País: Malta
Idioma: anglès
Font: Medicines Authority
ETHYL SALICYLATE, HYDROXYETHYL SALICYLATE, METHYL NICOTINATE, METHYL SALICYLATE
The Mentholatum Company Limited
M02AX
ETHYL SALICYLATE, HYDROXYETHYL SALICYLATE, METHYL NICOTINATE, METHYL SALICYLATE
CUTANEOUS SPRAY, SOLUTION
ETHYL SALICYLATE 5 percent weight/weight ; HYDROXYETHYL SALICYLATE 5 percent weight/weight ; METHYL NICOTINATE 1.6 percent weight/weight ; METHYL SALICYLATE 1 percent weight/weight
OTC
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
Authorised
2006-11-27
FRONT FACE DEEP HEAT PAIN RELIEF SPRAY Fast relief from rheumatic pain, muscular aches & strains LEFT PANEL If you get any side effects talk to your doctor. You can also report side effects at www.mhra.gov.uk/yellowcard [http://www.mhra.gov.uk/yellowcard] . [http://www.mhra.gov.uk/yellowcard] FOR EXTERNAL USE ONLY ACTIVE INGREDIENTS: (W/W) Methyl nicotinate 1.6% 2-Hydroxyethyl salicylate 5.0% Methyl salicylate 1.0%, Ethyl salicylate 5.0% ALSO CONTAINS: Propan-2-ol, Butane. KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. Store below 25 o C. Do not use after the ‘Use by’ date shown on the bottom of the can. Ask your pharmacist how to dispose of medicines no longer required. WARNING: Pressurised container: protect from sunlight and do not expose to temperatures exceeding 50 o C. Do not pierce or burn even after use. Do not spray on a naked flame or any incandescent material. Keep away from sources of ignition. No smoking. PL00189/0012 EXTREMELY FLAMMABLE 210/270 э 100g 150ml℮/120g 180ml℮ Manufacturer and MA Holder The Mentholatum Co. Ltd, East Kilbride, G74 5PE Last revised May 2013 RIGHT PANEL DEEP HEAT PAIN RELIEF SPRAY is a pain relieving, warming, spray to be used on the skin. It is recommended for the relief of pain in muscles, tendons, joints or bones, lower back and thigh pain, sprains or strains. It can be used before and after exercise. DIRECTIONS FOR USE: ADULTS AND CHILDREN OVER 5 YEARS ONLY. - Always try on a small area first and use sparingly. - Shake can well before use - Hold the nozzle not less than 15cm (6”) from the site of pain and spray in 2-3 short bursts. Massage is not required. Protect the face when spraying around the neck/shoulders. - Repeat up to 3 times per day - Wash hands after use - Do not inhale CAUTION: DO NOT USE: - if Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mentholatum Deep Heat Spray Deep Heat Heat Spray Deep Heat Pain Relief Spray 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Methyl Nicotinate 1.60 %w/w_ _ 2-Hydroxyethyl Salicylate 5.00 %w/w Methyl Salicylate 1.00 %w/w_ _ Ethyl Salicylate 5.00 %w/w For excipients see 6.1 3 PHARMACEUTICAL FORM A pressurised container containing a clear colourless cutaneous spray solution with a characteristic odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of muscular pain, bursitis and tendinitis, including rheumatic pain, strains, sprains, fibrositis, lumbago and sciatica. Spray onto the affected parts when necessary before and after exercise. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND CHILDREN OVER 5 YEARS OF AGE Hold spray aperture about 15 centimetres (6 inches)_ _ from the skin of the affected area. Spray in 2-3 short bursts up to 3 times a day._ _ Not to be used on children under 5 years of age. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the ingredients. Hypersensitivity to aspirin or other non-steroidal anti-inflammatory drugs (including when taken by mouth) especially where associated with a history of asthma. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Do not use if you are allergic to any of the ingredients or medicines like aspirin. Consult your doctor before use if you are pregnant, breast-feeding, asthmatic or on any prescribed medicines. For external use only. Not to be sprayed onto broken skin. Avoid inhalation and contact with the eyes and sensitive areas of skin. Always try on a small area first. Always use sparingly since some people may experience discomfort particularly in those with sensitive skin or if used in hot weather or after a bath. Protect the face when spraying around the neck and shoulders. Discontinue use if excessive irritation or other unwanted effects occur. If symptoms persist consult your doctor. Not to be used on children under 5 years of age_._ Keep all medicines out of the re Llegiu el document complet