Package leaflet: Information for the user
Telbivudine 600mg tablets
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
- What Telbivudine is and what it is used for
- What you need to know before you take Telbivudine
- How to take Telbivudine
- Possible side effects
- How to store Telbivudine
- Contents of the pack and other information
- What Telbivudine is and what it is used for
Telbivudine contains the active substance Telbivudine. Telbivudine belongs to a group of medicines called antiviral medicines, which are used to treat infections caused by viruses.
Telbivudine is used to treat adults with chronic hepatitis B. Starting treatment with Telbivudine should only be considered when it is not possible or appropriate to use 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 Telbivudine reduces the amount of hepatitis B virus in the body by blocking its growth, resulting in less liver damage and improved liver function.
- What you need to know before you take Telbivudine
Do not take Telbivudine
- 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 Telbivudine Talk to your doctor.
Warnings and precautions
Talk to your doctor before taking Telbivudine:
- 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 Telbivudine.
- 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 Telbivudine.
During the treatment with Telbivudine:
– Telbivudine 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 Telbivudine 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 Telbivudine, call your doctor immediately.
Other side effects of this type of medicine
Telbivudine 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 Telbivudine. 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 Telbivudine, call your doctor immediately.
Some people may get very serious hepatitis symptoms when they stop taking medicines like Telbivudine.
Your doctor will monitor your health and do regular blood tests to check your liver after you stop treatment with Telbivudine. Tell your doctor immediately about any new or unusual symptoms that you notice after stopping treatment (see ?If you stop taking Telbivudine? in section 3 of this leaflet).
Take care not to infect other people
Even if you take Telbivudine, 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
Telbivudine is not recommended for use in children and adolescents.
Other medicines and Telbivudine
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 Telbivudine mainly leaves the body via the kidneys in the urine.
Do not take Telbivudine if you are using pegylated or standard interferon alfa (see ?Do not take Telbivudine?), 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 Telbivudine 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 Telbivudine during pregnancy.
- If you have hepatitis B and become pregnant, talk to your doctor about how you can best protect your baby. Telbivudine 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 Telbivudine. Tell your doctor if you are breast-feeding.
Driving and using machines
Telbivudine has a 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.
- How to take Telbivudine
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 Telbivudine to take
The recommended dose of Telbivudine is one 600mg 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 Telbivudine less frequently if you have kidney problems. Tell your doctor if you have, or have ever had, any kidney problems.
How long to take Telbivudine
Continue taking Telbivudine every day for as long as your doctor tells you. Do not change your dose or stop taking Telbivudine 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 Telbivudine than you should
If you have taken too much Telbivudine, 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 Telbivudine
- If you forget to take Telbivudine, 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 Telbivudine
Stopping treatment with Telbivudine may result in a worsening of your hepatitis B infection i.e. progression of the disease and abnormal test results (an increase of viral load, ALT increase). Do not stop Telbivudine unless your doctor tells you to. While you are taking Telbivudine, make sure you do not run out of Telbivudine.
Your doctor will monitor your health and do regular blood tests to check your liver after you stop treatment with Telbivudine 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.
- 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.
Telbivudine 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. By reporting side effects you can help provide more information on the safety of this medicine.
- How to store Telbivudine
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.
- Contents of the pack and other information
What Telbivudine contains
- The active substance is Telbivudine. Each tablet contains 600mg Telbivudine.
- The other ingredients are Cellulose, Microcrystalline; Povidone; Sodium Starch Glycolate; Silica, Colloidal Anhydrous; Magnesium Stearate; Hypromellose; Titanium Dioxide; Talc; Macrogol.
What Telbivudine looks like and contents of the pack
Telbivudine film-coated tablets are white to slightly yellowish, oval, film-coated tablets.
Pack Size:
Telbivudine film-coated tablets are supplied in packs of 5, 7, 14, 20, 28, 30, 40, 50, 56, 60, 98, 120, 240, 360 and 500 tablets.
Not all pack sizes may be marketed in your country.
Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO. +91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)