Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
leflunomide, Quantity: 10 mg
Arrotex Pharmaceuticals Pty Ltd
Leflunomide
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; colloidal anhydrous silica; povidone; crospovidone; magnesium stearate; lactose monohydrate; maize starch; titanium dioxide; hypromellose; macrogol 4000
Oral
30 Tablet
(S4) Prescription Only Medicine
Treatment of active rheumatoid arthritis.,Treatment of active psoriatic arthritis. Leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease. The combined use of leflunomide with other disease modifying antirheumatic drugs (DMARDs) has not been adequately studied (see Precautions).
Visual Identification: White, round biconvex tablet; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2015-12-22
LEFLUNOMIDE APOTEX TABLETS _Leflunomide_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about leflunomide. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT THIS MEDICINE IS USED FOR Leflunomide is used to treat rheumatoid arthritis and psoriatic arthritis. It belongs to a group of medicines called disease-modifying anti- rheumatic drugs (DMARDs). _HOW IT WORKS_ Leflunomide works by selectively interfering with the ability of white blood cells called lymphocytes to produce the disease response that ultimately leads to pain, inflammation and joint damage. Leflunomide helps to slow down the process of joint damage and to relieve the symptoms of the disease, such as joint tenderness and swelling, pain and morning stiffness. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. This medicine is not addictive. There is not enough information to recommend the use of this medicine in children under 18 years of age. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • leflunomide or teriflunomide • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue, throat or other parts of the body • rash, itching or hives on the skin. DO NOT TAKE THIS MEDICINE IF YO Belgenin tamamını okuyun
1 AUSTRALIAN PRODUCT INFORMATION LEFLUNOMIDE APOTEX (LEFLUNOMIDE) TABLET 1 NAME OF THE MEDICINE Leflunomide. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg or 20 mg of Leflunomide, as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Lactose monohydrate For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 10 MG TABLETS White, round biconvex tablet. 20 MG TABLETS Yellow, round biconvex tablets with a scoreline on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The treatment of: • Active Rheumatoid Arthritis. • Active Psoriatic Arthritis. This medicine is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease. The combined use of leflunomide with other Disease Modifying Anti-Rheumatic Drugs (DMARDs) has not been adequately studied (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). 2 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE RHEUMATOID ARTHRITIS & PSORIATIC ARTHRITIS Loading Dose Leflunomide therapy is started with a loading dose of 100 mg (five 20 mg tablets or ten10 mg tablets) once daily for three days. Avoiding a loading dose may decrease the risk of adverse events if leflunomide is used in combination with methotrexate. This could be especially important for patients at increased risk of haematological or hepatic toxicity, such as those receiving concomitant treatment with methotrexate or other immunosuppressive agents or on such medications in the recent past. (See SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE - CONCOMITANT USE WITH HEPATOTOXIC AND HAEMATOTOXIC AGENTS, AND HEPATOTOXICITY.) Maintenance Dose The recommended maintenance dose for rheumatoid arthritis is leflunomide 20 mg once daily. Doses higher than 20 mg/day are not recommended. If dosing at 20 mg/day is not well tolerated, the dose may be decreased to 10 mg daily. The recommended maintenance dose for psoriatic arthritis is 20 mg once daily. Liver enzymes and haematological parameters must be mon Belgenin tamamını okuyun