Do not take Factive if you are allergic to any of the ingredients in Factive or to any antibiotic called a “quinolone”.

Special Warnings with Factive: 

• Factive should not be used in children under the age of 18.
• Factive may cause a rare heart problem called prolongation of the QTc interval in some people. This condition can cause an abnormal heartbeat and result in sudden death.
• Factive can cause a condition called photoxicity. Photoxicity can make your skin sunburn easier. Do not use a sunlamp or tanning bed while taking Factive. Use a sunscreen and wear protective clothing if you must be out in the sun.

What should I tell my doctor or health care provider?

Tell your health care provider if you: 

• are pregnant, planning to become pregnant, or are breast feeding. The effects of Factive on unborn children and nursing infants are unknown. 
• or any family members have a rare heart condition known as congenital prolongation of the QTc interval. 
• have low potassium or magnesium levels. 
• have a slow heartbeat called bradycardia 
• have had a recent heart attack. 
• have had a history of convulsions (seizures or "fits"). 
• have kidney problems. 

Tell your health care provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your health care provider if you take: 

• medicines for your heart rhythm called “antiarrhythmics” 
• erythromycin 
• medicines for your mental health called “antipsychotics” or “tricyclic antidepressants” 
• medicines called “corticosteroids”, taken by mouth or by injection 
• medicines called diuretics such as furosemide and hydrochlorothiazide 
• antacids that contain magnesium or aluminum 
• ferrous sulfate (iron) 
• multivitamin that contains zinc or other metals 
• Videx (didanosine) 
• sucralfate 

These medicines may affect how Factive works, or Factive may affect how these medicines work.

What are some possible side effects of Factive? (This is NOT a complete list of side effects reported with Factive. Your health care provider can discuss with you a more complete list of side effects.)

Some signs of rare but serious side effects include: 

• a rare heart problem known as prolongation of the QTc interval 
• central nervous system problems including body shakes (tremors), restless feeling, lightheaded feelings, confusion, and hallucinations (seeing or hearing things that are not there) 
• tendon problems including tendonitis or rupture (“tears”) of a tendon 
• phototoxicity (making your skin sunburn easier) 

Factive and other quinolones may cause joint problems (arthropathy) in children. 

Some common side effects with Factive include: 

• rash. If you get a rash while taking Factive, stop Factive and call your healthcare provider right away. 
• diarrhea 
• nausea 
• headache 
• vomiting 
• stomach pain 
• dizziness 
• change in the way things taste in your mouth 

For more detailed information about Factive, ask your health care provider.

Posted 6/3/03