Entecavir polpharma

Package leaflet: Information for the patient

Entecavir Polpharma, 0.5 mg, film-coated tablets
Entecavir Polpharma, 1 mg, film-coated tablets
Entecavirum
Please read this leaflet carefully before using this medicine, as 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 other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Entecavir Polpharma is and what it is used for

Entecavir Polpharma film-coated tablets are an antiviral medicine used in adults for the
treatment of chronic (long-term) hepatitis B virus (HBV) infection. Entecavir Polpharma can be used
in patients with liver damage but whose liver still functions properly (with compensated liver function)
and in patients whose liver is damaged and does not function properly (with decompensated liver function).
Entecavir Polpharma film-coated tablets are also used to treat chronic (long-term) HBV infection in
children and adolescents aged 2 years to less than 18 years. Entecavir Polpharma 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. Entecavir Polpharma reduces the amount of virus
in the body and improves liver function.

2. Important information before using Entecavir Polpharma

When not to use Entecavir Polpharma:

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

Warnings and precautions
Before starting treatment with Entecavir Polpharma, discuss this with your doctor or
pharmacist.

• If the patient has any kidney disease, inform the doctor. This is important because Entecavir Polpharma 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 Entecavir Polpharma without consulting your doctor, as this may adversely affect the course of hepatitis. After stopping Entecavir Polpharma, 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 this may have on treatment with Entecavir Polpharma.
• If the patient is also infected with HIV (human immunodeficiency virus), inform the doctor. The patient should not take Entecavir Polpharma for the treatment of hepatitis B virus (HBV) infection unless also receiving anti-HIV medications, because in the future this may reduce the effectiveness of HIV treatment. Entecavir Polpharma does not treat HIV infection.
• Taking Entecavir Polpharma 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 spreading HBV to other people. A vaccine is available to protect individuals at risk of HBV infection.
• Entecavir Polpharma belongs to a group of medicines that can 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 sometimes be fatal. Lactic acidosis occurs more frequently in women, particularly those who are significantly overweight. While taking Entecavir Polpharma, 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
Entecavir Polpharma must not be used in children under 2 years of age or with body weight
less than 10 kg.
Entecavir Polpharma and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Entecavir Polpharma with food and drink
In most cases, Entecavir Polpharma 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 Entecavir
Polpharma due to lamivudine treatment failure, Entecavir Polpharma should be taken once daily on an empty stomach.
If liver disease is very advanced, the treating doctor may also recommend taking Entecavir Polpharma 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 Entecavir Polpharma regardless of meals.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
It has not been established that using Entecavir Polpharma during pregnancy is safe. Entecavir Polpharma should not be used during pregnancy unless specifically recommended by a doctor. It is important that women of reproductive age using Entecavir Polpharma use effective contraception to avoid becoming pregnant.
Breastfeeding is not recommended while taking Entecavir Polpharma. If the patient is breastfeeding, she should inform her doctor. It is not known whether entecavir, the active substance of Entecavir Polpharma, passes into human milk.
Driving and operating machinery
Dizziness, fatigue, and somnolence are commonly occurring adverse effects that may impair the ability to drive or operate machinery. If in doubt, consult your doctor.
Entecavir Polpharma 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 Entecavir Polpharma
Not every patient requires the same dose of Entecavir Polpharma.
This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult the doctor or pharmacist.
The recommended dose in adults is 0.5 mg or 1 mg once daily (orally).
The dose depends on:

• prior treatment for HBV infection and medicines used;
• presence of kidney function impairment; in such cases, the doctor may prescribe a lower dose or recommend less frequent dosing (less 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 weighing at least 32.6 kg may take 0.5 mg tablets or entecavir 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). No recommendations have been established for the use of entecavir in children under 2 years of age or with body weight less than 10 kg.
The appropriate dose should be determined by the doctor. Always follow the prescribed dose to ensure full effectiveness of the medicine and to minimize the risk of developing treatment resistance. Entecavir Polpharma should be taken for as long as directed by the doctor. The doctor will inform the patient when to stop treatment.
Some patients must take Entecavir Polpharma on an empty stomach (see Entecavir Polpharma with food and drink in section 2). If the doctor advises taking Entecavir Polpharma on an empty stomach, this means at least 2 hours after a meal and at least 2 hours before the next meal.
Taking more than the recommended dose of Entecavir Polpharma
Contact your doctor immediately.
Missing a dose of Entecavir Polpharma
It is important not to miss any dose. If a dose of Entecavir Polpharma is missed, 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 treatment with Entecavir Polpharma without medical advice
After stopping Entecavir Polpharma, some patients may experience severe symptoms of hepatitis. Inform your doctor immediately about any changes in symptoms occurring after stopping 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 will experience them.
Patients treated with Entecavir Polpharma have reported the following adverse events:
Adults

• Common (affects at least 1 in 10 people): headache, insomnia, fatigue (very strong exhaustion), dizziness, somnolence, vomiting, diarrhoea, nausea, dyspepsia (indigestion), and increased liver enzyme activity in blood;
• Uncommon (affects at least 1 in 100 people): rash or hair loss;
• Rare (affects at least 1 in 1,000 people): 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 common (affects 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 or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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
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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Entecavir Polpharma

Do not store above 30°C. Store in the original packaging.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
The marking on the packaging following EXP indicates the expiry date, and following Lot/LOT indicates the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Entecavir Polpharma 0.5 mg contains

• The active substance is entecavir (in the form of entecavir monohydrate). Each tablet contains 0.5 mg or 1 mg of entecavir (as entecavir monohydrate).
• Other ingredients are: microcrystalline cellulose, lactose monohydrate, corn starch paste, crospovidone type A, magnesium stearate; film-coating ingredients: titanium dioxide (E171), polyethylene glycol 400, polysorbate 80, hypromellose 3 mPas (only for 0.5 mg tablets), hypromellose 6 mPas, iron oxide red (E172) (only for 1 mg tablets).

What Entecavir Polpharma looks like and contents of the pack
Entecavir Polpharma 0.5 mg are white, 10.1 mm x 3.7 mm +/- 0.2 mm, oval tablets with a score line on both sides.
Entecavir Polpharma 1 mg are pink, 12.8 mm x 4.8 mm +/- 0.2 mm, oval tablets with a score line on both sides.
The tablet can be divided into equal doses.
Each pack contains:

• 30 film-coated tablets in blisters OPA/Aluminium/PVC or
• 90 film-coated tablets in blisters OPA/Aluminium/PVC.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01