Entecavir Zentiva

Patient Information 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 Entecavir Zentiva is and what it is 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 Entecavir Zentiva is and what it is 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 whose liver is still working properly (with compensated liver disease) and in patients whose liver is not working 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 whose liver is damaged but still works 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 your doctor,as this may affect your hepatitis B infection. 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 possible effect 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 your hepatitis B virus infection if you are not also taking medicines for HIV, as this may reduce the future effectiveness of HIV treatment. Entecavir Zentiva does not treat HIV infection.
• Taking Entecavir Zentiva does not prevent the spread of hepatitis B virus to other peoplethrough sexual contact or blood contamination (including sharing needles). You should continue to take precautions to prevent the spread of hepatitis B virus. A vaccine is available to protect those at risk of becoming infected with hepatitis B virus.
• Entecavir Zentiva belongs to a group of medicines that may cause lactic acidosis (excess 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 rare but serious side effect can be fatal. Lactic acidosis occurs more often in women, especially if they are significantly overweight. While taking Entecavir Zentiva, your doctor will regularly monitor your condition.
• If you have been treated for hepatitis B before,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 the 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 food or without food.
If you have previously taken medicines containing lamivudine as the active substance,
consider the following recommendations. If your treatment has been switched to Entecavir Zentiva
due to lamivudine treatment failure, take Entecavir Zentiva once daily on an empty stomach. If your 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 years to less than 18 years of age, weighing at least 32.6 kg) can
take medicines containing entecavir without regard to 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 for advice. Up to now, it has not been proven 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 your doctor prescribes may be different from the dose for another patient.

Always take Entecavir Zentiva exactly as your doctor has told you. If you are not sure, check with 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 problems; in this case, your doctor may prescribe a lower dose or recommend that you take the medicine less frequently than once daily;
• the condition of your liver.

Use in children and adolescents

Entecavir Zentiva 0.5 mg
For children and adolescents (from 2 years 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 made 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 years 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 medicine works fully and to reduce the risk of developing resistance to treatment. You should keep taking Entecavir Zentiva for as long as your doctor recommends. Your doctor will tell you when to stop.

If you have been told 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 your 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 your 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, Entecavir Zentiva 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 enzymes 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 website.
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 instructions 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. The tablet coating contains 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. The tablet coating contains 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.
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.
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 further information on this medicine and its authorized names in the Member States of the European Economic Area, 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