SPASMEX ® Floroglucina bihydrate

SPASMEX ® is a drug based on floroglucine bihydrate

THERAPEUTIC GROUP: Spasmolytics / drugs for disorders of intestinal function

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications SPASMEX ® Floroglucina bihydrate

SPASMEX ® is indicated for the symptomatic treatment of spastic pain in the smooth muscles of the gastrointestinal, urogenital and biliary tracts.

Mechanism of action SPASMEX ® Floroglucina bihydrate

SPASMEX ® characterized by a very short plasma half-life (15 minutes), once absorbed tends to concentrate mainly on the gastro-intestinal, uro-genital and biliary tract, where it will carry out its therapeutic action.

The efficacy of SPASMEX ® in the treatment of spasm is linked to the presence of the active ingredient floroglorchine / floroglucinol, characterized by a spasmolytic activity directed towards the smooth muscular fibrocells of the aforementioned anatomical districts. The biological mechanism underlying this property involves the inhibition of the catechol-o-methyl-transferase enzyme, important in the normal metabolism of catecholamines, responsible for spasm.

Studies carried out and clinical efficacy

1 SPASMEX AND CISTITE

SPASMEX has proved particularly effective in rapidly relieving pain symptoms, improving quality of life, reducing temporary disability in women with interstitial cystitis. The anticholinergic and spasmolytic effect against the smooth muscles of the uro-genital apparatus was the biological basis to explain this important success.

2. SPASMEX AND URINARY INCONTINENCE

This study conducted on 193 patients suffering from urinary incontinence, showed how the use of SPASMEX for 12 weeks can guarantee a reduction in the daily number of evacuations and incontinence episodes, proving more effective than other drugs of the same pharmaceutical category but with different active principle.

3. CISAPRIDE And dyspepsia

This Russian study of 62 patients shows that treatment with SPASMEX may be particularly effective in reducing the number of urinary evacuations in patients with overactive bladder and in significantly increasing bladder volume. The most observed side effect was the onset of constipation.

Method of use and dosage

SPASMEX ® tablets: we recommend taking 6 tablets a day

SPASMEX ® suppositories: we recommend taking 3 compressed per day

Warnings SPASMEX ® Floroglucina bihydrate

Unfortunately, or fortunately, no particular reports have yet been received regarding the use of SPASMEX ® therefore it is strongly advised to keep the drug out of the reach of children, not to exceed the indicated doses, to consult your doctor before using it and not to associate it with other major painkillers.

SPASMEX ® tablets have a source of lactose, so it would be important to carefully evaluate its use in patients with lactose intolerance.

As with other anticholinergics, particular attention should be paid to glaucoma, pyloric stenosis, prostatic hypertrophy, intestinal atony, the elderly, reflux esophagitis, severe ulcerative colitis, myasthenic syndromes.

PREGNANCY AND BREASTFEEDING

The absence of side effects on the health of the child or mother does not place any restriction on use in the event of pregnancy and breastfeeding. Nevertheless it would always be advisable to use SPASMEX ® in case of real need and after consulting your doctor.

There are no studies in the literature that show the effects of SPASMEX ® during the first trimester of pregnancy, therefore in this period it would be better to avoid taking them.

Interactions

At the moment there are no studies showing significant interactions or incompatibility between SPASMEX ® of other drugs; it would however be advisable to avoid the simultaneous administration of other major painkillers, antihistamines, tricyclic antidepressants, fenotizaine, amantidine, butyrophenomas, which could enhance the therapeutic and toxic effects of the active ingredient.

Contraindications SPASMEX ® Floroglucina biidrata

It would be advisable to avoid taking SPASMEX ® in case of hypersensitivity to the drug or to one of its components.

Undesirable effects - Side effects

In case of hypersensitivity to one of its components, various skin allergic reactions may occur.

The anticholinergic action could cause dry mouth, decreased sweating, mydriasis, disturbance of accommodation, increased ocular tone, urinary retention, constipation and drowsiness.