Tablet

Sanofi-Synthelabo Inc.

Idarac (floctafenine) is used for short-term relief of acute pain of mild and moderate severity.

Do not take Idarac (floctafenine) if you are allergic to any ingredient in Idarac (floctafenine) or similar medications if you have gastro-intestinal bleeding, peptic ulcer or any other active inflammatory disease of the gastrointestinal tract.

Before using Idarac (floctafenine), tell your health care provider about any of the following: if you are pregnant, planning to become pregnant, or breastfeeding if you are taking any prescription or nonprescription medicine if you have any other medical condit

Idarac (floctafenine) can cause gastro-intestinal bleeding, peptic ulceration, gastric perforation which can be fatal.

Other: Ringing in the ears, blurred vision, dry mouth, thirst, bitter taste, anorexia, stomach cramps, flatulence, hot flushes and sweating, tachycardia, weakness and tiredness.

How much medicine you take and how often you take it depends on many factors, including the condition being treated and the age and weight of the patient. If you have any questions about the amount and/or frequency of Idarac (floctafenine) you are taking, talk with your health care provider. Carefully read the information provided with Idarac (floctafenine) and reread it each time you get this prescription refilled. Take Idarac (floctafenine) exactly as prescribed by your health care provider. Idarac (floctafenine) may be taken with food or milk to minimize gastric irritation. Do not lie down for 30 minutes after taking Idarac (floctafenine). Contact your health care provider if unexplained muscle pain, tenderness, or weakness occur, especially if accompanied by general body discomfort or fever. Tell your doctor your medical history, especially of: liver or kidney disease, blood disorders, ulcers, heart disease, alcohol use, high blood pressure, eye disease, allergies (especially drug allergies). Use caution when performing tasks requiring alertness. Limit alcohol intake as it may intensify the drowsiness effect of Idarac (floctafenine). Idarac (floctafenine) may cause stomach bleeding. Daily use of alcohol, especially when combined with Idarac (floctafenine), may increase your risk for stomach bleeding. Check with your doctor or pharmacist for more information. Do not take aspirin without consulting your doctor. Check the ingredients of any nonprescription medication you may be taking since many cough-and-cold formulas contain aspirin. Infrequently, Idarac (floctafenine) may increase the skin's sensitivity to sunlight. If this happens to you, avoid prolonged sun exposure, wear protective clothing and use a sunscreen. Avoid sunlamps. Caution is advised when this drug is used in the elderly. Idarac (floctafenine) should be used during pregnancy only if clearly needed. Discuss the risks and benefits with your doctor. Use of this drug during the last 6 months of pregnancy is not recommended. This drug is excreted into breast milk. Consult your doctor before breast-feeding. Idarac (floctafenine) may cause dizziness and changes in vision. Use caution while driving or performing other tasks requiring alertness, coordination, or physical dexterity. Lab tests will be necessary before, during, and after the use of Idarac (floctafenine). Be sure to keep appointments. Do not stop taking Idarac (floctafenine) without checking with your health care provider. Do not take more medicine than prescribed unless advised to do so by your health care provider. Contact your health care provider at once if you feel like you have taken too much of Idarac (floctafenine). Do not take any other over-the-counter or prescription medications without talking with your health care provider. This includes any herbal preparations or dietary supplements. If a dose is missed, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. If more than one dose is missed, contact your health care provider or pharmacist.

Store Idarac (floctafenine) in a cool, dry place at room temperature. Keep out of reach of children. Protect from light