Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
COAL TAR CICLOPIROX OLAMINE
Stiefel Laboratories (U.K.) Ltd.
Shampoo
1998-08-28
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tarmed AF Shampoo 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Shampoo A viscous, yellowish brown liquid shampoo. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tarmed AF is indicated for the treatment of scalp disorders such as dandruff, seborrhoeic dermatitis, eczema and the pruritus associated with these conditions. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION ADULTS: Tarmed AF is for topical application to the scalp. The hair should be wetted and sufficient Tarmed AF applied to produce an abundant lather. The scalp and adjacent areas should be vigorously massaged with the fingertips. The hair should then be thoroughly rinsed and the procedure repeated. Tarmed AF should be used two to three times weekly or as often as necessary for the treatment of scalp disorders. USE IN THE ELDERLY: The dosage instructions given above are suitable for the elderly. USE IN CHILDREN: The safety and effectiveness in children have not been established. 4.3 CONTRAINDICATIONS Patients with known hypersensitivity to any of the ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Tarmed AF is for external use only. As with all shampoo products avoid contact with the eyes. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. Coal tar solution 4 % w/w. Ciclopirox olamine 1 % w/w. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 06/07/2006_ _CRN 2025219_ _page number: 1_ 4.6 PREGNANCY AND LACTATION Tar shampoos and Ciclopirox olamine have been in wide use for many years without apparent adverse consequences. However, the safety of Tarmed AF in pregnant Lestu allt skjalið