CITALOPRAM

Citalopram should be administered as a single oral dose, either in the morning or in the evening. The tablets can be taken with or without food, but with fluid. Following treatment initiation, an antidepressant effect should not be expected for at least two weeks.

Treatment should continue until the patient has been free of symptoms for 4-6 months. Citalopram should be withdrawn slowly, it is advised that the dose is gradually reduced over a period of at least one to two weeks. Adults The recommended starting dose is 20 mg citalopram per day.

If necessary, the dose can be increased to a maximum of 40 mg per day, depending on the individual response of the patient. g 10-20 mg per day. Depending on the individual response of the patient, the dose can be increased to a maximum of 20 mg/day.

4 . Renal impairment Dosage adjustment is not required if the patient has mild to moderate renal impairment. No information is available on treatment of patients with severe renal impairment (creatinine clearance less than 20 ml/min).

Hepatic impairment An initial dose of 10 mg daily for the first two weeks of treatment is recommended in patients with mild or moderate hepatic impairment. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily.

2). Poor metabolisers regarding CYP2C19 For known poor CYP2C19 metabolisers an initial dose of 10 mg daily the first two weeks of treatment is recommended. 2). Withdrawal symptoms seen on discontinuation of SSRI Abrupt discontinuation should be avoided.

8 ). If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.

Adverse reactions 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 are presented at the MedDRA Preferred Term Level.

For the following reactions a dose-response was discovered:

Sweating increased, dry mouth, insomnia, somnolence, diarrhoea, nausea and fatigue. The table shows the percentage of adverse drug reactions associated with SSRIs and/or citalopram seen in either ≥ 1% of patients in double-blind placebo-controlled trials or in the post-marketing period.

Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to ≤ 1/100); rare (≥ 1/10000 to ≤ 1/1000); very rare (≤ 1/10000), not known (cannot be estimated from available data). 6). Bone fractures Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs.

The mechanism leading to this risk is unknown. 1). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

uk/yellowcard. Withdrawal symptoms seen on discontinuation of SSRI treatment Discontinuation of citalopram (particularly when abrupt) commonly leads to withdrawal symptoms. Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional instability, irritability, and visual disturbances are the most commonly reported reactions.

Generally these events are mild to moderate and are self-limiting, however, in some patients they may be severe and/or prolonged. 4).

2). 2). Use in children and adolescents under 18 years of age Antidepressants should not be used in the treatment of children and adolescents under the age of 18 years. Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.

If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms. In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.

Paradoxical anxiety Some patients with panic disorder may experience intensified anxiety symptoms at the start of treatment with antidepressants. This paradoxical reaction usually subsides within the first two weeks of starting treatment.

2). Hyponatraemia Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported as a rare adverse reaction with the use of SSRIs and generally reverse on discontinuation of therapy. Elderly female patients seem to be at particularly high risk.

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 remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.

It is general clinical experience that the risk of suicide may increase in the early stages of recovery. Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.

1. Citalopram is contraindicated in patients with known QT-interval prolongation or congenital long QT syndrome. 5). MAOIs (monoamine oxidase inhibitors) Some cases presented with features resembling serotonin syndrome. Citalopram should not be given to patients receiving Monoamine Oxidase Inhibitors (MAOIs) including selegiline in daily doses exceeding 10 mg/day.

Citalopram should not be given for fourteen days after discontinuation of an irreversible MAOI or for the time specified after discontinuation of a reversible MAOI (RIMA) as stated in the prescribing text of the RIMA. 5). 5).