Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
SALICYLIC ACID
Dr. August Wolff GmbH & Co.
10 %w/w
Cutaneous Solution
2001-04-06
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Psorimed 10 % cutaneous solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 100 g solution contains: 10 g Salicylic acid. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Cutaneous solution Clear, colourless or slightly yellow oily solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Initial treatment of mild to moderately severe psoriasis of the scalp. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 8 – 10 ml Psorimed are applied in a thin layer on the dry scalp by using the applicator. The duration of the application is 10 to 30 minutes; thereafter the solution is removed by rinsing with warm water. Psorimed is applied two to three times a week on not-consecutive days. The therapy will usually last 3 to 4 weeks. The duration of the treatment is decided by the doctor. The maximum dose of 2 g Salicylic acid per day must not be applied for longer than one week. The solution is applied by using the applicator which is screwed on the bottle. Care has to be taken that the Psorimed solution does not come into contact with eyes, nose and mucous membranes. In addition care should be taken that no solution trickles past the hairline. After treatment the solution is removed by rinsing with warm water. Then the hair should be washed with a mild shampoo. To avoid remnants of the solution to come in contact with eyes, either the eyes must be closed or the head must be leaned right back. 4.3 CONTRAINDICATIONS Sensitivity to salicylic acid and salicylates or any of the excipients of Psorimed. Third trimester of pregnancy. Neonates, infants and children under 12 years. Patients with reduced renal capacity (in patients with reduced renal capacity a preparation with a reduced content of active Read the complete document