Treatment for 3 months is recommended to consolidate response.
A longer-term treatment of responders may be considered to prevent relapse.
Elderly patients (> 65 years of age)
Initial treatment with half the usually recommended dose and a lower maximum dose should be considered (see 5.2 Pharmacokinetic properties).
Children and adolescents (< 18 years)
Not recommended, since efficacy has not been investigated in this population.
Reduced renal function
Cipralex dosage adjustment is not necessary in patients with mild or moderate renal impairment. Caution is advised in patients with severely reduced renal function (CLCR less than 30 ml/min) (see section
5.2 Pharmacokinetic properties).
Reduced hepatic function An initial dose of 5 mg daily for the first two weeks of treatment is recommended. Depending on individual patient response, the dose may be increased to 10 mg daily (see section 5.2 Pharmacokinetic properties).
Poor metabolisers of CYP2C19 For patients who are known to be poor metabolisers with respect to CYP2C19, an initial dose of 5 mg daily during the first two weeks of treatment is recommended. Depending on individual patient response, the dose may be increased to 10 mg daily (see section 5.2 Pharmacokinetic properties).
When stopping treatment with Cipralex the dose should be gradually reduced over a period of one or two weeks in order to avoid possible withdrawal reactions (see section 4.4 Special warnings and precautions for use).
Hypersensitivity to escitalopram or to any of the excipients.
Concomitant treatment with non-selective, irreversible monoamine oxidase inhibitors (MAOinhibitors) (see section 4.5 Interactions with other medicinal products and other forms of interaction).
4.4 Special warnings and special precautions for use
The use in children and adolescents under age of 18 is not recommended due to the lack of studies.
The following special warnings and precautions apply to the therapeutic class of SSRIs (Selective Serotonin Re-uptake Inhibitors).
Some patients with panic disorder may experience increased anxiety symptoms at the beginning of treatment with antidepressants. This paradoxical reaction usually subsides within the first two weeks of starting treatment. A low starting dose is advised to reduce the likelihood of an anxiogenic effect (see section 4.2 Posology and method of administration).
The medicinal product should be discontinued in any patient who develops seizures. SSRIs should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be carefully monitored. SSRIs should be discontinued if there is an increase in seizure frequency.
SSRIs should be used with caution in patients with a history of mania/hypomania. SSRIs should be discontinued in any patient entering a manic phase.
In patients with diabetes, treatment with an SSRI may alter glycaemic control. Insulin and/or oral hypoglycaemic dosage may need to be adjusted.
The possibility of suicide attempt is inherent in depression and may persist until significant improvement occurs, either spontaneously or following treatment.