Movelat Gel/Movelat Relief Gel

Country: Malta

Language: English

Source: Medicines Authority

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Active ingredient:

MUCOPOLYSACCHARIDE POLYSULFURIC, ACID ESTER, SALICYLIC ACID

Available from:

Genus Pharmaceuticals Limited Linthwaite, Huddersfied HD7 5QH, United Kingdom

ATC code:

M02AC

INN (International Name):

MUCOPOLYSACCHARIDE POLYSULFURIC ACID ESTER 0.2 % (W/W) SALICYLIC ACID 2 % (W/W)

Pharmaceutical form:

GEL

Composition:

MUCOPOLYSACCHARIDE POLYSULFURIC ACID ESTER 0.2 % (W/W) SALICYLIC ACID 2 % (W/W)

Prescription type:

OTC

Therapeutic area:

TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN

Authorization status:

Withdrawn

Authorization date:

2006-05-31

Patient Information leaflet

                                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
                                
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Summary of Product characteristics

                                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
                                
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