Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nicotinamide
Diomed Developments Ltd
Nicotinamide
40mg/1gram
Cutaneous gel
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13060100; GTIN: 5016379262005
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE USING THIS PRODUCT. Keep this leaflet. You may need to read it again. Ask your doctor or pharmacist if you need more information or advice. IN THIS LEAFLET: 1. What Freederm Treatment Gel is and what it is used for 2. Before you use Freederm Treatment Gel 3. How to use Freederm Treatment Gel 4. Possible side effects 5. How to store Freederm Treatment Gel 6. Further information 1. WHAT FREEDERM TREATMENT GEL IS AND WHAT IT IS USED FOR • Freederm Treatment Gel is a skin treatment for inflamed pimples and spots. • The medical term for this condition is mild to moderate inflammatory acne vulgaris. It involves inflamed pimples (papules) and spots containing pus (pustules), often with skin redness (erythema) and some tenderness. The condition occurs mainly on the face, back and chest. • Freederm Treatment Gel is suitable for use by ADULTS, CHILDREN AND THE ELDERLY. • The ACTIVE INGREDIENT in this product is nicotinamide. This ingredient treats pimples and spots by its anti-inflammatory activity, which reduces swelling, redness and tenderness. • Nicotinamide is not an antibiotic, it is related to an essential vitamin in our diet (Vitamin B 3 ). 2. BEFORE YOU USE FREEDERM TREATMENT GEL DO NOT USE Freederm Treatment Gel if you are ALLERGIC (HYPERSENSITIVE) to nicotinamide or any of the other ingredients of Freederm Treatment Gel listed in Section 6. TAKE CARE when using this product: • Only apply it to your skin. • When using it on your face, keep it away from your eyes, and avoid getting it inside your nostrils, on your lips or inside your mouth. • Depending on how sensitive your skin tends to be, it may be a good idea initially to test the gel on a small area, and wait 24 hours before using it on larger areas. This is especially advisable if you have unusually sensitive skin or if you are treating the face (as generally applies when using any new treatment for the first time). USING OTHER MEDICINES Freederm Treatment Gel is not known to affect, or to be af Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Freederm Treatment 4% w/w Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Nicotinamide 4% w/w For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Topical gel 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the topical treatment of mild to moderate inflammatory acne vulgaris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apply to the affected area twice daily after the skin has been thoroughly washed with warm water and soap. Enough gel should be used to cover the affected area. No difference in dose or dose schedule is recommended for adults, children or the elderly. For topical administration only. 4.3 CONTRAINDICATIONS Contraindicated in persons who have shown hypersensitivity to any of its components. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE For external use only and to be kept away from the eyes and mucous membranes, including those of the nose and mouth. If excessive dryness, irritation or peeling occurs reduce the dosage to one application per day or every other day. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.6 PREGNANCY AND LACTATION Vitamin B derivative requirements such as nicotinamide, are increased during pregnancy and infancy. Nicotinamide is excreted in breast milk. As with all medicines, care should be exercised during the first trimester of pregnancy. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None known. 4.8 UNDESIRABLE EFFECTS The most frequently encountered adverse effect reported is dryness of the skin. Other less frequent adverse effects include pruritus, erythema, burning sensation and irritation. REPORTING OF SUSPECTED ADVERSE REACTIONS Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. Olvassa el a teljes dokumentumot