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LEFLUNOMIDE

Take this medicine only as directed by your doctor. Do not take more or less of it, and do not take it more often than your doctor ordered.

Dosing

The dose of leflunomide will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of leflunomide. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • For rheumatoid arthritis:
    • Adults At first, 100 mg once a day for three days, then 20 mg once a day. Your doctor may decrease the dose as needed.
    • Children Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of this medicine, take it as soon as possible. However, if you do not remember the missed dose until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For leflunomide, the following should be considered:

Allergies Tell your doctor if you have ever had any unusual or allergic reaction to leflunomide. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy Leflunomide must not be taken during pregnancy because it may cause birth defects in humans. Women of childbearing age are advised to use reliable contraception before receiving leflunomide.

Breast-feeding It is not known whether leflunomide passes into the breast milk. However, leflunomide is not recommended during breast-feeding, because it may cause unwanted effects in nursing babies.

Children Although there is no specific information comparing use of leflunomide in children with use in any other age group, use is not recommended in children up to 18 years of age.

Older adults Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way as they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of leflunomide in the elderly with use in other age groups.

Males

Studies have not been done in animals or humans to determine if leflunomide will cause birth defects in the children of men taking leflunomide at the time of conception. However, it is recommended that men taking this medicine use condoms as a form of birth control during sexual intercourse. Men taking leflunomide who intend to father a child, should stop taking the medicine and tell their doctor immediately.

Other medicines Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC] medicine.

• Disease of the immune system or
• Infections, severe Leflunomide may decrease the body's ability to fight infection

• Liver disease, including hepatitis B or C or
• Renal disease The chance of side effects may be increased