Entecavir Polpharma

Package Leaflet: Information for the Patient

Entecavir Polpharma, 0.5 mg, Film-Coated Tablets

Entecavir Polpharma, 1 mg, Film-Coated Tablets

Entecavir

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

• Keep this 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

Entecavir Polpharma in the form of film-coated tablets is an antiviral medicine used in adults for the treatment of chronic (long-term) viral hepatitis

type B (HBV).Entecavir Polpharma can be used in patients with damaged liver function, but still functioning properly (with compensated liver function) and in patients whose liver is damaged and not functioning properly (with decompensated liver function).

Entecavir Polpharma in the form of film-coated tablets is also used for the treatment of 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 functioning properly (with compensated liver function).
Hepatitis B virus infection can lead to liver damage. Entecavir Polpharma reduces the amount of virus in the body and improves liver function.

2. Important information before taking Entecavir Polpharma

When not to take Entecavir Polpharma:

• if you are 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 it with your doctor or pharmacist.

• If you have ever had kidney disease,tell your doctor. This is important because Entecavir Polpharma is eliminated from the body by the kidneys and may require a dose reduction or a change in the dosing schedule.
• Do not stop taking Entecavir Polpharma without consulting your doctor,as this may have a negative impact on the course of hepatitis. After stopping Entecavir Polpharma, 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 the treatment with Entecavir Polpharma.
• If you are also infected with HIV(human immunodeficiency virus), tell your doctor. You should not take Entecavir Polpharma to treat hepatitis B virus infection if you are not receiving HIV treatment, as this may reduce the future effectiveness of HIV treatment. Entecavir Polpharma does not treat HIV infection.
• Taking Entecavir Polpharma does not prevent the infection of other people with hepatitis B virus (HBV)through sexual contact or bodily fluids (including infected blood). Therefore, it is essential to take appropriate precautions to prevent the infection of others with HBV. A vaccine is available to protect people at risk of HBV infection.
• Entecavir Polpharma belongs to a group of medicines that can cause lactic acidosis(an 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 Entecavir Polpharma, your doctor will regularly monitor your condition.
• If you have been previously treated for chronic hepatitis B,tell your doctor.

Children and adolescents

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

Entecavir Polpharma and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Entecavir Polpharma with food and drink

In most cases, Entecavir Polpharma can be taken with or without food.
If you have previously taken medicines containing lamivudine as the active substance, consider the following recommendations. If treatment has been switched to Entecavir Polpharma due to lamivudine treatment failure, take Entecavir Polpharma once daily on an empty stomach.
If liver disease is very advanced, your 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) can take Entecavir Polpharma with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The use of Entecavir Polpharma during pregnancy is not recommended unless clearly necessary. Women of childbearing potential taking Entecavir Polpharma should use effective contraception to avoid becoming pregnant.
Do not breastfeed during treatment with Entecavir Polpharma. If you are breastfeeding, inform your doctor. It is not known whether entecavir, the active substance of Entecavir Polpharma, passes into human breast milk.

Driving and using machines

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

Entecavir Polpharma contains lactose

This medicine contains lactose. If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Entecavir Polpharma

The same dose of Entecavir Polpharma is not required for all patients.

Entecavir Polpharma.

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 condition.

For 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 can take 0.5 mg tablets or entecavir oral solution. For patients weighing between 10 kg and 32.5 kg, entecavir oral solution is recommended. All doses are taken once daily (orally). There are no recommendations for the use of entecavir in children under 2 years of age or weighing less than 10 kg.
The recommendation for the correct dose is the responsibility of the doctor. Always take the dose recommended by your doctor to ensure the full effectiveness of the medicine and to limit the development of resistance to treatment. Entecavir Polpharma should be taken for as long as your doctor recommends. Your doctor will inform you about the end of treatment.
Some patients may need to take Entecavir Polpharma on an empty stomach (see Entecavir Polpharma with food and drink in section 2). If your doctor recommends 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.

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 you miss a dose of Entecavir Polpharma, 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 the missed dose.

Do not stop taking Entecavir Polpharma without consulting your doctor

After stopping Entecavir Polpharma, some patients may experience severe hepatitis symptoms. Inform your doctor immediately about any changes in symptoms after stopping treatment.
If you have any further questions about 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.
Patients treated with Entecavir Polpharma have reported the following side effects:

Adults

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

Children and adolescents

The 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 for fighting infections).

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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
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 Entecavir Polpharma

Do not store above 30°C. Store in the original package.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 (as entecavir monohydrate). Each tablet contains 0.5 mg or 1 mg of entecavir (as entecavir monohydrate).
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, maize starch, crospovidone type A, magnesium stearate; coating: titanium dioxide (E171), macrogol 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 dividing line on both sides.
Entecavir Polpharma, 1 mg, are pink, 12.8 mm x 4.8 mm +/- 0.2 mm, oval tablets with a dividing line on both sides.
The tablet can be divided into equal doses.
Each pack contains:

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01
Date of last revision of the leaflet:August 2022