When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to telithromycin or similar medicines, or if you have myasthenia gravis or a history of liver problems caused by antibiotics.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed. Take this medicine at the same time each day.
• Swallow the tablet whole. Do not crush, break, or chew it.
• Take all of the medicine in your prescription to clear up your infection, even if you feel better after the first few doses.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. Do not take more than one dose in 24 hours.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are also using cisapride or pimozide. Do not use colchicine with this medicine if you have kidney or liver problems.
• Some medicines can affect how telithromycin works. Tell your doctor if you are using any of the following:
  
  • Amlodipine, atorvastatin, carbamazepine, colchicine, cyclosporine, digoxin, diltiazem, itraconazole, ketoconazole, lovastatin, metoprolol, midazolam, phenobarbital, phenytoin, rifampin, simvastatin, sirolimus, sotalol, tacrolimus, theophylline, triazolam, verapamil
  • Blood thinner (including warfarin)
  • Ergot medicines (including dihydroergotamine, ergotamine)
  • Medicines for heart rhythm problems (including dofetilide, procainamide, quinidine)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, heart disease, or heart rhythm problems.
• This medicine may cause the following problems:
  
  • Liver problems
  • Changes in heart rhythm, including QT prolongation
• This medicine can cause diarrhea. Call your doctor if the diarrhea becomes severe, does not stop, or is bloody. Do not take any medicine to stop diarrhea until you have talked to your doctor. Diarrhea can occur 2 months or more after you stop taking this medicine.
• This medicine may cause fainting, dizziness, or vision problems. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision or other vision problems
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fainting, dizziness, lightheadedness
• Fast, pounding, or uneven heartbeat
• Muscle pain, tenderness, or weakness
• Severe diarrhea that may be bloody

If you notice these less serious side effects, talk with your doctor:

• Mild diarrhea

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088