1. Name Of The Medicinal Product
Transvasin Heat Rub Cream
Boots Pain Relief Heat Rub
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Cream
4. Clinical Particulars
4.1 Therapeutic Indications
For the relief of rheumatic and muscular pain and the symptoms of sprains and strains.
4.2 Posology And Method Of Administration
Route of administration: Cutaneous
Directions for use
Massage gently into the affected area until the cream is entirely absorbed. Apply at least twice daily until the symptoms abate.
Adults, Children and the Elderly
Quantities are not critical and are not specified on the data sheet. The amount used should be consistent with the directions for use, and will vary with the size of the treated area.
4.3 Contraindications
Sensitivity to the product or any of its ingredients.
4.4 Special Warnings And Precautions For Use
Transvasin/Boots Pain Relief Heat Cream should not be applied to broken or sensitive skin, for example around the eyes or scrotal skin. Avoid use on mucous membranes.
For external use only.
Transvasin/Boots Pain Relief Heat Cream is a rubefacient and within a few minutes of application a sensation of warmth is felt, followed by a reddening of the skin. This erythema does not indicate intolerance.
Discontinue use if rash develops.
Hands should be washed immediately after use.
Not for use with occlusive dressings.
Patients are advised against excessive exposure to sunlight of treated areas in order to avoid the possibility of photosensitivity.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
Although there have been no reports of adverse effects, as with all medicines, care should be taken when administering to pregnant or lactating women.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
Reported effects have taken the form of localised sensitisation reactions and have invariably subsided following withdrawal of the medication.
4.9 Overdose
As this is a topical application, with small amounts of actives, adverse systemic effects are unlikely, even after oral ingestion.
Treatment:
No special measures are necessary.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Hexyl Nicotinate and Ethyl Nicotinate are rubefacients. Tetrahydrofurfuryl Salicylate is used for musculoskeletal, joint, peri-articular and soft tissue disorders.
5.2 Pharmacokinetic Properties
None stated.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Purified Water Ph Eur
Methylhydroxybenzoate Ph Eur
Cetostearyl Alcohol BP
Stearic Acid 1973 BPC
Polysorbate 20 Ph Eur
Sorbitan Monostearate BP
Perfume
6.2 Incompatibilities
None known
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
Do not store above 25°C.
6.5 Nature And Contents Of Container
Collapsible aluminium tubes with membrane, containing 3, 3.5, 5, 7.5, 10, 30, 40, 45, 80 or 120g of product with a polyamide-imide lacquer internal coating and polypropylene piercer cap packed in a cardboard outer.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Thornton & Ross Ltd
Linthwaite
Huddersfield
West Yorkshire
HD7 5QH
United Kingdom
8. Marketing Authorisation Number(S)
PL 00240/0062
9. Date Of First Authorisation/Renewal Of The Authorisation
12th April 2004
10. Date Of Revision Of The Text
21.01.2008
11 DOSIMETRY (IF APPLICABLE)
Not Applicable
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)
Not Applicable
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