CIPRAMIL Film-coated tablet (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

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

2. Qualitative and quantitative composition

20 mg tablet: Each tablet contains 20 mg citalopram (as 24.98 mg citalopram hydrobromide). Excipients with known effect: Lactose. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Film-coated tablet. 20 mg tablet: White, oval, scored, film-coated tablet marked C and N symmetrically around the score. The tablet can be divided into equal doses.

4.1. 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. ...

4.2. 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 ...

4.3. Contraindications

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

4.4. 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 ...

4.5. 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 ...

4.6. Fertility, pregnancy and lactation

Pregnancy Published data on pregnant women (more than 2500 exposed outcomes) indicate no malformative foeto/neonatal toxicity, however, citalopram should not be used during pregnancy unless clearly necessary ...

4.7. 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 ...

4.8. 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 ...

4.9. 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 ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: antidepressants, selective serotonin reuptake inhibitors ATC-code: N06AB04 Mechanism of action Biochemical and behavioural studies have shown that citalopram is ...

5.2. Pharmacokinetic properties

Absorption Absorption is almost complete and independent of food intake (Tmax average/mean 3.8 hours). Oral bioavailability is about 80%. Distribution The apparent volume of distribution (V ...

5.3. 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 ...

6.1. List of excipients

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

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

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

6.6. Special precautions for disposal and other handling

None.

7. Marketing authorization holder

Lundbeck Limited, Iveco House, Station Road, Watford, Hertfordshire, WD17 1ET, UK

8. Marketing authorization number(s)

Cipramil 20 mg film-coated tablets PL 0458/0058 Citalopram 20 mg film-coated tablets

9. Date of first authorization / renewal of the authorization

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

10. Date of revision of the text

January 2021

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