CIPRALEX Oral drops, solution (2017)
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Περιεχόμενα
Name of the medicinal product
CIPRALEX 20 mg/ml oral drops, solution.
Qualitative and quantitative composition
Each ml of solution contains: 20 mg escitalopram (as 25.551 mg escitalopram oxalate). Each drop contains 1 mg escitalopram. Excipients with known effect: each drop contains 4.7 mg ethanol. For the full ...
Pharmaceutical form
Oral drops, solution. Clear, nearly colourless to yellowish solution with a bitter taste.
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
Safety of daily doses above 20 mg (20 drops) has not been demonstrated. Cipralex is administered as a single daily dose and may be taken with or without food. Cipralex oral drops, solution can be mixed ...
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). Use in children and adolescents under 18 years of age Cipralex should ...
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). The oral drops, solution is bioequivalent ...
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
Propyl gallate Citric acid anhydrous Ethanol 96% Sodium hydroxide Purified water
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 3 years. After opening, the drops should be used within 8 weeks.
Special precautions for storage
After opening the bottle should not be stored above 25°C.
Nature and contents of container
15 ml in a brown glass bottle with dropper applicator (polyethylene), and child-proof screw cap (polypropylene).
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)
PL 13761/0028
Date of first authorization / renewal of the authorization
Date of first authorisation: 03 January 2008 Date of latest renewal: 11 December 2011
Date of revision of the text
August 2017
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