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  • Spasmex
    / Tec-O-Pharm


    Active Ingredient
    Trospium Chloride 15 mg, 30 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    30 X 15 mg

    partial basket chart 64797 19755

    Film Coated Tablets

    30 X 30 mg

    partial basket chart 21296 19923

    Related information


    Dosage

    Dosage for 15 mg: The recommended dose is 3 times a day 1 film-coated tablet (corresponding to a daily dose of 45 mg trospium chloride). The film coated tablets are to be swallowed whole with a sufficient quantity of liquid. There is no limit for the duration of the treatment if the drug is well tolerated.
    Dosage for 30 mg: One tablet (30mg) in the morning. If needed, half a tablet (15mg) may be added in the evening. In patients with severely impaired renal function (Creatinine clearance between 10 and 30 ml/ min/ 1.73 m² ) a daily dose of 15 mg should not be exceeded. Spasmex 30 is contra-indicated in children below 12 years of age.
    Mode and duration of treatment: The film-coated tablets should be swallowed whole with a sufficient quantity of liquid before a meal on an empty stomach. The necessity of a continuation of treatment should be monitored at regular intervals of 3 – 6 months.
    For full details see prescribing information.


    Indications

    For the treatment of vegetative bladder dysfunction accompanied by urgency and/or frequency and/or urinary incontinence.


    Contra-Indications

    Mechanical stenosis of the G.I. tract. Retention of urine in prostatic adenoma. Narrow-angle glaucoma, tachyarrhythmia and myasthenia gravis.
    Spasmex 30 is contra-indicated in patients with: Hypersensitivity to the active ingredient trospium chloride or any of the excipients, Urinary retention, Narrow-angle glaucoma, Tachyarrhythmia, Myasthenia gravis, Severe chronic inflammatory bowel disease (ulcerative colitis or Crohn’s disease), Toxic megacolon, Renal impairment requiring dialysis (Creatinine clearance < 10 ml/ min/1.73 m²). Children below the age of 12 years.


    Special Precautions

    Special care should be taken with trospium chloride in patients with – an obstruction in the gastro-intestinal tract (e.g. pyloric stenosis) – obstructed passage of urine outflow with the risk of residual urine – autonomous neuropathy – hiatus hernia with reflux oesophagitis – as well as in patients where a fast heart rate is not desired e.g. those with thyroid hyperactivity, coronary heart disease and heart insufficiency. The use of trospium chloride is not recommended in patients with impaired liver function, as there is no available data. Trospium chloride is mainly excreted via the kidneys. In patients with severely impaired renal function notable increases in plasma levels were observed. Therefore in this patient group, even by only mild to moderately impaired kidney function, treatment should only be commenced with caution. Before starting treatment, organic causes of urinary frequency, urgency , and urge incontinence, such as heart or kidney disorders, polydipsia, as well as infections and tumours in the urinary organs should be excluded. Patients suffering from the rarely observed hereditary galactose intolerance, lactase deficiency or glucose-galactose-malabsorption should not take Spasmex 30.
    Effects on ability to drive & use machines: Due to accommodation disturbances the ability to drive or operate machines may be impaired.


    Side Effects

    Side effects may occur due to the anticholinergic properties of Spasmex 15, such as decreased secretion of sweat and saliva, gastrointestinal disorders, urinary retention and disorder of heart-rate. Other side effects which may occur are accommodation disturbances of the eyes, particularly in patients with hypermetropia who are visually not sufficiently corrected. One case of an allergic reaction (anaphylaxis) due to the active ingredient was reported.
    For full details see prescribing information.


    Drug interactions

    The following interactions may occur: Increase in the anticholinergic effect of amantadine, tricyclic antidepressants, quinidine, antihistamines and disopyramide as well as an, Increase in the tachycardic effect of ß-sympathomimetics, Decrease in the effect of prokinetics (e.g. metoclopramid and cisaprid). Because trospium chloride influences the gastro-intestinal motility and secretion it can not be ruled out that the ingestion of concurrently taken drugs will not be changed. During concurrent intake of medicines that contain substances such as Guar, colestyramine and colestipol, it can not be ruled out that the resorption of trospium chloride will not be reduced. Therefore the concurrent use of medications which contain these substances is not recommended. Investigations into metabolic interactions connected with trospium chloride were examined in vitro using cytochrome P-450 enzymes which are involved in the metabolism of drug substances (P450 1A2, 2A6, 2C6, 2C9, 2C19, 2D6, 2E1, 3A4). Thereby no influence by trospium chloride could be determined on the metabolic activities. Due to the fact that trospium chloride is only metabolised to a small extent, and that an ester hydrolysis represents the only relevant metabolic pathway, no interactions as a consequence of metabolism are to be expected. In addition, neither clinical studies nor pharmacovigilance have revealed data which indicate clinically relevant interactions.
    For full details see prescribing information.


    Pregnancy and Lactation

    No evidence of malformation was found in animal studies. Nonetheless, Spasmex 15 should not be taken during pregnancy or when nursing a child unless absolutely necessary because of the lack of experience with this drug in humans. Trospium chloride passes the placental barrier and is excreted into the breast milk.
    For full details see prescribing information.


    Overdose

    The highest single dose of trospium chloride which has been given to humans orally is 360 mg. Dry mouth, tachycardia and micturition disturbances were observed. Cases of severe overdose or intoxication with trospium chloride have not been reported up till now. Expected signs of an overdose are increased anticholinergic symptoms such as visual disturbances, tachycardia, a dry mouth and reddening of the skin.
    Upon presentation of an overdose, the following measured should be taken: Gastric lavage and impairment of resorption (e.g. activated charcoal), Local application of pilocarpine in patients with glaucoma, Catheterisation by urinary retention, Administration of a parasympathomimetic in severe cases (e.g. neostigmine), Administration of beta-ß-blockers in cases of insufficient response, manifest tachycardia and/ or circulatory instability (e.g. starting with 1 mg Propanolol i.v. under ECG and blood pressure surveillance).


    Manufacturer
    Dr. Pfleger Chemische Fabrik GmbH
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