Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
ACETYLSALICYLIC ACID; CAMPHOR; MENTHOL; METHYL SALICYLATE
DEVRIES & CO. LTD
M02AC
SPRAY
MENTHOL 1.4 %; ACETYLSALICYLIC ACID 1.2 %; CAMPHOR 0.6 %; METHYL SALICYLATE 0.6 %
TOPICAL
Not required
THORNTON & ROSS LTD, UK
PREPARATIONS WITH SALICYLIC ACID DERIVATIVES
Relief of light muscular and rheumatic pains.
2018-05-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed without a doctor's prescription RADIAN B SPRAY ACTIVE INGREDIENTS: menthol 1.4% acetylsalicylic acid 1.2% camphor 0.6% methyl salicylate 0.6% Inactive ingredients and allergens: see section 2 under ‘Important information about some of this medicine’s ingredients’, and section 6 ‘Additional information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, consult your doctor or pharmacist. Use this medicine according to the instructions in the section about dose in this leaflet. Consult your pharmacist if you need further information. Consult your doctor if your symptoms get worse or do not improve. 1. WHAT IS THIS MEDICINE INTENDED FOR? This medicine is used to relieve mild rheumatic and muscle pain. THERAPEUTIC GROUP: methyl salicylate and acetylsalicylic acid are salicylates. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE: SPECIAL WARNINGS ABOUT USING THIS MEDICINE • Avoid contact of the product with eyes, mucous membranes (such as the mouth and the nose), face, and sensitive areas. In case of contact, rinse with water immediately. • Do not inhale the spray. • Flammable substance; do not use near painted or polished surfaces, fire, naked flame, hot surfaces and confined areas. - Do not light a cigarette or go near fire until the product has dried completely - risk of severe burns. Flammable substance: Fabric (clothing, bed and table linen, etc.) that has been in contact with this product burns more easily and is a serious fire hazard. Laundering the clothing and bedding may reduce product residues but will not necessarily remove it completely. CHILDREN AND ADOLESCENTS Do not use on children under 12 years old. OTHER MEDICINES AND RADIAN B IF YOU ARE TAKING OR HAVE RECENTLY TAKEN OTHER MEDICINES, INCLUDING NONPRESCRIPTION MEDICATIONS AND DIETARY SUPPLEMENTS, TELL Pročitajte cijeli dokument
1 NAME OF THE MEDICINAL PRODUCT Radian B Spray 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Menthol 1.4 %w/v Acetylsalicylic Acid 1.2 %w/v Camphor 0.6 %w/v Methyl Salicylate 0.6 %w/v Excipients with known effect: Citronella oil (contains geraniol, citronellol, Eugenol, benzyl benzoate, citral) 1.00 %w/v Industrial methylated spirit 80.0% %w/v For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Spray for topical application to human beings. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of light muscular and rheumatic pains. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For external application For Adults and Children over 12 years: Spray as required on the affected area followed by a second application after 10-15 minutes, if required. Smooth in or massage if preferred. If necessary, repeat application up to three times daily, reducing to morning and evening when acute symptoms subside. When convenient, use after a warm bath. ELDERLY: The adult dose is appropriate. CHILDREN UNDER 12: Do not use on children under 12 years of age. 4.3 CONTRAINDICATIONS Not to be used on children under 12 years old. Do not apply to skin abrasions. Do not apply to irritated skin. Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Contraindicated where there is known hypersensitivity to aspirin, other salicylates, or other non-steroidal anti-inflammatory drugs (including when taken by mouth) especially where associated with a history of asthma. If irritation develops, use of the product should be discontinued. Pregnancy and lactation. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Do not use near the face, eyes and other sensitive areas. If symptoms persist, consult a doctor. Wash hands thoroughly after use. FLAMMABLE: Do not spray near naked flame or hot surface. Should not be placed on or used near polished or painted surfaces. Do not use in confined spaces and avoid inhaling the spray. Instruct patients not to smoke or go near naked flames- risk of severe burns Pročitajte cijeli dokument