SSRI - Antidepressant
1. NAME OF MEDICINAL PRODUCT
Cipram 10 mg film-coated tablets
Cipram 20 mg film-coated tablets
Cipram 40 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Cipram 10 mg: Each tablet contains 10 mg citalopram (as 12.49 mg citalopram
Cipram 20 mg: Each tablet contains 20 mg citalopram (as 24.98 mg citalopram
Cipram 40 mg: Each tablet contains 40 mg citalopram (as 49.96 mg citalopram
For excipients, see section 6.1
3. PHARMACEUTICAL FORM
3.1 Description of the tablets
10 mg tablets are round, white, film-coated, marked with "CL" on one side.
20 mg: White, oval, scored, film-coated tablets marked "C" and "N"
symmetrically around the score.
40 mg: White, oval, scored, film-coated tablets marked "C" and "R"
symmetrically around the score.
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
Treatment of depression and prevention of relapse/recurrence.
Panic disorder with or without agoraphobia. Obsessive-compulsive disorder (OCD)
4.2 Posology and method of administration
Cipram should be administered as a single oral dose of 20 mg daily.
Dependent on individual patient response and severity of depression the dose
may be increased to a maximum of 60 mg daily.
Treating panic disorder
A single oral dose of 10 mg is recommended for the first week before
increasing the dose to 20 mg daily. The dose may be further increased, up to
a maximum of 60 mg daily dependent on individual patient response.
An initial dose of 20 mg daily is recommended. The dose can be increased in
increments of 20 mg to 60 mg daily if necessary, based on clinical judgment.
Elderly patients (65 years of age)
In elderly patients the dose may be increased to a maximum of 40 mg daily.
Children and adolescents (<18 years)
Not recommended, as safety and efficacy have not been established in this
Reduced renal function
Dosage adjustment is not necessary in patients with mild or moderate renal
impairment. No information is available on treatment of patients with
severely reduced renal function (creatinine clearance <20 ml/min).
Reduced hepatic function
Patients with reduced hepatic function should receive dosages of no more
than 30 mg/ day.
Duration of treatment
The antidepressant effect usually sets in after 2 to 4 weeks. Treatment with
antidepressants is symptomatic and must therefore be continued for an
appropriate length of time, usually up to 6 months after recovery in order
to prevent relapse. In patients with recurrent depression (unipolar)
maintenance therapy may need to be continued for a number of years to
prevent new episodes.
Maximum effectiveness of Cipram in treating panic disorder is reached after
about 3 months and the response is maintained during continued treatment.
The onset of action in treating OCD is 2-4 weeks with further improvement
When stopping therapy the drug should be gradually withdrawn during a couple
4.2.2 Method of administration
Cipram tablets are administered as a single daily dose.
Cipram tablets can be taken anytime of the day without regard to food
Hypersensitivity to citalopram or to any of the excipients.
MAOIs (monoamine oxidase inhibitors)
Cases of serious and sometimes fatal reactions have been reported in
patients receiving an SSRI in combination with 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.
Cipram must not be used in combination with a MAOI including selegiline in
doses above 10 mg daily. Treatment with citalopram may be instituted 14 days
after discontinuation of non-selective MAOIs and minimum one day after
discontinuation of moclobemide. Treatment with MAOIs may be introduced 7
days after discontinuation of citalopram (see 4.5 Interactions).
4.4 Special warnings and special precautions for use.
Cipram should not be used in the treatment of children and adolescents under
the age of 18 years. 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 patients should be carefully monitored for the
appearance of suicidal symptoms.
Treatment of elderly patients and patient with reduced kidney and liver
function, see 4.2.1 Posology.
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 is advised to reduce the likelihood of a paradoxical
anxiogenic effect (see section 4.2).
Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion
(SIADH), has been reported as a rare adverse reaction with the use of SSRIs.
Especially elderly female patients seem to be a risk group.
The possibility of suicide attempt is inherent in depression and may persist
until significant improvement occurs, either spontaneously or following
Patients being treated with antidepressants should be monitored carefully
especially at the beginning of treatment for clinical worsening and/or the
emergence of suicidality (suicidal ideation and behaviour). This precaution
should also be observed when treating other psychiatric disorders because of
the possibility of co-morbidity with major depressive disorder.
Patients who are started on therapy should be observed closely for clinical
worsening, suicidality, or unusual changes in behavior. Families and
caregivers should be advised to closely observe the patient and to
communicate with the prescribes.
In patients with manic-depressive illness a change towards the manic phase
may occur. Should the patient enter a manic phase citalopram should be
Although animal experiments have shown that citalopram has no epileptogenic
potential it should, like other antidepressants, be used with caution in
patients with a history of seizures.
As described for other psychotropics citalopram may modify insulin and
glucose responses calling for adjustment of the antidiabetic treatment in
diabetic patients; in addition the depressive illness itself may affect
patients' glucose balance.
Rarely, the occurrence of "serotonin syndrome" has been reported in patients
receiving SSRIs. A combination of symptoms, possibly including agitation,
confusion, tremor, myoclonus and hyperthermia, may indicate the development
of this condition
There have been reports of cutaneous bleeding abnormalities such as
ecchymoses and purpura with SSRIs. Caution is advised in patients taking
SSRIs, particularly with concomitant use of oral anticoagulants; drugs known
to affect platelet function (e.g. atypical antipsychotics and phenothiazines,
most tricyclic antidepressants, acetylsalicylic acid and non-steroidal
anti-inflammatory drugs (NSAIDs), ticlopidine and dipyridamole) as well as
in patients with a history of bleeding disorders (see section 4.5).
After prolonged administration abrupt cessation of SSRIs may produce
withdrawal symptoms such as dizziness, paraesthesia, tremor, anxiety, nausea
and palpitation in some patients. It is recommended that withdrawal of
treatment should proceed by tapering off the dosage over one to two weeks to
avoid occurrence of discontinuation symptoms. These symptoms are not
indicative of addiction.
The tablets contain lactose monohydrate. Patients with rare hereditary
problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose
malabsorption should not receive this medicine.