Movelat Relief Cream
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 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.
Salicylic acid may increase skin permeability for other topically applied medications (see section 5.1).
4.6 Fertility, pregnancy and lactation
As with most medicines, patients must seek the doctor's or pharmacist’s advice before using if they are pregnant or breast feeding.
Pregnancy
Do not use during the first trimester or during late pregnancy.
Breastfeeding
Not to be used on the breast area during lactation.
4.7 Effects on ability to drive and use machines
None
4.8 Undesirable effects
In this section, frequencies of undesirable effects are defined as follows: Very common (> 1/10); common (> 1/100 to < 1/10); uncommon (> 1/1,000 to < 1/100); rare (> 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Skin and subcutaneous tissue disorders
Uncommon: Local skin reactions/irritations (e.g. redness, burning sensation or rashes).
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
Overdose associated with localised/topical application is unlikely.
Following accidental ingestion of Movelat/Movelat Relief, 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
Pharmacotherapeutic group: topical agent used in the treatment of myalgia and arthralgia.
ATC code: D02AF (Salicylic acid preparations).
The Mucopolysaccharide polysulphate component of Movelat/Movelat Relief 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 for its keratolytic activity. Salicylic acid also has anti-inflammatory and analgesic properties.
Due to the route of administration and topical nature of the product, the effects of mucopolysaccharide and salicylic acid are topical/localised only.
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 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
6.1 List of excipients
Glycerol 85%
Stearic acid
Anhydrous eucerine
Myristyl alcohol
Emulsifying cetostearyl alcohol
Ethanolamine
Thymol
Isopropyl alcohol 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 06831/0176
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
24/05/2006
10 DATE OF REVISION OF THE TEXT
04/08/2016