Entekavir Adamed

Package Leaflet: Information for the User

Entekavir Adamed, 0.5 mg, Film-Coated Tablets

Entecavir

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Entekavir Adamed and what is it used for
• 2. Important information before taking Entekavir Adamed
• 3. How to take Entekavir Adamed
• 4. Possible side effects
• 5. How to store Entekavir Adamed
• 6. Contents of the pack and other information

1. What is Entekavir Adamed and what is it used for

Entekavir Adamed in the form of film-coated tablets is an antiviral medicine used in adults to treat chronic (long-lasting) hepatitis B virus (HBV) infection.

(HBV).Entekavir Adamed can be used in patients with damaged liver function, but still functioning properly (with compensated liver function) and in patients with liver function that is not functioning properly (with decompensated liver function).

Entekavir Adamed in the form of tablets is also used to treat chronic

(long-lasting) HBV infection in children and adolescents from 2 years to less than 18 years of age.Entekavir Adamed can be used in children whose liver is damaged but still functions properly (with compensated liver function).
Hepatitis B virus infection can lead to liver damage. Entekavir Adamed reduces the amount of virus in the body and improves liver function.

2. Important information before taking Entekavir Adamed

When not to take Entekavir Adamed

• If you are allergic (hypersensitive) to entecavir or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Entekavir Adamed, discuss this with your doctor or pharmacist.

• If you have ever had kidney disease,tell your doctor. This is important because Entekavir Adamed is removed from the body by the kidneys and may need a dose reduction or a change in the dosing schedule.
• Do not stop taking Entekavir Adamed without consulting your doctor, as this may affect the course of hepatitis B. After stopping Entekavir Adamed, your doctor will monitor your condition and perform blood tests for several months.
• Discuss with your doctor whether your liver is functioning properly, and if not, what potential impact this may have on your treatment with Entekavir Adamed.
• If you are also infected with HIV (Human Immunodeficiency Virus), tell your doctor. You should not take Entekavir Adamed to treat hepatitis B if you are not receiving HIV treatment, as this may reduce the future effectiveness of HIV treatment. Entekavir Adamed does not treat HIV infection.
• Taking Entekavir Adamed does not prevent the transmission of hepatitis B virus to othersthrough sexual contact or bodily fluids (including infected blood). Therefore, it is essential to take appropriate precautions to prevent the transmission of HBV to others. A vaccine is available to protect individuals at risk of HBV infection.
• Entekavir Adamed belongs to a group of medicines that can cause lactic acidosis(excess of lactic acid in the blood) and liver enlargement. Symptoms such as nausea, vomiting, and abdominal pain may indicate the development of lactic acidosis. This is a rare but serious side effect, sometimes fatal. Lactic acidosis occurs more frequently in women, especially those who are significantly overweight. During treatment with Entekavir Adamed, your doctor will regularly monitor your condition.
• If you have been previously treated for chronic hepatitis B,tell your doctor.

Children and adolescents

Entekavir Adamed should not be used in children under 2 years of age or weighing less than 10 kg.

Entekavir Adamed and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.

Taking Entekavir Adamed with food and drink

In most cases, Entekavir Adamed can be taken with or without food. However, if you have previously taken medicines containing lamivudine as the active substance, consider the following recommendations. If treatment has been switched to Entekavir Adamed due to lamivudine treatment failure, take Entekavir Adamed once daily on an empty stomach. If liver disease is very advanced, your doctor may also recommend taking Entekavir Adamed on an empty stomach. This means taking the medicine at least 2 hours after a meal and at least 2 hours before the next meal.
Children and adolescents (from 2 to less than 18 years of age) can take Entekavir Adamed with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or planning to have a baby, ask your doctor for advice. So far, it has not been shown that taking Entekavir Adamed during pregnancy is safe. Entekavir Adamed should not be used during pregnancy unless it is clearly necessary. It is essential for women of childbearing age taking Entekavir Adamed to use effective contraception to avoid becoming pregnant.
Do not breastfeed while taking Entekavir Adamed. If you are breastfeeding, tell your doctor. It is not known whether entecavir, the active substance of Entekavir Adamed, passes into human milk.

Driving and using machines

Dizziness, fatigue, and drowsiness are common side effects that may affect your ability to drive and use machines. If you are unsure, consult your doctor.

Entekavir Adamed contains lactose

This medicine contains lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Entekavir Adamed

Not all patients need to take the same dose of Entekavir Adamed.

Always take this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.
The recommended dose for adultsis 0.5 mg or 1 mg once daily (orally).

The dose depends on:

• previous treatment for HBV infection and the medicines used;
• the presence of kidney function disorders; in this case, your doctor may prescribe a lower dose or recommend taking the medicine less frequently than once daily;
• the patient's liver function.

For children and adolescents(from 2 to less than 18 years of age), your doctor will determine the appropriate dose based on the child's body weight. Children weighing at least 32.6 kg can take a 0.5 mg tablet or entecavir oral solution. For patients weighing from 10 kg to 32.5 kg, entecavir oral solution is recommended. All doses are taken once daily (orally). There are no recommendations for Entekavir Adamed in children under 2 years of age or weighing less than 10 kg.
Your doctor will determine the appropriate dose based on the child's body weight.
Always follow the dose recommended by your doctor to ensure the full effectiveness of the medicine and to limit the development of resistance to treatment. Take Entekavir Adamed for as long as your doctor recommends. Your doctor will inform you about the end of treatment.
Some patients may need to take Entekavir Adamed on an empty stomach (see Entekavir Adamed with food and drink in section 2). If your doctor recommends taking Entekavir Adamed on an empty stomach, this means taking the medicine at least 2 hours after a meal and at least 2 hours before the next meal.

If you take more Entekavir Adamed than you should

Contact your doctor immediately.

If you forget to take Entekavir Adamed

It is important not to miss any dose. If you miss a dose of Entekavir Adamed, take it as soon as possible, and then take the next dose at the usual time. If it is almost time for the 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 make up for a missed dose.

Do not stop taking Entekavir Adamed without consulting your doctor

After stopping Entekavir Adamed, some people may experience severe hepatitis symptoms. Immediately inform your doctor about any changes in symptoms after stopping treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Patient groups treated with entecavir have reported the following side effects:

Adults:

• common (at least 1 in 100 patients): headache, insomnia, fatigue, dizziness, drowsiness, vomiting, diarrhea, nausea, dyspepsia, and increased liver enzyme activity in the blood;
• uncommon (at least 1 in 1,000 patients): rash, hair loss;
• rare (at least 1 in 10,000 patients): severe allergic reactions.

Children and adolescents:

Side effects observed in children and adolescents are similar to those in adults and are described above, with the following difference:
very common (at least 1 in 10 patients): low neutrophil count (a type of white blood cell important in fighting infections).
If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02 222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Entekavir Adamed

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton. The expiry date refers to the last day of the month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Entekavir Adamed contains

• The active substance is entecavir. Each film-coated tablet contains 0.5 mg of entecavir (as entecavir monohydrate).
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, maize starch, crospovidone (type A), magnesium stearate. Tablet coating Opadry White YS-1-7003: titanium dioxide (E 171), hypromellose 3 mPas, hypromellose 6 mPas, macrogol 400, polysorbate 80.

What Entekavir Adamed looks like and contents of the pack

Oval, white tablet, 10.1 mm in length and 3.7 mm in thickness, with a dividing line on both sides.
The dividing line is not intended for breaking the tablet.
Entekavir Adamed 0.5 mg film-coated tablets are available in packs of 30 film-coated tablets.

Marketing authorization holder:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer/Importer:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
MEDIS INTERNATIONAL a.s.,
výrobní závod Bolatice
Průmyslová 961/16,
747 23 Bolatice,
Czech Republic

Date of last revision of the package leaflet: