País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Methyl salicylate; Racementhol; Eucalyptus oil; Turpentine oil
Colep Laupheim GmbH & Co KG
M02AC
Methyl salicylate; Racementhol; Eucalyptus oil; Turpentine oil
0 percent weight/weight
Cream
Preparations with salicylic acid derivatives
Marketed
1990-07-16
PACKAGE LEAFLET : INFORMATION FOR THE USER MENTHOLATUM DEEP HEAT CREAM READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE 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 is your symptoms do not improve. - If any side effects become serious or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. WHAT IS 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 menthol, eucalyptus oil, methyl salicylate, turpentine oil or any of the other ingredients in this medicine (listed in 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 Do not smoke or go near nak Llegiu el document complet
Health Products Regulatory Authority 20 February 2020 CRN009JFH Page 1 of 3 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 the active substances or to any of the excipients listed in section 6.1 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 and only on unbroken skin. Avoid contact with the eyes and sensitive areas of 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. This medicine contains 1mg propylene glycol in each 100mg which is equivalent to 10mg in 1g of cream. Propylene glycol may cause skin irritation. This medicine contains 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 per Llegiu el document complet