SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Movelat Gel Movelat Relief Gel Movelat Relief Sport Gel

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Mucopolysaccharide polysulphate (MPS)    0.2% w/w

Salicylic acid    2.0% w/w

3    PHARMACEUTICAL FORM

Topical Gel.

4    CLINICAL PARTICULARS

4.1 Therapeutic indications

Movelat/Movelat Relief/Movelat Relief Sport is a mild to moderate antiinflammatory and analgesic topical preparation for the symptomatic relief of muscular pain and stiffness, sprains and strains and pain due to rheumatic and nonserious arthritic conditions.

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/Movelat Relief Sport is contra-indicated in children under 12 years of age.

4.3 Contraindications

Not to be used on large areas of skin, broken or sensitive skin or on mucous membranes. Not to be used on children under 12 years of age. Not to be used in individuals with a known sensitivity to any active or inactive component of the formulation.

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

For external use only. The stated dose should not be exceeded. If the condition persists or worsens, consult a Doctor. 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 before use if pregnant, breast-feeding, asthmatic 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 use if excessive irritation or other unwanted effects occur.

4.5 Interaction 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 salicylates may increase the effect of coumarin anticoagulants. It is therefore advisable that caution be exercised with patients who are taking coumarin anticoagulants.

Do not use during the first trimester or during late pregnancy. As with most medicines, patients must seek the doctor’s advice before using if they are pregnant or breast feeding.

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

Allergic skin reactions (which may include redness, burning sensation or rashes) may occur in individuals sensitive to salicylates.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Following accidental ingestion of Movelat/Movelat Relief/Movelat Relief Sport, individuals may present with the symptoms of salicylate poisoning (hyperventilation, tinnitus, deafness, vasodilation, sweating). The stomach should be emptied and plasma salicylate, plasma pH and electrolytes should be monitored. Forced alkaline diuresis may be required if the plasma salicylate levels are in excess of 500 mg/litre (3.6 mmol/litre) in adults or 300 mg/litre (2.2 mmol/litre) in children.

5.1 Pharmacodynamic properties

The Mucopolysaccharide polysulphate component of Movelat/Movelat Relief/Movelat Relief Sport is recognised as having:

A weak inhibitory effect of PGE₂ synthesis and an indirect effect on LTB₄ production based on in vitro studies.

Anti-coagulant activity: as a heparinoid.

Thrombolytic activity: through potentiation of urokinase activity.

Anti-exudatory activity: through inhibition of hyaluronidase.

Salicylic acid is employed in the formulation of Movelat/Movelat Relief/Movelat Relief Sport for its keratolytic activity.

5.2 Pharmacokinetic properties

Radiochemical studies of absorption following cutaneous application of mucopolysaccharide polysulphate have shown that between 0.3 and 4% of the mucopolysaccharide administered is absorbed by tissues other than at the site of application within the first eight hours. Typically between 1.7% and 4.6% will be absorbed within two to four days. Animal studies have also shown that mucopolysaccharide is bound intracellularly within the subcutis. Peak serum concentrations following cutaneous application are below the threshold of physiological relevance for coagulation.

Mucopolysaccharide is excreted in the urine partly unchanged and partly as depolymerized, shorter chain length molecules.

The plasma level of salicylic acid following cutaneous application of Movelat/Movelat Relief/Movelat Relief Sport has been shown to remain constant at approximately 0.2 pg/ml even after repeated dosing. The total excretion of salicylate reaches a constant figure of approximately 12 mg/day. Over a seven-day period, approximately 6.9% of the administered dose is excreted renally, primarily as salicylic acid.

5.3 Preclinical safety data

None stated.

PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Isopropyl alcohol Monoethanolamine Carbomer (Carbopol 940)

Disodium edetate (Titriplex III) Polyethylene glyceryl-oleate (Tagat O) Rosemary oil Purified water

6.2    Incompatibilities

None.

6.3    Shelf life

5 years.

6.4    Special precautions    for storage

Store below 25°C.

6.5    Nature and contents    of container

Lacquered aluminium tubes.

Pack sizes: 14, 40, 50, 80, 100, 125 g

6.6 Special precautions for disposal

Not applicable.

7    MARKETING AUTHORISATION HOLDER

Genus Pharmaceuticals Limited

T/A Genus Pharmaceuticals

Linthwaite

Huddersfield

HD75QH

UK

8    MARKETING AUTHORISATION NUMBER(S)

PL 06831/0177

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

24/05/2006

10 DATE OF REVISION OF THE TEXT

09/04/2015