Država: Malta
Jezik: engleski
Izvor: Medicines Authority
METHYL SALICYLATE, MENTHOL
Colep Laupheim GmbH & Co.KG Fockestrasse 12, 88471 Laupheim, Germany
M02AX
METHYL SALICYLATE 30 % (W/W) MENTHOL 8 % (W/W)
CREAM
METHYL SALICYLATE 30 % (W/W) MENTHOL 8 % (W/W)
OTC
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
Authorised
2006-11-27
1 PATIENT INFORMATION LEAFLET DEEP HEAT MAX STRENGTH MENTHOL AND METHYL SALICYLATE 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 Deep Heat Max Strength 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 Deep Heat Max Strength is and what it is used for 2. Before you use Deep Heat Max Strength 3. How to use Deep Heat Max Strength 4. Possible side effects 5. How to store Deep Heat Max Strength 6. Further Information 1. WHAT DEEP HEAT MAX STRENGTH IS AND WHAT IT IS USED FOR Deep Heat Max Strength is a non-greasy, pain relieving cream to be applied to the skin. It is used for the relief of muscular pains and stiffness including: • Backache and lumbago • Sciatica (pain in the lower back and thigh) • Fibrositis (muscle tenderness or stiffness) • Rheumatic pain (in muscles, tendons, joints or bones) • Bruises • Sprains 2. BEFORE YOU USE DEEP HEAT MAX STRENGTH DO NOT USE DEEP HEAT MAX STRENGTH IF YOU HAVE AN ALLERGY • to any of the INGREDIENTS (see Section 6) • to PAINKILLERS such as aspirin, ibuprofen and other non-steroid AL ANTI-INFLAMMATORY DRUGS (NSAIDS). DO NOT USE DEEP HEAT MAX STRENGTH ON: • children under 5 years of age 2 • your eyes or other sensitive areas. If this occurs accidentally wash away with plenty of clean water • broken or inflamed skin. Deep Heat Max Strength is only for use on the skin. Do not take by mouth. TAKE SPECIAL CARE WITH DEEP HEAT MAX STRENGTH See your doctor before using Deep Heat Max Strength if you: • are pregnant or breastfeeding • have asthma. TAKING OTHER MEDICINES Please tell your doctor or pharmacist Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Deep Heat Maximum Strength Deep Heat Max Strength 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Methyl salicylate 30.00% w/w Menthol 8.00% w/w (Racementhol or Levomenthol) For excipients see 6.1 3. PHARMACEUTICAL FORM Cutaneous cream CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS For the symptomatic relief of muscular pains and stiffness, including backache, sciatica, lumbago, fibrositis, rheumatic pain, bruises and sprains. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Apply a thin layer with gentle massage to the affected area 2 to 3 times daily. Not to be used on children under 5 years of age. 4.3. CONTRA-INDICATIONS 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 The label will state: Do not use if you are allergic to any of the ingredients. Do not use if you have a history of asthma associated with allergic reaction to aspirin or other painkilling medicines known as non-steroidal anti-inflammatory drugs. Check with your doctor if you are unsure. Consult your doctor before use if: - you are pregnant or breast feeding - you are on blood thinning medicines For external use and only on unbroken skin. Always try on a small area first. Avoid contact with the eyes and sensitive areas of the skin. Some people may experience local discomfort if used during hot weather or after a hot bath. Not for use with occlusive dressings. Wash hands thoroughly after use. Discontinue use if excessive irritation occurs. Not to be used on children under 5 years of age. Keep all medicines out of the reach and sight of children. If symptoms persist consult your doctor. 4.5. INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Although no adequately controlled interaction studies have been undertaken, it is possible that excessive use of topical sali Pročitajte cijeli dokument