Sebivo

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes Sebivo. If you are concerned about side effects, discuss the risks and benefits of Sebivo with your doctor.

The following side effects have been reported by at least 1% of people taking Sebivo. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• cough
• Diarrhea
• dizziness
• fatigue
• headache
• nausea
• rash
• runny or stuffy nose

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• pain, weakness, or tenderness in your muscles
• signs of liver problems (e.g., yellow eyes or skin, abdominal pain, loss of appetite, pale stools, itchy skin, or dark urine)

Seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., difficulty breathing, Hives, or swelling of the face or throat)
• signs of lactic acidosis (e.g., severe tiredness or weakness, unusual muscle pain, trouble breathing, stomach pain with nausea and vomiting, feeling cold - especially in the arms and legs, dizziness or lightheadedness, fast or irregular heartbeat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Sebivo.

Each white-to-slightly-yellowish, film-coated, ovaloid-shaped tablet, imprinted with "LDT" on one side contains telbivudine 600 mg. Nonmedicinal ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate; coating: hypromellose, polyethylene glycol, talc, and titanium dioxide.

Do not take Sebivo if you:

• are allergic to telbivudine or to any of the ingredients of Sebivo
• are taking the medication pegylated interferon alfa-2a

There may be an interaction between telbivudine and interferons (e.g., interferon alpha-2b, peginterferon alfa-2a, peginterferon alfa-2b).

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. In many cases, interactions are intended or are managed by close monitoring. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Sebivo. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Sebivo.

Kidneys: People with Kidney Disease may need a different dose of the medication. Be sure you tell your doctor if you have a history of kidney disease. Let your doctor know about all the medications you are taking because some medications can affect the kidneys.

Laboratory tests: Your doctor will order certain laboratory tests to check your response to Sebivo.

Lactic acidosis: If you experience symptoms of lactic acidosis, contact your doctor immediately. Symptoms of lactic acidosis include severe tiredness or weakness, unusual muscle pain, trouble breathing, stomach pain with nausea and vomiting, feeling cold (especially in the arms and legs), dizziness or lightheadedness, and fast or irregular heartbeat.

Liver problems: Sebivo can cause liver problems. Your doctor may monitor your liver function while you are taking this medication, especially if you have risk factors for liver problems. If you experience symptoms of liver problems (e.g., abdominal pain, persistent vomiting, feeling unwell, Fever, itching, yellowing of the skin and eyes, dark urine), contact your doctor immediately.

Muscle problems: Rarely, telbivudine may lead to a serious muscle problem. Contact your doctor if you experience muscle pain, muscle tenderness, or muscle weakness.

Stopping the medication: If you stop the medication, your hepatitis B infection could get worse. Take the medication exactly as prescribed by your doctor, and do not stop taking the medication without checking with your doctor first.

Pregnancy: Sebivo should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Sebivo, contact your doctor immediately.

Breast-feeding: It is not known if telbivudine passes into breast milk. If you are a breast-feeding mother and are taking Sebivo, it may affect your baby. Breast-feeding is not recommended for women taking Sebivo.

Children: The safety and effectiveness of using Sebivo have not been established for children under 16 years of age.

Seniors: People over the age of 65 years may have an increased risk of developing side effects due to decreases in kidney function.