URISPAS Film-coated tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Urispas 200 mg Film-coated Tablets.
Qualitative and quantitative composition
Each tablet contains as active ingredient: flavoxate hydrochloride 200 mg. Excipient with known effect: Each tablet contains 64 mg of lactose monohydrate. For the full list of excipients, see section 6.1. ...
Pharmaceutical form
Film-coated tablet. White, film-coated tablets embossed with F 200.
Therapeutic indications
Urispas is indicated for the symptomatic relief of dysuria, urgency, nocturia, vesical supra-pubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethro-cystitis and ...
Posology and method of administration
Posology Adults (elderly included) The recommended adult dosage is one tablet three times a day for as long as required. Paediatric population The safety and efficacy of Urispas in children aged <12 years ...
Contraindications
Hypersensitivity to the active substance or to any of the of the excipients listed in section 6.1; Gastrointestinal obstructive conditions or ileus Gastro-intestinal haemorrhage Achalasia Urinary retention ...
Special warnings and precautions for use
The use in children below the age of <12 years is not recommended. Since the renal clearance of the active metabolite accounts more than 50% of the dose, renal impairment may significantly affect the product ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Fertility, pregnancy and lactation
Fertility There are no data on the effect of flavoxate on human fertility. Flavoxate has no effect on animal fertility. Pregnancy There are no or limited amount of data from the use of flavoxate in pregnant ...
Effects on ability to drive and use machines
Patients should be informed that if somnolence or blurred vision occur they should not drive or use machines.
Undesirable effects
The source of the below ADRs frequencies is represented by data collected through clinical trials, observational studies, and spontaneous reporting. In the table below, adverse reactions are reported and ...
Overdose
No risk following overdose has been identified in the post-marketing experience.
Pharmacodynamic properties
<b>Pharmacotherapeutic Group:</b> Urinary antispasmodics – Flavoxate <b>ATC code:</b> G04BD02 Flavoxate hydrochloride (and its main metabolite methyl flavone carboxylic acid, MFCA) is an antispasmodic ...
Pharmacokinetic properties
Oral studies in man have indicated that flavoxate is readily absorbed from the intestine and converted, to a large extent, almost immediately to MFCA. Following an IV dose (equimolar to 100 mg), the following ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction and development. Carcinogenicity ...
List of excipients
Tablet Core: Lactose monohydrate Sodium starch glycolate Povidone Talc Magnesium stearate Cellulose microcrystalline Tablet Coating: Hypromellose Cellulose microcrystalline Macrogol 6000 Macrogol stearate ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 30°C. Keep blister strips in the outer carton.
Nature and contents of container
PVC/aluminium blister strips in pack sizes of 84, 90, 100 and 250 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Recordati Pharmaceuticals Limited, Origin, Western Road, Bracknell, RG12 1US, United Kingdom
Marketing authorization number(s)
PL 25046/0006
Date of first authorization / renewal of the authorization
Date of first authorisation: 30 May 1997 Date of latest renewal: 14 August, 2007
Date of revision of the text
01/04/2020
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