CIPRALEX Film-coated tablet (2018)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
CIPRALEX 5 mg film-coated tablets. CIPRALEX 10 mg film-coated tablets. CIPRALEX 20 mg film-coated tablets.
Qualitative and quantitative composition
Cipralex 5 mg: Each tablet contains 5 mg escitalopram (as oxalate). Cipralex 10 mg: Each tablet contains 10 mg escitalopram (as oxalate). Cipralex 20 mg: Each tablet contains 20 mg escitalopram (as oxalate). ...
Pharmaceutical form
Cipralex 5 mg: Round, white, film-coated tablet of 6 mm marked with EK on one side. Cipralex 10 mg: Oval, white, scored, film-coated tablet of 8 5.5 mm marked with E and L on each side of the score on ...
Therapeutic indications
Treatment of major depressive episodes. Treatment of panic disorder with or without agoraphobia. Treatment of social anxiety disorder (social phobia). Treatment of generalised anxiety disorder. Treatment ...
Posology and method of administration
Posology Safety of daily doses above 20 mg has not been demonstrated. Major depressive episodes Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients, listed in section 6.1. Concomitant treatment with non-selective, irreversible monoamine oxidase inhibitors (MAO-inhibitors) is contraindicated ...
Special warnings and precautions for use
The following special warnings and precautions apply to the therapeutic class of SSRIs (Selective Serotonin Re-uptake Inhibitors). Paediatric population Cipralex should not be used in the treatment of ...
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions Contraindicated combinations Irreversible non-selective MAOIs Cases of serious reactions have been reported in patients receiving an SSRI in combination with a non-selective, ...
Fertility, pregnancy and lactation
Pregnancy For escitalopram only limited clinical data are available regarding exposed pregnancies. Animal studies have shown reproductive toxicity (see section 5.3). Cipralex should not be used during ...
Effects on ability to drive and use machines
Although escitalopram has been shown not to affect intellectual function or psychomotor performance, any psychoactive medicinal product may impair judgement or skills. Patients should be cautioned about ...
Undesirable effects
Adverse reactions are most frequent during the first or second week of treatment and usually decrease in intensity and frequency with continued treatment. Tabulated list of adverse reactions Adverse reactions ...
Overdose
Toxicity Clinical data on escitalopram overdose are limited and many cases involve concomitant overdoses of other drugs. In the majority of cases mild or no symptoms have been reported. Fatal cases of ...
Pharmacodynamic properties
Pharmacotherapeutic group: antidepressants, selective serotonin reuptake inhibitors ATC code: N06AB10 Mechanism of action Escitalopram is a selective inhibitor of serotonin (5-HT) re-uptake with high affinity ...
Pharmacokinetic properties
Absorption Absorption is almost complete and independent of food intake. (Mean time to maximum concentration (mean T<sub>max</sub>) is 4 hours after multiple dosing). As with racemic citalopram, the absolute ...
Preclinical safety data
No complete conventional battery of preclinical studies was performed with escitalopram since the bridging toxicokinetic and toxicological studies conducted in rats with escitalopram and citalopram showed ...
List of excipients
Tablet core: Microcrystalline cellulose Colloidal anhydrous silica Talc Croscarmellose sodium Magnesium stearate Coating: Hypromellose Macrogol 400 Titanium dioxide (E171)
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Blister: Transparent; PVC/PE/PVdC/Aluminium blister, pack with an outer carton; 14, 28, 56, 98 tablets Unit dose; 49x1, 56x1, 98x1, 100x1, 500x1 tablets (5, 10 and 20 mg) Blister: White; PVC/PE/PVdC/Aluminium ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
H. Lundbeck A/S, Ottilavaj 9, 2500 Valby, Denmark
Marketing authorization number(s)
Cipralex 5 mg film-coated tablets: PL 13761/0008 Cipralex 10 mg film-coated tablets: PL 13761/0009 Cipralex 20 mg film-coated tablets: PL 13761/0011
Date of first authorization / renewal of the authorization
10 June 2002/13 January 2016
Date of revision of the text
15 January 2018
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
