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SPC: EMSELEX Prolonged-release tablet (2020)

Αναφορές

Βιβλιογραφική αναφορά

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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

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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