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 Entecavir Synoptis is and what it is 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 Entecavir Synoptis is and what it is used for

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

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.

HBVinfection can 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.

Do not stop taking Entecavir Synoptis without talking to your doctor

Some patients 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.

Tell your doctor if:

• You have ever had any liver problems other than hepatitis B.
• You are also infected with HIV (human immunodeficiency virus). You should not take Entecavir Synoptis to treat hepatitis B virus infection if you are not also taking medicines to treat HIV infection. Entecavir Synoptis will not treat HIV infection, and you may develop resistance to HIV treatment.

Taking Entecavir Synoptis does not stop you from infecting others with hepatitis B virus (HBV) through sexual contact or body fluids (including blood)

Therefore, it is important to take precautions to prevent the spread of HBV to others. A vaccine is available to protect those at risk from becoming infected with HBV.

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 might indicate the development of lactic acidosis. This rare but serious side effect has occasionally been fatal. Lactic acidosis occurs more often in women, especially those who are overweight.

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. However, if you have previously taken a medicine containing lamivudine, you should follow the instructions below.

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.

Driving and using machines

Dizziness, fatigue, and somnolence are common side effects that may affect your ability to drive or operate machines.

Entecavir Synoptis contains lactose and maltodextrin

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 Synoptis

The dose of Entecavir Synoptis that you need to take may vary depending on several factors

Always take Entecavir Synoptis exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.

Recommended dose

For adults, the recommended dose is 0.5 mg or 1 mg once daily (by mouth).

The dose depends on:

• previous treatment for HBV infection and the medicines used
• whether you have kidney problems; your doctor may prescribe a lower dose or recommend that you take it less often
• the condition of your liver

For children and adolescents (aged 2 to less than 18 years), your doctor will determine the correct dose based on your 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 possible, 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

Some patients 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 seen in adults.

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 carton, blister, or bottle.

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

There are no special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.

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.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, crospovidone, hypromellose, magnesium stearate.

Entecavir Synoptis 0.5 mg and 1 mg film-coated tablets:

Tablet coating Opadry II OY-LS-28908 (white) and Opadry II 57U240038 (pink)

What Entecavir Synoptis looks like and contents of the pack

Entecavir Synoptis 0.5 mg and 1 mg film-coated tablets are available in packs of 30, 60, or 90 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Synoptis Pharma Sp. z o.o., ul. Krakowiaków 65, 02-255 Warszawa, Poland

Manufacturers: 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 & 1 mg comprimidos recubiertos con película EFG; Poland: Entecavir Synoptis; France: ENTECAVIR PHARMATHEN 0.5 mg & 1 mg, comprimé pelliculé

Date of last revision of the leaflet: January 2022