Land: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
acitretin
Apotex Pty Ltd
Acitretin
Medicine Registered
Registered
NOVATIN _Acitretin_ 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 Novatin capsules. 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 taking Novatin Capsules 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 IS NOVATIN USED FOR Novatin contains the active ingredient acitretin. Novatin is used to treat severe psoriasis (skin disease with thickened patches of red skin, often with silvery scales) and other severe disorders of the skin. Novatin belongs to a group of medicines called retinoids, which are very similar to Vitamin A. Vitamin A, which we obtain from food, is important for the normal growth and development of the body, especially the skin. In severe psoriasis and some other skin disorders, where there is problem with the normal development of the skin, Novatin helps return the skin to normal. There are many different types of medicines used to treat skin conditions. Your doctor may have prescribed Novatin for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS WHY NOVATIN HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE NOVATIN _DO NOT TAKE NOVATIN IF:_ • YOU ARE PREGNANT, OR INTEND TO BECOME PREGNANT DURING TREATMENT OR IN THE 3 YEARS AFTER STOPPING TREATMENT. THE POSSIBILITY THAT YOU MAY BE PREGNANT MUST BE RULED OUT BY YOU AND YOUR DOCTOR BEFORE YOU START TAKING NOVATIN. A PREGNANCY TEST MUST BE NEGATIVE WHEN PERFORMED WITHIN ONE WEEK BEFORE BEGINNING OF TREATMENT. NOVATIN IS HIGHLY TERATOGENIC AND THERE IS AN EXTREMELY HIGH RISK THAT A SEVERELY DEFORMED BABY WILL RESULT IF TAKEN BEFORE OR DURING PREGNANCY, NO MATTER FOR Lestu allt skjalið
1 AUSTRALIAN PRODUCT INFORMATION NOVATIN™ (ACITRETIN) CAPSULES 1 NAME OF THE MEDICINE Acitretin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard gelatin capsule contains 10 mg or 25 mg of acitretin as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Gelatin For the full list of excipients see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM Novatin acitretin capsules are available in 10 and 25 mg capsules. 10 MG CAPSULE: Hard gelatin capsule containing a yellow powder with a white to off-white body and a brown cap printed in black with “A10” on the capsule body. 25 MG CAPSULE: Hard gelatin capsule containing a yellow powder with a yellow to light yellow body and a brown cap printed in black with “A25” on the capsule body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe intractable psoriasis in all its forms Severe forms of disorders of keratinisation such as hyperkeratosis palmaris et plantaris pustulosis palmaris et plantaris ichthyosis keratosis follicularis (Darier's disease) lichen planus affecting the skin or the mucosae pityriasis rubra pilaris 2 4.2 DOSE AND METHOD OF ADMINISTRATION Novatin hard gelatin capsule is intended for oral administration. DOSAGE Acitretin should only be prescribed by physicians who are experienced in the use of systemic retinoids and understand the risk of teratogenicity associated with acitretin therapy. ADULTS Because there are differences in the absorption and rate of metabolism of acitretin, the dosage must be individually adjusted. The capsules should be taken preferably once daily with meals, or with milk. An initial dosage of 25 mg or 30 mg for about two to four weeks may give satisfactory therapeutic results. The maintenance dose must be based on clinical efficacy and tolerance. In general, a daily dosage of 25 - 50 mg taken for a further six to eight weeks achieves optimal therapeutic results. Therapy can be terminated in patients with psoriasis whose lesions have resolved sufficiently. Relapses should be trea Lestu allt skjalið