ENTECAVIR ACCORD 0.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Entecavir Accord 0.5 mg film-coated tablets EFG

Entecavir Accord 1 mg film-coated tablets EFG

entecavir

Read all of this leaflet carefully before you start 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 Accord and what is it used for
2. What you need to know before you take Entecavir Accord
3. How to take Entecavir Accord
4. Possible side effects
5. Storing Entecavir Accord
6. Package contents and further information

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

Entecavir Accord tablets is an antiviral medicine used to treat long-term (chronic) infection with hepatitis B virus (HBV) in adults. Entecavir Accord may be used in patients whose liver is damaged but still works adequately (compensated liver disease) and in patients whose liver is damaged and does not work adequately (decompensated liver disease).

Entecavir Accord tablets is also used to treat long-term (chronic) infection with HBV in children and adolescents from 2 to less than 18 years of age. Entecavir Accord may be used in children whose liver is damaged but still works adequately (compensated liver disease).

Hepatitis B virus infection can damage your liver. Entecavir Accord reduces the amount of virus in your body and improves the condition of your liver.

2. What you need to know before you take Entecavir Accord

Do not take Entecavir Accord

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Entecavir Accord

• if you have ever had problems with your kidneys, inform your doctor. This is important because Entecavir Accord is removed from the body by the kidneys and it may be necessary to adjust your dose or treatment schedule.

• do not stop taking Entecavir Accord without talking to your doctor, as your hepatitis may get worse when treatment is stopped. When you stop treatment with Entecavir Accord, your doctor will monitor you and perform blood tests for several months.

• ask your doctor if your liver is working properlyand, if not, about the possible effects that treatment with Entecavir Accord may have.

• , make sure to inform your doctor. You should not take Entecavir Accord to treat your hepatitis B infection unless you are also taking medicines to treat your HIV infection, as otherwise the effectiveness of future HIV treatments may be reduced. Entecavir Accord will not control your HIV infection.

• taking Entecavir Accord will not prevent you from infecting other people with hepatitis B virus (HBV)through sexual contact or body fluids (including blood contamination). Therefore, it is important that you take appropriate precautions to prevent other people from becoming infected with HBV. There is a vaccine to protect people at risk of HBV infection.

• Entecavir Accord belongs to a class of medicines that can cause lactic acidosis (excess of lactic acid in the blood) and liver enlargement. Symptoms such as nausea, vomiting, and stomach pain could indicate the development of lactic acidosis. On rare occasions, this rare but serious side effect has been fatal. Lactic acidosis occurs more frequently in women, especially those who are overweight. Your doctor will monitor you regularly while you are taking Entecavir Accord.

• , please inform your doctor.

Children and adolescents

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

Taking Entecavir Accord with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking Entecavir Accord with food and drinks

In most cases, you can take Entecavir Accord with or without food. However, if you have received previous treatment with another medicine containing lamivudine as the active ingredient, you should consider the following. If you have switched to Entecavir Accord because treatment with lamivudine was not successful, you should take Entecavir Accord on an empty stomach, once a day. If your liver disease is very advanced, your doctor will also instruct you to take Entecavir Accord on an empty stomach. Empty stomach means at least 2 hours after and 2 hours before the next meal.

Children and adolescents (from 2 to less than 18 years of age) can take Entecavir Accord with or without food.

Pregnancy, breastfeeding, and fertility

Tell your doctor if you are pregnant or planning to become pregnant. It has not been shown that the use of Entecavir Accord is safe during pregnancy. You should not take Entecavir Accord during pregnancy unless clearly necessary, as determined by your doctor. It is important that women of childbearing age using Entecavir Accord use an effective method of contraception to prevent pregnancy.

You should not breastfeed during treatment with Entecavir Accord. If you are breastfeeding, tell your doctor. It is not known whether entecavir, the active ingredient of Entecavir Accord, is excreted in breast milk.

Driving and using machines

Dizziness, fatigue, and drowsiness are common side effects that may affect your ability to drive or use machines. If you are unsure, consult your doctor.

Entecavir Accord contains soy polysaccharides and sodium

This medicine contains soy polysaccharide. If you are allergic to soy, do not use this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Entecavir Accord

Not all patients need to take the same dose of Entecavir Accord.

Follow exactly the instructions of your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

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

Your dose will depend on:

• if you have been previously treated for HBV infection, as well as the medicine you received.
• if you have kidney problems. Your doctor may prescribe a lower dose or indicate that you take it less frequently than once a day.
• the condition of your liver.

For children and adolescents(from 2 to less than 18 years of age), Entecavir Accord 0.5 mg tablets are available or an oral solution of entecavir may be available.

Your pediatrician will decide on the appropriate dose based on the child's body weight. Children with a weight of at least 32.6 kg can take the 0.5 mg tablets or an oral solution of entecavir may be available. For patients weighing from 10 kg to 32.5 kg, an oral solution of entecavir is recommended. All doses should be taken once a day (by mouth). There are no recommendations for entecavir in children under 2 years of age or weighing less than 10 kg.

Your doctor will advise you on the correct dose for you. Always take the dose recommended by your doctor to ensure that the medicine is fully effective and to reduce the development of resistance to treatment. Take Entecavir Accord for as long as your doctor tells you. Your doctor will tell you when to stop treatment.

Some patients must take Entecavir Accord on an empty stomach (see Entecavir Accord with food and drinksin Section 2). If your doctor tells you to take Entecavir Accord on an empty stomach, empty stomach means at least 2 hours after a meal and 2 hours before the next meal.

Entecavir Accord is only available as 0.5 and 1 mg film-coated tablets. For patients who cannot swallow tablets or for whom a dose reduction is recommended, other medicines containing entecavir with more suitable formulations may be available.

If you take more Entecavir Accord than you should

Contact your doctor immediately.

If you forget to take Entecavir Accord

It is important that you do not miss any dose. If you miss a dose of Entecavir Accord, you should take it as soon as possible and 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 missed doses.

Do not stop taking Entecavir Accord without talking to your doctor

Some people develop severe hepatitis symptoms when they stop taking Entecavir Accord. Tell your doctor immediately if you notice any changes in your symptoms after stopping treatment.

If you have any further questions on the use of this medicine, 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 Accord have reported the following side effects:

Adults

• common (at least 1 in 100 patients): headache, insomnia, fatigue, dizziness, drowsiness, vomiting, diarrhea, nausea, dyspepsia, and increased levels of liver enzymes in the blood.
• uncommon (at least 1 in 1,000 patients): skin rash, hair loss.
• rare (at least 1 in 10,000 patients): severe allergic reaction.

Children and adolescents

The side effects experienced in children and adolescents are similar to those experienced in adults as described above, with the following difference:

Very common (at least 1 in 10 patients): low levels of neutrophils (a type of white blood cell important in fighting infection).

If you experience side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

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 Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Entecavir Accord

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

After opening the bottle, use it within 90 days.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and further information

Composition of Entecavir Accord

• The active substance is entecavir.

Entecavir Accord 0.5 mg film-coated tablets

Each tablet contains entecavir monohydrate equivalent to 0.5 mg of entecavir.

Entecavir Accord 1 mg film-coated tablets

Each tablet contains entecavir monohydrate equivalent to 1 mg of entecavir.

• The other ingredients are:

Tablet core:calcium carbonate, pregelatinized starch, sodium carmellose, soy polysaccharide, citric acid monohydrate, sodium stearyl fumarate.

Film coating:

Entecavir Accord 0.5 mg film-coated tablets

hypromellose, titanium dioxide (E171), macrogol, and polysorbate 80

Entecavir Accord 1 mg film-coated tablets

hypromellose, titanium dioxide (E171), macrogol, iron oxide red (E172)

See section 2 "Entecavir Accord contains soy polysaccharides and sodium"

Appearance and package contents

Entecavir Accord 0.5 mg film-coated tablets: white to off-white, triangular, biconvex, with "J" engraved on one side and "110" on the other.

Entecavir Accord 1 mg film-coated tablets: pink, triangular, biconvex, with "J" engraved on one side and "111" on the other.

Entecavir Accord is supplied in boxes containing 30 x 1 or 90 x 1 film-coated tablets (in single-dose blisters) and in bottles containing 30 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est 6ª planta

08039 Barcelona,

Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder.

Accord Healthcare Limited, UK

Tel: 0044 208 863 1427

Date of last revision of this leaflet:{MM/YYYY}

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.