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.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and is intended for your use only. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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 to treat 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), as well as in patients with damaged liver function that is not functioning properly (with decompensated liver function).

Entecavir Polpharma in the form of film-coated tablets is 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 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 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, the patient should discuss it with their doctor or pharmacist.

• If the patient has had any kidney disease,they should inform their doctor. This is important because Entecavir Polpharma is excreted 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 a doctor,as this may have a negative impact on the course of hepatitis. After stopping Entecavir Polpharma, the doctor will monitor the patient's condition and perform blood tests for several months.
• The patient should discuss with their doctor whether their liver is functioning properlyand, if not, what potential impact this may have on the treatment with Entecavir Polpharma.
• If the patient is also infected with HIV (human immunodeficiency virus),they should inform their doctor. The patient should not take Entecavir Polpharma to treat hepatitis B virus infection if they are not receiving HIV treatment, as this may reduce the effectiveness of future HIV treatment. Entecavir Polpharma does not treat HIV infection.
• Taking Entecavir Polpharma does not prevent the transmission of hepatitis B virus to other peoplethrough sexual contact or bodily fluids (including infected blood). Therefore, it is essential to take appropriate precautions to prevent the transmission of HBV to other people. 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 that can be fatal. Lactic acidosis occurs more frequently in women, especially those who are significantly overweight. During treatment with Entecavir Polpharma, the doctor will regularly monitor the patient's condition.
• If the patient has been previously treated for chronic hepatitis B,they should inform their 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

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Entecavir Polpharma with food and drink

In most cases, Entecavir Polpharma can be taken with or without food.
If the patient has previously taken medicines containing lamivudine as the active substance,
they should consider the following recommendations. If the treatment has been changed to Entecavir Polpharma due to the ineffectiveness of lamivudine treatment, Entecavir Polpharma should be taken once a day, on an empty stomach.
If the liver disease is very advanced, the doctor will 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
It has not been shown that taking Entecavir Polpharma during pregnancy is safe. Entecavir Polpharma should not be taken during pregnancy unless it is specifically recommended by a doctor. It is essential for women of childbearing age taking Entecavir Polpharma to use effective contraception to avoid becoming pregnant.
During treatment with Entecavir Polpharma, the patient should not breastfeed. If the patient is breastfeeding, they should inform their doctor. It is not known whether entecavir, the active substance of Entecavir Polpharma, passes into human milk.

Driving and using machines

Dizziness, fatigue, and drowsiness are common side effects that may impair the ability to drive and use machines. In case of any doubts, the patient should consult their doctor.

Entecavir Polpharma contains lactose

This medicine contains lactose. If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Entecavir Polpharma

Not all patients require the same dose of Entecavir Polpharma.

Entecavir Polpharma.

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose for adultsis 0.5 mg or 1 mg once a day (orally).

The dose depends on:

• previous treatment of HBV infection and the medicines used;
• the presence of kidney function disorders; in this case, the doctor may prescribe a lower dose or recommend taking the medicine less frequently than once a day;
• 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 a day (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 appropriate dose is the responsibility of the doctor. The patient should always take the dose recommended by the 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 the doctor recommends. The doctor will inform the patient 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 the 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

The patient should immediately contact their doctor.

Missing a dose of Entecavir Polpharma

It is essential not to miss any dose. If a dose of Entecavir Polpharma is missed, the patient should 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, the patient should not take the missed dose. They should wait and take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.

Do not stop taking Entecavir Polpharma without consulting a doctor

After stopping Entecavir Polpharma, some patients may experience severe hepatitis symptoms. The patient should immediately inform their doctor about any changes in symptoms after stopping treatment.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Entecavir Polpharma can cause side effects, although not everybody gets them.
Patient taking Entecavir Polpharma have reported the following side effects:

Adults

• common (at least 1 in 10 patients): headache, insomnia, fatigue, dizziness, drowsiness, 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 in fighting infections).

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather 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 indicates the expiry date, and after the abbreviation Lot/LOT, it indicates the batch number.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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 (in the form of 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 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 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