DETRUNORM Film-coated tablet (2018)
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Περιεχόμενα
Name of the medicinal product
Detrunorm 15 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 15 mg propiverine hydrochloride equivalent to 13.64 mg propiverine. Excipients with known effect: Each film-coated tablet contains 100.7 mg lactose monohydrate. For the ...
Pharmaceutical form
Film-coated tablet. White, round, biconvex film-coated tablets.
Therapeutic indications
Symptomatic treatment of urinary incontinence and/or increased urinary frequency and urgency in patients with overactive bladder syndrome or neurogenic detrusor overactivity from spinal cord injuries. ...
Posology and method of administration
Film-coated tablets for oral use. The recommended daily doses are as follows: Adults: As a standard dose one film-coated tablet (=15 mg propiverine hydrochloride) twice daily is recommended, this may be ...
Contraindications
The drug is contraindicated in patients who have demonstrated hypersensitivity to the active substance or to any of the excipients and in patients suffering from one of the following disorders: obstruction ...
Special warnings and precautions for use
The drug should be used with caution in patients suffering from: autonomic neuropathy renal impairment (see section 4.2) hepatic impairment (see section 4.2) Symptoms of the following diseases may be ...
Interaction with other medicinal products and other forms of interaction
Increased effects due to concomitant medication with tricyclic antidepressants (e. g. imipramine), tranquillisers (e.g. benzodiazepines), anticholinergics (if applied systemically), amantadine, neuroleptics ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of propiverine in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Detrunorm 15 mg film-coated tablets are not recommended ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Propiverine may produce drowsiness and blurred vision. This may impair the patients ability to exert activities that ...
Undesirable effects
Within each system organ class, the undesirable effects are ranked under heading of frequency using the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), ...
Overdose
Symptoms Overdose with the muscarinic receptor antagonist propiverine can potentially result in severe anticholinergic effects. Peripheral and central nervous system disturbances may occur, such as: severe ...
Pharmacodynamic properties
Pharmacotherapeutic group: Urologicals, drugs for urinary frequency and incontinence ATC code: G04BD06 Mechanism of action Inhibition of calcium influx and modulation of intracellular calcium in urinary ...
Pharmacokinetic properties
General characteristics of the active substance Propiverine is nearly completely absorbed from the gastrointestinal tract. It undergoes extensive first pass metabolism. Effects on urinary bladder smooth ...
Preclinical safety data
In long term oral dose studies in two mammalian species the main treatment related effect were changes in the liver (including elevation of hepatic enzymes). These were characterised by hepatic hypertrophy ...
List of excipients
Tablet core: Lactose monohydrate Cellulose, powdered Magnesium stearate Tablet film coat: Hypromellose Cellulose, microcrystalline Stearic acid Talc Titanium dioxide (E171)
Incompatibilities
Not applicable.
Shelf life
4 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
They are available in PVC/PVDC/aluminium blister packs of 14, 20, 28, 30, 49, 50, 56, 60, 84, 98, 100, 112, 168, 252, 300 or 500 tablets and multipacks containing 280 (10 packs of 28) film-coated tablets. ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Amdipharm UK Ltd., Capital House, 85 King William Street, London, EC4N 7BL, United Kingdom
Marketing authorization number(s)
PL 20072/0243
Date of first authorization / renewal of the authorization
05/08/2016
Date of revision of the text
03/02/2018
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