Movelat Cream/Movelat Relief Cream

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

MUCOPOLYSACCHARIDE POLYSULFURIC, ACID ESTER, SALICYLIC ACID

Disponível em:

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

Código ATC:

M02AC

DCI (Denominação Comum Internacional):

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

Forma farmacêutica:

CREAM

Composição:

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

Tipo de prescrição:

OTC

Área terapêutica:

TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN

Status de autorização:

Withdrawn

Data de autorização:

2006-05-31

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
MOVELAT CREAM
mucopolysaccharide polysulfate (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 Cream is and what it is used for
2. What you need to know before you use Movelat Cream
3. How to use Movelat Cream
4. Possible side-effects
5. How to store Movelat Cream
6. Contents of the pack and other information
1. WHAT MOVELAT CREAM IS AND WHAT IT IS USED FOR
Movelat Cream contains the active substances mucopolysaccharide
polysulfate (MPS)
and salicylic acid.
Movelat Cream 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 CREAM
Do not use Movelat Cream:
• 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
Cream (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 Cream should NOT be used on children under the age of 12 years
old.
Warnings and precautions
-

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Movelat Cream
Movelat Relief Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mucopolysaccharide polysulphate (MPS)
0.2% w/w
Salicylic acid
2.0% w/w
Excipients with known effect:
Cetostearyl alcohol and wool alcohol ointment.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Topical Cream.
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 massaged 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