Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Methyl Salicylate ; Racementhol; Eucalyptus Oil; Turpentine oil
The Mentholatum Company Ltd.
M02AC
Methyl Salicylate ; Racementhol; Eucalyptus Oil; Turpentine oil
0 percent weight/weight
Cream
Product not subject to medical prescription
Preparations with salicylic acid derivatives
Marketed
1990-07-16
Cream Patient Information Leaflet 212mm 42mm 20mm 140mm Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. Nevertheless you still need to use Mentholatum Deep Heat Cream carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • You must see a doctor if your symptoms do not improve. • If any of the side effects become serious or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Mentholatum Deep Heat Cream is and what it is used for 2. Before you use Mentholatum Deep Heat Cream 3. How to use Mentholatum Deep Heat Cream 4. Possible side effects 5. How to store Mentholatum Deep Heat Cream 6. Further information 1. WHAT MENTHOLATUM DEEP HEAT CREAM IS AND WHAT IT IS USED FOR Mentholatum Deep Heat Cream is a non-greasy, pain relieving cream to be applied to the skin. It is used for the relief of muscular pains including: • Fibrositis (muscle tenderness or stiffness) • Muscle strains • Arthroses (pain in the joints) 2. BEFORE YOU USE MENTHOLATUM DEEP HEAT CREAM DO NOT USE MENTHOLATUM DEEP HEAT CREAM IF YOU HAVE AN ALLERGY • to any of the INGREDIENTS (see end of Section 2 and Section 6) • to PAINKILLERS such as ASPIRIN, IBUPROFEN and other NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS). DO NOT USE MENTHOLATUM DEEP HEAT CREAM ON: • children under 5 years of age • your eyes or other sensitive areas. If this occurs accidentally wash away with plenty of clean water • broken or inflamed skin. Mentholatum Deep Heat Cream is only for use on the skin. Do not take by mouth. TAKE SPECIAL CARE WITH MENTHOLATUM DEEP HEAT CREAM See your doctor before using Mentholatum Deep Heat Cream if you: • are pregnant or breastfeeding • have asthma. TAKING OTHER MEDICINES Please tell your doctor or pharmacist if you are taking or have recently taken any other medicin Прочитать полный документ
Health Products Regulatory Authority 25 September 2018 CRN008N67 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mentholatum Deep Heat Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Methyl salicylate 12.80 %w/w Racemic menthol 5.91 %w/w Eucalyptus oil 1.97 %w/w Turpentine oil 1.47 %w/w Excipients - contains wool fat (lanolin) 0.5% w/w, cetostearyl alcohol 18% w/w and propylene glycol 1.0% w/w. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Cream White cream with an odour of menthol and methyl salicylate. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the local management of the symptoms of fibrositis, muscle strains and arthroses. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For adults and children over 5 years. Directions for use: Apply a thin layer to the affected part with gentle massage 2 to 3 times daily. 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 Health Products Regulatory Authority 25 September 2018 CRN008N67 Page 2 of 4 Do not use of 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 and only on unbroken skin. Avoid contact with the eyes and sensitive areas of the skin. Always try on a small area first. Some people may experience discomfort particularly those with sensitive skin or if used in hot weather or after a bath. Wash hands immediately after use. Mentholatum Deep Heat Cream contains propylene glycol which may cause skin irritation and wool fat (lanolin) and cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis). Discontinue use if excessive irritation or other unwanted effects occur. If symptoms persist consult your doctor. Not to be used on ch Прочитать полный документ