CIPRAMIL 40 MG TABLETS

Israel - English - Ministry of Health

Buy It Now

Active ingredient:
CITALOPRAM AS HYDROBROMIDE
Available from:
LUNDBECK ISRAEL LTD
ATC code:
N06AB04
Pharmaceutical form:
FILM COATED TABLETS
Composition:
CITALOPRAM AS HYDROBROMIDE 40 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
H.LUNDBECK A/S, DENMARK
Therapeutic group:
CITALOPRAM
Therapeutic area:
CITALOPRAM
Therapeutic indications:
For the treatment of states of depresion and panic disorder.
Authorization number:
142 50 32025 00
Authorization date:
2014-12-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

28-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

30-08-2017

ודילע רשואוקדבנ ונכותותואירבהדרשמי"עעבקנהז ןולע טמרופ

2114 2114

םיחקורהתונקת יפל ןכרצל ןולע

ו"משתה )םירישכת( 6891

אפורםשרמב תבייח וז הפורת

הפורתב י/שמתשת םרטבופוס דע ןולעהתאןויעב י/ארק

.הזןולעאורקל ךילאבורקה רחאםדאואהחפשמןבל תתל ץלמומ

צ לימארפי 02 ג"מ לימארפיצ 02 ג"מ

תוילבט תוילבט

:בכרה

הילבט לכ לימארפיצלש 02 ג"מ הליכמ :

CitalopramHydrobromideequivalent tocitalopram20mg

לימארפיצלשהילבט לכ 02 :הליכמ ג"מ

CitalopramHydrobromideequivalent tocitalopram 20mg

:םיליעפאלםירמוח

MaizeStarch , Lactose Monohydrate,MicrocrystallineCellulose,Copovidone, Glycerol85%,

CroscarmelloseSodium, Hypromellose5,MagnesiumStearate, TitaniumDioxide(E171),

Macrogol400

:תיטיופרתוקמרפהצובק םייביטקלסןינוטורס תגיפסיבכעמ תצובקמהפורת (SSRI)

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םדב הכומנ 1

(ילמשחעזנב לפוטמ ךניה םא ECT 1)

?ךלשםויםויהייחלעהפורתה עיפשת ךיא

וגפללולעוזהפורתבשומישה לכבותונכוסמתונוכמתלעפהב ,בכרבהגיהנב תוריהזבייחמ ןכלעותונרעבם

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יאליגבםיריעצ םילפוטמב תאזהצלמה 11-42

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1םילוחה תיבל

שואןוירהתננכתמורישכתבתלפוטמ ךניה םא אלאךמצע תעדלעלופיטה תאיקיספתלא,ןוירהב ךניה

1אפורה םעיצעייתה

אפורב ץעוויהלילבתכשוממ הפוקתלוזהפורתבשמתשהלןיא 1

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Page 1 of 15

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"רשואו קדבנ ונכותו תואירבה דרשמ י"ע עבקנ הז ןולע טמרופ

Summary of Product Characteristics

NAME OF MEDICINAL PRODUCT

Cipramil 20 mg Tablets

Cipramil 40mg Tablets

QUALITATIVE AND QUANTITATIVE COMPOSITION

Cipramil 20mg: Each tablet contains 20 mg citalopram (as 24.98 mg citalopram

hydrobromide).

Cipramil 40mg: Each tablet contains 40 mg citalopram (as 49.96 mg citalopram

hydrobromide).

For full list of excipients, see section 6.1.

PHARMACEUTICAL FORM

Film-coated tablet (tablet).

Cipramil 20 mg: White, oval, scored, film-coated tablets marked “C” and “N

symmetrically around the score.

Cipramil 40 mg: White, oval, scored, film-coated tablets marked “C” and “R

symmetrically around the score.

The tablet can be divided into equal doses.

4.

CLINICAL PARTICULARS

4.1. Therapeutic indications

For the treatment of states of Depression and Panic disorder

4.2. Posology and method of administration

Posology

Depression

Citalopram should be administered as a single oral dose of 20 mg daily. Dependent

on individual patient response this may be increased to a maximum of 40 mg daily.

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

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents,

and young adults in short-term studies. These studies did not show an increase in the risk of

suicidal thoughts and behavior with antidepressant use in patients over age 25; there was a

reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and

Precautions (4.4)].

In patients of all ages who are started on antidepressant therapy monitor closely for clinical

worsening and emergence of suicidal thoughts and behaviors. Advise families and caregivers

of the need for close observation and communication with the prescriber [see Warnings and

Precautions (4.4)].

Page 2 of 15

patients with recurrent depression (unipolar) maintenance therapy may need to be

continued for a number of years to prevent new episodes

Panic Disorder A single oral dose of 10 mg daily is recommended for the first week

before increasing the dose to 20 mg daily. Dependent on individual patient

response, the dose may be further increased, up to a maximum of 40 mg daily.

Duration of treatment

Maximum effectiveness of citalopram in treating panic disorder is reached after

about 3 months and the response is maintained during continued treatment.

Elderly patients (>65 years of age)

For elderly patients the dose should be decreased to half the recommended dose,

e.g. 10-20mg daily. The recommended maximum dose for the elderly is 20mg daily.

Children and adolescents (<18 years)

Cipramil should not be used in the treatment of children and adolescents under

the age of 18 years, 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 (see section 5.2).

Reduced renal function

Dosage adjustment is not required if the patient has mild or moderate renal

impairment.

Caution is advised in patients with severe renal impairment (creatinine clearance

<30 mL / min, 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 SSRI

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 reactions (see section 4.4 and 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

Citalopram tablets are administered as a single daily dose. Citalopram tablets can be

taken any time of the day without regard to food intake.

4.3 Contra-indications

Hypersensitivity to citalopram or to any of the excipients (see section 6.1).

MAOIs (monoamine oxidase inhibitors)

Citalopram should not be given to patients receiving Monoamine Oxidase

Inhibitors (MAOIs) (including selegiline in daily doses exceeding 10 mg/day.

Page 3 of 15

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. MAOIs should not

be introduced for seven days after discontinuation of citalopram (see section 4.5

Citalopram is contraindicated in the combination with linezolid unless there are

facilities for close observation and monitoring of blood pressure (see section

4.5).

Concomitant treatment with pimozide (see also section 4.5).

Citalopram is contraindicated in patients with known QT-interval prolongation

or congenital long QT syndrome.

4.4 Special warnings and precautions for use

Treatment of elderly patients and patients with reduced kidney and liver function, see

section 4.2.

Use in children and adolescents under 18 years of age

Antidepressants should not be used in the treatment of children and adolescents under

age of 18 years. Suicide related behaviors (suicide attempt and suicidal thoughts), and

hostility (predominately 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. A low starting dose 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 a rare adverse reaction with the use of SSRIs and generally

reverse on discontinuation of therapy. Elderly female patients seem to be at higher 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.

Other psychiatric conditions for which citalopram are 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.

Page 4 of 15

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.

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 may be detrimental.

Mania

In patients with manic-depressive illness a change towards the manic phase may occur.

Should the patient enter a manic phase citalopram should be discontinued.

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. Citalopram should be discontinued if there is an increase in seizure

frequency.

Diabetes

In patients with diabetes, treatment with an SSRI may alter glycaemic control. Insulin

and/or oral hypoglycaemic dosage may need to be adjusted.

Serotonin syndrome

In rare cases, serotonin syndrome has been reported in patients using SSRIs. A

combination of symptoms such as agitation, tremor, myoclonus, and hyperthermia may

indicate the development of this condition. Treatment with citalopram should be

discontinued immediately and symptomatic treatment initiated.

Serotonergic medicines

Citalopram should not be used concomitantly with medicinal products with serotonergic

effects such as sumatriptan or other triptans, tramadol, oxitriptan, and tryptophan.

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 SSRIs, particularly with concomitant use of oral

anticoagulants; drugs 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).

ECT (electroconvusive therapy)

There is limited clinical experience of concurrent administration of SSRIs and ECT;

therefore caution is advisable.

St. John´s Wort

Undesirable effects may be more common during concomitant use of citalopram

and herbal preparations containing St John’s wort (Hypericum perforatum).

Therefore citalopram and St John’s wort preparations should not be taken

concomitantly (see section 4.5).

Page 5 of 15

Withdrawal symptoms seen on discontinuation of SSRI treatment

Withdrawal symptoms when treatment is discontinued are common, particularly if

discontinuation is abrupt (see section 4.8). In a recurrence prevention clinical trial with

citalopram, adverse events after discontinuation of active treatment were seen in 40%

of patients versus 20% in patients continuing citalopram.

The risk of withdrawal symptoms may be dependent on several factors including the

duration and dose of therapy and the rate of dose reduction. Dizziness, sensory

disturbances (including paraesthesia), sleep disturbances (including insomnia and

intense dreams), agitation or anxiety, nausea and/or vomiting, tremor, confusion,

sweating, headache, diarrhea, palpitations, emotional instability, irritability, and visual

disturbances are the most commonly reported reactions. Generally these symptoms

are mild to moderate, however, in some patients they may be severe in intensity.

They usually occur within the first few days of discontinuing treatment, but there have

been very rare reports of such symptoms in patients who have inadvertently missed a

dose.

Generally these symptoms are self-limiting and usually resolve within 2 weeks, though

in some individuals they may be prolonged (2-3 months or more). It is therefore

advised that citalopram should be gradually tapered when discontinuing treatment

over a period of several weeks or months, according to the patient's needs (see

“Withdrawal Symptoms Seen on Discontinuation of SSRI, Section 4.2).

Psychosis

Treatment of psychotic patients with depressive episodes may increase psychotic

symptoms.

QT interval prolongation

Citalopram has been found to cause a dose-dependent prolongation of the QT-

interval. Cases of QT interval prolongation and ventricular arrhythmia including

torsade de pointes have been reported during the post-marketing period,

predominantly in patients of female gender, with hypokalemia, 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 arrhythmias and should be corrected before treatment with

citalopram is started.

If patients with stable cardiac disease are treated, an ECG review should be

considered before treatment is started.

If signs of cardiac arrhythmia occur during treatment with citalopram, the treatment

should be withdrawn and an ECG should be performed.

Excipients

The tablets contain lactose monohydrate. Patients with rare hereditary problems of

galactose intolerance, the Lapp deficiency or glucose-galactose malabsorption

should not receive this medicine.

4.5 Interactions with other medicaments and other forms of interaction..

Pharmacodynamic interactions

At the pharmacodynamic level cases of serotonin syndrome with citalopram,

moclobemide and buspirone have been reported.

Contraindicated combinations

MAO-inhibitors

Page 6 of 15

The simultaneous use of citalopram and MAO-inhibitors can result in severe

undesirable effects, including the serotonin syndrome (see section 4.3).

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 irreversible MAOI selegiline, the reversible MAOIs linezolid and

moclobemide and in patients who have recently discontinued SSRI and have been

started on a MAOI.

Some cases presented with features resembling serotonin syndrome. Symptoms of

an active substance interaction with a MAOI include:

hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid

fluctuations of vital signs, mental status changes that include confusion, irritability

and extreme agitation progressing to delirium and coma (see section 4.3)

Pimozide

Co administration of a single dose of pimozide 2 mg to subjects treated with racemic

citalopram 40 mg/day for 11 days caused an increase in AUC and Cmax of pimozide,

although not consistently throughout the study. The co-administration of pimozide

and citalopram resulted in a mean increase in the QTc interval of approximately 10

msec. Due to the interaction noted at a low dose of pimozide, concomitant

administration of citalopram and pimozide is contraindicated.

Combinations requiring precaution for use

Selegiline (selective MAO-B inhibitor)

A pharmacokinetic / pharmacodynamic interaction study with concomitantly

administered citalopram (20 mg daily) and selegiline (10 mg daily) (a selective

MAO-B inhibitor) demonstrated no clinically relevant interactions. The concomitant

use of Citalopram and Selegiline (in doses above 10 mg daily) is contraindicated (see

section 4.3).

Serotonergic medicinal products

Lithium and tryptophan

No pharmacodynamic interactions have been found in clinical studies in which

citalopram has been given concomitantly with lithium. However there have been

reports of enhanced effects when SSRIs have been given with lithium or tryptophan

and therefore the concomitant use of citalopram with these drugs should be

undertaken with caution. Routine monitoring of lithium levels should be continued as

usual.

Co administration with serotonergic medicinal products (e.g. tramadol, sumatriptan)

may lead to enhancement of 5-HT associated effects. Until further information is

available, the simultaneous use of citalopram and 5-HT agonists, such as

sumatriptan and other triptans, is not recommended (see section 4.4).

St. John's Wort

Dynamic interactions between SSRIs and herbal remedy St John’s wort (Hypericum

perforatum) can occur, resulting in an increase in undesirable effects (see section

4.4). Phrmacokinetic interactions have not been investigated.

Haemorrhage Caution is warrented for patients who are being treated simultaneously

with anticoagulants, medicinal products that affect platelet function, such as non-

steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid, dipyridamol, and

ticlopidine or other medicines (e.g. atypical antipsychotics, phenothiazines, tricyclic

antidepressants) ) that can increase the risk of haemorrhage (see section 4.4).

ECT (electroconvusive therapy)

There are no clinical studies establishing the risks or benefits of the combined use of

electroconvulsive therapy (ECT) and citalopram (see section 4.4).

Alcohol

Page 7 of 15

No pharmacodynamic or pharmacokinetic interactions have been demonstrated

between citalopram and alcohol. However, the combination of citalopram and alcohol

is not advisable.

Medicinal products lowering the seizure threshold

SSRIs can lower the seizure threshold. Caution is advised when concomitantly using

other medicinal products capable of lowering the seizure threshold (e.g.

antidepressants [tricyclics, SSRIs], neuroleptics [phenothiazines, thioxanthenes, and

butyrophenones]), mefloquin, bupropion and tramadol.

OT interval prolongation

Pharmacokinetic and pharmacodynamic studies between citalopram and other

medicinal products that prolong the QT interval have not been performed. An additive

effect of citalopram and these medicinal products cannot be excluded. Therefore, co-

administration of citalopram with medicinal products that prolong the QT interval,

such as Class IA and III antiarrhythmics, antipsycotics (e.g. fentiazine derviatives,

pimozide, haloperidol), tricyclic antidepressants , certain antimicrobial agents (e.g.

sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarian treatment

particularly halofantrine), certain antihistamines (astemizole, mizolastine) etc.,

should only be prescribed after careful consideration.

Pharmacoknetic interactions

Biotransformation of citalopram to demethylcitalopram is mediated by CYP2C19

(approx. 38%), CYP3A4 (approx. 31%) and CYP2D6 (approx. 31%) isozymes of the

cytochrome P450 system. The fact that citalopram is metabolised by more than one

CYP means that inhibition of its biotransformation is less likely and co-administration

of citalopram with other drugs in clinical practice has very low likelihood of producing

pharmacokinetic medicinal product interactions.

Food

The absorption and other pharmacokinetic properties of citalopram have not been

reported to be affected by food.

Effect of other medicinal products on the pharmacokinetics of citalopram

Co-administration with ketoconazole (potent CYP3A4 inhibitor) did not change the

pharmacokinetics of citalopram.

A pharmacokinetic interaction study of lithium and citalopram did not reveal any

pharmacokinetic interactions (see also above).

Cimetidine (potent CYP2D6, 3A4 and 1A2 inhibitor) caused a moderate increase in

the average steady state levels of citalopram. Caution is advised when administering

citalopram in combination with cimetidine. Dose adjustment may be warranted.

Effects of citalopram on other medicinal products

A pharmacokinetic / pharmacodynamic interaction study with concomitant

administration of citalopram and metoprolol (a CYP2D6 substrate) showed a twofold

increase in metoprolol concentrations, but no statistically significant increase in the

effect of metoprolol on blood pressure and heart rate in healthy volunteers. Caution is

recommended when metoprolol and citalopram are co-administered. Dose

adjustment may be warranted.

Citalopram and demethylcitalopram are negligible inhibitors of CYP2C9, CYP2E1 and

CYP3A4, and only weak inhibitors of CYP1A2, CYP2C19 and CYP2D6 as compared

to other SSRIs established as significant inhibitors.

Levomepromazine, digoxin, carbamazepine

No change or only very small changes of clinical importance were observed when

citalopram was given with CYP1A2 substrates (clozapine and theophylline), CYP2C9

(warfarin), CYP2C19 (imipramine and mephenytoin), CYP2D6 (sparteine, imipramine,

Page 8 of 15

amitriptyline, risperidone) and CYP3A4 (warfarin, carbamazepine (and its metabolite

carbamazepine epoxide) and triazolam).

No pharmacokinetic interaction was observed between citalopram and

levomepromazine, or digoxin, (indicating that citalopram neither induce nor inhibit P-

glycoprotein).

Desipramine, imipramine

In a pharmacokinetic study no effect was demonstrated on either citalopram or

imipramine levels, although the level of desipramine, the primary metabolite of

imipramine, was increased. When desipramine is combined with citalopram, an

increase of the desipramine plasma concentration has been observed. A reduction of

the desipramine dose may be needed.

4.6 Fertility, pregnancy and lactation

Pregnancy

Published data on pregnant women (more than 2500 exposed outcomes) indicate no

malformative feto-/ neonatal toxicity. However, citalopram should not be used during

pregnancy unless clearly necessary and only after careful consideration of risk/benefit.

Neonates should be observed if maternal use of citalopram continues into the later

stages of pregnancy, particularly in the third trimester. Abrupt discontinuation should

be avoided during pregnancy. .

The following symptoms may occur in the neonates after maternal SSRIs/SNRI use

in later stages of pregnancy: respiratory distress, cyanosis, apnoea, hypoglycaemia,

hypotona, hyperreflexia, jitteriness, irritability, lethargy, constant crying, somnolence,

tremor, hypertonia, increased muscle tone, difficulty in 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 in pregnancy, particularly

in late pregnancy, may increase the risk of persistent pulmonary hypertension in the

newborn (PPHN). The observed risk was approximately 5 cases per 1000

pregnancies. In the general population 1 to 2 cases of PPHN per 1000 pregnancies

occur.

Breast-feeding

Citalopram is excreted into breast milk. It is estimated that the suckling infant will

receive about 5% of the weight related maternal daily dose (in mg/kg). No or only

minor events have been observed in the infants. However, the existing information is

insufficient for assessment of the risk to the child.

Caution is recommended.

Fertility

Animal data have shown that citalopram may affect sperm quality (see section 5.3).

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.

4.7

Effects on ability to drive and use machines

Citalopram has minor or moderate influence on the ability to drive and use

machines. Psychoactive medicinal products can reduce the ability to make

Page 9 of 15

judgments and to react to emergencies. Patients should be informed of these

effects and be warned that their ability to drive a car or operate machinery could be

affected.

4.8 Undesirable effects

Adverse effects 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-

≥1/1000, ≤

≤<1/1000); very rare

(≤(<1/10000), not known (can not be estimated from available data).

Page 10 of 15

MedDRA SOC

Frequency

Preferred term

Blood and lymphatic

disorders

Not Known

Thrombocytopenia

Immune system

disorders

Not Known

Hypersensitivity, anaphylactic

reaction

Endocrine disorders

Not Known

Inappropriate ADH secretion

Metabolism and

nutrition disorders

Common

Appetite decreased, weight

decreased

Uncommon

Increased appetite, weight

increased

Rare

Hyponatremia

Not Known

Hypokalaemia

Psychiatric disorders

Common

Agitation, libido decreased,

anxiety, nervousness,

confusional state, abnormal

orgasm (female), abnormal

dreams

Uncommon

Aggression, depersonalization,

hallucination, mania

Not Known

Panic attack, bruxism,

restlessness, suicidal ideation,

suicidal behaviour

Nervous system

disorders

Very common

Somnolence, insomnia

Common

Tremor, paraesthesia,

dizziness, disturbance in

attention

Uncommon

Syncope

Rare

Convulsion grand mal,

dyskinesia, taste disturbance

Not Known

Convulsions, serotonin

syndrome, extrapyramidal

disorder, akathisia, movement

disorder

Eye disorders

Uncommon

Mydriasis

Not Known

Visual disturbance

Ear and labyrinth

disorders

Common

Tinnitus

Cardiac disorders

Uncommon

Bradycardia, tachycardia

Not Known

Electrocardiogram QT

prolongation, Ventricular

arrhythmia including torsade de

pointes

Vascular disorders

Rare

Haemorrhage

Not Known

Orthostatic hypotension

Respiratory thoracic

and mediastinal

disorders

Common

Yawning

Not Known

Epistaxis

Gastrointestinal

disorders

Very common

Dry mouth, nausea

Common

Diarrhoea, vomiting,

constipation

Not Known

Gastrointestinal haemorrhage

(including rectal haemorrhage)

Hepatobiliary disorders

Rare

Hepatitis

Not Known

Liver function test abnormal

Skin and subcutaneous

tissue disorders

Very common

Sweating increased

Common

Pruritus

Uncommon

Urticaria, alopecia, rash,

purpura, photosensitivity

Not Known

Ecchymosis, angioedemas

Musculoskeletal,

Common

Myalgia, arthralgia

Page 11 of 15

connective tissue and

bone disorders

Renal and urinary

disorders

Uncommon

Urinary retention

Reproductive system

and breast disorders

Common

Impotence, ejaculation disorder,

ejaculation failure

Uncommon

Female: Menorrhagia

Not Known

Galactorrhoea

Female: Metrorrhagia

Male: Priapism

General disorders and

administration site

conditions

Common

Fatigue

Uncommon

Oedema

Rare

Pyrexia

Number of patients: Citalopram / placebo = 1346 / 545

Cases of suicidal ideation and suicidal behaviours have been reported during citalopram

therapy or early after treatment discontinuation (see section 4.4).

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.

QT interval prolongation

Cases of QT prolongation and ventricular arrhythmia including torsade de pointes have

been reported during the post-marketing period, predominantly in patients of femal gender,

with hypokalaemia, or with pre-existing QT interval prolongation of other cardiac diseases

(see section 4.3, 4.4, 4.5, 4.9, 5.1).

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. It is therefore advised that when citalopram treatment is no

longer required, gradual discontinuation by dose tapering should be carried out (see section

4.2 and 4.4).

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.

Any suspected adverse events should be reported to the Ministry of Health according to the

National Regulation by using an online form

http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic

@moh.gov.il

4.9 Overdose

Toxicity

Comprehensive clinical data on citalopram overdose are limited and many cases involve

concomitant overdoses of other drugs/alcohol. Fatal cases of citalopram overdose have

been reported with citalopram alone; however, the majority of fatal cases have involved

overdose with concomitant medications.

Symptoms

The following symptoms have been seen in reported overdose of citalopram:

convulsion, tachycardia, somnolence, QT Interval prolongation, coma, vomiting, tremor,

hypotension, cardiac arrest, nausea, serotonin syndrome, agitation, bradycardia,

dizziness, bundle branch block, QRS prolongation, hypertension, and mydriasis, torsade

Page 12 of 15

de pointes, stupor, sweating, cyanosis, hyperventilation and atrial and ventricular

arrhythmia.

Management

There is no specific antidote to citalopram. Treatment should be symptomatic and

supportive. Activated charcoal, osmotically working laxative (such as sodium sulphate)

and stomach evacuation should be considered. If consciousness is impaired the patient

should be intubated. ECG and vital signs should be monitored. .

ECG monitoring is advisable in case of overdose in patients with congestive heart

failure/bradyarrhythmias, in patients using concomitant medications that prolong the QT

interval, or in patients with altered metabolism, e.g. liver impairment.

5.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antidepressants, selective serotonin reuptake inhibitors

ATC-code: N 06 AB 04

Mechanism of action

Biochemical and behavioral studies have shown that citalopram is a potent inhibitor of the

serotonin (5-HT)-uptake. Tolerance to the inhibition of 5-HT-uptake is not induced by long-

term treatment with citalopram.

Citalopram is a very selective Serotonin Reuptake Inhibitor (SSRI) with no, or minimal, effect

on noradrenaline (NA), dopamine (DA) and gamma aminobutyric acid (GABA) uptake.

, citalopram has not or very low affinity for a series of receptors including 5-HT

. 5-HT

and D

receptors, α

-, α

β-adrenoceptors, histamine H

muscarine cholinergic,

benzodiazepine, and opioid receptors..

The main metabolites of citalopram are all SSRIs although their potency and selectivity

ratios are lower than those of citalopram. However, the selectivity ratios of the metabolites

are higher than those of many of the newer SSRls. The metabolites do not contribute to the

antidepressant effect.

Pharmacodynamic effects

Suppression of rapid eye movement (REM) sleep is considered a predictor of

antidepressant activity. Like tricylic antidepressants, other SSRI's and MAO inhibitors,

citalopram suppresses REM-sleep and increases deep slow-wave sleep.

Although citalopram does not bind to opioid receptors it potentiates the anti- nociceptive

effect of commonly used opioid analgesics..

In humans citalopram does not impair cognitive (intellectual function) and psychomotor

performance and has no or minimal sedative properties, either alone or in combination with

alcohol.

Citalopram did not reduce saliva flow in a single dose study in human volunteers and in

none of the studies in healthy volunteers did citalopram have significant influence on

cardiovascular parameters. Citalopram has no effect on the serum levels of prolactin and

growth hormone. Citalopram like other SSRIs may increase plasma prolactin, an effect

secondary to the prolactin stimulating role of serotonin and of no clinical importance.

In a double-blind, placebo-controlled ECG study in healthy subjects, the change from

Page 13 of 15

baseline in QTc (Fridericia-correction) was 7.5 (90%CI 5.9-9.1) msec at the 20 mg/day dose

and 16.7 (90%CI 15.0-18.4) msec at the 60 mg day/dose (see sections 4.3, 4.4, 4.5, 4.8 and

4.9).

5.2

Pharmacokinetic properties

Absorption

Absorption is almost complete and independent of food intake (T

mean 3 hours). Oral

bioavailability is about 80%.

Distribution

The apparent volume of distribution (V

is about 12-17 L/kg. The plasma protein binding is

below 80% for citalopram and its main metabolites.

Biotransformation

Citalopram is metabolized to the active demethylcitaloprarn, didemethylcitalopram,

citalopram-N-oxide and an inactive deaminated propionic acid derivative. All the active

metabolites are also SSRls, although weaker than the parent compound. Unchanged

citalopram is the predominant compound in plasma. The concentrations of

demethylcitalopram and didemethylcitalopram are usually 30-50% and 5-10% of the

citalopram concentration, respectively. The biotransformation of citalopram to

demethylcitalopram is mediated by CYP2C19 (approx. 38%), CYP3A4 (approx. 31%) and

CYP2D6 (approx. 31%).

Elimination

The elimination half-life (T

) is about 1.5 days and the systemic citalopram plasma

clearance (Cl

) is about 0.3-0.4 L/min, and oral plasma clearance (Cl

oral

) is about 0.4 L/min.

Citalopram is excreted mainly via the liver (85%) and the remainder (15%) via the kidneys.

12-23 % of the daily dose is excreted in urine as unchanged citalopram. Hepatic (residual)

clearance is about 0.3 L/min and renal clearance about 0.05-0.08 L/min.

Linearity

The kinetics is linear. Steady state plasma levels are achieved in 1-2 weeks. Average

concentrations of 300 nmol/L (165-400 nmol/L) are achieved at a daily dose of 40 mg.

Elderly patients (≥ 65 years)

Longer half-lives (1.5-3.75 days) and decreased clearance values (0.08-0.3 L/min) due to a

reduced rate of metabolism have been demonstrated in elderly patients. Steady state values

were about twice as high in the elderly as in younger patients treated with the same dose.

Reduced hepatic function

Citalopram is eliminated more slowly in patients with reduced hepatic function. The half-life

of citalopram is about twice as long and steady state citalopram concentrations at a given

dose will be about twice as high as in patients with normal liver function.

Reduced renal function

Citalopram is eliminated more slowly in patients with mild to moderate reduction or renal

function, without any major impact on the pharmacokinetics of citalopram. At present no

information is available for treatment of patients with severely reduced renal function

(creatinine clearance < 30 mL/min) (see section 4.2).

Polymorphism

In vivo investigations have shown that the metabolism of citalopram exhibits no clinically

Page 14 of 15

important polymorphism of the sparteine/debrisoquine oxidation (CYP2D6). For CYP2C19,

as a precaution, an initial dose of 10 mg should be considered for known poor metabolisers

(see section 4.2).

5.3 Preclinical safety data

Acute toxicity

Citalopram has low acute toxicity.

Chronic toxicity

In chronic toxicity studies there were no findings of concern for the therapeutic use of

citalopram.

Reproduction studies

Based on data from reproduction toxicity studies (segment I, II and III) there is no reason

to have special concern for the use of citalopram in women of child-bearing potential.

Embryotoxicity studies in rats with doses of 56 mg/kg/day, which cause maternal toxicity

showed bone anomalies in the region of the vertebral column and ribs. The maternal plasma

level was then 2-3 times the therapeutic concentration in man. In rats citalopram did not have

any effect on fertility, pregnancy and postnatal development but diminished the birth weight of

the pups. Citalopram and its metabolites reach foetal concentrations, which are 10-15 times

the maternal plasma level.

Animal data have shown that citalopram induces a reduction of fertility index and pregnancy

index, reduction in number in implantation and abnormal sperm at exposure well in excess of

human exposure.

Mutagenic and carcinogenic potential

Citalopram has no mutagenic or carcinogenic potential.

6.

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablets: Maize starch, Lactose monohydrate, Microccystalline-cellulose, Copolyvidone,

Glycerol 85%, Croscarmellose Sodium, Magnesium stearate, Hypromellose (5 mPa.s),

Macrogol 400, Titanium dioxide (E171).

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Each pack has an expiry date.

Citalopram tablets are valid for 5 years.

6.4 Special precautions for storage

Store below 30°C.

6.5 Nature and contents of container

Press through blisters of 14, 28, 56, 98 and 100 tablets.

Not all sizes may be marketed.

6.6 Special precautions for disposal

Any unused product or waste material should be disposed of in accordance with local

Page 15 of 15

requirements.

Manufacturer

H. Lundbeck A/S

Ottiliavej 9

DK-2500 Copenhagen- Valby

Denmark

Drug license number

Cipramil 20mg - 102 51 28198 00

Cipramil 40mg – 142.50.32025 00

Name and address of license holder

Lundbeck Israel

4 Derech HaShalom

Tel Aviv

Israel

העדוה העדוה

לע לע

הרמחה הרמחה

(

(

עדימ עדימ

)תוחיטב )תוחיטב ךיראת

__

28.03.2013

םש

רישכת

_תילגנאב

Cipramil 20mg __Cipramil 40mg

_

רפסמ

________םושיר

32025

__

28198

_

םש

לעב

םושירה

קבדנול_

לארשי

______מ"עב

אפורל ןולעב אפורל ןולעב

םיטרפ

לע

םי/יונישה

םי/שקובמה טסקט

שדח טסקט

יחכונ קרפ

ןולעב

Fertility

Animal data have shown that citalopram may affect sperm

quality (see section 5.3).

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.

Fertility,

pregnancy and

lactation

ןכרצל ןולעב ןכרצל ןולעב םיטרפ

לע

םי/יונישה

םי/שקובמה קרפ

ןולעב טסקט יחכונ טסקט

שדח

1

.

ינפל שומישה הפורתב :םא אפורל רפס ,לימארפיצב לופיטה ינפל .תותיווע לש הירוטסיה וא היספליפא ךל שי תא קיספהל שי הילע הלח םא וא יטפליפא ףקתה שי םא לימארפיצב לופיטה .("יאוול תועפות" ףיעס םג האר) םיפקתהה תורידתב ב וא ןואכידב הרמחה וא תוינדבוא תובשחמ

תערפה

הדרחה

ךל תויהל תולוכי הדרח תוערפהמ וא/ו ןואכידמ לבוס ךנה םא תובשחמ .ךמצעב העיגפ לע וא תוינדבוא תובשחמ םימעפל ןוויכ ,ןואכיד-ידגונב לופיטה תליחתב תורבגומ תויהל תולולע ולא הפורתה לש ןואכידה תדגונ העפשההש דע ןמז שרדנש .רתוי ךורא ןמז םיתעל ךא ,םייעובש ללכ ךרדב .תשגרומ :םא ךכ בושחתש רתוי הובג יוכיס םייק

.ךמצעב העיגפ לע וא תוינדבוא תובשחמ רבעב ךל ויה

התא םא ריעצ רגובמ הארה םיינילק םירקחממ עדימ . תחתמ) םיריעצ םירגובמב תינדבוא תוגהנתהל ןוכיסב הילע ליגל

ולפוט רשא תירטאיכיספ הלחממ םילבוסה ( ןואכיד-ידגונב

ךתלחמל רושקה דחוימ עדימ םילולע הדרחה תערפה לש ןואכידה לש םינימסתה ,םיתעל ןכתי .תימצע-העיגפ לע וא תוינדבוא תובשחמ םג לולכל האלמה העפשהה תגשהל דע ורימחי וא וכשמי ולא םינימסתו .ןואכידה תדגונ הפורתה לש רתוי הובג הרקי הז רבדש יוכיסה ליגל תחתמ ,ריעצ רגובמ ךנה םא

תשמתשה אל םלועמו .ןכ ינפל ןואכיד תדגונ הפורתב

119070

תובוגת תויתפורת-ןיב לומאריפיד ,ןידיפולקיט הקנה ,ןוירה תוירופו ליעפה רמוחה ,םארפולטיצ יכ וארה םייח ילעבב םירקחמ ,יטרואית ןפואב .ערזה לש תוכיאה תא תיחפמ ,לימארפיצב לע העפשה התפצנ םרט םלוא ,תוירופ לע עיפשהל לולע רבדה .םדאב תוירופ תועטב תלטנ םא :רתוי הובג ןונימ :(םייח-ינכסמ תויהל םילוכי םקלח רשא) רתי ןונימ ינימסת תמדרת

4

.

יאוול תועפות םיעיפומ םא אפורל דימ תונפלו שומישה תא קיספהל שי :םיאבה םינימסתה תורידתב הילע הלח םא וא הנושארל יטפליפא ףקתה ךל שי םייטפליפאה םיפקתהה

תופסונ יאוול תועפות

ןכלו תששעל ןוכיס הלעמ) הפב שבוי םייניש חצחצל שי ליגרהמ ההובג תורידתב

דע) תורידנ תועפות

1:1000

(םילפוטמ

רידס אל רוזחמ

119070

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