Spasmed® 5, 15
tablets
![SpasmedRR 5, 15](javascript:obrazek_big("http://promedcs.cz//en/../img/baleni/600_spasmed(1).jpg", "en"); "SpasmedRR 5, 15")
- Manufacturer:
- PRO.MED.CS Praha a.s.
- Marketing authorisation holder:
- PRO.MED.CS Praha a.s.
- Composition:
- Trospium chloride 5 mg or 15 mg in 1 tablet
- Indication group:
- spasmolytic, anticholinergic agent
The following information is for health professionals only.
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Characteristics:
Trospium chloride a quaternary ammonium derivate belongs to the group of parasympatolytic components.It is a competitive antagonist of acetylcholine on muscarine receptors, especially M1 and M3 and it causes relaxation of detrusor smooth muscle. Trospium lead to increase in maximum urinary bladder capacity, number of episodes of urge incontinence and micturation frequency are decreased. Trospium do not readily pass the blood-brain barrier, accordingly incidence of central nervous system-related adverse effects is very low. Prior to the beginning of Spasmed® tbl. therapy, it is necessary exclude hormonally and organically conditioned disorders of the urinary bladder emptying.
Indications:
Symptomatic treatment in functional disorders of the urinary bladder (detrusor instability) as well as in spastic neurogenic bladder due to supranuclear lesion of the spinal cord (detrusor hyperreflexia). The symptoms comprise polakisuria, urgency and urge incontinence.
Contraindications:
Hypersensitivity to any component. Urine retention of organic origin (prostatic hypertrophy, tumour, stricture of urethra). Disorders of the intestinal motility and intestine obstruction. Narrow- angle glaucoma. Myasthenia gravis. Tachyarrhythmia. Children bellow 14 years of age. Spasmed® 5, 15 can be administered in pregnancy and lactation only if really necessary.
Undesirable effects:
Spasmed® tbl. is usually well tolerated. Dryness in the mouth, sweating suppression, feeling of fullness in the stomach, obstipation and tachyarrhythmia, blurred vision can appear, urine retention especially in higher doses.
Interactions:
The anticholinrgic effect of tricyclic antidepressants, quinidine, antihistamines, disopyramide, amantadine as well as the tachycardic effect of β-sympatomimetics may be increased by concomitant treatment with Spasmed® 5,15. Caution: Due to accommodation disturbances the ability to drive or operate machines may be impaired. Prior to commencement of treatment it is necessary to exclude organically conditioned disorses of the urinary bladder emptying. The preparation is not suitable for incontinence caused by stress relaxation of the sfincters.
Dosage:
It depends on the severity of the illness and the patient’s response to therapy. Recommended initial dose 15 -30 mg daily may be increased to 45 mg daily (divided in 3 doses).
When really necessary the maximum daily dose is 135 mg. The tablets are to the swallowed unchewed and sufficiently washed down .
Package:
30 or 50 tablets of 5 mg,
30 or 50 tablets of 15 mg.
Complete information about the preparation is included in the drug information sheet.
Date of the latest revision of the text: November 3, 2004
The preparation is available on medical prescription only.