Entecavir Sinoptis

Package Leaflet: Information for the User

Entecavir Synoptis, 0.5 mg, Film-Coated Tablets

Entecavir Synoptis, 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 and Other Information

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

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

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

HBVcan cause damage to the liver. Entecavir Synoptis reduces the amount of virus in the body and improves liver function.

Entecavir Synoptis is also used to treat chronic HBV infection in children and adolescents from 2 to less than 18 years of age.

Chronic HBV infectioncan cause damage to the liver. Entecavir Synoptis reduces the amount of virus in the body and improves liver function.

2. Before you take Entecavir Synoptis

Do not take Entecavir Synoptis

• 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 Synoptis, tell your doctor or pharmacist if you have ever had any kidney problems. This is important because Entecavir Synoptis is removed from the body by the kidneys and you may need a lower dose or to take it less often.

• If you have had any previous liver problems, tell your doctor. This is important because some people taking Entecavir Synoptis have had severe liver problems.

Do not stop taking Entecavir Synoptis without talking to your doctor first

Some people who stop taking Entecavir Synoptis have had severe liver problems. Your doctor will monitor your liver function for several months after you stop taking Entecavir Synoptis.

• Tell your doctor if you have ever had HIV (human immunodeficiency virus) infection. You should not take Entecavir Synoptis to treat chronic hepatitis B virus infection if you are not also taking medicines to control your HIV infection. Entecavir Synoptis will not control your HIV infection, and you may develop resistance to HIV medicines.

Taking Entecavir Synoptis does not stop you from infecting others with HBV

HBVcan be passed on through sexual contact or body fluids (including blood). You should continue to take precautions to prevent passing HBV to others.

Entecavir Synoptis belongs to a group of medicines that can cause lactic acidosis (a build-up of lactic acid in the blood) and an enlarged liver

Symptoms such as nausea, vomiting, and abdominal pain can indicate the development of lactic acidosis. This rare but serious side effect has sometimes been fatal. Lactic acidosis occurs more often in women, especially those who are overweight. Your doctor will monitor you while you are taking Entecavir Synoptis.

• If you have been treated for chronic hepatitis B before, tell your doctor.

Children and adolescents

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

Entecavir Synoptis with other medicines

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

Taking Entecavir Synoptis with food and drink

Entecavir Synoptis can be taken with or without food. If you have taken medicines containing lamivudine in the past, talk to your doctor about the best way to take Entecavir Synoptis.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is not known if entecavir is safe to use during pregnancy. Entecavir Synoptis should not be used during pregnancy unless clearly necessary. Women who can become pregnant should use effective contraception while taking Entecavir Synoptis. If you are breastfeeding, tell your doctor. It is not known if entecavir passes into breast milk.

Driving and using machines

Dizziness, fatigue, and somnolence (sleepiness) are common side effects that may affect your ability to drive or use machines. If you are affected, do not drive or use machines.

Entecavir Synoptis contains lactose and maltodextrin

This medicine contains lactose and maltodextrin (glucose). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Entecavir Synoptis

The dose of Entecavir Synoptis may vary from person to person

Always take Entecavir Synoptis exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose is:

• For adults: 0.5 mg or 1 mg once daily (by mouth).
• The dose depends on:
  • previous treatment for HBV and the medicines used
  • kidney problems; your doctor may prescribe a lower dose or recommend taking it less often
  • liver function

For children and adolescents (from 2 to less than 18 years of age): your doctor will decide the correct dose based on the child's weight.

If you take more Entecavir Synoptis than you should

Contact your doctor or pharmacist immediately.

If you forget to take Entecavir Synoptis

It is important that you do not miss any doses of Entecavir Synoptis. If you miss a dose, take it as soon as you remember, then 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 Synoptis without talking to your doctor first

Some people who stop taking Entecavir Synoptis have had severe liver problems. Tell your doctor immediately if you notice any changes in your symptoms after stopping Entecavir Synoptis.

4. Possible side effects

Like all medicines, Entecavir Synoptis can cause side effects, although not everybody gets them.

Adults

Common (affects up to 1 in 10 people):

• headache, insomnia, fatigue, dizziness, somnolence
• nausea, vomiting, diarrhea, dyspepsia
• increased liver enzymes in the blood

Uncommon (affects up to 1 in 100 people):

• rash
• hair loss

Rare (affects up to 1 in 1,000 people):

• severe allergic reactions

Children and adolescents

Side effects in children and adolescents are similar to those in adults and include:

Very common (affects more than 1 in 10 people):

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

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. How to store Entecavir Synoptis

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, bottle, or carton.

The expiry date refers to the last day of that month.

There are no special storage conditions for this medicine.

After first opening the bottle, the tablets should be used within 30 days.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Entecavir Synoptis contains

• The active substance is entecavir. Each film-coated tablet contains 0.5 mg or 1 mg of entecavir (as entecavir monohydrate).
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, crospovidone (type A), hydroxypropylcellulose, magnesium stearate.

Entecavir Synoptis 0.5 mg, film-coated tablets Tablet coating Opadry II OY-LS-28908 (white): titanium dioxide (E 171), lactose monohydrate, hypromellose 15 mPas, macrogol 4000, hypromellose 3 mPas, hypromellose 50 mPas. Entecavir Synoptis, 1 mg, film-coated tablets Tablet coating Opadry II 57U240038 (pink): hypromellose 15 mPas, titanium dioxide (E 171), polydextrose (E 1200), talc, maltodextrin, triglycerides of saturated fatty acids with medium chain length, iron oxide red (E 172), iron oxide yellow (E 172).

What Entecavir Synoptis looks like and contents of the pack

Entecavir Synoptis, 0.5 mg, film-coated tablets White to off-white, triangular tablets with "0.5" engraved on one side, 8.4 mm ± 0.2 mm in size and 3.7 mm ± 0.3 mm in thickness. Entecavir Synoptis, 1 mg, film-coated tablets Pink, triangular tablets with "1" engraved on one side, 10.6 mm ± 0.2 mm in size and 4.5 mm ± 0.3 mm in thickness. Entecavir Synoptis is available in cardboard boxes containing blisters of OPA/Aluminum/PVC/Aluminum or HDPE bottles with a child-resistant closure.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Synoptis Pharma Sp. z o. o. ul. Krakowiaków 65 02-255 Warszawa

Manufacturer

Pharmathen S.A. Dervenakion 6 Pallini Attiki, 15351 Greece Pharmathen International S.A. Industrial Park Sapes Rodopi Prefecture, Block No 5 Rodopi, 69300 Greece Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 90449 Nürnberg Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Denmark Entecavir Pharmathen United Kingdom Entecavir Germany Entecavir Heumann 0.5 mg & 1 mg Filmtabletten Italy Entecavir Kabi Spain Entecavir Kabi 0.5 mg comprimidos recubiertos con película EFG Entecavir Kabi 1.0 mg comprimidos recubiertos con película EFG Poland Entecavir Synoptis France ENTECAVIR PHARMATHEN 0.5 mg, comprimé pelliculé ENTECAVIR PHARMATHEN 1 mg, comprimé pelliculé

Date of last revision of the leaflet: January 2022