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Summary of Product Characteristics SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Citalopram 20 mg Film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains citalopram hydrobromide equivalent to 20 mg of citalopram. Excipient with known effect Each tablet contains 53.28 mg of lactose monohydrate For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. A white, oval, normal convex film-coated tablet debossed with “CM” scoreline “20” on one side and “G” on the other. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of major depressive episodes. 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 mg daily. In general, improvement in patients starts after 2-4 weeks. As with all antidepressant medicinal products, dosage should be reviewed and adjusted, if necessary, within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate. Although there may be an increased potential for undesirable effects at higher doses, if after some weeks on the recommended dose insufficient response is seen, some patients may benefit from having their dose increased up to a maximum of 40 mg a day (see section 5.1). Dosage adjustments should be made carefully on an individual patient basis, to maintain the patient at the lowest effective dose. 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 to give adequate protection against the possibility of a relapse. Panic disorder Adults: A single oral dose of 10 mg is recommended for the first week before increasing the dose to 20 mg daily. Dependent on individual patient response, the dose may be increased to a maximum of 40 mg daily. Patients should be started on 10 mg/day and the dose gradually increased in 10 mg steps according to the patient’s response up to the recommended dose. A low initial starting dose is recommended to minimise the potential worsening of panic symptoms, which is generally recognised to occur early in the treatment of this disorder. Although there may be an increased potential for undesirable effects at higher doses, if after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually up to a maximum of 40 mg/day (see section 5.1). Dosage adjustments should be made carefully on an individual patient basis, to maintain the patients at the lowest effective dose. The maximum efficacy of citalopram in the treatment of panic disorder is achieved after approximately 3 months. Depending on the patient’s individual response, it may be necessary to continue treatment for several months or more. There is insufficient data on efficacy from clinical studies lasting more than 6 months. Elderly (> 65 years of age) For elderly patients the dose should be decreased to half of the recommended dose, e.g. 10-20 mg daily. The recommended starting dose is 10 mg daily. The recommended maximum dose is 20 mg daily. Paediatric population The safety and efficacy of citalopram has not been established in the treatment of children and adolescents under the age of 18 years. Thus, citalopram should not be used in this population (see section 4.4). Reduced hepatic function: 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. Caution and extra careful dose titration is advised in patients with severely reduced hepatic function. These patients should be clinically monitored (see section 5.2). Reduced renal function: Dosage adjustment is not necessary for patients with mild to moderate renal dysfunction. No information is available for cases of severe impairment of renal function (creatinine clearance <30 mL/minute). Particular caution is therefore advised with patients with severe renal impairment (see section 5.2). Poor metabolisers of CYP2C19: An initial dose of 10 mg daily during the first two weeks of treatment is recommended for patients who are known to be poor metabolisers with respect to CYP2C19. The dose may be increased to a maximum of 20 mg daily depending on individual patient response (see section 5.2). Withdrawal symptoms seen on discontinuation of citalopram: Abrupt discontinuation should be avoided. When stopping treatment with citalopram the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal symptoms (see sections 4.4and 4.8). 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. Method of administration For oral use. Citalopram should be administered as a single dose, either in the morning or in the evening. The tablets can be taken with or without food, but with fluid. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Monoamine Oxidase Inhibitors (MAOIs) (see sections 4.4 and 4.5): Cases of serious and sometimes fatal reactions have been reported in patients receiving an SSRI in combination with monoamine oxidase inhibitors (MAOI), including the selective MAOI selegiline and the reversible MAOI (RIMA), moclobemide and in patients who have recently discontinued an SSRI and have been started on a MAOI. Some cases presented with features resembling serotonin syndrome. Citalopram should not be given to patients receiving 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), e.g. moclobemide, as stated in the prescribing text of the RIMA. MAOIs should not be introduced for seven days after discontinuation of citalopram (see section 4.5). 5-HT agonists: Sumatriptan's serotonergic effects are suspected to be enhanced by SSRIs. Until further evidence is available it is advised not to use citalopram simultaneously with 5-HT agonists e.g. Sumatriptan. Citalopram is contraindicated in combination with linezolid unless there are facilities for close observation and monitoring of blood pressure (see section 4.5). Citalopram should not be used concomitantly with pimozide (see also section 4.5). Citalopram is contraindicated in patients with known QT-interval prolongation or congenital long QT syndrome. Citalopram is contraindicated together with medicinal products that are known to prolong the QT-interval (see section 4.5). 4.4 Special warnings and precautions for use Elderly patients and patients with renal or hepatic impairment Treatment of elderly patients and patients with reduced kidney and liver function, see section 4.2. Paediatric population under 18 years of age Citalopram should not be used in the treatment of children and adolescents under the age of 18 years (see section 4.2). Suicide-related behaviours (suicide attempts 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. 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. Other psychiatric conditions for which citalopram is prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders. 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. A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old. Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present. Diabetes In patients with diabetes, treatment with an SSRI may alter glycaemic control. Insulin and or oral hypoglycaemic dosage may need to be adjusted. Seizures Seizures are a potential risk with antidepressant drugs. Citalopram should be discontinued in any patient who develops seizures. Citalopram should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be carefully monitored.
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