Full Prescribing Info
Each gram of cream contains Thiocolchicoside 2.5 mg.
Excipients/Inactive Ingredients: Carbomer 940, disodium EDTA, isopropyl alcohol, propylene glycol, glycerol, sodium hydroxide pellets, purified water, light liquid paraffin, isopropyl myristate, polyoxyl 40 hydrogenated castor oil.
Pharmacotherapeutic group: Muscle relaxant. ATC code: MO3BX05.
Pharmacology: Pharmacodynamics: Thiospas contains thiocolchicoside, which is a semi-synthetic sulphurated derivative of colchicoside, with myorelaxant pharmacological activity.
In-vitro, thiocolchicoside only binds to GABA-A and strychnine-sensitive glycine receptors. Thiocolchicoside acting as a GABA-A receptor antagonist, its myorelaxant effects could be exerted at the supra spinal level, via complex regulatory mechanism, although a glycinergic mechanism of action cannot be excluded. The characteristics of the interaction of thiocolchicoside with GABA-A receptors are qualitatively and quantitatively shared by its main circulating metabolite, the glucuronidated derivative.
Pharmacokinetics: Following topical administration of thiocolchicoside cream at recommended doses, the plasma levels of thiocolchicoside were below the minimum level determined.
This shows that after topical administration it has no systemic absorption and therefore also the level of tolerability is good.
Thiospas is indicated in lumbosacral sciatica (back pain), cervical-brachial neuralgia (pain and contracture of the neck, shoulder and upper limbs), stubborn stiff neck, post-traumatic and post-operative pain syndromes.
Adjuvant treatment of painful muscle contractures in acute spinal pathology in adults and adolescents from 16 years onwards.
Dosage/Direction for Use
Apply a quantity of cream according to the size of the area by gently rubbing in the affected skin area and surrounding area to be treated 2-3 times day. The treatment duration varies, but for most acute cases usually 7-10 days treatment is enough for recovering. The treatment duration is determined by a physician.
Children: The medicine is not recommended in children under 17 years.
Mode of administration: Topical.
No overdosage symptoms have been reported in patients treated with Thiocolchicoside. Should overdosage occurs, medical supervision and symptomatic measures are recommended.
Thiocolchicoside must not be used: In patients hypersensitive to the active substance or to any of the excipients used in the formulation.
Flaccid paralysis.
Muscular hypotonia.
During the entire pregnancy period.
During lactation.
In women of childbearing potential not using contraception.
Thiocolchicoside should be prescribed cautiously to people with H/O seizure.
Special Precautions
Thiocolchicoside is not recommended for use in children.
Treatment should be appropriately reduced in the event of occurrence of side effects.
The use, especially if prolonged, the products for topical use may give rise to sensitization phenomena. If they occur, the patient must stop treatment and appropriate therapy instituted.
Thiospas contains propylene glycol: May cause skin irritation.
Effects on Ability to Drive and Use Machines: Although after the administration of thiocolchicoside cream somnolence should be considered a very rare occurrence, it is necessary to take account of this possibility.
Use In Pregnancy & Lactation
Pregnancy: There are limited data on the use of thiocolchicoside in pregnant women. Therefore, the potential hazards for the embryo and foetus are unknown.
Studies in animals have shown teratogenic effects.
Thiocolchicoside cream is contraindicated during pregnancy and in women of childbearing potential not using contraception (see Contraindications).
Breast-feeding: Since it passes into the mother's milk, the use of thiocolchicoside is contraindicated during breastfeeding (see Contraindications).
Fertility: In a fertility study performed in rats, no impairment of fertility was seen at doses up to 12 mg/kg, i.e. at dose levels inducing no clinical effect. Thiocolchicoside and its metabolites exert aneugenic activity at different concentration levels, which is a risk factor for impairment of human fertility.
Adverse Reactions
There are reported cases of rash and skin rash. See also Precautions.
Rare cases of drowsiness have been reported (see Effects on Ability to Drive and Use Machines under Precautions).
Adverse Drug Reactions: Inform doctors about unexpected reactions after using drugs.
Drug Interactions
None are known.
Store in dry place, temperature below 30°C. Protect from direct sunlight. Do not freeze.
Shelf-Life: 24 months.
MIMS Class
Muscle Relaxants
ATC Classification
M03BX05 - thiocolchicoside ; Belongs to the class of other centrally-acting muscle relaxants.
Cream 0.25% (pale yellow to yellow color, viscous) x 30 g x 1's.
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