Adverse reactions : תופעות לוואי

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-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 the available data).

System organ class          Frequency              Undesirable effect 
Blood and lymphatic disorders                   Not known              Thrombocytopenia

Immune system disorders     Not known              Hypersensitivity, anaphylactic reaction Endocrine disorders         Not known              Inappropriate ADH secretion Hyperprolactinaemia3
Common                 Appetite decreased, weight decreased
Metabolism and nutrition    Uncommon               Increased appetite, weight increased disorders
Rare                   Hyponatraemia
Not known              Hypokalaemia
Very common            Sleep disorder
Agitation, libido decreased, anxiety,
Common                 nervousness, confusional state, abnormal
Psychiatric disorders                              orgasm (female), abnormal dreams, apathy Aggression, depersonalisation,
Uncommon hallucination, mania, libido increased
Panic attack, bruxism, restlessness, suicidal
Not known ideation, suicidal behaviour1
Very common            Somnolence, insomnia, headache

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Tremor, paraesthesia, dizziness,
Common disturbance in attention, migraine, amnesia
Uncommon          Syncope
Nervous system disorders                                      Convulsion grand mal, dyskinesia, taste Rare disturbance
Convulsions, serotonin syndrome,
Not known         extrapyramidal disorder, akathisia,
movement disorder
Mydriasis (which may lead to acute narrow
Uncommon          angle glaucoma), see section 4.4 Special
Eye disorders                                  warnings and precautions for use Not known         Visual disturbance
Ear and labyrinth disorders                    Common            Tinnitus

Common            Palpitations

Cardiac disorders            Uncommon          Bradycardia, tachycardia QT-prolongation, ventricular arrhythmia
Not known including torsade de pointes
Rare              Haemorrhage
Vascular disorders
Not known         Orthostatic hypotension
Common            Yawning, rhinitis
Respiratory thoracic and mediastinal disorders        Rare              Coughing
Not known         Epistaxis
Very common       Dry mouth, nausea
Gastrointestinal disorders                     Diarrhoea, vomiting, constipation, Common            dyspepsia, abdominal pain, flatulence,
salivary hypersecretion
Gastrointestinal haemorrhage (including
Not known rectal haemorrhage)
Rare              Hepatitis
Hepatobiliary disorders
Not known         Liver function test abnormal
Very common       Sweating increased
Common            Pruritus
Skin and subcutaneous tissue disorders                               Urticaria, alopecia, rash, purpura, Uncommon photosensitivity reaction
Not known         Ecchymosis, angioedemas
Musculoskeletal and connective tissue            Common            Myalgia, arthralgia disorders
Not Known        Rhabdomyolysis4
Renal and urinary disorders                    Uncommon          Urinary retention


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Impotence, ejaculation disorder, ejaculation
Common failure
Reproductive system and     Uncommon               Female: Menorrhagia breast disorders
Female: Metrorrhagia, postpartum
Not known              haemorrhage2
Male: Priapism,
Galactorrhoea


Very common            Asthenia
General disorders and
Common                 Fatigue administration site conditions                  Uncommon               Oedema
Rare                   Pyrexia, malaise

Number of patients: citalopram / placebo = 1346 / 545
1
Cases of suicidal ideation and suicidal behaviours have been reported during citalopram therapy or early after treatment discontinuation (see section 4.4).
2
This event has been reported for the therapeutic class of SSRIs/SNRIs (see sections 4.4 and 4.6).
3
This event has been reported for the therapeutic class of SSRIs/SNRIs (see section 5.1).
4   Cases have been observed during post-marketing use.


Cases of QT-prolongation and ventricular arrhythmia 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, 4.4, 4.5, 4.9 and 5.1).

Class effects
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.

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 section 4.4).
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. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/

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