Country: Malta
Language: English
Source: Medicines Authority
MUCOPOLYSACCHARIDE POLYSULFURIC, ACID ESTER, SALICYLIC ACID
Genus Pharmaceuticals Limited Linthwaite, Huddersfied HD7 5QH, United Kingdom
M02AC
MUCOPOLYSACCHARIDE POLYSULFURIC ACID ESTER 0.2 % (W/W) SALICYLIC ACID 2 % (W/W)
GEL
MUCOPOLYSACCHARIDE POLYSULFURIC ACID ESTER 0.2 % (W/W) SALICYLIC ACID 2 % (W/W)
OTC
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
Withdrawn
2006-05-31
PACKAGE LEAFLET: INFORMATION FOR THE USER MOVELAT GEL mucopolysaccharide polysulphate (MPS) 0.2% w/w and salicylic acid 2.0% w/w Read all of this leaflet carefully before you start using this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness or injury are the same as yours. - If you get any side-effects, talk to your doctor or pharmacist. This includes any possible side-effects not listed in this leaflet. What is in this leaflet 1. What Movelat Gel is and what it is used for 2. What you need to know before you use Movelat Gel 3. How to use Movelat Gel 4. Possible side-effects 5. How to store Movelat Gel 6. Contents of the pack and other information 1. WHAT MOVELAT GEL IS AND WHAT IT IS USED FOR Movelat Gel contains the active substances mucopolysaccharide polysulfate (MPS) and salicylic acid. Movelat Gel is a mild to moderate anti-inflammatory and analgesic (pain-relieving) preparation which, when applied to the skin, provides relief from muscular pain and stiffness, sprains and strains, and pain due to rheumatic and non-serious arthritic conditions. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE MOVELAT GEL Do not use Movelat Gel: • if you are allergic (hypersensitive) to mucopolysaccharide polysulfate, salicylic acid (or any other aspirin-like medicine) or other related painkillers known as non-steroidal anti-inflammatory drugs (NSAIDS). This is particularly important if you suffer from asthma • if you are allergic to any of the other ingredients of Movelat Gel (listed in section 6) • if you have broken skin, infected skin or eczema • on large areas of skin • on or near sensitive areas such as the mouth, eyes or ano-genital regions. Movelat Gel should NOT be used on children under the age of 12 years old. Warnings and precautions - Movelat Gel is for exte Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Movelat Gel Movelat Relief Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Mucopolysaccharide polysulphate (MPS) 0.2% w/w Salicylic acid 2.0% w/w For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Topical Gel. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Movelat/Movelat Relief is a mild to moderate anti-inflammatory and analgesic topical preparation for the symptomatic relief of muscular pain and stiffness, sprains and strains and pain due to rheumatic and non-serious arthritic conditions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS OF AGE: Two to six inches (5 -15 cm) to be applied to the affected area up to four times a day. CHILDREN: The use of Movelat/Movelat Relief is contra-indicated in children under 12 years of age. 4.3 CONTRAINDICATIONS Keep away from the eyes. Not to be used on large areas of skin, broken or sensitive skin, infected skin, eczema or on mucous membranes. Not to be used on children under 12 years of age. Hypersensitivity to the active substance(s) 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. Not to be used on the breast area during lactation (see section 4.6). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE For external use only. The stated dose should not be exceeded. If the condition persists or worsens, consult a doctor or pharmacist. Although systemic absorption of topical salicylate is much less than for oral dosage forms, the side effects of salicylates are theoretically possible. Consult a doctor or pharmacist before use if pregnant, breast-feeding, asthmatic have pre-existing renal damage or on any prescribed medicines. 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. Discontinue u Read the complete document