Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
acitretin, Quantity: 25 mg
Douglas Pharmaceuticals Australia Pty Ltd
Acitretin
Capsule, hard
Excipient Ingredients: titanium dioxide; microcrystalline cellulose; purified water; iron oxide red; sodium ascorbate; iron oxide yellow; Gelatin; maltodextrin; sodium lauryl sulfate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid
Oral
100 Capsules, 60 Capsules
Medicine Registered
(S4) Prescription Only Medicine
Acitretin may be used for the treatment of:,? 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
Visual Identification: 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; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-05-23
1 ZETIN CAPSULES ZETIN ® _Acitretin 10 mg and 25 mg capsules _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about ZETIN. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. 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. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is ZETIN. It contains the active ingredient acitretin. It is used to treat: • psoriasis • keratinisation disorders 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. _HOW IT WORKS _ Acitretin, the active ingredient of ZETIN, belongs to a group of medicines called retinoids. It is very similar to Vitamin A which is obtained from our diet and is vital for the normal growth and development of the body, especially the skin. Psoriasis is a skin disease with thickened patches of red skin, often with silvery scales. ZETIN is used to treat severe psoriasis and other severe skin disorders. ZETIN works to return skin to normal when problems with the normal development of the skin are present, as in the case of severe psoriasis and some other skin disorders. There is no evidence that this medicine is addictive. _USE Aqra d-dokument sħiħ
1 AUSTRALIAN PRODUCT INFORMATION – ZETIN (ACITRETIN) CAPSULES 1 NAME OF THE MEDICINE Acitretin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ZETIN (acitretin) is a retinoid for the oral treatment of severe cases of psoriasis and disorders of keratinisation. It is available in 10 and 25 mg capsules. For full list of excipients, see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM ZETIN hard gelatin capsule is intended for oral administration. ZETIN 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. ZETIN 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 T HERAPEUTIC INDICATIONS ZETIN (acitretin) may be used for the treatment of: • Severe intractable psoriasis in all its forms • Severe forms of disorders of keratinisation such as: o hyperkeratosis palmaris et plantaris o pustulosis palmaris et plantaris o ichthyosis o keratosis follicularis (Darier's disease) o lichen planus affecting the skin or the mucosae o pityriasis rubra pilaris 2 4.2 D OSE AND METHOD OF ADMINISTRATION ZETIN 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 Aqra d-dokument sħiħ