- Approval Id
- 65d010ad18c5c038
- Drug Approval Emc Name
- Movelat Cream
- Drug Name
- Movelat Cream
- Company Address
- Linthwaite, Huddersfield, West Yorks, HD7 5QH
- Company Website
- http://www.thorntonandross.co.uk
- Company Medical Info Direct Line
- +44 (0) 1484 848164
- Company Medical Info Email
- thorntonross@medinformation.co.uk
- Company Customer Care Direct Line
- +44(0)1484 848200
- Atc Code
- M02AC
- Legal Category
- Pharmacy
- Authorisation Holder
- Thornton & Ross Ltd.
Linthwaite
Huddersfield
HD7 5QH
UK
- Authorisation Number
- PL 00240/0552
- Authorisation Date
- 24/05/2006
- Instruction Authorisation Holder
- Thornton & Ross Ltd.
Linthwaite
Huddersfield
HD7 5QH
UK
- Instruction Authorisation Number
- PL 00240/0552
- Instruction Authorisation Date
- 24/05/2006
- Instruction Composition
- | | |
| --- | --- |
| Mucopolysaccharide polysulphate (MPS) Salicylic acid | 0.2% w/w 2.0% w/w |
| \*\*Excipients with known effect:\*\* | |
| Cetostearyl alcohol Eucerin Anhydrous (containing Lanolin) | 2.25% w/w 8.25% w/w |
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Topical Cream.
- Instruction 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.
Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
\*\*Ingredients with specified warnings\*\*
This medicine contains cetostearyl alcohol and lanolin which may cause local skin reactions (e.g. contact dermatitis).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
None4.8 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 or search for 'MHRA Yellow Card' in the Google Play or Apple App Store4.9 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.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic group: topical agent used in the treatment of myalgia and arthralgia.
ATC code: M02AC (Topical Products for Joint and Muscular Pain – Preparations with salicylic acid derivatives).
Mucopolysaccharide polysulphate is a non-steroidal drug recognised as having:
• Anti-inflammatory activity: through 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, a non-steroidal anti-inflammatory drug, is employed in the formulation for its keratolytic activity; and 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 μg/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.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Glycerol 85%
Stearic acid
Anhydrous eucerine (Containing Lanolin)
Myristyl alcohol
Emulsifying cetostearyl alcohol
Ethanolamine
Thymol
Isopropyl alcohol
Purified water6.2 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 g6.6 Special precautions for disposal and other handling
Not applicable.
- Instruction Content
- ## Composition
| | |
| --- | --- |
| Mucopolysaccharide polysulphate (MPS) Salicylic acid | 0.2% w/w 2.0% w/w |
| \*\*Excipients with known effect:\*\* | |
| Cetostearyl alcohol Eucerin Anhydrous (containing Lanolin) | 2.25% w/w 8.25% w/w |
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Topical Cream.
## 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.
Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
\*\*Ingredients with specified warnings\*\*
This medicine contains cetostearyl alcohol and lanolin which may cause local skin reactions (e.g. contact dermatitis).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
None4.8 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 or search for 'MHRA Yellow Card' in the Google Play or Apple App Store4.9 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.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: topical agent used in the treatment of myalgia and arthralgia.
ATC code: M02AC (Topical Products for Joint and Muscular Pain – Preparations with salicylic acid derivatives).
Mucopolysaccharide polysulphate is a non-steroidal drug recognised as having:
• Anti-inflammatory activity: through 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, a non-steroidal anti-inflammatory drug, is employed in the formulation for its keratolytic activity; and 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 μg/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
Glycerol 85%
Stearic acid
Anhydrous eucerine (Containing Lanolin)
Myristyl alcohol
Emulsifying cetostearyl alcohol
Ethanolamine
Thymol
Isopropyl alcohol
Purified water6.2 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 g6.6 Special precautions for disposal and other handling
Not applicable.
- Company Detail Path
- /organization/thornton-and-ross-ltd
