PRILIGY Film-coated tablet (2021)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Priligy 30 mg film-coated tablets. Priligy 60 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains dapoxetine hydrochloride equivalent to 30 mg or 60 mg dapoxetine. Excipient with known effect: Lactose. Each 30 mg tablet contains 45.88 mg of lactose. Each 60 mg tablet ...
Pharmaceutical form
Film-coated tablet. The 30 mg film-coated tablets are light grey, round, convex, approximately 6.5 mm in diameter and debossed with 30 inside a triangle on one side. The 60 mg film-coated tablets are grey, ...
Therapeutic indications
Priligy is indicated for the treatment of premature ejaculation (PE) in adult men aged 18 to 64 years. Priligy should only be prescribed to patients who meet all the following criteria: An intravaginal ...
Posology and method of administration
Posology Adult men (aged 18 to 64 years) The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. Treatment with Priligy should not ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Significant pathological cardiac conditions such as: Heart failure (NYHA class II-IV). Conduction abnormalities ...
Special warnings and precautions for use
General recommendations Priligy is only indicated in men with Premature Ejaculation who meet all the criteria listed in sections 4.1 and 5.1. Priligy should not be prescribed to men who have not been diagnosed ...
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions Potential for interaction with monoamine oxidase inhibitors In patients receiving an SSRI in combination with a monoamine oxidase inhibitor (MAOI), there have been reports ...
Pregnancy and lactation
Priligy is not indicated for use by women. Animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy or embryonal/foetal development (see section 5.3). It is ...
Effects on ability to drive and use machines
Priligy has minor or moderate influence on the ability to drive and use machines. Dizziness, disturbance in attention, syncope, blurred vision and somnolence have been reported in subjects receiving dapoxetine ...
Undesirable effects
Summary of the safety profile Syncope and orthostatic hypotension have been reported in clinical trials (see section 4.4). The following adverse drug reactions were reported during Phase 3 clinical trials ...
Overdose
No case of overdose has been reported. There were no unexpected adverse events in a clinical pharmacology study of Priligy with daily doses up to 240 mg (two 120 mg doses given 3 hours apart). In general, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other Urologicals ATC code: G04BX14 Mechanism of action Dapoxetine is a potent selective serotonin reuptake inhibitor (SSRI) with an IC<sub>50</sub> of 1.12 nM, while its major ...
Pharmacokinetic properties
Absorption Dapoxetine is rapidly absorbed with maximum plasma concentrations (C<sub>max</sub>) occurring approximately 1-2 hours after tablet intake. The absolute bioavailability is 42% (range 15-76%), ...
Preclinical safety data
A full assessment of the safety pharmacology, repeat dose toxicology, genetic toxicology, carcinogenicity, dependence/withdrawal liability, phototoxicity and developmental reproductive toxicology of dapoxetine ...
List of excipients
<u>Tablet core:</u> Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate <u>Tablet coating:</u> Lactose monohydrate Hypromellose Titanium dioxide ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Child-resistant PVC-PE-PVDC/Alu blister in compliance multi-fold packages of 1, 2, 3 and 6 film-coated tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
This medicinal product should not be disposed of via wastewater or household waste. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
A. Menarini Farmaceutica Internazionale SRL, Menarini House, Mercury Park, Wycombe Lane, Wooburn Green, Buckinghamshire, HP10 0HH
Marketing authorization number(s)
PL 41549/0001 PL 41549/0002
Date of first authorization / renewal of the authorization
Date of first authorisation: 17 December 2008 Date of last renewal: 17 December 2013
Date of revision of the text
23<sup>rd</sup> September 2021
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