SEBIVO 600 mg. 28 tablets

What is Sebivo is and what it is used?

Sebivo contains the active substance telbivudine. Sebivo belongs to the group of medicines called antiviral drugs used for treatment of infections caused by viruses.
Sebivo is used to treat adults with chronic hepatitis B.
Hepatitis B is caused by infection with hepatitis B, 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. This leads to a reduction of the 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. Tell your doctor. If you think you may be allergic, ask advice from your doctor.

Warnings and Precautions
Talk to your doctor before taking Sebivo:
- If you have or have had kidney problems. Your doctor may order laboratory tests to check your kidneys are working properly before and during treatment. According to the results of these tests your doctor may advise you to change how often you take Sebivo.
- If you suffer from cirrhosis (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 take medicines that may cause muscle problems (if you are not sure, talk to your doctor or pharmacist).
- If you are infected with HIV, hepatitis C or D, or are treated with antiviral drugs.
If any of the above applies to you, tell your doctor before taking Sebivo.

During the treatment with Sebivo:
- Sebivo can cause persistent unexplained muscle weakness or muscle pain (myopathy). Muscle symptoms may worsen and become serious, sometimes can lead to breakdown of muscle tissue (rhabdomyolysis), which can cause kidney damage.
- Uncommonly Sebivo can cause numbness, tingling, pain and / or burning sensation in the arms and / or legs (peripheral neuropathy).
If you have any of these symptoms during treatment with Sebivo, call your doctor immediately.

Other side 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 that can sometimes lead to death. Lactic acidosis occurs more often in women, particularly if they are overweight. Your doctor will monitor you regularly while you are taking Sebivo. If during the taking Sebivo you experience muscle pain, severe and persistent stomach pain with nausea and vomiting, severe and persistent trouble breathing or you are tired, tell your doctor immediately.
Some patients may get very serious hepatitis symptoms when they stop taking medicines like Sebivo. After stopping treatment with Sebivo Your doctor will monitor your health and will do regular blood tests for liver function evaluation. Tell your doctor immediately if after discontinuation of treatment with Sebivo notice any new or unusual symptoms (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 (HBV) through sexual contact or contact with infected blood or other body fluids. If you have sexual contact with a partner who is not immune against hepatitis B, always use condoms and avoid the exchange of body fluids. Never share needles with another person. Do not share personal items that could contain in itself blood or body fluids, such as toothbrushes or razors. To prevent infection with HBV vaccine.

Children and adolescents
Use Sebivo is not recommended for 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 through the kidneys into the urine.
Do not take Sebivo, if you are being treated with pegylated or standard interferon alfa (see. "Do not take Sebivo"), as the combination of both drugs may increase the risk of developing peripheral neuropathy (numbness, tingling and / or burning in the hands and / or legs). Tell your doctor or pharmacist if you are being treated with interferon.

Pregnancy and lactation
- Do not use Sebivo during pregnancy unless your doctor tells you. If you are pregnant or think you may be pregnant, tell your doctor before taking Sebivo. Your doctor will discuss with you the possible risks of taking Sebivo during pregnancy.
- If you have hepatitis B and become pregnant, talk to your doctor about how best to protect your child. It is not known whether Sebivo reduces the risk of passing your hepatitis B virus on the fetus.
- Do not breast-feed during treatment with Sebivo. Tell your doctor if you are breastfeeding. 3. How to take Sebivo
Always take this medicine exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.

How much Sebivo to take?
The recommended dose of Sebivo is one 600 mg tablet once a day. Take the tablet at the same time each day.
The tablet can be taken with or without food. Swallow the tablet whole with some water. Do not chew, split or crush it.
If you have kidney problems, you may need to take Sebivo less frequently. Tell your doctor if you have or have had kidney problems.

How long to take Sebivo?
Continue taking Sebivo every day for as long as you have been told by your doctor. Do not change your dose or stop taking Sebivo, without talking to your doctor. This drug is indicated for long term treatment, which may last for months or years. Your doctor will regularly monitor your condition to check whether the treatment is having the desired effect.

If you take more dose of Sebivo

If you take more dose Sebivo, or if someone else accidentally takes your tablets, go for advice your doctor or hospital. Take with you the pack of tablets 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 the next dose at the usual time.
- In case remain until 4:00 the next, skip the missed dose and take the next one at the usual time.
Do not take a double dose to make up for a forgotten tablet. This can increase your chance of getting side effects. If you are not sure what to do, ask your doctor or pharmacist.

If you stop taking Sebivo
Stopping treatment with Sebivo may result in a worsening of hepatitis B infection, eg. disease progression and abnormal results of tests (increased viral load, increased ALT). Do not stop taking Sebivo, unless your doctor tells you to do. Try, while taking Sebivo, not to be without Sebivo.
Your doctor will monitor your health and will conduct regular blood tests to check the condition of your liver after you stop treatment with Sebivo, as it is possible after stopping treatment hepatitis B infection to get worse or become very serious . 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 can be serious:
- Persistent muscle weakness or muscle pain
- Numbness, tingling, pain and / or burning sensation in the hands and / or feet
If you experience any of these side effects, tell 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
- Rash
- Fatigue (tiredness)
- Results of blood tests, showing higher levels of certain liver enzymes (eg. ALT, AST), amylase, lipase or creatine kinase

Uncommon (may affect up to 1 in 100 people)
- Pain in the joints
- Persistent muscle weakness or muscle pain (myopathy / myositis), muscle cramps
- Pain in the back, neck and hips
- Numbness, tingling, pain and / or burning sensation in the hands and / or feet or around the mouth
- Pain in lower back or hip and may radiate into the leg (sciatica)
- Taste disorders
- Feeling unwell (malaise)
Rare (may affect up to 1 in 1000 people)
- An excess of lactic acid in the blood (lactic acidosis)
- Breaking the muscles (rhabdomyolysis)
If you get any side effects, tell your doctor or pharmacist. This includes any possible effects not listed in this leaflet.

5. How to store Sebivo?
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date 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 you notice that the pack is damaged or shows signs of tampering.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information
What Sebivo?
- The active substance is telbivudine. Each tablet contains 600 mg telbivudine.
- The other ingredients are: microcrystalline cellulose; 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 pale yellow, oval film-coated tablets with "LDT" imprinted on one side.
Sebivo film-coated tablets are available in packs of 28 or 98 tablets. Not all pack sizes may be marketed.