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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Emselex 7.5 mg and 15 mg prolonged-release tablets (2012)

Εκδότης

Εκδότης Novartis Pharmaceuticals UK Ltd
Διεύθυνση Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

Name of the medicinal product

Emselex® 7.5 mg prolonged-release tablets. Emselex® 15 mg prolonged-release tablets.

Qualitative and quantitative composition

Emselex 7.5 mg prolonged-release tablets: Each tablet contains 7.5 mg of darifenacin (as hydrobromide) ...

Pharmaceutical form

Prolonged-release tablets. Emselex 7.5 mg prolonged-release tablets: White round, convex tablet, debossed ...

Therapeutic indications

Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur ...

Posology and method of administration

Adults The recommended starting dose is 7.5 mg daily. After 2 weeks of starting therapy, patients should ...

Contraindications

Emselex is contraindicated in patients with: Hypersensitivity to the active substance or to any of the ...

Special warnings and precautions for use

Emselex should be administered with caution to patients with autonomic neuropathy, hiatus hernia, clinically ...

Interaction with other medicinal products and other forms of interaction

Effects of other medicinal products on darifenacin Darifenacin metabolism is primarily mediated by the ...

Pregnancy and lactation

Fertility There are no human fertility data for darifenacin. Darifenacin had no effect on male or female ...

Effects on ability to drive and use machines

No studies of the effects of Emselex on the ability to drive and use machines have been performed. As ...

Undesirable effects

Consistent with the pharmacological profile, the most commonly reported adverse reactions were dry mouth ...

Overdose

Emselex has been administered in clinical trials at doses up to 75 mg (five times maximum therapeutic ...

Pharmacodynamic properties

Pharmacotherapeutic group: Urinary antispasmodic ATC code: G04BD10 Darifenacin is a selective muscarinic ...

Pharmacokinetic properties

Darifenacin is metabolised by CYP3A4 and CYP2D6. Due to genetic differences, about 7% of Caucasians lack ...

Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, ...

List of excipients

Tablet core: Calcium hydrogen phosphate, anhydrous Hypromellose Magnesium stearate Film coat: Polyethylene ...

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

Keep the blister packs in the outer carton in order to protect from light.

Nature and contents of container

Clear PVC/CTFE/aluminium or PVC/PVDC/aluminium blisters in cartons containing 7, 14, 28, 49, 56 or 98 ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom

Marketing authorization number(s)

Emselex 7.5 mg prolonged-release tablets: EU/1/04/294/001-006 EU/1/04/294/013 EU/1/04/294/015-020 EU/1/04/294/027 ...

Date of first authorization / renewal of the authorization

22.10.2004

Date of revision of the text

14.12.2011
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.