Sebivo 20 mg/ml oral solution

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.

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.

Do not take Sebivo

• if you are allergic (hypersensitive) to telbivudine or any of the other ingredients of Sebivo (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. If you think you may be allergic, ask your doctor for advice.

Take special care with 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.
• 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 cause 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 effects of this type of medicine
Sebivo belongs to a class of medicines (a nucleoside analogue) that can cause an excess of lactic acid in the blood (lactic acidosis) and enlargement of the liver (hepatomegaly) with fatty liver (steatosis). Lactic acidosis is a rare but serious side effect which can occasionally be fatal. Lactic acidosis occurs more often in women, particularly if they are very overweight. 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 and tiredness 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
Sebivo does not reduce the risk of infecting others with hepatitis B virus (HBV) through sexual contact or exposure to contaminated blood or other 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.

Use in children
Sebivo is not recommended for use in children under 16 years of age.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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.

Taking Sebivo with food and drink
You can take Sebivo with or without food.

Pregnancy and breast-feeding

• Do not use Sebivo during pregnancy unless your doctor recommends it. If you are pregnant or think you may be, tell your doctor before taking Sebivo. 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. It is not known whether Sebivo reduces the risk of passing your hepatitis B virus on to your unborn baby.
• Do not breast-feed during treatment with Sebivo. Tell your doctor if you are breast-feeding.

Important information about some of the ingredients of Sebivo

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.

Always take Sebivo exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much Sebivo to take

The usual 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

Do not change your dose or stop taking Sebivo without talking to your doctor. Take Sebivo every day and continue your treatment exactly as prescribed unless your doctor says otherwise. Your doctor will make regular checks to make sure that Sebivo is working. Your hepatitis B symptoms may get worse or become very serious if you stop taking Sebivo.

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 almost time for 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. 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.

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

The frequencies are defined as very common affects more than 1 patient in 10 common uncommon rare very rare not known affects 1 to 10 patients in 100 affects 1 to 10 patients in 1,000 affects 1 to 10 patients in 10,000 affects less than 1 patient in 10,000 frequency cannot be estimated from the available data.

Some uncommon 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 side effects

• Dizziness, headache
• Cough
• Diarrhoea, feeling sick (nausea), stomach (abdominal) pain
• Skin rash
• Tiredness (fatigue)
• Blood test results show higher levels of liver enzymes, amylase, lipase or creatine kinase

Uncommon side effects

• 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
• Sciatica (pain in lower back or hip and may radiate into the leg)
• Taste disturbance
• Feeling unwell (malaise)

Frequency not known
Excess of lactic acid in the blood (lactic acidosis) and muscle breakdown (rhabdomyolysis) have been reported.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Sebivo 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.

Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom

Manufacturer

Novartis Pharma S.A.S.
26, rue de la Chapelle
F-68330 Huningue
France

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

BelgiëBelgiqueBelgien Novartis Pharma N.V. TélTel 32 2 246 16 11 LuxembourgLuxemburg Novartis Pharma GmbH Tel 49 911 273 0

Novartis Pharma Services Inc. . 359 2 489 98 28 Magyarország Novartis Hungária Kft. Pharma Tel. 36 1 457 65 00

eská republika Novartis s.r.o. Tel 420 225 775 111 Malta Novartis Pharma Services Inc. Tel 356 2298 3217

Danmark Novartis Healthcare AS Tlf 45 39 16 84 00 Nederland Novartis Pharma B.V. Tel 31 26 37 82 111

Deutschland Novartis Pharma GmbH Tel 49 911 273 0 Norge Novartis Norge AS Tlf 47 23 05 20 00

Eesti Novartis Pharma Services Inc. Tel 372 66 30 810 Österreich Novartis Pharma GmbH Tel 43 1 86 6570

Novartis Hellas A.E.B.E. 30 210 281 17 12 Polska Novartis Poland Sp. z o.o. Tel. 48 22 550 8888

España Novartis Farmacéutica, S.A. Tel 34 93 306 42 00 Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel 351 21 000 8600

France Novartis Pharma S.A.S. Tél 33 1 55 47 66 00 România Novartis Pharma Services Inc. Tel 40 21 31299 01

Ireland Novartis Ireland Limited Tel 353 1 260 12 55 Slovenija Novartis Pharma Services Inc. Tel 386 1 300 75 50

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Novartis Slovakia s.r.o. Tel 421 2 5542 5439

Italia Novartis Farma S.p.A. Tel 39 02 96 54 1 SuomiFinland Novartis Finland Oy PuhTel 358 010 6133 200

Novartis Pharma Services Inc. 357 22 690 690 Sverige Novartis Sverige AB Tel 46 8 732 32 00

Latvija Novartis Pharma Services Inc. Tel 371 67 887 070 United Kingdom Novartis Pharmaceuticals UK Ltd. Tel 44 1276 698370

Lietuva

Novartis Pharma Services Inc.
Tel: +370 5 269 16 50

This leaflet was last approved in

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 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 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.