Adverse reactions : תופעות לוואי

4.8       Undesirable effects

Adverse events, observed in clinical studies at frequencies listed below, are often associated with the illness and are not necessarily related to treatment.

Frequency estimate: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare
(≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

MedDra system        Common          Uncommon            Rare        Very    Frequency not organ class                                                          rare    known 

Endocrine                                                                    Hyperprolactinem disorders                                                                    ia, Inappropriate antidiuretic hormone secretion.
Metabolism and       Anorexia                                                Hyponatraemia, nutrition                                                                    weight increased, disorders                                                                    weight decreased.

Psychiatric                          Hallucination,      Mania               suicidal ideation disorders                            confusional                             (see section 4.4) stage,
aggression
MedDra system      Common          Uncommon           Rare       Very   Frequency not organ class                                                      rare   known 

Nervous system     Agitation,      Extrapyramidal     Convulsi          Serotonin disorders          nervousness,    disorder, ataxia   on                syndrome, anxiety,                                             neuroleptic insomnia,                                            malignant somnolence,                                          syndrome-like tremor,                                              events,
headache,                                            paresthesia, dizziness                                            dysgeusia, and SIADH have been reported (see also section 4.4).
Psychomotor restlessness/akat hisia (see section
4.4).


Eye disorders                                                           Glaucoma, Mydriasis.

Renal and                                                               micturition urinary                                                                 disorder disorders                                                               (including urinary retention, urinary incontinence,
pollakiuria,
nocturia and enuresis)

Cardiac            Palpitations/ disorders          tachycardia
Vascular                           (Orthostatic)                        Haemorrhage disorders                          hypotension                          (e.g.
gastrointestinal haemorrhage,
gynaecological haemorrhage,
ecchymosis,
purpura).

Gastrointestinal   Abdominal disorders          pain,
constipation,
diarrhoea,
dry mouth,
dyspepsia,
nausea,
vomiting
MedDra system       Common          Uncommon            Rare        Very   Frequency not organ class                                                         rare   known 

Hepatobiliary                                           Hepatic disorders                                               function abnormal
Skin and            Hyperhydrosi    Cutaneous           Photose            Stevens-Johnson subcutaneous        s               hypersensitivity    nsitivity          syndrome***/ tissue disorders    Sweating        reactions (incl.    reaction           Toxic Epidermal angioneurotic                          Necrolysis***,
oedema, rash,                          Erythema pruritis)                              multiforme***

Musculoskeletal,                    Arthralgia,                            **Bone fractures connective                          myalgia tissue and bone disorders
Reproductive                        Abnormal                               Anorgasmia, system and                          (delayed)          Galactorrh          menstrual breast disorders                    ejaculation        oea                 disorders (such as amenorrhea,
hypomenorrhea,
metrorrhagia,
menorrhagia).
****postpartum haemorrhage

General             Asthenia,                                              drug withdrawal disorders and       malaise                                                syndrome administration                                                             including drug site reactions                                                             withdrawal syndrome neonatal (see section 4.6).

*Nausea, sometimes accompanied by vomiting is the most frequently observed symptom associated with fluvoxamine treatment. This side effect usually diminishes within the first two weeks of treatment.

** Class effects: Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving Selective Serotonin Reuptake Inhibitors (SSRIs) and Tricyclic Antidepressants (TCAs). The mechanism leading to this risk is unknown.
*** Estimated frequency of post-marketing surveillance reported adverse reactions; not observed in placebo-controlled clinical trials
**** This event has been reported for the therapeutic class of SSRIs/SNRIs (see sections 4.4, 4.6).


Cases of suicidal ideation and suicidal behaviours have been reported during fluvoxamine therapy or early after treatment discontinuation (see section 4.4).
Withdrawal symptoms seen on discontinuation of fluvoxamine treatment 
Discontinuation of fluvoxamine (particularly when abrupt) commonly leads to withdrawal symptoms. Dizziness, sensory disturbance (including paraesthesia, visual disturbance and electric shock sensations), sleep disturbances (including insomnia and intense dreams), agitation and anxiety, irritability, confusion, emotional instability, nausea and/or vomiting, diarrhoea, sweating, palpitations, headache and tremor 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 fluvoxamine treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see section 4.2 and section 4.4).
Paediatric population

In one 10-week placebo-controlled trial in children and adolescents with OCD, frequently reported adverse events with a higher incidence than placebo, were: insomnia, asthenia, agitation, hyperkinesia, somnolence and dyspepsia. Serious adverse events in this study included: agitation and hypomania.

Convulsions in children and adolescents have been reported during use outside clinical trials.

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 /http://sideeffects.health.gov.il Additionally, you can also report to Padagis.co.il