Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
BENZOYL PEROXIDE POTASSIUM HYDROXYQUINOLIN SULFATE
Ferndale Pharmaceuticals Ltd
BENZOYL PEROXIDE POTASSIUM HYDROXYQUINOLIN SULFATE
%v/v
Gel
Product not subject to medical prescription
Withdrawn
2006-05-18
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Quinoderm Lotio-Gel 5% 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Benzoyl Peroxide B.P. 5.00 % Potassium Hydroxyquinoline Sulphate B.P. 0.50 % 3 PHARMACEUTICAL FORM Gel. Gel formulated to give the colour and consistency of a creamy white lotion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acne. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration For topical use only. Adults, Children and the Elderly. Initial use should be preceded by a patch test with the product left on the skin behind the ear for 12 hours. If no undue reaction occurs application should be once to thrice daily to the affected areas. The Lotio-Gel should be applied sparingly by gentle massage over all the affected area. A single course of treatment should not extend beyond three months unless there is clear evidence of response. 4.3 CONTRAINDICATIONS Acne Rosacea. Patients with known sensitivity to either of the active ingredients should not use Quinoderm Lotio-Gel 5% 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Contact with mouth and eyes should be avoided. Care should be taken to avoid contact with dyed fabrics as this product may adversely affect dye fastness. In a few isolated cases, overreaction to Quinoderm Lotio-Gel 5% may occur. To minimise this possibility, select a small area of skin behind the ear, apply the Lotio-Gel and leave for twelve hours. If severe irritation or pronounced redness occurs, do not proceed with treatment. The product should only be used with caution in areas of thin or sensitive skin. Fair skinned individuals are likely to be particularly sensitive to irritation. IRISH MEDICINES BOARD _____________________________________________________________________________________________________________ Izlasiet visu dokumentu