Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Potassium iodide; Iodine
Ovelle Limited
D08AG; D08AG03
Potassium iodide; Iodine
2.5 %w/v + 2.5 percent weight/volume
Cutaneous solution
Product not subject to medical prescription
Iodine products; iodine
Marketed
1992-10-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Iodine Tincture (Alcoholic Iodine Solution BP), Cutaneous Solution Iodine 2.5% w/v Potassium Iodide 2.5% w/v 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Contains Iodine 2.5% w/v and Potassium Iodide 2.5% w/v. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous Solution. Iodine Tincture is a brownish yellow liquid with a characteristic odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Antiseptic for minor cuts, wounds, and abrasions and unbroken skin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Not for use in children under 2 years (see section 4.3). Clean the affected area. Apply topically using cotton wool. Do not cover with an occlusive dressing. Do not use for mor two weeks. When the wound has begun to heal discontinue use. If the wound has not begun to heal in two weeks, discon use and contact your doctor. 4.3 CONTRAINDICATIONS Do not use during pregnancy or lactation (see section 4.6). Hypersensitivity to the ingredient iodine or any of the excipients. Do not use on children under 2 years of age (see section 4.2). Regular use is contraindicated for children and users with thyroid disorders (in particular nodular goiter). Do not use for prolonged periods. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Iodine may cause sensitivity reactions. For external use only. Product should not be ingested internally. Iodine stains the skin a deep reddish-brown. Do not apply to mucous membranes. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Interference with thyroid function tests has occurred. The effects of iodine and iodides on the thyroid may be altered by other compounds including amiodarone and lithium. 4.6 PREGNANCY AND LACTATION I R I S H M E D I C I N E S B O A R D ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Прочетете целия документ