February 9, 2010
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Novo-Leflunomide

(leflunomide)

DIN (Drug Identification Number)

02261251 NOVO-LEFLUNOMIDE 10MG TABLET
02261278 NOVO-LEFLUNOMIDE 20MG TABLET

How does Novo-Leflunomide work? What will it do for me?

Leflunomide is used to treat some of the symptoms associated with rheumatoid arthritis, such as inflammation, swelling, stiffness, and joint pain. It works by blocking the body's ability to produce the immune cells that cause these problems.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

How should I use Novo-Leflunomide?

The average starting dose of leflunomide is 100 mg once daily for the first three days, followed by 20 mg once a day. Your doctor may change the dose as required.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that this medication be taken exactly as prescribed by your doctor. Leflunomide may be taken with or without food, but it should be taken at the same time every day with a full glass of water or other fluid. This medication should be taken on a regular basis for it to work effectively. If you miss a dose, take it as soon as possible. If you don't remember your dose until the next day, skip the missed dose and resume your regular schedule. Do not take a double dose to make up for a missed one.

Store this medication away from heat, direct light, and moisture. Do not store it in the bathroom.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does Novo-Leflunomide come in?

10 mg
Each white to off-white, round, film-coated tablet, engraved "N" on one side and "10" on the other side, contains leflunomide 10 mg. Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, lactose anhydrous, lactose monohydrate impalpable, magnesium stearate, polydextrose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, talc, titanium dioxide, and triethyl citrate.

20 mg
Each cream, triangular shaped, film-coated tablet, engraved "N" on one side and "20" on the other side, contains leflunomide 20 mg. Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxide yellow, lactose anhydrous, lactose monohydrate impalpable, magnesium stearate, polydextrose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, talc, titanium dioxide, and triethyl citrate.

Some medications may have other generic brands available. Always ask your doctor or pharmacist about the safety of switching between brands of the same medication.

Who should NOT take Novo-Leflunomide?

Leflunomide should not be taken by:

  • anyone allergic to leflunomide or to any of the ingredients in the medication
  • pregnant women
  • breast-feeding women
  • fertile men, unless they practice reliable contraception techniques
  • people with extremely low levels of protein in the blood
  • people with immunodeficiency due to causes other than rheumatoid arthritis (e.g., AIDS, transplant recipients taking medications that suppress the immune system)
  • people with impaired bone marrow function or other blood disorders due to causes other than rheumatoid arthritis
  • people with impaired liver function
  • people with moderate-to-severe kidney function impairment
  • people with severe infections
  • women who may become pregnant, unless they use reliable contraception before, during, and for a period of 2 years after treatment with leflunomide

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