Entecavir Zentiva

Package Leaflet: Information for the Patient

Entecavir Zentiva, 0.5 mg, Film-Coated Tablets

Entecavir Zentiva, 1 mg, Film-Coated Tablets

Entecavir

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

• 1. What is Entecavir Zentiva and what is it used for
• 2. Before you take Entecavir Zentiva
• 3. How to take Entecavir Zentiva
• 4. Possible side effects
• 5. How to store Entecavir Zentiva
• 6. Contents of the pack and other information

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

Entecavir Zentiva is an antiviral medicine used to treat chronic (long-term) hepatitis B virus (HBV) infection in adults.

(HBV).Entecavir Zentiva can be used in patients with liver damage, but still functioning properly (with compensated liver disease) and in patients with liver damage that is not functioning properly (with decompensated liver disease).

Entecavir, the active substance of Entecavir Zentiva, is also used to treat chronic (long-term) HBV infection in children and adolescents from 2 years to less than 18 years of age.

18 years.Medicines containing entecavir can be used in children with liver damage, but still functioning properly (with compensated liver disease).
Hepatitis B virus infection can lead to liver damage.
Entecavir Zentiva reduces the amount of virus in the body and improves liver function.

2. Before you take Entecavir Zentiva

Do not take Entecavir Zentiva

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

Warnings and precautions

Before taking Entecavir Zentiva, discuss this with your doctor or pharmacist.

• If you have ever had any kidney problems,tell your doctor. This is important because Entecavir Zentiva is removed from the body by the kidneys and may need a dose adjustment or a change in dosing schedule.
• Do not stop taking Entecavir Zentiva without consulting a doctor,as this may affect the condition of your liver. After stopping Entecavir Zentiva, your doctor will monitor your condition and perform blood tests for several months.
• Discuss with your doctor whether your liver is working properlyand, if not, what the potential impact on your treatment with Entecavir Zentiva may be.
• If you are also infected with HIV (Human Immunodeficiency Virus),tell your doctor. You should not take Entecavir Zentiva to treat hepatitis B virus infection if you are not receiving medicines to treat HIV, as the effectiveness of future HIV treatment may be reduced. Entecavir Zentiva does not treat HIV infection.
• Taking Entecavir Zentiva does not prevent the spread of hepatitis B virus to other people through sexual contact or body fluids (including infected blood). Therefore, it is important to take appropriate precautions to prevent the spread of hepatitis B virus to other people. A vaccine is available to protect people at risk of hepatitis B virus infection.
• Entecavir Zentiva belongs to a group of medicines that can cause lactic acidosis (excess of lactic acid in the blood)and an enlarged liver. 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 often in women, especially those who are significantly overweight. While taking Entecavir Zentiva, your doctor will regularly monitor your condition.
• If you have been previously treated for chronic hepatitis B,tell your doctor.

Children and adolescents

Medicines containing entecavir must not be used in children below 2 years of age or weighing less than 10 kg.

Entecavir Zentiva with other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, and about any medicines you plan to take.

Entecavir Zentiva with food and drink

In most cases, Entecavir Zentiva 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 Zentiva due to lamivudine treatment failure, take Entecavir Zentiva once daily on an empty stomach. If liver disease is very advanced, your doctor will also recommend taking Entecavir Zentiva 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.
Entecavir Zentiva 0.5 mg
Children and adolescents (from 2 to less than 18 years of age, weighing at least 32.6 kg) can take medicines containing entecavir with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice. Up to now, it has not been shown that Entecavir Zentiva is safe during pregnancy. Entecavir Zentiva should not be used during pregnancy unless clearly necessary. It is important that women of childbearing age using Entecavir Zentiva use effective contraception to prevent pregnancy.
Do not breast-feed during treatment with Entecavir Zentiva. If you are breast-feeding, tell your doctor. It is not known whether entecavir, the active substance of Entecavir Zentiva, passes into human breast milk.

Driving and using machines

Dizziness, fatigue, and somnolence are common side effects that may affect your ability to drive or operate machinery. If you are affected, do not drive or operate machinery.

Entecavir Zentiva contains lactose

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Entecavir Zentiva

The dose of Entecavir Zentiva that you need to take may vary.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose for adultsis 0.5 mg or 1 mg once daily (orally).

The dose depends on:

• previous treatment for hepatitis B virus infection and the medicines used;
• the presence of kidney problems; in this case, your doctor may prescribe a lower dose or recommend less frequent administration;
• the condition of your liver.

Use in children and adolescents

Entecavir Zentiva 0.5 mg
For children and adolescents (from 2 to less than 18 years of age), your doctor will determine the appropriate dose based on the child's weight.
Children and adolescents weighing at least 32.6 kg can take 0.5 mg tablets or may be given an oral solution containing entecavir. Entecavir oral solution is recommended for patients weighing from 10 kg to 32.5 kg. All doses are taken once daily (orally). No recommendations are available for entecavir in children below 2 years of age or weighing less than 10 kg.
Entecavir Zentiva 1 mg
For children and adolescents (from 2 to less than 18 years of age), Entecavir Zentiva is available as 0.5 mg film-coated tablets or may be given an oral solution containing entecavir.
Your doctor will determine the appropriate dose based on the child's weight.
Your doctor will recommend the dose that is right for you. Always take the dose recommended by your doctor to ensure the full effect of the medicine and to reduce the development of resistance. You should keep taking Entecavir Zentiva for as long as your doctor recommends. Your doctor will tell you when to stop.

Some patients may need to take Entecavir Zentiva on an empty stomach

(see Entecavir Zentiva with food and drink in section 2).

If your doctor recommends that you take Entecavir Zentiva on an empty stomach, this means

at least 2 hours after a meal and at least 2 hours before the next meal.

If you take more Entecavir Zentiva than you should

Contact a doctor or pharmacist immediately.

If you forget to take Entecavir Zentiva

It is important that you do not miss any dose of Entecavir Zentiva. If you miss a dose, take it as soon as possible, then take the next dose at the usual time. If it is almost time for your 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 forgotten dose.

Do not stop taking Entecavir Zentiva without consulting a doctor

After stopping Entecavir Zentiva, some people have had severe liver problems. You should immediately tell your doctor about any changes in your symptoms after stopping treatment.
If you have any further questions on the use of this product, 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 Zentiva have reported the following side effects:

Adults

Common(may affect up to 1 in 10 people):

• insomnia (inability to sleep)
• fatigue (extreme tiredness)
• headache, dizziness, somnolence
• vomiting, diarrhea, nausea, dyspepsia (indigestion)
• increased liver enzyme activity in the blood

Uncommon(may affect up to 1 in 100 people):

• rash
• hair loss

Rare(may affect up to 1 in 1,000 people):

• severe allergic reactions

Children and adolescents

Side effects seen in children and adolescents are similar to those seen in adults and are described above, with the following difference:
Very common(may affect more than 1 in 10 people):

• low neutrophil count (a type of white blood cell important for fighting infections).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the websiteor contact your local pharmacist for more information.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Entecavir Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister or carton after EXP. The expiry date refers to the last day of that month.
There are no special storage conditions for this medicine.
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 pack and other information

What Entecavir Zentiva contains

• Entecavir Zentiva 0.5 mg
• The active substance is entecavir. One film-coated tablet contains 0.5 mg of entecavir (as entecavir monohydrate).
• The other ingredients are: lactose monohydrate, microcrystalline cellulose PH 101, microcrystalline cellulose PH 102, crospovidone (Type B), and magnesium stearate. Tablet coating: opadry white YS-1-7003 (contains titanium dioxide (E 171), hypromellose 3 mPas, hypromellose 6 mPas, macrogol 400, and polysorbate 80).

Entecavir Zentiva 1 mg

• The active substance is entecavir. One film-coated tablet contains 1 mg of entecavir (as entecavir monohydrate).
• The other ingredients are: lactose monohydrate, microcrystalline cellulose PH 101, microcrystalline cellulose PH 102, crospovidone (Type B), and magnesium stearate. Tablet coating: opadry white YS-1-7003 (contains titanium dioxide (E 171), hypromellose 3 mPas, hypromellose 6 mPas, macrogol 400, and polysorbate 80).

What Entecavir Zentiva looks like and contents of the pack

Entecavir Zentiva 0.5 mg
The film-coated tablets are white to off-white, round, and biconvex, approximately 7 mm in diameter, and smooth on both sides.
Entecavir Zentiva0.5 mg film-coated tablets are available in cardboard boxes containing 30 or 90 film-coated tablets in blisters of OPA/Aluminium/PVC/Aluminium foil.
Entecavir Zentiva 1 mg
The film-coated tablets are white to off-white, round, and biconvex, approximately 8.9 mm in diameter, with a score line on one side, and smooth on the other side. The score line is not intended for breaking the tablet.
Entecavir Zentiva1 mg film-coated tablets are available in cardboard boxes containing 30 or 90 film-coated tablets in blisters of OPA/Aluminium/PVC/Aluminium foil.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Zentiva k.s.
U kabelovny 130, Dolni Mĕcholupy
102 37 Prague 10
Czech Republic

Manufacturer

S.C. Laropharm S.R.L.
Șos. Alexandriei nr. 145A
Oras Bragadiru
Jud. Ilfov 077025, Romania
To obtain more detailed information on this medicine and its authorized names in the European Economic Area countries, contact the representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00
Date of last revision of the leaflet:March 2023