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Baraclude (entecavir) – Package leaflet - J05AF10

Updated on site: 05-Oct-2017

Medication nameBaraclude
ATC CodeJ05AF10
Substanceentecavir
ManufacturerBristol-Myers Squibb Pharma EEIG

Package leaflet: Information for the user

Baraclude 0.5 mg film-coated tablets

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.

What is in this leaflet

1.What Baraclude is and what it is used for

2.What you need to know before you take Baraclude

3.How to take Baraclude

4.Possible side effects

5.How to store Baraclude

6.Contents of the pack and other information

1.What BARACLUDE is and what it is used for

Baraclude tablets are anti-viral medicines, used to treat chronic (long term) hepatitis B virus (HBV) infection in adults. Baraclude can be used in people whose liver is damaged but still functions

properly (compensated liver disease) and in people whose liver is damaged and does not function properly (decompensated liver disease).

Baraclude tablets are also used to treat chronic (long term) HBV infection in children and adolescents aged 2 years to less than 18 years. Baraclude can be used in children whose liver is

damaged but still functions properly (compensated liver disease).

Infection by the hepatitis B virus can lead to damage to the liver. Baraclude reduces the amount of virus in your body, and improves the condition of the liver.

2. What you need to know before you take BARACLUDE

Do not take Baraclude

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

Warning and precautions

Talk to your doctor or pharmacist before taking Baraclude

if you have ever had problems with your kidneys, tell your doctor. This is important because Baraclude is eliminated from your body through the kidneys and your dose or dosing schedule may need to be adjusted.

do not stop taking Baraclude without your doctor’s advice since your hepatitis may worsen after stopping treatment. When your treatment with Baraclude is stopped, your doctor will continue to monitor you and take blood tests for several months.

discuss with your doctor whether your liver functions properly and, if not, what the possible effects on your Baraclude treatment may be.

if you are also infected with HIV (human immunodeficiency virus) be sure to tell your doctor. You should not take Baraclude to treat your hepatitis B infection unless you are taking medicines for HIV at the same time, as the effectiveness of future HIV treatment may be reduced. Baraclude will not control your HIV infection.

taking Baraclude will not stop you from infecting other people with hepatitis B virus (HBV) through sexual contact or body fluids (including blood contamination). So, it is important to take appropriate precautions to prevent others from becoming infected with HBV. A vaccine is available to protect those at risk from becoming infected with HBV.

Baraclude belongs to a class of medicines that can cause lactic acidosis (excess of lactic acid in your blood) and enlargement of the liver. Symptoms such as nausea, vomiting and stomach 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, particularly if they are very overweight. Your doctor will monitor you regularly while you are receiving Baraclude.

if you have previously received treatment for chronic hepatitis B, please inform your doctor.

Children and adolescents

Baraclude should not be used for children below 2 years of age or weighing less than 10 kg.

Other medicines and Baraclude

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

Baraclude with food and drink

In most cases you may take Baraclude with or without food. However, if you have had a previous treatment with a medicine containing the active substance lamivudine you should consider the following. If you were switched over to Baraclude because the treatment with lamivudine was not successful, you should take Baraclude on an empty stomach once daily. If your liver disease is very advanced, your doctor will also instruct you to take Baraclude on an empty stomach. Empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal.

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

Pregnancy, breast-feeding and fertility

Tell your doctor if you are pregnant or planning to become pregnant. It has not been demonstrated that Baraclude is safe to use during pregnancy. Baraclude must not be used during pregnancy unless specifically directed by your doctor. It is important that women of childbearing age receiving treatment with Baraclude use an effective method of contraception to avoid becoming pregnant.

You should not breast-feed during treatment with Baraclude. Tell your doctor if you are breast- feeding. It is not known whether entecavir, the active ingredient in Baraclude, is excreted in human breast milk.

Driving and using machines

Dizziness, tiredness (fatigue) and sleepiness (somnolence) are common side effects which may impair your ability to drive and use machines. If you have any concerns consult your doctor.

Baraclude contains lactose

This medicinal product 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 BARACLUDE

Not all patients need to take the same dose of Baraclude.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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

Your dose will depend on:

whether you have been treated for HBV infection before, and what medicine you received.

whether you have kidney problems. Your doctor may prescribe a lower dose for you or instruct you to take it less often than once a day.

the condition of your liver.

For children and adolescents (from 2 to less than 18 years of age), your child's doctor will decide the right dose based on your child's weight. The Baraclude oral solution is recommended for patients weighing from 10 kg to 32.5 kg.Children weighing at least 32.6 kg may take the oral solution or the 0.5 mg tablet. All dosing will be taken once daily orally (by mouth). There are no recommendations for Baraclude in children less than 2 years of age or weighing less than 10 kg.

Your doctor will advise you on the dose that is right for you. Always take the dose recommended by your doctor to ensure that your medicine is fully effective and to reduce the development of resistance to treatment. Take Baraclude as long as your doctor has told you. Your doctor will tell you if and when you should stop the treatment.

Some patients must take Baraclude on an empty stomach (see Baraclude with food and drink in Section 2). If your doctor instructs you to take Baraclude on an empty stomach, empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal.

If you take more Baraclude than you should

Contact your doctor at once.

If you forget to take Baraclude

It is important that you do not miss any doses. If you miss a dose of Baraclude, take it as soon as possible, and then take your next scheduled dose at its regular time. If it is almost time for your next dose, do not take the missed dose. Wait and take the next dose at the regular time. Do not take a double dose to make up for a forgotten dose.

Do not stop Baraclude without your doctor’s advice

Some people get very serious hepatitis symptoms when they stop taking Baraclude. Tell your doctor immediately about any changes in symptoms that you notice 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 Baraclude have reported the following side effects:

common (at least 1 in 100 patients): headache, insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (sleepiness), vomiting, diarrhoea, nausea, dyspepsia (indigestion), and increased blood levels of liver enzymes.

uncommon (at least 1 in 1,000 patients): rash, hair loss. rare (at least 1 in 10,000 patients): severe allergic reaction.

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or. 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.How to store BARACLUDE

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 bottle, blister or carton after EXP.

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

Blister packs: do not store above 30°C. Store in the original carton.

Bottle packs: do not store above 25°C. Keep the bottle tightly closed.

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 Baraclude contains

The active substance is entecavir. Each film-coated tablet contains 0.5 mg entecavir.

The other ingredients are:

Tablet core: crospovidone, lactose monohydrate, magnesium stearate, cellulose microcrystalline and povidone.

Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171), and polysorbate 80 (E433).

What Baraclude looks like and contents of the pack

The film-coated tablets (tablets) are white to off-white and triangular-shaped. They are marked with “BMS” on one side and “1611” on the other. Baraclude 0.5 mg film-coated tablets are supplied in cartons containing 30 x 1 or 90 x 1 film-coated tablet (in unit-dose blisters) and in bottles containing 30 film-coated tablets.

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

BRISTOL-MYERS SQUIBB PHARMA EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

Manufacturer: Bristol-Myers Squibb S.r.l. Contrada Fontana del Ceraso 03012 Anagni (FR)

Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Belgique/België/Belgien

Lietuva

N.V. Bristol-Myers Squibb Belgium S.A.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

Tél/Tel: + 32 2 352 76 11

Tel: +370 52 369140

България

Luxembourg/Luxemburg

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. N.V. Bristol-Myers Squibb Belgium S.A.

Teл.: + 359 800 12 400

Tél/Tel: + 32 2 352 76 11

Česká republika

Magyarország

Bristol-Myers Squibb spol. s r.o.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

Tel: + 420 221 016 111

Tel.: + 36 1 301 9700

Danmark

Malta

Bristol-Myers Squibb

BRISTOL-MYERS SQUIBB S.R.L.

Tlf: + 45 45 93 05 06

Tel: + 39 06 50 39 61

Deutschland

Nederland

Bristol-Myers Squibb GmbH & Co. KGaA

Bristol-Myers Squibb B.V.

Tel: + 31 (0)30 300 2222

Eesti

Norge

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Bristol-Myers Squibb Norway Ltd

Tel: +372 640 1030

Tlf: + 47 67 55 53 50

Ελλάδα

Österreich

BRISTOL-MYERS SQUIBB A.E.

Bristol-Myers Squibb GesmbH

Τηλ: + 30 210 6074300

Tel: + 43 1 60 14 30

España

Polska

BRISTOL-MYERS SQUIBB, S.A.

BRISTOL-MYERS SQUIBB POLSKA SP. Z O.O.

Tel: + 34 91 456 53 00

Tel.: + 48 22 5796666

France

Portugal

Bristol-Myers Squibb SARL

Bristol-Myers Squibb Farmacêutica Portuguesa,

Tél: + 33 (0)810 410 500

S.A.

 

Tel: + 351 21 440 70 00

Hrvatska

România

Bristol-Myers Squibb spol. s r.o.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

TEL: +385 1 7100 030

Tel: + 40 (0)21 272 16 00

Ireland

Slovenija

Bristol-Myers Squibb Pharmaceuticals Ltd

Bristol-Myers Squibb spol. s r.o.

Tel: + 353 (1 800) 749 749

Tel: +386 1 2355 100

Ísland

Slovenská republika

Vistor hf.

Bristol-Myers Squibb spol. s r.o.

Sími: + 354 535 7000

Tel: + 421 2 59298411

Italia

Suomi/Finland

BRISTOL-MYERS SQUIBB S.R.L.

Oy Bristol-Myers Squibb (Finland) Ab

Tel: + 39 06 50 39 61

Puh/Tel: + 358 9 251 21 230

Κύπρος

Sverige

BRISTOL-MYERS SQUIBB A.E.

Bristol-Myers Squibb AB

Τηλ: + 357 800 92666

Tel: + 46 8 704 71 00

Latvija

United Kingdom

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Bristol-Myers Squibb Pharmaceuticals Ltd

Tel: +371 67708347

Tel: + 44 (0800) 731 1736

This leaflet was last revised in

Other sources of information

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

Package leaflet: Information for the user

Baraclude 1 mg film-coated tablets

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.

What is in this leaflet

1.What Baraclude is and what it is used for

2.What you need to know before you take Baraclude

3.How to take Baraclude

4.Possible side effects

5.How to store Baraclude

6.Contents of the pack and other information

1. What BARACLUDE is and what it is used for

Baraclude tablets are anti-viral medicines, used to treat chronic (long term) hepatitis B virus (HBV) infection in adults. Baraclude can be used in people whose liver is damaged but still functions

properly (compensated liver disease) and in people whose liver is damaged and does not function properly (decompensated liver disease).

Baraclude tablets are also used to treat chronic (long term) HBV infection in children and adolescents aged 2 years to less than 18 years. Baraclude can be used in children whose liver is

damaged but still functions properly (compensated liver disease).

Infection by the hepatitis B virus can lead to damage to the liver. Baraclude reduces the amount of virus in your body, and improves the condition of the liver.

2. What you need to know before you take BARACLUDE

Do not take Baraclude

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

Warning and precautions

Talk to your doctor or pharmacist before taking Baraclude

if you have ever had problems with your kidneys, tell your doctor. This is important because Baraclude is eliminated from your body through the kidneys and your dose or dosing schedule may need to be adjusted.

do not stop taking Baraclude without your doctor’s advice since your hepatitis may worsen after stopping treatment. When your treatment with Baraclude is stopped, your doctor will continue to monitor you and take blood tests for several months.

discuss with your doctor whether your liver functions properly and, if not, what the possible effects on your Baraclude treatment may be.

if you are also infected with HIV (human immunodeficiency virus) be sure to tell your doctor. You should not take Baraclude to treat your hepatitis B infection unless you are taking medicines for HIV at the same time, as the effectiveness of future HIV treatment may be reduced. Baraclude will not control your HIV infection.

taking Baraclude will not stop you from infecting other people with hepatitis B virus (HBV) through sexual contact or body fluids (including blood contamination). So, it is important to take appropriate precautions to prevent others from becoming infected with HBV. A vaccine is available to protect those at risk from becoming infected with HBV.

Baraclude belongs to a class of medicines that can cause lactic acidosis (excess of lactic acid in your blood) and enlargement of the liver. Symptoms such as nausea, vomiting and stomach 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, particularly if they are very overweight. Your doctor will monitor you regularly while you are receiving Baraclude.

if you have previously received treatment for chronic hepatitis B, please inform your doctor.

Children and adolescents

Baraclude should not be used for children below 2 years of age or weighing less than 10 kg.

Other medicines and Baraclude

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

Baraclude with food and drink

In most cases you may take Baraclude with or without food. However, if you have had a previous treatment with a medicine containing the active substance lamivudine you should consider the following. If you were switched over to Baraclude because the treatment with lamivudine was not successful, you should take Baraclude on an empty stomach once daily. If your liver disease is very advanced, your doctor will also instruct you to take Baraclude on an empty stomach. Empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal.

Pregnancy, breast-feeding and fertility

Tell your doctor if you are pregnant or planning to become pregnant. It has not been demonstrated that Baraclude is safe to use during pregnancy. Baraclude must not be used during pregnancy unless specifically directed by your doctor. It is important that women of childbearing age receiving treatment with Baraclude use an effective method of contraception to avoid becoming pregnant.

You should not breast-feed during treatment with Baraclude. Tell your doctor if you are breast- feeding. It is not known whether entecavir, the active ingredient in Baraclude, is excreted in human breast milk.

Driving and using machines

Dizziness, tiredness (fatigue) and sleepiness (somnolence) are common side effects which may impair your ability to drive and use machines. If you have any concerns consult your doctor.

Baraclude contains lactose

This medicinal product 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 BARACLUDE

Not all patients need to take the same dose of Baraclude.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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

Your dose will depend on:

whether you have been treated for HBV infection before, and what medicine you received.

whether you have kidney problems. Your doctor may prescribe a lower dose for you or instruct you to take it less often than once a day.

the condition of your liver.

For children and adolescents (from 2 to less than 18 years of age), Baraclude oral solution or Baraclude 0.5 mg tablets are available

Your doctor will advise you on the dose that is right for you. Always take the dose recommended by your doctor to ensure that your medicine is fully effective and to reduce the development of resistance to treatment. Take Baraclude as long as your doctor has told you. Your doctor will tell you if and when you should stop the treatment.

Some patients must take Baraclude on an empty stomach (see Baraclude with food and drink in Section 2). If your doctor instructs you to take Baraclude on an empty stomach, empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal.

If you take more Baraclude than you should

Contact your doctor at once.

If you forget to take Baraclude

It is important that you do not miss any doses. If you miss a dose of Baraclude, take it as soon as possible, and then take your next scheduled dose at its regular time. If it is almost time for your next dose, do not take the missed dose. Wait and take the next dose at the regular time. Do not take a double dose to make up for a forgotten dose.

Do not stop Baraclude without your doctor’s advice

Some people get very serious hepatitis symptoms when they stop taking Baraclude. Tell your doctor immediately about any changes in symptoms that you notice 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 Baraclude have reported the following side effects:

common (at least 1 in 100 patients): headache, insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (sleepiness), vomiting, diarrhoea, nausea, dyspepsia (indigestion), and increased blood levels of liver enzymes.

uncommon (at least 1 in 1,000 patients): rash, hair loss. rare (at least 1 in 10,000 patients): severe allergic reaction.

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or. 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. How to store BARACLUDE

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 bottle, blister or carton after EXP.

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

Blister packs: do not store above 30°C. Store in the original carton.

Bottle packs: do not store above 25°C. Keep the bottle tightly closed.

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 Baraclude contains

The active substance is entecavir. Each film-coated tablet contains 1 mg entecavir.

The other ingredients are:

Tablet core: crospovidone, lactose monohydrate, magnesium stearate, cellulose microcrystalline and povidone.

Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171), and iron oxide red.

What Baraclude looks like and contents of the pack

The film-coated tablets (tablets) are pink and triangular-shaped. They are marked with “BMS” on one side and “1612” on the other. Baraclude 1 mg film-coated tablets are supplied in cartons containing 30 x 1 or 90 x 1 film-coated tablet (in unit-dose blisters) and in bottles containing 30 film-coated tablets.

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

BRISTOL-MYERS SQUIBB PHARMA EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

Manufacturer: Bristol-Myers Squibb S.r.l. Contrada Fontana del Ceraso 03012 Anagni (FR)

Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Belgique/België/Belgien

Lietuva

N.V. Bristol-Myers Squibb Belgium S.A.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

Tél/Tel: + 32 2 352 76 11

Tel: +370 52 369140

България

Luxembourg/Luxemburg

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. N.V. Bristol-Myers Squibb Belgium S.A.

Teл.: + 359 800 12 400

Tél/Tel: + 32 2 352 76 11

Česká republika

Magyarország

Bristol-Myers Squibb spol. s r.o.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

Tel: + 420 221 016 111

Tel.: + 36 1 301 9700

Danmark

Malta

Bristol-Myers Squibb

BRISTOL-MYERS SQUIBB S.R.L.

Tlf: + 45 45 93 05 06

Tel: + 39 06 50 39 61

Deutschland

Nederland

Bristol-Myers Squibb GmbH & Co. KGaA

Bristol-Myers Squibb B.V.

Tel: + 31 (0)30 300 2222

Eesti

Norge

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Bristol-Myers Squibb Norway Ltd

Tel: +372 640 1030

Tlf: + 47 67 55 53 50

Ελλάδα

Österreich

BRISTOL-MYERS SQUIBB A.E.

Bristol-Myers Squibb GesmbH

Τηλ: + 30 210 6074300

Tel: + 43 1 60 14 30

España

Polska

BRISTOL-MYERS SQUIBB, S.A.

BRISTOL-MYERS SQUIBB POLSKA SP. Z O.O.

Tel: + 34 91 456 53 00

Tel.: + 48 22 5796666

France

Portugal

Bristol-Myers Squibb SARL

Bristol-Myers Squibb Farmacêutica Portuguesa,

Tél: + 33 (0)810 410 500

S.A.

 

Tel: + 351 21 440 70 00

Hrvatska

România

Bristol-Myers Squibb spol. s r.o.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

TEL: +385 1 7100 030

Tel: + 40 (0)21 272 16 00

Ireland

Slovenija

Bristol-Myers Squibb Pharmaceuticals Ltd

Bristol-Myers Squibb spol. s r.o.

Tel: + 353 (1 800) 749 749

Tel: +386 1 2355 100

Ísland

Slovenská republika

Vistor hf.

Bristol-Myers Squibb spol. s r.o.

Sími: + 354 535 7000

Tel: + 421 2 59298411

Italia

Suomi/Finland

BRISTOL-MYERS SQUIBB S.R.L.

Oy Bristol-Myers Squibb (Finland) Ab

Tel: + 39 06 50 39 61

Puh/Tel: + 358 9 251 21 230

Κύπρος

Sverige

BRISTOL-MYERS SQUIBB A.E.

Bristol-Myers Squibb AB

Τηλ: + 357 800 92666

Tel: + 46 8 704 71 00

Latvija

United Kingdom

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Bristol-Myers Squibb Pharmaceuticals Ltd

Tel: +371 67708347

Tel: + 44 (0800) 731 1736

This leaflet was last revised in

Other sources of information

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

Package leaflet: Information for the user

Baraclude 0.05 mg/ml oral solution

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.

What is in this leaflet

1.What Baraclude is and what it is used for

2.What you need to know before you take Baraclude

3.How to take Baraclude

4.Possible side effects

5.How to store Baraclude

6.Contents of the pack and other information

1. What BARACLUDE is and what it is used for

Baraclude oral solution is an anti-viral medicine, used to treat chronic (long term) hepatitis B virus (HBV) infection in adults. Baraclude can be used in people whose liver is damaged but still

functions properly (compensated liver disease) and in people whose liver is damaged and does not function properly (decompensated liver disease).

Baraclude oral solution is also used to treat chronic (long term) HBV infection in children and adolescents aged 2 years to less than 18 years. Baraclude can be used in children whose liver is

damaged but still functions properly (compensated liver disease).

Infection by the hepatitis B virus can lead to damage to the liver. Baraclude reduces the amount of virus in your body, and improves the condition of the liver.

2. What you need to know before you take BARACLUDE

Do not take Baraclude

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

Warning and precautions

Talk to your doctor or pharmacist before taking Baraclude

if you have ever had problems with your kidneys, tell your doctor. This is important because Baraclude is eliminated from your body through the kidneys and your dose or dosing schedule may need to be adjusted.

do not stop taking Baraclude without your doctor’s advice since your hepatitis may worsen after stopping treatment. When your treatment with Baraclude is stopped, your doctor will continue to monitor you and take blood tests for several months.

discuss with your doctor whether your liver functions properly and, if not, what the possible effects on your Baraclude treatment may be.

if you are also infected with HIV (human immunodeficiency virus) be sure to tell your doctor. You should not take Baraclude to treat your hepatitis B infection unless you are taking medicines for HIV at the same time, as the effectiveness of future HIV treatment may be reduced. Baraclude will not control your HIV infection.

taking Baraclude will not stop you from infecting other people with hepatitis B virus (HBV) through sexual contact or body fluids (including blood contamination). So, it is important to take appropriate precautions to prevent others from becoming infected with HBV. A vaccine is available to protect those at risk from becoming infected with HBV.

Baraclude belongs to a class of medicines that can cause lactic acidosis (excess of lactic acid in your blood) and enlargement of the liver. Symptoms such as nausea, vomiting and stomach 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, particularly if they are very overweight. Your doctor will monitor you regularly while you are receiving Baraclude.

if you have previously received treatment for chronic hepatits B, please inform your doctor.

Children and adolescents

Baraclude should not be used for children below 2 years of age or weighing less than 10 kg.

Other medicines and Baraclude

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

Baraclude with food and drink

In most cases you may take Baraclude with or without food. However, if you have had a previous treatment with a medicine containing the active substance lamivudine you should consider the following. If you were switched over to Baraclude because the treatment with lamivudine was not successful, you should take Baraclude on an empty stomach once daily. If your liver disease is very advanced, your doctor will also instruct you to take Baraclude on an empty stomach.Empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal.

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

Pregnancy, breast-feeding and fertility

Tell your doctor if you are pregnant or planning to become pregnant. It has not been demonstrated that Baraclude is safe to use during pregnancy. Baraclude must not be used during pregnancy unless specifically directed by your doctor. It is important that women of childbearing age receiving treatment with Baraclude use an effective method of contraception to avoid becoming pregnant.

You should not breast-feed during treatment with Baraclude. Tell your doctor if you are breast- feeding. It is not known whether entecavir, the active ingredient in Baraclude, is excreted in human breast milk.

Driving and using machines

Dizziness, tiredness (fatigue) and sleepiness (somnolence) are common side effects which may impair your ability to drive and use machines. If you have any concerns consult your doctor.

Baraclude contains maltitol, methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216)

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

This product contains methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216) that may cause allergic reactions (possibly delayed).

3. How to take BARACLUDE

Not all patients need to take the same dose of Baraclude.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

For adults the recommended dose is either 0.5 mg (10 ml) or 1 mg (20 ml) once daily orally (by mouth).

Your dose will depend on:

whether you have been treated for HBV infection before, and what medicine you received.

whether you have kidney problems. Your doctor may prescribe a lower dose for you or instruct you to take it less often than once a day.

the condition of your liver.

For children and adolescents (from 2 to less than 18 years of age), your child's doctor will decide the right dose based on your child's weight. The correct dose of Baraclude oral solution for children and adolescents is calculated by body weight and is taken once daily orally (by mouth) as shown below:

Body Weight

Recommended Once Daily Dose of Oral

Solution

 

10.0 - 14.1 kg

4.0 ml

14.2 - 15.8 kg

4.5 ml

15.9 - 17.4 kg

5.0 ml

17.5 - 19.1 kg

5.5 ml

19.2 - 20.8 kg

6.0 ml

20.9 - 22.5 kg

6.5 ml

22.6 - 24.1 kg

7.0 ml

24.2 - 25.8 kg

7.5 ml

25.9 - 27.5 kg

8.0 ml

27.6 - 29.1 kg

8.5 ml

29.2 - 30.8 kg

9.0 ml

30.9 - 32.5 kg

9.5 ml

At least 32.6 kg

10.0 ml

There are no dosing recommendations for Baraclude in children less than 2 years of age or weighing less than 10 kg.

Your doctor will advise you on the dose that is right for you. Always take the dose recommended by your doctor to ensure that your medicine is fully effective and to reduce the development of resistance to treatment. Take Baraclude as long as your doctor has told you. Your doctor will tell you if and when you should stop the treatment.

Baraclude oral solution is designed as a ready-to-use product. Do not dilute or mix this solution with water or anything else.

Baraclude oral solution comes with a measuring spoon with markings from 0.5 up to 10 milliliters. Use the spoon as follows:

1.Hold the spoon in a vertical (upright) position and fill it gradually to the mark corresponding to the prescribed dose. Holding the spoon with the volume marks facing you, check that it has been filled to the proper mark.

2.Swallow the medicine directly from the measuring spoon.

3.After each use, rinse the spoon with water and allow it to air dry.

Some patients must take Baraclude on an empty stomach (see Baraclude with food and drink in Section 2). If your doctor instructs you to take Baraclude on an empty stomach, empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal.

If you take more Baraclude than you should

Contact your doctor at once.

If you forget to take Baraclude

It is important that you do not miss any doses. If you miss a dose of Baraclude, take it as soon as possible, and then take your next scheduled dose at its regular time. If it is almost time for your next dose, do not take the missed dose. Wait and take the next dose at the regular time. Do not take a double dose to make up for a forgotten dose.

Do not stop Baraclude without your doctor’s advice

Some people get very serious hepatitis symptoms when they stop taking Baraclude. Tell your doctor immediately about any changes in symptoms that you notice 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 Baraclude have reported the following side effects:

common (at least 1 in 100 patients): headache, insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (sleepiness), vomiting, diarrhoea, nausea, dyspepsia (indigestion), and increased blood levels of liver enzymes.

uncommon (at least 1 in 1,000 patients): rash, hair loss. rare (at least 1 in 10,000 patients): severe allergic reaction.

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or. 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. How to store BARACLUDE

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on bottle or carton after EXP. That expiry date refers to the last day of that month.

Do not store above 30°C. Keep the bottle in the outer carton in order to protect from light.

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 Baraclude contains

The active substance is entecavir. Each ml of oral solution contains 0.05 mg entecavir.

The other ingredients are: citric acid anhydrous, maltitol (E965), methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), orange flavour (acacia and natural flavours), sodium citrate, sodium hydroxide, hydrochloric acid and purified water.

What Baraclude looks like and contents of the pack

The oral solution is a clear, colorless to pale yellow solution. Baraclude 0.05 mg/ml oral solution is supplied in a bottle containing 210 ml oral solution. Each carton includes a measuring spoon (polypropylene) with markings from 0.5 ml up to 10 ml

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

BRISTOL-MYERS SQUIBB PHARMA EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

Manufacturer: Bristol-Myers Squibb S.r.l. Contrada Fontana del Ceraso 03012 Anagni (FR)

Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Belgique/België/Belgien

Lietuva

N.V. Bristol-Myers Squibb Belgium S.A.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

Tél/Tel: + 32 2 352 76 11

Tel: +370 52 369140

България

Luxembourg/Luxemburg

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. N.V. Bristol-Myers Squibb Belgium S.A.

Teл.: + 359 800 12 400

Tél/Tel: + 32 2 352 76 11

Česká republika

Magyarország

Bristol-Myers Squibb spol. s r.o.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

Tel: + 420 221 016 111

Tel.: + 36 1 301 9700

Danmark

Malta

Bristol-Myers Squibb

BRISTOL-MYERS SQUIBB S.R.L.

Tlf: + 45 45 93 05 06

Tel: + 39 06 50 39 61

Deutschland

Nederland

Bristol-Myers Squibb GmbH & Co. KGaA

Bristol-Myers Squibb B.V.

Tel: + 31 (0)30 300 2222

Eesti

Norge

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Bristol-Myers Squibb Norway Ltd

Tel: +372 640 1030

Tlf: + 47 67 55 53 50

Ελλάδα

Österreich

BRISTOL-MYERS SQUIBB A.E.

Bristol-Myers Squibb GesmbH

Τηλ: + 30 210 6074300

Tel: + 43 1 60 14 30

España

Polska

BRISTOL-MYERS SQUIBB, S.A.

BRISTOL-MYERS SQUIBB POLSKA SP. Z O.O.

Tel: + 34 91 456 53 00

Tel.: + 48 22 5796666

France

Portugal

Bristol-Myers Squibb SARL

Bristol-Myers Squibb Farmacêutica Portuguesa,

Tél: + 33 (0)810 410 500

S.A.

 

Tel: + 351 21 440 70 00

Hrvatska

România

Bristol-Myers Squibb spol. s r.o.

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft.

TEL: +385 1 7100 030

Tel: + 40 (0)21 272 16 00

Ireland

Slovenija

Bristol-Myers Squibb Pharmaceuticals Ltd

Bristol-Myers Squibb spol. s r.o.

Tel: + 353 (1 800) 749 749

Tel: +386 1 2355 100

Ísland

Slovenská republika

Vistor hf.

Bristol-Myers Squibb spol. s r.o.

Sími: + 354 535 7000

Tel: + 421 2 59298411

Italia

Suomi/Finland

BRISTOL-MYERS SQUIBB S.R.L.

Oy Bristol-Myers Squibb (Finland) Ab

Tel: + 39 06 50 39 61

Puh/Tel: + 358 9 251 21 230

Κύπρος

Sverige

BRISTOL-MYERS SQUIBB A.E.

Bristol-Myers Squibb AB

Τηλ: + 357 800 92666

Tel: + 46 8 704 71 00

Latvija

United Kingdom

Bristol-Myers Squibb Gyógyszerkereskedelmi Kft. Bristol-Myers Squibb Pharmaceuticals Ltd

Tel: +371 67708347

Tel: + 44 (0800) 731 1736

The measuring spoon is manufactured by: Comar Plastics Division, One Comar Place, Buena, NJ 08310, USA.

Authorised Representative in the EEA for Comar Plastics: MDSS, Burckhardstrasse 1, 30163 Hannover, Germany

This leaflet was last revised in

Other sources of information

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

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