you need to know before starting to takeEntecavirTarbis

3. How to takeEntecavirTarbis

4. Possible side effects

5. Storage ofEntecavirTarbis

6. Contents of the pack and additional information

Entecavir Tarbis tablets are an antiviral medication used to treat chronic (long-term) infection caused 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 Tarbis tablets are also used to treat chronic (long-term) infection caused 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 virus infection can damage the liver. Entecavir reduces the amount of virus in the body and improves liver condition.

Do not take Entecavir Tarbis

• if you are allergic (hypersensitive)to entecavir or any of the other components 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 Tarbis 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 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 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 Tarbis with other medicines

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

Entecavir Tarbis 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 changed to entecavir because lamivudine treatment was unsuccessful, take entecavir on an empty stomach, once a day. If your liver disease is very 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 intend to become pregnant. 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 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 in 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 Tarbis contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Entecavir Tarbis contains soy polysaccharides

This medicine contains soy polysaccharides. If you are allergic to soy, do not use 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(from2years of age to less than 18years of age), your pediatrician will decide on the appropriate dose based on the child's body weight. Entecavir oral solution is recommended for patients with a weight between 10kg and 32.5kg. Children weighing at least 32.6 kg can take the oral solution or 0.5mg tablets. There are no recommendations for entecavir in children under 2years of age or weighing less than 10kg.

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 Tarbis 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 Tarbis 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 Tarbis

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 Tarbis 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 will experience them.

Patients treated with entecavir have reported the following adverse effects:

Adults

• frequent (in at least 1 in 100 patients): headache, insomnia (inability to sleep), extreme fatigue, dizziness, somnolence (drowsiness), vomiting, diarrhea, nausea, dyspepsia (indigestion), and increased levels of liver enzymes in the blood.
• infrequent (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 difference:

Very frequent (in at least 1 in 10 patients): 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 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.

Do not dispose of medications 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 packaging and medications you no longer need. This will help protect the environment.

Composition of Entecavir Tarbis

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

The other components are:

Core of the tablet: calcium carbonate (E-170), pregelatinized cornstarch, sodium carmellose, soy polysaccharides, citric acid monohydrate, sodium stearate fumarate.

Film coating: hypromellose, titanium dioxide (E-171), macrogol 400, iron oxide red (E-172).

Appearance of the product and contents of the package

The film-coated tablets are pink, biconvex triangular. They are marked with “J” on one side and with “111” on the other side. The Entecavir Tarbis 1 mg tablets are supplied in boxes containing 7 x 1, 10 x 1, 14 x 1, 20 x 1, 28 x 1, 30 x 1, 50 x 1, 56 x 1, 60 x 1, 80 x 1, 84 x 1, 90 x 1, 100 x 1, 112 x 1, 120 x 1, 200 x 1 or 500 x 1 film-coated tablets (in single-dose blisters) and in blisters with 7, 10, 14, 20, 28, 30, 50, 56, 60, 80, 84, 90, 100, 112, 120, 200 or 500 film-coated tablets.

In addition, the film-coated tablets are available in bottles containing 30 or 90 film-coated tablets.

Only some package sizes may be marketed in your country.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible manufacturer:

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany:Entecavir Amarox 1 mg Filmtabletten

Spain:Entecavir Tarbis 1 mg film-coated tablets EFG

Netherlands:Entecavir Amarox 1 mg filmomhulde tabletten

United Kingdom:Entecavir 1 mg film-coated tablets

Sweden:Entecavir Amarox 1 mg Filmdragerad tablett

Last review date of this leaflet:October 2023

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.gob.es/)