Երկիր: Միացյալ Թագավորություն
Լեզու: անգլերեն
Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nicotinamide
Dermal Laboratories Ltd
Nicotinamide
40mg/1gram
Cutaneous gel
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13060100; GTIN: 5016379297007
IN THIS LEAFLET: 1. What Nicam Gel is and what it is used for 2. Before you use Nicam Gel 3. How to use Nicam Gel 4. Possible side effects 5. How to store Nicam Gel 6. Further information 1. WHAT NICAM GEL IS AND WHAT IT IS USED FOR • Nicam 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. • Nicam 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 NICAM GEL DO NOT USE Nicam Gel if you are ALLERGIC (HYPERSENSITIVE) to nicotinamide or any of the other ingredients of Nicam 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 Nicam Gel is not known to affect, or to be affected by, any other medicines. PREGNANCY AND BREAST-FEEDING There are no specific restrictions to using Nicam during pregnancy or breast-feeding. Vitamin B derivative requirements, such as nicotinamide, are increased during pregnancy and infancy. However, although there are no known potential risks, as with any medicine caution Կարդացեք ամբողջական փաստաթուղթը
OBJECT 1 NICAM 4% W/W GEL Summary of Product Characteristics Updated 07-Dec-2017 | Dermal Laboratories Limited 1. Name of the medicinal product NICAM 4% w/w GEL 2. Qualitative and quantitative composition Nicotinamide 4% w/w. 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.m Կարդացեք ամբողջական փաստաթուղթը