TROSPIUM CHLORIDE Film-coated tablet (2018)
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Περιεχόμενα
Name of the medicinal product
Trospium chloride 20mg film-coated tablets.
Qualitative and quantitative composition
The active ingredient is trospium chloride. Each film-coated tablet contains 20 mg of trospium chloride. Excipients with known effect: Each film-coated tablet contains 10 mg of lactose monohydrate and ...
Pharmaceutical form
Film-coated tablet. Brownish yellow to light brown round, biconvex film-coated tablets, debossed with L on one side and l on other side.
Therapeutic indications
Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder (e.g. idiopathic or neurologic detrusor overactivity).
Posology and method of administration
Posology One film-coated tablet twice daily (equivalent to 40 mg of trospium chloride per day). The need for continued treatment should be reassessed at regular intervals of 3-6 months. Patients with renal ...
Contraindications
Trospium chloride is contraindicated in patients with urinary retention, severe gastro-intestinal condition (including toxic megacolon), myasthenia gravis, narrow-angle glaucoma, and tachyarrhythmia. ...
Special warnings and precautions for use
Trospium chloride should be used with caution by patients: with obstructive conditions of the gastrointestinal tract such as pyloric stenosis, with obstruction of the urinary flow with the risk of formation ...
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions The following potential pharmacodynamic interactions may occur: Potentiation of the effect of drugs with anticholinergic action (such as amantadine, tricyclic antidepressants) ...
Pregnancy and lactation
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). In rats, placental transfer ...
Effects on ability to drive and use machines
Principally, disorders of accommodation can lower the ability to actively participate in road traffic and to use machines. However, examinations of parameters characterising the ability to participate ...
Undesirable effects
Undesirable effects observed with trospium chloride such as dry mouth, dyspepsia and constipation mainly reflect the typical anticholinergic properties of the active ingredient. In Phase-III clinical studies, ...
Overdose
After administration of a maximum single dose of 360 mg trospium chloride to healthy volunteers, dryness of the mouth, tachycardia and disorders of micturition were observed to an increased extent. No ...
Pharmacodynamic properties
Pharmacotherapeutic group: Urologicals, Urinary Antispasmodics ATC code: G04BD09 Trospium chloride is a quaternary derivative of nortropane and therefore belongs to the class of parasympatholytic or anticholinergic ...
Pharmacokinetic properties
Absorption After oral administration of trospium chloride, maximum plasma levels are reached at 4-6 hours. Following a single dose of 20mg the maximum plasma level is about 4ng/ml. Within the tested interval, ...
Preclinical safety data
Non-clinical data reveal no special hazard to humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction. Placental ...
List of excipients
Core: Cellulose microcrystalline Lactose monohydrate Maize starch Povidone Croscarmellose sodium Silica colloidal anhydrous Magnesium stearate Coating: Sucrose Copovidone Titanium dioxide (E171) Macrogol ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 30 months.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
PVC/PVDC-Aluminium blisters in cartons of 30, 50, 60, 100 film-coated tablets per carton. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Glenmark Pharmaceuticals Europe Limited, Laxmi House, 2B Draycott Avenue, Harrow, Middlesex HA3 0BU, UK
Marketing authorization number(s)
PL 25258/0108
Date of first authorization / renewal of the authorization
25/02/2018
Date of revision of the text
25/02/2018
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