Entecavir adamed

Package leaflet: Information for the user

Entekavir Adamed, 0.5 mg, film-coated tablets
Entecavirum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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

Leaflet 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 can 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 to treat chronic (long-term) HBV infection in children and adolescents aged 2 years to less than 18 years. Entekavir Adamed can be used in children whose liver is damaged but still functions properly (with compensated liver function).
Hepatitis B virus infection may 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 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 via 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 adversely affect the course of hepatitis. After discontinuation of Entekavir Adamed, the doctor will monitor the patient's condition and perform blood tests for several months.
• Discuss with the doctor whether the liver is functioning properly, and if not, what potential impact this 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) infection 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 transmission of 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 HBV transmission to others. 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 may occasionally 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 weighing 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 previously took 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 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 (aged 2 to less than 18 years) may take Entekavir Adamed regardless of meals.
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 that use of 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 who are taking Entekavir Adamed use effective contraception to avoid pregnancy.
Breastfeeding is not recommended during treatment with Entekavir Adamed. If the patient is breastfeeding, she should inform her doctor. It is not known whether entecavir, the active substance in Entekavir Adamed, passes into human breast milk.
Driving and operating machinery
Dizziness, fatigue, and somnolence are common adverse effects that may impair the ability to drive or operate 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 their 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 as directed 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 medicines used;
• presence of renal 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), the doctor will determine the appropriate dose based on the child's body weight. Children with a body weight of at least 32.6 kg may take the 0.5 mg tablet or entecavir in the form of oral solution. For patients with body weight between 10 kg and 32.5 kg, entecavir oral solution is recommended. All doses are taken once daily (orally). There are no established recommendations for the use of Entekavir Adamed in children under 2 years of age or with body weight below 10 kg.
The doctor will determine the appropriate dose according to the child's body weight.
Determining the correct dose is the responsibility of the doctor. Always take the dose prescribed by your doctor to ensure full effectiveness of the medicine and to minimize the risk of developing treatment resistance. Entekavir Adamed should be taken for as long as your doctor recommends. Your 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.

If you miss 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 medicinal products, this medicine can cause adverse reactions, although not everyone experiences them.
Patients treated with entecavir have reported the following adverse effects:
Adults:

• Common (at least 1 in 100 patients): headache, insomnia, feeling of fatigue (very severe exhaustion), dizziness, somnolence, vomiting, diarrhoea, nausea, dyspepsia (indigestion), and increased liver enzyme activity in 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:
Adverse reactions observed in children and adolescents are similar to those occurring in adults and described above, with the following difference:
Very common (at least 1 in 10 patients): low neutrophil granulocyte count (a type of white blood cells important in fighting infections).
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Reporting of adverse reactions
If any adverse reactions occur, including those 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49-21-301, fax: +48 22 49-21-309, website:
https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this 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 must 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 coated tablet contains 0.5 mg of entecavir (as entecavir monohydrate).
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, pregelatinized corn starch, crospovidone (type A), magnesium stearate. The tablet coating Opadry White YS-1-7003: titanium dioxide (E 171), hypromellose 3 mPas, hypromellose 6 mPas, polyethylene glycol 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 thick, with a score line on both sides.
The score line on the tablet is not intended for breaking the tablet.
Entekavir Adamed 0.5 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
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