EMSELEX Prolonged-release tablet (2020)
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Περιεχόμενα
Name of the medicinal product
Emselex 7.5 mg prolonged-release tablets.
Qualitative and quantitative composition
Each tablet contains 7.5 mg of darifenacin (as hydrobromide). For the full list of excipients, see section 6.1.
Pharmaceutical form
Prolonged-release tablet. White round, convex tablet, debossed with DF on one side and 7.5 on the reverse.
Therapeutic indications
Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome.
Posology and method of administration
Posology Adults The recommended starting dose is 7.5 mg daily. After 2 weeks of starting therapy, patients should be reassessed. For those patients requiring greater symptom relief, the dose may be increased ...
Contraindications
Emselex is contraindicated in patients with: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Urinary retention. Gastric retention. Uncontrolled narrow-angle ...
Special warnings and precautions for use
Emselex should be administered with caution to patients with autonomic neuropathy, hiatus hernia, clinically significant bladder outflow obstruction, risk for urinary retention, severe constipation or ...
Interaction with other medicinal products and other forms of interaction
Effects of other medicinal products on darifenacin Darifenacin metabolism is primarily mediated by the cytochrome P450 enzymes CYP2D6 and CYP3A4. Therefore, inhibitors of these enzymes may increase darifenacin ...
Fertility, pregnancy and lactation
Pregnancy There are limited amount of data from the use of darifenacin in pregnant women. Studies in animals have shown toxicity to parturition (for details, see section 5.3). Emselex is not recommended ...
Effects on ability to drive and use machines
As with other antimuscarinic agents, Emselex may produce effects such as dizziness, blurred vision, insomnia and somnolence. Patients experiencing these side effects should not drive or use machines. For ...
Undesirable effects
Summary of the safety profile Consistent with the pharmacological profile, the most commonly reported adverse reactions were dry mouth (20.2% and 35% for the 7.5 mg and 15 mg dose, respectively, 18.7% ...
Overdose
Emselex has been administered in clinical trials at doses up to 75 mg (five times maximum therapeutic dose). The most common adverse reactions seen were dry mouth, constipation, headache, dyspepsia and ...
Pharmacodynamic properties
Pharmacotherapeutic group: Urologicals, drugs for urinary frequency and incontinence ATC code: G04BD10 Mechanism of action Darifenacin is a selective muscarinic M3 receptor antagonist (M3 SRA) in vitro. ...
Pharmacokinetic properties
Darifenacin is metabolised by CYP3A4 and CYP2D6. Due to genetic differences, about 7% of the Caucasians lack the CYP2D6 enzyme and are said to be poor metabolisers. A few percent of the population have ...
Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. There were no effects on fertility ...
List of excipients
Tablet core: Calcium hydrogen phosphate, anhydrous Hypromellose Magnesium stearate Film coat: Polyethylene glycol Hypromellose Titanium dioxide (E171) Talc
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 tablets as unit pack or in multipacks containing 140 (10x14) tablets. Not all pack sizes may be marketed. ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Merus Labs Luxco II S.à R.L., 26-28, rue Edward Steichen, L-2540 Luxembourg
Marketing authorization number(s)
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
Date of first authorisation: 22 October 2004 Date of latest renewal: 24 September 2009
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