Citalopram 20 Oethmaan 20 mg FC tablets

CITALOPRAM 20 OETHMAAN is indicated for the treatment of:

• Depression and prevention of relapse
• Panic disorders with or without agoraphobia
• Obsessive-compulsive disorder (OCD)

Posology

Depression: 20 mg a day as a single dose. Dosage may be increased by 20 mg a day at intervals of at least one week to a maximum of 60 mg depending on the patientu2019s response.

Panic disorder: 10 mg a day as a single dose for the first week then increasing to 20 mg a day. The dose may be increased thereafter as required to a maximum of 60 mg a day depending on the patient's response.

Obsessive compulsive disorder: 20 mg a day as a single dose. This dose can be increased by 20 mg increments to a maximum of 60 mg a day depending on the patient's response.

Special populations:

Elderly: 20 mg a day as a single dose. Depending on the patient's response, the dose can be increased to a maximum of 30 mg a day.

Reduced hepatic function: Dose should be halved.

Reduced renal function: Dose adjustment is not necessary in cases of mild or moderate renal impairment.

The onset of action is seen within 2 to 4 weeks. Treatment should be continued for an appropriate length of time (up to six months) after recovery in order to prevent relapse. The medicine should be gradually withdrawn during a couple of weeks when stopping therapy (see section 4.8).

Method of administration

CITALOPRAM 20 OETHMAAN may be taken with or without food in the morning or evening.

• Hypersensitivity to citalopram or any of the ingredients in the formulation.
• MAOls (monoamine oxidase inhibitors): Cases of serious and sometimes fatal reactions have been reported in patients receiving an SSRI in combination with a monoamine oxidase inhibitor (MAOI), including the selective MAO-B inhibitor 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 20 OETHMAAN must not be used in combination with a MAOI, including selegiline in doses above 10 mg daily. Treatment with CITALOPRAM 20 OETHMAAN may be instituted 14 days after discontinuation of non-selective MAOls and minimum one day after discontinuation of moclobemide. Treatment with MAOls may be introduced 7 days after discontinuation of citalopram (See section 4.5).
• Severe renal impairment (creatine clearance less than 20 ml/min).
• Safety and efficacy in pregnancy and lactation has not been established.
• Children under the age of 18 years (see section 4.4 and 4.8).
• Concomitant treatment with pimozide (See section 4.5).
• CITALOPRAM 20 OETHMAAN is contraindicated in combination with linezolid (See section 4.5).
• CITALOPRAM 20 OETHMAAN is contraindicated in patients with known QT interval prolongation or congenital long QT syndrome (see sections 4.4, 4.8 and 5.1).

CITALOPRAM 20 OETHMAAN should be used with caution in:

Use in children and adolescents under 18 years of age u2013 CITALOPRAM 20 OETHMAAN 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. (See section 4.3).

In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.

Elderly patients - longer half-life and decreased clearance due to a reduced rate of metabolism. A lower dose is recommended in the elderly.

Hepatic impairment - clearance of CITALOPRAM 20 OETHMAAN is reduced. Cautious dosage titration and a lower maximum dose are recommended.

Renal impairment - elimination is decreased. If creatine clearance is less than 20 ml/min CITALOPRAM 20 OETHMAAN should not be used (see section 4.3).

Seizures or history thereof - there is an increased risk of seizures. CITALOPRAM 20 OETHMAAN should be discontinued in any patient who develops seizures. CITALOPRAM 20 OETHMAAN should be used with caution in patients with controlled epilepsy and avoided in patients who are poorly controlled epileptics. CITALOPRAM 20 OETHMAAN should be discontinued if there is an increase in seizure frequency.

ECT (electroconvulsive therapy) - Care is advised in patients receiving electroconvulsive therapy.

Mania or history of mania - condition may be re-activated. CITALOPRAM 20 OETHMAAN should be discontinued if the patient enters the manic phase.

CITALOPRAM 20 OETHMAAN may cause a reduction in heart rate. Caution is advised in patients with a pre-existing slow heart rate.

Diabetes mellitus - In patients with diabetes, treatment with an SSRI including CITALOPRAM 20 OETHMAAN may alter glycaemic control. Insulin and/or oral hypoglycaemic dosage may need to be adjusted.

Use with other medicines - CITALOPRAM 20 OETHMAAN should not be used with monoamine oxidase inhibitors, imipramine, other serotonergic medicines, moclobemide, alcohol, warfarin, and cimetidine (see section 4.5).

Suicide/suicidal thoughts or clinical worsening - Patients with major depressive disorder, both adults and children, may experience worsening of their depression and or the emergence of suicidal ideation and behaviour, whether or not they are taking antidepressant medicine. This risk may persist until significant remission occurs. A causal role, however, for antidepressant medicines in inducing such behaviour has not been established. Patients being treated with CITALOPRAM 20 OETHMAAN should, nevertheless, be observed closely for clinical worsening and suicidality, especially at the beginning of a course of therapy, or at any time of dose changes, either increases or decreases.

Because of the possibility of co-morbidity between major depressive disorder and other psychiatric and non-psychiatric disorders, the same precautions observed when treating patients with major depressive disorder should be observed when treating patients with other psychiatric and non-psychiatric disorders.

The following symptoms have been reported in patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and non-psychiatric: anxiety, agitation, panic attacks, insomnia, irritability, hostility (aggressiveness, impulsivity, akathisia, hypomania and mania). Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, consideration should be given to changing the therapeutic regimen, including possibly discontinuing CITALOPRAM 20 OETHMAAN, in patients for whom such symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.

If the decision is made to discontinue treatment, CITALOPRAM 20 OETHMAAN should be tapered (see section 4.4 and 4.8 WITHDRAWAL SYMPTOMS).

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. A low starting dose of CITALOPRAM 20 OETHMAAN is advised to reduce the likelihood of a paradoxical anxiogenic effect (see section 4.2).

Hyponatraemia - Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported as an adverse reaction with the use of SSRIs and generally reverses on discontinuation of therapy. Elderly female patients seem to be at higher risk.

Akathisia/psychomotor restlessness - The use of SSRIs/SNRIs has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still. This is most likely to occur within the first few weeks of treatment. In patients who develop these symptoms, increasing the dose of CITALOPRAM 20 OETHMAAN may be detrimental.

Serotonin syndrome - Serotonin syndrome has been reported in patients using SSRIs. Serotonin syndrome is more likely to occur after an increase in dose. A combination of symptoms such as agitation, tremor, myoclonus, and hyperthermia may indicate the development of this condition. Treatment with CITALOPRAM 20 OETHMAAN should be discontinued immediately and symptomatic treatment initiated.

Serotonergic medicines - CITALOPRAM 20 OETHMAAN should not be used concomitantly with medicines with serotonergic effects such as sumatriptan or other triptans, tramadol, oxitriptan, and tryptophan (see section 4.5).

Haemorrhage - There have been reports of cutaneous bleeding time and/or bleeding abnormalities such as ecchymoses, gynaecological haemorrhages, gastrointestinal bleedings, and other cutaneous or mucous bleedings with SSRIs (see section 4.8). Caution is advised in patients taking CITALOPRAM 20 OETHMAAN, particularly with concomitant use of active substances known to affect platelet function or other active substances that can increase the risk of haemorrhage, as well as in patients with a history of bleeding disorders (see section 4.5).

Post-partum haemorrhage - There has been evidence of an association between antidepressants [particularly selective serotonin reuptake inhibitors (SSRIs) and serotonin non-selective reuptake inhibitors (SNRIs)] and post-partum haemorrhage (PPH). Observational data indicate an increased risk (less than 2-fold) of postpartum haemorrhage PPH following SSRI/SNRI exposure within the month prior to birth. Healthcare professionals should be aware of the potential risk of PPH while making treatment decisions for prescribing SSRI/SNRI towards the end of pregnancy. Patients should be advised to inform their doctors before taking SSRI/SNRI if they have history of bleeding disorders, such as von Willebrand disease (VWD) or haemophilia or if they are pregnant.

St. John's Wort - Undesirable effects may be more common during concomitant use of CITALOPRAM 20 OETHMAAN and herbal preparations containing St John's wort (Hypericum perforatum). Therefore CITALOPRAM 20 OETHMAAN and St John's wort preparations should not be taken concomitantly (see section 4.5).

Psychosis - Treatment of psychotic patients with depressive episodes may increase psychotic symptoms.

QT interval prolongation - CITALOPRAM 20 OETHMAAN has been found to cause a dose-dependent prolongation of the QT interval. Cases of QT interval prolongation and ventricular dysrhythmia including torsade de pointes have been reported during the post-marketing period, predominantly in patients of female gender, with hypokalaemia, or with pre-existing QT prolongation or other cardiac diseases (see sections 4.3, 4.5, 4.8, 4.9 and 5.1). Caution is advised in patients with significant bradycardia; or in patients with recent acute myocardial infarction or uncompensated heart failure. Electrolyte disturbances such as hypokalaemia and hypomagnesaemia increase the risk for malignant dysrhythmias and should be corrected before treatment with CITALOPRAM 20 OETHMAAN is started. If patients with stable cardiac disease are treated, an ECG review should be considered before treatment is started. If signs of cardiac dysrhythmia occur during treatment with CITALOPRAM 20 OETHMAAN, the treatment should be withdrawn, and an ECG should be performed.

Safety and efficacy in pregnancy and lactation has not been established.

Pregnancy

The following symptoms may occur in neonates after maternal SSRI use in later stages of pregnancy: respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycaemia, hypertonia, hypotonia, hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying, somnolence and difficulty sleeping. These symptoms could be due to either serotonergic effects or discontinuation symptoms. In a majority of instances the complications begin immediately or soon (< 24 hours) after delivery.

Epidemiological data have suggested that the use of SSRIs such as CITALOPRAM 20 OETHMAAN in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN).

Neonates should be observed if maternal use of CITALOPRAM 20 OETHMAAN continues into the later stages of pregnancy, particularly in the third trimester. Abrupt discontinuation should be avoided during pregnancy.

Breastfeeding

CITALOPRAM 20 OETHMAAN is excreted into the breast milk.

Fertility

Animal data have shown that citalopram may affect sperm quality. Human case reports with some SSRIs have shown that an effect on sperm quality is reversible. Impact on human fertility has not been observed so far.

CITALOPRAM 20 OETHMAAN may impair performance of skilled tasks. If affected these patients should not operate machinery or drive.

a. Summary of the safety profile

Adverse events observed with CITALOPRAM 20 OETHMAAN are most frequent during the first one or two weeks of treatment, and usually decrease in intensity and frequency as the depressive state improves.

For the following reactions a dose-response was discovered: Sweating increased, dry mouth, insomnia, somnolence, diarrhoea, nausea and fatigue.

b. Tabulated list of adverse reactions

System Organ Class Adverse reaction Frequency

Blood and lymphatic system disorders Thrombocytopenia Frequency not known

Immune system disorders Hypersensitivity Anaphylactic reaction Frequency not known

Endocrine disorders Inappropriate antidiuretic hormone secretion Frequency not known

Metabolism and nutrition disorders Appetite decreased Weight decreased Increased appetite Weight increased Hyponatraemia Hypokalaemia Frequency not known

Psychiatric disorders Female and male: Libido decreased Frequent Agitation Anxiety Nervousness Frequency not known

(See section 4.8).

Toxicity

Fatal cases of CITALOPRAM 20 OETHMAAN overdose have been reported with CITALOPRAM 20 OETHMAAN alone; however, the majority of fatal cases have involved overdose with concomitant medicines/alcohol.

Symptoms of overdose:

Tiredness, weakness, sedation, dizziness, tremor, nausea, somnolence, sinus tachycardia, sedation, convulsion, QT interval prolongation, coma, vomiting, tremor, hypotension, cardiac arrest, nausea, serotonin syndrome, agitation, bradycardia, dizziness, bundle branch block, QRS prolongation, hypertension, and mydriasis, torsade de pointes, stupor, sweating, cyanosis, hyperventilation, and atrial- and ventricular dysrhythmia.

Treatment of overdose: Treatment is symptomatic and supportive. There is no specific antidote to CITALOPRAM 20 OETHMAAN. Activated charcoal, osmotically working laxative (such as sodium sulphate) and stomach evacuation should be considered. If consciousness is impaired the patient should be intubated. Monitoring of cardiac and vital signs necessary and medical surveillance is advisable for about 24 hours.