Entecavir adamed

Package leaflet: Information for the user

Entekavir Adamed, 1 mg, film-coated tablets
Entecavirum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

Entekavir Adamed in the form of film-coated tablets is an antiviral medicine used in adults for the treatment of chronic (long-term) hepatitis B virus (HBV) infection. Entekavir Adamed may be used in patients with liver damage but whose liver still functions properly (with compensated liver function) and in patients whose liver does not function properly (with decompensated liver function).
Entekavir Adamed in tablet form is also used for the treatment of chronic (long-term) HBV infection in children and adolescents aged 2 years to less than 18 years. Entekavir Adamed may 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 number of viruses in the body and improves liver function.

2. Important information before taking Entekavir Adamed

When not to take Entekavir Adamed

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

Warnings and precautions
Before starting treatment with Entekavir Adamed, discuss this with your doctor or
pharmacist.

• If the patient has any kidney disease, inform the doctor. This is
  important because Entekavir Adamed is eliminated from the body through the kidneys, and it may be
  necessary to reduce the dose or adjust the dosing schedule.

• Do not stop taking Entekavir Adamed without consulting your doctor, as this may negatively affect the course of hepatitis. After stopping Entekavir Adamed, the doctor will monitor the patient's condition and perform blood tests for several months.

• Discuss with your doctor whether the liver is functioning properly, and if not, what potential impact its condition may have on treatment with Entekavir Adamed.

• If the patient is also infected with HIV (human immunodeficiency virus), inform the doctor. The patient should not take Entekavir Adamed for the treatment of hepatitis B virus (HBV) unless also receiving anti-HIV medications, as this may reduce the effectiveness of future HIV treatment. Entekavir Adamed does not treat HIV infection.

• Taking Entekavir Adamed does not prevent spreading the hepatitis B virus (HBV) to others through sexual contact or bodily fluids (including infected blood). Therefore, it is important to take appropriate precautions to prevent transmission of HBV to other people. A vaccine is available to protect individuals at risk of HBV infection.

• Entekavir Adamed belongs to a group of medicines that may cause lactic acidosis (excess lactic acid in the blood) and hepatomegaly (enlarged liver). Symptoms such as nausea, vomiting, and abdominal pain may indicate the development of lactic acidosis. This is a rare but serious adverse effect, which in some cases may be fatal. Lactic acidosis occurs more frequently in women, particularly those with significant overweight. During treatment with Entekavir Adamed, the doctor will regularly monitor the patient's condition.

• If the patient has previously been treated for chronic hepatitis B, inform the treating doctor.

Children and adolescents
Entekavir Adamed must not be used in children under 2 years of age or with body weight less than 10 kg.
Entekavir Adamed and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Taking Entekavir Adamed with food and drink
In most cases, Entekavir Adamed can be taken with or without food. However, if the patient has previously taken medicines containing lamivudine as the active substance, the following recommendations should be considered. If treatment has been switched to Entekavir Adamed due to lamivudine treatment failure, Entekavir Adamed should be taken once daily on an empty stomach. If liver disease is very advanced, the treating doctor will 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.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or planning to become pregnant, she should consult her doctor. To date, it has not been established whether using Entekavir Adamed during pregnancy is safe. Entekavir Adamed should not be used during pregnancy unless specifically recommended by a doctor. It is important that women of childbearing potential using Entekavir Adamed use effective contraception to avoid becoming pregnant.
During treatment with Entekavir Adamed, breastfeeding is not recommended. If the patient is breastfeeding, she should inform her doctor. It is not known whether entecavir, the active substance of Entekavir Adamed, passes into human breast milk.
Driving and operating machinery
Dizziness, fatigue, and drowsiness are common adverse effects that may impair the ability to drive or operate moving machinery.
If in doubt, consult your doctor.
Entekavir Adamed contains lactose
This medicine contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.

3. How to take Entekavir Adamed

Not all patients require the same dose of Entekavir Adamed.
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
The recommended dose in adults is 0.5 mg or 1 mg once daily (orally).
The dose of the medicine depends on:

• prior treatment for HBV infection and medications used;
• presence of kidney function impairment; in such cases, the doctor may prescribe a lower dose or recommend taking the medicine less frequently than once daily;
• the patient's liver condition.

In children and adolescents (aged 2 to less than 18 years), Entekavir Adamed is available as 0.5 mg tablets or as an oral solution containing entecavir.
The doctor will determine the appropriate dose based on the child's body weight.
The correct dose must be determined by the doctor. Always follow the prescribed dose to ensure full effectiveness of the medicine and to minimize the development of treatment resistance. Entekavir Adamed should be taken for as long as prescribed by the doctor. The doctor will inform you when to stop treatment.
Some patients must take Entekavir Adamed on an empty stomach (see Entekavir Adamed with food and drink in section 2). If your doctor advises taking Entekavir Adamed on an empty stomach, this means at least 2 hours after a meal and at least 2 hours before the next meal.
Taking more Entekavir Adamed than prescribed
Contact your doctor immediately.
Missing a dose of Entekavir Adamed
It is important not to miss any doses. If you miss a dose of Entekavir Adamed, take it as soon as possible, 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 medical advice
In some patients, severe symptoms of hepatitis may occur after stopping Entekavir Adamed. Inform your doctor immediately about any changes in symptoms occurring after discontinuation of treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Patients treated with entecavir have reported the following adverse effects:
Adults:

• frequently (at least 1 in 100 patients): headache, insomnia, fatigue (extreme exhaustion), dizziness, somnolence, vomiting, diarrhoea, nausea, dyspepsia (indigestion), and increased liver enzyme activity in blood;
• uncommonly (at least 1 in 1,000 patients): rash, hair loss;
• rarely (at least 1 in 10,000 patients): severe allergic reactions.

Children and adolescents
Adverse reactions observed in children and adolescents are similar to those occurring in adults, as described above, with the following difference:

• very commonly (at least 1 in 10 patients): low neutrophil granulocyte count (a type of white blood cell important in fighting infections).

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions allows the collection of additional information on the safety of the medicine.

5. How to store Entekavir Adamed

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack or carton. The expiry date refers to the last day of the stated 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 packaging and other information

What Entekavir Adamed contains

• The active substance is entecavir. Each film-coated tablet contains 1 mg of entecavir (as entecavir monohydrate).
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, pregelatinized corn starch, crospovidone (type A), magnesium stearate.
  Film coating Opadry Pink 13B540014: titanium dioxide (E 171), hypromellose 6 mPas, polyethylene glycol 400, polysorbate 80, iron oxide red (E 172).

What Entekavir Adamed looks like and contents of the pack
An oval, pink tablet measuring 12.8 mm in length and 4.8 mm in thickness, with a score line on both sides.
The score line on the tablet is not intended for breaking the tablet.
Entekavir Adamed 1 mg film-coated tablets are available in cardboard boxes containing 30 film-coated tablets.

Marketing Authorisation Holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturer/Importer:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

MEDIS INTERNATIONAL a.s.,
výrobní závod Bolatice
Průmyslová 961/16,
747 23 Bolatice,
Czech Republic