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SPC, UK: CITALOPRAM Film-coated tablets (2018)

Αναφορές

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

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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