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Sebivo (telbivudine) – Package leaflet - J05AF11

Updated on site: 10-Oct-2017

Medication nameSebivo
ATC CodeJ05AF11
Substancetelbivudine
ManufacturerNovartis Europharm Limited

Package leaflet: Information for the user

Sebivo 600 mg film-coated tablets

Telbivudine

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 Sebivo is and what it is used for

2.What you need to know before you take Sebivo

3.How to take Sebivo

4.Possible side effects

5.How to store Sebivo

6.Contents of the pack and other information

1.What Sebivo is and what it is used for

Sebivo contains the active substance telbivudine. Sebivo belongs to a group of medicines called antiviral medicines, which are used to treat infections caused by viruses.

Sebivo is used to treat adults with chronic hepatitis B. Starting treatment with Sebivo should only be considered when it is not possible or appropriate to use an alternative medicine to which the hepatitis B virus is less likely to develop resistance. Your doctor will decide which treatment is most appropriate for you.

Hepatitis B is caused by infection with the hepatitis B virus, which multiplies in the liver and causes liver damage. Treatment with Sebivo reduces the amount of hepatitis B virus in the body by blocking its growth, resulting in less liver damage and improved liver function.

2. What you need to know before you take Sebivo

Do not take Sebivo

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

-if you are being treated with pegylated or standard interferon alfa (see “Taking other

medicines”).

If this applies to you, do not take Sebivo. Talk to your doctor.

Warnings and precautions

Talk to your doctor before taking Sebivo:

-if you have or have had any kidney problems. Your doctor may order laboratory tests to check your kidneys are working properly before and during treatment. Depending on the results of these tests your doctor may advise you to change how often you take Sebivo.

-if you suffer from cirrhosis of the liver (a serious condition which causes liver “scarring”). In this case your doctor will want to monitor you more closely.

-if you have had a liver transplant.

-if you are taking any medicines that may cause muscle problems (talk to your doctor or pharmacist if you are unsure).

-if you are infected with HIV, hepatitis C or D, or are being treated with any antiviral medicines. If any of these applies to you, tell your doctor before you take Sebivo.

During the treatment with Sebivo:

-Sebivo can cause persistent unexplained muscle weakness or muscle pain (myopathy). Muscle symptoms may progress and become serious, sometimes leading to muscle breakdown (rhabdomyolysis) which can cause kidney damage.

-Uncommonly Sebivo can induce numbness, tingling, pain and/or burning sensations in the arms

and/or legs (peripheral neuropathy).

If you experience any of these symptoms during your treatment with Sebivo, call your doctor immediately.

Other side effects of this type of medicine

Sebivo can cause an excess of lactic acid in the blood (lactic acidosis) which is usually associated with an enlargement of the liver (hepatomegaly). Lactic acidosis is a rare but serious side effect which can occasionally be fatal. Your doctor will monitor you regularly while you are receiving Sebivo. If you experience muscle pain, severe and persistent stomach pain with nausea and vomiting, severe and persistent trouble breathing, tiredness or abdominal discomfort while taking Sebivo, call your doctor immediately.

Some people may get very serious hepatitis symptoms when they stop taking medicines like Sebivo. Your doctor will monitor your health and do regular blood tests to check your liver after you stop treatment with Sebivo. Tell your doctor immediately about any new or unusual symptoms that you notice after stopping treatment (see “If you stop taking Sebivo” in section 3 of this leaflet).

Take care not to infect other people

Even if you take Sebivo, you may still infect others with hepatitis B virus (HBV) through sexual contact or exposure to contaminated blood or other body fluids. If you have sexual intercourse with a partner who is not immune against hepatitis B, always use condoms and avoid any other exchange of body fluids. Never share needles. Do not share personal items that could have blood or body fluids on them, such as toothbrushes or razor blades. A vaccine is available to prevent infection with HBV.

Children and adolescents

Sebivo is not recommended for use in children and adolescents.

Other medicines and Sebivo

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

Your doctor or pharmacist needs to know about other medicines because some medicines could affect your kidneys and because Sebivo mainly leaves the body via the kidneys in the urine.

Do not take Sebivo if you are using pegylated or standard interferon alfa (see “Do not take Sebivo”), because the combination of these medicines may increase your risk of developing peripheral neuropathy (numbness, tingling, and/or burning sensations in the arms and/or legs). Tell your doctor or pharmacist if you are being treated with interferon.

Pregnancy and breast-feeding

-Do not use Sebivo during pregnancy unless your doctor recommends it. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will discuss with you the potential risks of taking Sebivo during pregnancy.

-If you have hepatitis B and become pregnant, talk to your doctor about how you can best protect your baby. Sebivo may reduce the risk of passing your hepatitis B virus on to your unborn baby if taken in combination with Hepatitis B immune globulin and Hepatitis B vaccine.

-Do not breast-feed during treatment with Sebivo. Tell your doctor if you are breast- feeding.

Driving and using machines

Sebivo has minor influence on the ability to drive and use machines. If you feel dizzy while taking this medicine, do not drive a vehicle or use any tools or machines.

3.How to take Sebivo

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

How much Sebivo to take

The recommended dose of Sebivo is one 600 mg tablet once a day. Take the tablet at about the same time each day.

The tablet can be taken with or without food. Swallow it whole with some water. Do not chew, split or crush it.

You may need to take Sebivo less frequently if you have kidney problems. Tell your doctor if you have, or have ever had, any kidney problems.

How long to take Sebivo

Continue taking Sebivo every day for as long as your doctor tells you. Do not change your dose or stop taking Sebivo without talking to your doctor. This medicine is intended for long-term treatment, possibly lasting for months or years. Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.

If you take more Sebivo than you should

If you have taken too much Sebivo, or if someone else accidentally takes your tablets, go to your doctor or hospital for advice straight away. Take the pack of tablets with you and show it to your doctor.

If you forget to take Sebivo

-If you forget to take Sebivo, take it as soon as you remember and then take your next dose at its regular time.

-However, if it is within 4 hours before your next dose, skip the dose you missed and take the next one at the usual time.

Do not take a double dose to make up for a forgotten tablet. This may increase the chance of you getting unwanted side effects. Ask your doctor or pharmacist if you are not sure what to do.

If you stop taking Sebivo

Stopping treatment with Sebivo may result in a worsening of your hepatitis B infection i.e. progression of the disease and abnormal test results (increase of viral load, ALT increase). Do not stop Sebivo unless your doctor tells you to. While you are taking Sebivo, make sure you do not run out of Sebivo.

Your doctor will monitor your health and do regular blood tests to check your liver after you stop treatment with Sebivo since your hepatitis B infection may get worse or become very serious after stopping treatment. Tell your doctor immediately about any new or unusual 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.

Some side effects could be serious:

-Persistent muscle weakness or muscle pain

-Numbness, tingling, pain and/or burning sensation in the arms and/or legs If you experience any of these, call your doctor immediately.

Sebivo may also cause other side effects:

Common (may affect up to 1 in 10 people)

-Dizziness, headache

-Cough

-Diarrhoea, feeling sick (nausea), stomach (abdominal) pain

-Skin rash

-Tiredness (fatigue)

-Blood test results show higher levels of some liver enzymes (e.g. ALT, AST), amylase, lipase or creatine kinase

Uncommon (may affect up to 1 in 100 people)

-Joint pain

-Persistent muscle weakness or muscle pain (myopathy/myositis), muscle cramp

-Back, neck and flank pain

-Numbness, tingling, pain and/or burning sensation in the arms and/or legs or around the mouth

-Pain in lower back or hip that may radiate into the leg (sciatica)

-Taste disturbance

-Feeling unwell (malaise)

Rare (may affect up to 1 in 1,000 people)

-Excess of lactic acid in the blood (lactic acidosis)

-Muscle breakdown (rhabdomyolysis)

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.How to store Sebivo

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.

This medicinal product does not require any special storage conditions.

Do not use this medicine if the pack is damaged or shows signs of tampering.

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 to protect the environment.

6. Contents of the pack and other information

What Sebivo contains

-The active substance is telbivudine. Each tablet contains 600 mg telbivudine.

-The other ingredients are: cellulose, microcrystalline; povidone; sodium starch glycolate; silica, colloidal anhydrous; magnesium stearate; hypromellose; titanium dioxide (E171); talc; macrogol.

What Sebivo looks like and contents of the pack

Sebivo film-coated tablets are white to slightly yellowish, oval, film-coated tablets with “LDT” imprinted on one side.

Sebivo film-coated tablets are supplied in packs of 28 or 98 tablets. Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

Manufacturer

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

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

België/Belgique/Belgien

Lietuva

Novartis Pharma N.V.

Novartis Pharma Services Inc.

Tél/Tel: +32 2 246 16 11

Tel: +370 5 269 16 50

България

Luxembourg/Luxemburg

Novartis Pharma Services Inc.

Novartis Pharma N.V.

Тел.: +359 2 489 98 28

Tél/Tel: +32 2 246 16 11

Česká republika

Magyarország

Novartis s.r.o.

Novartis Hungária Kft. Pharma

Tel: +420 225 775 111

Tel.: +36 1 457 65 00

Danmark

Malta

Novartis Healthcare A/S

Novartis Pharma Services Inc.

Tlf: +45 39 16 84 00

Tel: +356 2122 2872

Deutschland

Nederland

Novartis Pharma GmbH

Novartis Pharma B.V.

Tel: +49 911 273 0

Tel: +31 26 37 82 111

Eesti

Norge

Novartis Pharma Services Inc.

Novartis Norge AS

Tel: +372 66 30 810

Tlf: +47 23 05 20 00

Ελλάδα

Österreich

Novartis (Hellas) A.E.B.E.

Novartis Pharma GmbH

Τηλ: +30 210 281 17 12

Tel: +43 1 86 6570

España

Polska

Novartis Farmacéutica, S.A.

Novartis Poland Sp. z o.o.

Tel: +34 93 306 42 00

Tel.: +48 22 375 4888

France

Portugal

Novartis Pharma S.A.S.

Novartis Farma - Produtos Farmacêuticos, S.A.

Tél: +33 1 55 47 66 00

Tel: +351 21 000 8600

Hrvatska

România

Novartis Hrvatska d.o.o.

Novartis Pharma Services Romania SRL

Tel. +385 1 6274 220

Tel: +40 21 31299 01

Ireland

Slovenija

Novartis Ireland Limited

Novartis Pharma Services Inc.

Tel: +353 1 260 12 55

Tel: +386 1 300 75 50

Ísland

Slovenská republika

Vistor hf.

Novartis Slovakia s.r.o.

Sími: +354 535 7000

Tel: +421 2 5542 5439

Italia

Suomi/Finland

Novartis Farma S.p.A.

Novartis Finland Oy

Tel: +39 02 96 54 1

Puh/Tel: +358 (0)10 6133 200

Κύπρος

Sverige

Novartis Pharma Services Inc.

Novartis Sverige AB

Τηλ: +357 22 690 690

Tel: +46 8 732 32 00

Latvija

United Kingdom

Novartis Pharma Services Inc.

Novartis Pharmaceuticals UK Ltd.

Tel: +371 67 887 070

Tel: +44 1276 698370

This leaflet was last revised in

Other sources of information

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

Package leaflet: Information for the user

Sebivo 20 mg/ml oral solution

Telbivudine

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 Sebivo is and what it is used for

2.What you need to know before you take Sebivo

3.How to take Sebivo

4.Possible side effects

5.How to store Sebivo

6.Contents of the pack and other information

1. What Sebivo is and what it is used for

Sebivo contains the active substance telbivudine. Sebivo belongs to a group of medicines called antiviral medicines, which are used to treat infections caused by viruses.

Sebivo is used to treat adults with chronic hepatitis B. Starting treatment with Sebivo should only be considered when it is not possible or appropriate to use an alternative medicine to which the hepatitis B virus is less likely to develop resistance. Your doctor will decide which treatment is most appropriate for you.

Hepatitis B is caused by infection with the hepatitis B virus, which multiplies in the liver and causes liver damage. Treatment with Sebivo reduces the amount of hepatitis B virus in the body by blocking its growth, resulting in less liver damage and improved liver function.

2. What you need to know before you take Sebivo

Do not take Sebivo

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

-if you are being treated with pegylated or standard interferon alfa (see “Taking other

medicines”).

If this applies to you, do not take Sebivo. Talk to your doctor.

Warnings and precautions

Talk to your doctor before taking Sebivo:

-if you have or have had any kidney problems. Your doctor may order laboratory tests to check your kidneys are working properly before and during treatment. Depending on the results of these tests your doctor may advise you to change how often you take Sebivo.

-if you suffer from cirrhosis of the liver (a serious condition which causes liver “scarring”). In this case your doctor will want to monitor you more closely.

-if you have had a liver transplant.

-if you are taking any medicines that may cause muscle problems (talk to your doctor or pharmacist if you are unsure).

-if you are infected with HIV, hepatitis C or D, or are being treated with any antiviral medicines. If any of these applies to you, tell your doctor before you take Sebivo.

During the treatment with Sebivo:

-Sebivo can cause persistent unexplained muscle weakness or muscle pain (myopathy). Muscle symptoms may progress and become serious, sometimes leading to muscle breakdown (rhabdomyolysis) which can cause kidney damage.

-Uncommonly Sebivo can induce numbness, tingling, pain and/or burning sensations in the arms

and/or legs (peripheral neuropathy).

If you experience any of these symptoms during your treatment with Sebivo, call your doctor immediately.

Other side effects of this type of medicine

Sebivo can cause an excess of lactic acid in the blood (lactic acidosis) which is usually associated with an enlargement of the liver (hepatomegaly). Lactic acidosis is a rare but serious side effect which can occasionally be fatal. Your doctor will monitor you regularly while you are receiving Sebivo. If you experience muscle pain, severe and persistent stomach pain with nausea and vomiting, severe and persistent trouble breathing, tiredness or abdominal discomfort while taking Sebivo, call your doctor immediately.

Some people may get very serious hepatitis symptoms when they stop taking medicines like Sebivo. Your doctor will monitor your health and do regular blood tests to check your liver after you stop treatment with Sebivo. Tell your doctor immediately about any new or unusual symptoms that you notice after stopping treatment (see “If you stop taking Sebivo” in section 3 of this leaflet).

Take care not to infect other people

Even if you take Sebivo, you may still infect others with hepatitis B virus (HBV) through sexual contact or exposure to contaminated blood or other body fluids. If you have sexual intercourse with a partner who is not immune against hepatitis B, always use condoms and avoid any other exchange of body fluids. Never share needles. Do not share personal items that could have blood or body fluids on them, such as toothbrushes or razor blades. A vaccine is available to prevent infection with HBV.

Children and adolescents

Sebivo is not recommended for use in children and adolescents.

Other medicines and Sebivo

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

Your doctor or pharmacist needs to know about other medicines because some medicines could affect your kidneys and because Sebivo mainly leaves the body via the kidneys in the urine.

Do not take Sebivo if you are using pegylated or standard interferon alfa (see “Do not take Sebivo”), because the combination of these medicines may increase your risk of developing peripheral neuropathy (numbness, tingling, and/or burning sensations in the arms and/or legs). Tell your doctor or pharmacist if you are being treated with interferon.

Pregnancy and breast-feeding

-Do not use Sebivo during pregnancy unless your doctor recommends it. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will discuss with you the potential risks of taking Sebivo during pregnancy.

-If you have hepatitis B and become pregnant, talk to your doctor about how you can best protect your baby. Sebivo may reduce the risk of passing your hepatitis B virus on to your unborn baby if taken in combination with Hepatitis B immune globulin and Hepatitis B vaccine.

-Do not breast-feed during treatment with Sebivo. Tell your doctor if you are breast- feeding.

Driving and using machines

Sebivo has minor influence on the ability to drive and use machines. If you feel dizzy while taking this medicine, do not drive a vehicle or use any tools or machines.

Sebivo contains sodium

Sebivo oral solution contains approximately 47 mg of sodium per 600 mg dose (30 ml). If you are on a controlled sodium diet, ask your doctor for advice.

3. How to take Sebivo

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

How much Sebivo to take

The recommended dose of Sebivo is 30 ml of oral solution (600 mg telbivudine) once a day. Take Sebivo at about the same time each day. It can be taken with or without food.

For full instructions on how to take Sebivo, see section “Instructions for use” at the end of this leaflet.

Remove the dosing cup and open the bottle. Slowly and carefully pour the solution from the bottle into the dosing cup until it reaches the prescribed amount. Swallow the entire contents of the dosing cup immediately.

If you cannot measure the prescribed amount precisely using the dosing cup alone, you should use the oral syringe. Detailed instructions on how to use this are given in the section “Instructions for use”.

Your dose may be reduced if you have kidney problems. Tell your doctor if you have, or have ever had, any kidney problems.

How long to take Sebivo

Continue taking Sebivo every day for as long as your doctor tells you. Do not change your dose or stop taking Sebivo without talking to your doctor. This medicine is intended for long-term treatment, possibly lasting for months or years. Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.

If you take more Sebivo than you should

If you have taken too much Sebivo, or if someone else accidentally takes your oral solution, go to your doctor or hospital for advice straight away. Take the pack with you and show it to the doctor.

If you forget to take Sebivo

-If you forget to take Sebivo, take it as soon as you remember and then take your next dose at its regular time.

-However, if it is within 4 hours before your next dose, skip the dose you missed and take the next one at the usual time.

Do not take a double dose to make up for a forgotten dose. This may increase the chance of you getting unwanted side effects. Ask your doctor or pharmacist if you are not sure what to do.

If you stop taking Sebivo

Stopping treatment with Sebivo may result in a worsening of your hepatitis B infection i.e. progression of the disease and abnormal test results (increase of viral load, ALT increase). Do not stop Sebivo unless your doctor tells you to. While you are taking Sebivo, make sure you do not run out of Sebivo.

Your doctor will monitor your health and do regular blood tests to check your liver after you stop treatment with Sebivo since your hepatitis B infection may get worse or become very serious after stopping treatment. Tell your doctor immediately about any new or unusual 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.

Some side effects could be serious:

-Persistent muscle weakness or muscle pain

-Numbness, tingling, pain and/or burning sensation in the arms and/or legs If you experience any of these, call your doctor immediately.

Sebivo may also cause other side effects:

Common (may affect up to 1 in 10 people)

-Dizziness, headache

-Cough

-Diarrhoea, feeling sick (nausea), stomach (abdominal) pain

-Skin rash

-Tiredness (fatigue)

-Blood test results show higher levels of some liver enzymes (e.g. ALT, AST), amylase, lipase or creatine kinase

Uncommon (may affect up to 1 in 100 people)

-Joint pain

-Persistent muscle weakness or muscle pain (myopathy/myositis), muscle cramp

-Back, neck and flank pain

-Numbness, tingling, pain and/or burning sensation in the arms and/or legs or around the mouth

-Pain in lower back or hip that may radiate into the leg (sciatica)

-Taste disturbance

-Feeling unwell (malaise)

Rare (may affect up to 1 in 1,000 people)

-Excess of lactic acid in the blood (lactic acidosis)

-Muscle breakdown (rhabdomyolysis)

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. How to store Sebivo

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

Do not store above 30 C. Do not freeze.

Use within 2 months of opening the bottle.

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 to protect the environment.

6. Contents of the pack and other information

What Sebivo contains

-The active substance is telbivudine. 30 ml oral solution contain 600 mg telbivudine.

-The other ingredients are: benzoic acid, sodium saccharin, passion fruit flavouring, sodium hydroxide, citrc acid anhydrous, water.

What Sebivo looks like and contents of the pack

Sebivo 20 mg/ml oral solution is supplied as 300 ml of a clear, colourless to pale yellow solution in an brown glass bottle with a child-resistant white polypropylene closure, including a polyethylene sealing disc and a guarantee ring. The pack contains an oral dosing cup made of polypropylene with embossed graduations from 5 to 30 ml in 5 ml increments and a polypropylene oral syringe with graduations of 1 ml to 10 ml in 0.5 ml increments.

Marketing Authorisation Holder

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

Manufacturer

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

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

België/Belgique/Belgien

Lietuva

Novartis Pharma N.V.

Novartis Pharma Services Inc.

Tél/Tel: +32 2 246 16 11

Tel: +370 5 269 16 50

България

Luxembourg/Luxemburg

Novartis Pharma Services Inc.

Novartis Pharma N.V.

Тел.: +359 2 489 98 28

Tél/Tel: +32 2 246 16 11

Česká republika

Magyarország

Novartis s.r.o.

Novartis Hungária Kft. Pharma

Tel: +420 225 775 111

Tel.: +36 1 457 65 00

Danmark

Malta

Novartis Healthcare A/S

Novartis Pharma Services Inc.

Tlf: +45 39 16 84 00

Tel: +356 2122 2872

Deutschland

Nederland

Novartis Pharma GmbH

Novartis Pharma B.V.

Tel: +49 911 273 0

Tel: +31 26 37 82 111

Eesti

Norge

Novartis Pharma Services Inc.

Novartis Norge AS

Tel: +372 66 30 810

Tlf: +47 23 05 20 00

Ελλάδα

Österreich

Novartis (Hellas) A.E.B.E.

Novartis Pharma GmbH

Τηλ: +30 210 281 17 12

Tel: +43 1 86 6570

España

Polska

Novartis Farmacéutica, S.A.

Novartis Poland Sp. z o.o.

Tel: +34 93 306 42 00

Tel.: +48 22 375 4888

France

Portugal

Novartis Pharma S.A.S.

Novartis Farma - Produtos Farmacêuticos, S.A.

Tél: +33 1 55 47 66 00

Tel: +351 21 000 8600

Hrvatska

România

Novartis Hrvatska d.o.o.

Novartis Pharma Services Romania SRL

Tel. +385 1 6274 220

Tel: +40 21 31299 01

Ireland

Slovenija

Novartis Ireland Limited

Novartis Pharma Services Inc.

Tel: +353 1 260 12 55

Tel: +386 1 300 75 50

Ísland

Slovenská republika

Vistor hf.

Novartis Slovakia s.r.o.

Sími: +354 535 7000

Tel: +421 2 5542 5439

Italia

Suomi/Finland

Novartis Farma S.p.A.

Novartis Finland Oy

Tel: +39 02 96 54 1

Puh/Tel: +358 (0)10 6133 200

Κύπρος

Sverige

Novartis Pharma Services Inc.

Novartis Sverige AB

Τηλ: +357 22 690 690

Tel: +46 8 732 32 00

Latvija

United Kingdom

Novartis Pharma Services Inc.

Novartis Pharmaceuticals UK Ltd.

Tel: +371 67 887 070

Tel: +44 1276 698370

This leaflet was last revised in

Other sources of information

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

INSTRUCTIONS FOR USE

Please read these instructions carefully so that you know how to use the solution correctly.

1.Bottle containing the oral solution.

2.Child-resistant screw cap with a guarantee-ring. Always close the bottle with the cap after use.

3.Oral dosing cup for measuring out the dose. Always put the dosing cup back onto the cap after use and cleaning.

4.Oral syringe for measuring out doses that cannot be precisely measured using the cup.

Preparing a dose of medicine using the dosing cup

1.Remove the dosing cup.

2.Simultaneously press down (2a) and turn the child-resistant cap (2b) to the left to open the bottle.

3.Before pouring any solution into the cup, please check the position of the appropriate graduation to avoid any potential waste or spillage.

Holding the cup at eye level, carefully and slowly pour the prescribed amount of solution from the bottle into the dosing cup until the solution reaches the top of the appropriate graduation.

Note: If the amount poured into the cup exceeds the required dose, discard the excess in the sink. Do not pour it back into the bottle.

4.Drink the solution or administer it to the patient immediately.

5.Close the bottle by screwing the cap back on tightly.

6.Immediately rinse the dosing cup with water.

7.Remove the water from the dosing cup, wipe it with a clean tissue and place it back on top of the cap.

Preparing a 6 ml dose of medicine using the oral syringe

1.Remove the dosing cup.

2.Simultaneously press down (2a) and turn the child- resistant cap (2b) to the left to open the bottle.

3.Before pouring any solution into the cup, please check the position of the 5 and 10 ml marks to avoid any potential waste or spillage.

Holding the cup at eye level, carefully and slowly pour the solution from the bottle into the cup until it comes to about halfway between the 5 ml and 10 ml marks.

4.Withdraw all the solution from the cup into the syringe.

5.Turn the syringe to the upright position and incline it slightly so that the air bubbles rise to the top.

6.Push the plunger carefully and slowly to remove the air until a droplet of solution appears.

7.Hold the syringe above the cup.

8.Push the plunger slowly and carefully until the solution reaches the 6 ml mark.

9.Immediately swallow the solution direct from the syringe.

10.Discard the solution left in the cup into the sink. Do not pour it back into the bottle as this could cause contamination.

11.Close the bottle firmly.

12.Rinse the cup and syringe with clean water.

13.Dry the cup with a clean tissue and place it back over the cap of the bottle.

14.Allow the syringe to air-dry and store with the bottle.

ANNEX IV

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS

OF THE MARKETING AUTHORISATION

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR for telbivudine, the scientific conclusions of CHMP are as follows:

Based on a cumulative review submitted by the MAH with this PSUR, a total of 96 cases of lactic acidosis were reported with telbivudine, including 54 cases as a secondary event of a serious underlying condition, such as rhabdomyolysis or myopathy and 26 cases with no evident primary cause, although CPK elevation were often associated. Moreover, one literature case report of severe refractory lactic acidosis was reported during the review period in a patient receiving telbivudine monotherapy and for whom no underlying serious condition was reported. In cumulative, seven fatal cases of lactic acidosis were recorded including six cases where lactic acidosis was reported as a symptom or secondary to rhabdomyolysis. Overall, it is acknowledged that it remains difficult to clearly conclude whether lactic acidosis causes muscle events or lactic acidosis follows muscular damage.

Based on the available evidence, the PRAC considered that the telbivudine SmPC should be updated to reinforce the current warning in section 4.4 of the SmPC on lactic acidosis, notably by highlighting the potential fatal outcome of telbivudine-induced lactic acidosis in a context of rhabdomyolysis and to delete the current information in section 4.8 of the SmPC that lactic acidosis has been reported with telbivudine exclusively as a secondary event (since it is not always the case).

Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing telbivudine were warranted.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the Marketing Authorisation

On the basis of the scientific conclusions for telbivudine the CHMP is of the opinion that the benefit-risk balance of the medicinal product containing telbivudine is unchanged subject to the proposed changes to the product information.

The CHMP recommends that the terms of the Marketing Authorisation should be varied.

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