Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
COAL TAR SOLUTION STRONG CADE OIL
Quinoderm Ltd
1.25/0.5 %w/w
Shampoo
1988-04-18
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gelcotar Shampoo 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For excipients see 6.1. 3 PHARMACEUTICAL FORM Shampoo Gelcotar Shampoo is a clear, viscous shampoo, deep red to brown in colour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Psoriasis of the scalp, seborrhoeic dermatitis and dandruff. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ROUTE OF ADMINISTRATION For topical use only. Adults, children and the elderly Wet the scalp and hair with warm water. Sufficient Gelcotar Shampoo should be applied to produce a generous lather. Massage the scalp and surrounding area with the fingertips. Rinse and repeat. Finally rinse the hair and scalp thoroughly. Use twice weekly or as directed by the Medical Practitioner. 4.3 CONTRAINDICATIONS Patients with known sensitivity or intolerance to strong coal tar or cade oil should not use Gelcotar Shampoo. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Contact with eyes and other mucosal surfaces should be avoided. All medicines should be kept out of the reach of children. Gelcotar Shampoo can be easily removed by warm water. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. Strong Coal Tar Solution 1.25 % w / w Cade Oil 0.50 % w / w IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/07/2006_ _CRN 2025837_ _page number: 1_ 4.6 PREGNANCY AND LACTATION Gelcotar Shampoo is not contra-indicated in pregnancy or lactation. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Not applicable. 4.8 UNDESIRABLE EFFECTS Although carcinogenicity of coal tar has been demonstrated in animal studies, no studies demonstrating an increased risk of skin cancer with nor Prečítajte si celý dokument