Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Belladonna alkaloids
Cuxson Gerrard & Company Ltd
M02AX; M02AX10
Belladonna alkaloids
0.25 percent weight/weight
Medicated plaster
Product not subject to medical prescription
Other topical products for joint and muscular pain; various
Marketed
1983-04-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Belladonna 0.25% w/w Medicated Plaster 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Belladonna Alkaloids (as Hyoscyamine) 0.25% w/w. Also contains Lanolin 19.7% w/w. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Medicated Plaster An evenly perforated plaster consisting of a white cloth coated with a medicated adhesive, faced with a white silicon paper and packed in a sealed printed pack. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of muscle pains associated with strains and similar conditions of mild muscle injury. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION One plaster to be applied over the affected area as required. Plaster to be removed after 2 – 3 days. Apply another plaster if required. Children: Not recommended for use by children under 10 years of age. 4.3 CONTRAINDICATIONS Do not use if you suffer from Glaucoma. Do not use if you are allergic to adhesive plasters. Do not use if you are using a medication that contains antihistamines. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 1. Occasional local irritation may occur while using this product. 2. If the skin beneath the plaster begins to hurt, remove the plaster immediately and wash with soap and water. 3. If symptoms persist consult your doctor. 4. Keep out of the sight and reach of children. 5. Report any unwanted effects to your doctor or pharmacist. 6. Do not use if you have inflamed or broken skin. 7. Do not use if you have applied any other medication to the skin. 8. Contains lanolin - may cause local skin reactions (e.g. contact dermatitis) 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION 1. The plaster should not be applied over other medication which has been applied to the skin as there is the potential for occlusion which may affect the action of the other medication. 2. Atropine is an antimuscarinic and may be absorbed. It has the potential for interacting with other drugs having a similar affect such as a Läs hela dokumentet