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SPC, UK: Cipramil Tablets (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Lundbeck Limited
Διεύθυνση :
Lundbeck House, Caldecotte Lake Business Park, Caldecotte, Milton Keynes, MK7 8LG
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Δωρεάν εγγραφή

Name of the medicinal product

Cipramil 10 mg film-coated tablets. Citalopram 10 mg film-coated tablets. Cipramil 20 mg film-coated tablets. Citalopram 20 mg film-coated tablets. Cipramil 40 mg film-coated tablets. Citalopram 40 mg ...

Qualitative and quantitative composition

10 mg tablet: Each tablet contains 10 mg citalopram (as 12.49 mg citalopram hydrobromide). 20 mg tablet: Each tablet contains 20 mg citalopram (as 24.98 mg citalopram hydrobromide). 40 mg tablet: Each ...

Pharmaceutical form

Film-coated tablet 10 mg tablet: White, round, film-coated tablet marked CL on one side. 20 mg tablet: White, oval, scored, film-coated tablet marked C and N symmetrically around the score. The tablet ...

Therapeutic indications

Treatment of depressive illness in the initial phase and as maintenance against potential relapse/recurrence. Cipramil/Citalopram is also indicated in the treatment of panic disorder with or without agoraphobia. ...

Posology and method of administration

Posology MAJOR DEPRESSIVE EPISODES 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 ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients (see section 6.1). Monoamine Oxidase Inhibitors (MAOIs). Some cases presented with features resembling serotonin syndrome. Citalopram ...

Special warnings and precautions for use

Suicide/suicidal thoughts or clinical worsening Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant ...

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 ...

Fertility, pregnancy and lactation

Pregnancy A large amount of data on pregnant women (more than 2500 exposed outcomes) indicate no malformative foeto / neonatal toxicity. Citalopram can be used during pregnancy if clinically needed, taking ...

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 frequent during the first one or two weeks of treatment and usually attenuate subsequently. The adverse reactions ...

Overdose

Toxicity Comprehensive clinical data on citalopram overdose 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 Mechanism of action Biochemical and behavioural studies have shown that citalopram is a potent inhibitor ...

Pharmacokinetic properties

Absorption Absorption is almost complete and independent of food intake (T maxaverage/mean 3.8 hours). Oral bioavailability is about 80%. Distribution The apparent volume of distribution (Vd)β is about ...

Preclinical safety data

Acute toxicity Citalopram has low acute toxicity. Chronic toxicity In chronic toxicity studies there were no findings of concern for the therapeutic use of citalopram. Reproduction studies Based on data ...

List of excipients

Tablet core: Maize starch Lactose Microcystalline-cellulose Copolyvidone Glycerol Croscarmellose Sodium Type A Magnesium stearate Coating: Methylhydroxypropyl-cellulose Macrogol Titanium dioxide

Incompatibilities

Not applicable.

Shelf life

5 years.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Press through packs (UPVC/PVdC with aluminium closure) 28 tablets.

Special precautions for disposal and other handling

None.

Marketing authorization holder

Lundbeck Limited Lundbeck House Caldecotte Lake Business Park Caldecotte Milton Keynes MK7 8LF United Kingdom (Manufacturer: H. Lundbeck A/S, DK-2500 Copenhagen-Valby, Denmark)

Marketing authorization number(s)

Cipramil 10 mg film-coated tablets: PL 0458/0057 Citalopram 10 mg film-coated tablets. Cipramil 20 mg film-coated tablets: PL 0458/0058 Citalopram 20 mg film-coated tablets. Cipramil 40mg film-coated tablets: ...

Date of first authorization / renewal of the authorization

First authorisation: 17 March 1995 Renewal of authorisation: 16 March 2010

Date of revision of the text

13/11/2012