Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
leflunomide, Quantity: 10 mg
Southern Cross Pharma 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
Leflunomide generichealth is indicated for the treatment of: - Active Rheumatoid Arthritis; - Active Psoriatic Arthritis. Leflunomide generichealth is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease.,The combined use of Leflunomide generichealth with other Disease Modifying Anti-Rheumatic 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
Licence status A
2014-04-02
CONSUMER MEDICINE INFORMATION LEFLUNOMIDE GENERICHEALTH (LEFLUNOMIDE) FILM-COATED TABLETS PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START LEFLUNOMIDE GENERICHEALTH. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Leflunomide generichealth. It does not contain all of 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 taking Leflunomide generichealth 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 need to read it again. WHAT LEFLUNOMIDE GENERICHEALTH IS USED FOR Leflunomide generichealth is a type of medicine used to treat rheumatoid or psoriatic arthritis. Leflunomide generichealth 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. Leflunomide generichealth 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. Your doctor, however, may have prescribed Leflunomide generichealth for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor's prescription. BEFORE YOU TAKE LEFLUNOMIDE GENERICHEALTH _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE LEFLUNOMIDE GENERICHEALTH IF YOU: • have any diseases which reduce your body's natural defences such as bacterial or viral infections; • have an illness which severely lowers your body's resistance to disease, such as AIDS; • have any diseases of the blood or bone marrow, such as anaemia; • have any serious skin disorders, such as Stevens- Johnson syndrome, toxic epidermal necrolysis or erythema multiforme; • have liver disease; • have a condition called hypoproteinaem Read the complete document
AUSTRALIAN PRODUCT INFORMATION – LEFLUNOMIDE GENERICHEALTH (LEFLUNOMIDE) FILM-COATED TABLETS 1 NAME OF THE MEDICINE Leflunomide. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Leflunomide generichealth tablets contains the active ingredient leflunomide. Each tablet contains 10 mg or 20 mg of leflunomide as the active ingredient. List of excipients with known effects: lactose monohydrate and sugars. _ _ For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Leflunomide generichealth 10 mg: white, round biconvex film-coated tablets. Leflunomide generichealth 20 mg: yellow, round biconvex film-coated tablets with a scoreline on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Leflunomide generichealth is indicated for the treatment of: • Active Rheumatoid Arthritis. • Active Psoriatic Arthritis. Leflunomide generichealth is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease. The combined use of Leflunomide generichealth with other Disease Modifying Anti-Rheumatic Drugs (DMARDs) has not been adequately studied (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). 4.2 DOSE AND METHOD OF ADMINISTRATION RHEUMATOID ARTHRITIS AND PSORIATIC ARTHRITIS Loading Dose Leflunomide therapy is started with a loading dose of 100 mg 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, eg. those receiving concomitant treatment with methotrexate or other immunosuppressive agents or on Leflunomide generichealth PI v2.0 Page 2 of 30 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 2 Read the complete document