RESOLOR Film-coated tablet (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Resolor 1 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 1 mg prucalopride (as succinate). Excipients with known effect: Each film-coated tablet contains 142.5 mg lactose (as monohydrate). For the full list of excipients, see ...
Pharmaceutical form
Film-coated tablet (tablet). White to off-white, round, biconvex tablets marked PRU 1 on one side.
Therapeutic indications
Resolor is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.
Posology and method of administration
Posology Adults 2 mg once daily with or without food, at any time of the day. Due to the specific mode of action of prucalopride (stimulation of propulsive motility), exceeding the daily dose of 2 mg is ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Renal impairment requiring dialysis. Intestinal perforation or obstruction due to structural or functional disorder ...
Special warnings and precautions for use
Renal excretion is the main route of elimination of prucalopride (see section 5.2). A dose of 1 mg is recommended in subjects with severe renal impairment (see section 4.2). Caution should be exercised ...
Interaction with other medicinal products and other forms of interaction
Prucalopride has a low pharmacokinetic interaction potential. It is extensively excreted unchanged in urine (approximately 60% of the dose) and in vitro metabolism is very slow. Prucalopride did not inhibit ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential have to use effective contraception during treatment with prucalopride. Pregnancy There is a limited amount of data from the use of prucalopride ...
Effects on ability to drive and use machines
Resolor may have a minor influence on the ability to drive and use machines, since dizziness and fatigue have been observed in clinical studies, particularly during the first day of treatment (see section ...
Undesirable effects
Summary of the safety profile In an integrated analysis of 17 double-blind placebo-controlled studies, Resolor was given orally to approximately 3,300 patients with chronic constipation. Of these, over ...
Overdose
In a study in healthy volunteers, treatment with prucalopride was well tolerated when given in an up-titrating scheme up to 20 mg once daily (10 times the recommended therapeutic dose). An overdose may ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other drugs for constipation ATC code: A06AX05 Mechanism of action Prucalopride is a dihydrobenzofurancarboxamide with gastrointestinal prokinetic activities. Prucalopride is ...
Pharmacokinetic properties
Absorption Prucalopride is rapidly absorbed; after a single oral dose of 2 mg in healthy subjects, C<sub>max</sub> was attained in 2-3 hours. The absolute oral bioavailability is >90%. Concomitant intake ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and ...
List of excipients
Tablet core: Lactose monohydrate Microcrystalline cellulose Colloidal silicon dioxide Magnesium stearate Tablet coating: Hypromellose Lactose monohydrate Triacetin Titanium dioxide (E171) Macrogol
Incompatibilities
Not applicable.
Shelf life
4 years.
Special precautions for storage
Store in the original blister in order to protect from moisture.
Nature and contents of container
Aluminium/aluminium perforated unit dose blisters (calendar marked) containing 7 tablets. Each pack contains 7 1, 14 1, 28 1 or 84 1 film-coated tablet. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50–58 Baggot Street Lower, Dublin 2, Ireland
Marketing authorization number(s)
EU/1/09/581/001 (28 tablets) EU/1/09/581/003 (7 tablets) EU/1/09/581/005 (14 tablets) EU/1/09/581/007 (84 tablets)
Date of first authorization / renewal of the authorization
Date of first authorisation: 15 October 2009 Date of latest renewal: 06 June 2014
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