CITALOPRAM Film-coated tablet (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Citalopram 10mg Tablets.
Qualitative and quantitative composition
10mg citalopram (as hydrobromide). For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. White, 6mm round, biconvex tablets.
Therapeutic indications
Treatment of depressive illness in the initial phase and as maintenance against potential relapse/recurrence. Citalopram is also indicated in the treatment of panic disorder with or without agoraphobia. ...
Posology and method of administration
Posology Treating depression Adults Citalopram should be administered as a single oral dose of 20 mg daily. Dependent on individual patient response, the dose may be increased to a maximum of 40 mg daily. ...
Contraindications
Hypersensitivity to citalopram or to any of the excipients (see section 6.1). MAOIs (monoamine oxidase inhibitors) Some cases presented with features resembling serotonin syndrome. Citalopram should not ...
Special warnings and precautions for use
Treatment of older people and patients with reduced kidney and liver function, see section 4.2. Use in children and adolescents under 18 years of age Antidepressants should not be used in the treatment ...
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions At the pharmacodynamic level cases of serotonin syndrome with citalopram and moclobemide and buspirone have been reported. Contraindicated combinations MAO-inhibitors The simultaneous ...
Pregnancy and lactation
Pregnancy Published data on pregnant women (more than 2500 exposed outcomes) indicate no malformative feto/neonatal toxicity. However, citalopram should not be used during pregnancy unless clearly necessary ...
Effects on ability to drive and use machines
Citalopram has minor or moderate influence on the ability to drive and use machines. Patients who are prescribed psychotropic medication may be expected to have some impairment of general attention and ...
Undesirable effects
Adverse effects observed with citalopram are in general mild and transient. They are most prominent during the first one or two weeks of treatment and usually attenuate as the depressive state improves. ...
Overdose
Toxicity Comprehensive clinical data on citalopram are limited and many cases involve concomitant overdoses of other drugs/alcohol. Fatal cases of citalopram overdose have been reported with citalopram ...
Pharmacodynamic properties
Pharmacotherapeutic group: antidepressants, selective serotonin reuptake inhibitors ATC code: N06AB04 Biochemical and behavioural studies have shown that citalopram is a potent inhibitor of serotonin (5-HT) ...
Pharmacokinetic properties
Absorption Absorption is almost complete and independent of food intake (T<sub>max</sub> average/mean 3.8 hours). Oral bioavailability is about 80%. Distribution The apparent volume of distribution (V ...
Preclinical safety data
Citalopram has low acute toxicity. In chronic toxicity studies there were no findings of concern for the therapeutic use of citalopram. Based on data from reproduction toxicity studies (segment I, II and ...
List of excipients
Tablet core: Mannitol Microcrystalline cellulose Colloidal anhydrous silica Magnesium stearate Tablet coat: Hypromellose Titanium dioxide (E171) Macrogol 6000
Incompatibilities
Not applicable.
Shelf life
5 years.
Special precautions for storage
None.
Nature and contents of container
PVC/PVDC/aluminium blisters. Pack size: 28 tablets.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Zentiva Pharma UK Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom Trading as: Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Marketing authorization number(s)
PL 17780/0036
Date of first authorization / renewal of the authorization
26 March 2009
Date of revision of the text
30/07/2018
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