Adverse reactions : תופעות לוואי

4.8     Undesirable effects
Summary of the safety profile
Adverse reactions reported as very common (>1/10) in clinical studies were nausea, dry mouth, headache and sweating (including night sweats).

Tabulated list of adverse reactions
Adverse reactions are listed below by system organ class, frequency category and decreasing order of medical seriousness within each frequency category.

Frequencies are defined as: 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).

Body System           Very          Common            Uncommon          Rare               Very Rare     Not Known Common
Blood and                                                               Agranulocytosis*   Thrombocyt lymphatic                                                               , Aplastic         o-paenia* system                                                                  anaemia*, disorders                                                               Pancytopaenia*, Neutropaenia*
Immune                                                                  Anaphylactic system                                                                  reaction* disorders
Endocrine                                                               Inappropriate      Blood disorders                                                               antidiuretic       prolactin hormone            increased* secretion*
Metabolism            Insomnia      Decreased                           Hyponatraemia* and nutrition                       appetite disorders
Psychiatric                        Confusional           Mania,             Delirium*                          Suicidal disorders                          state*,               Hypomania,                                            ideation and Depersonalization     Hallucination,                                        suicidal *, Abnormal           Derealization,                                        behavioursa, dreams,               Abnormal                                              Aggressionb Nervousness,          orgasm,
Libido decreased,     Bruxism*,
Agitation*,           Apathy
Anorgasmia
Nervous            Headache*c,     Akathisia*,           Syncope,           Neuroleptic         Tardive system             Dizziness,      Tremor,               Myoclonus,         Malignant           dyskinaesia* disorders          Sedation        Paraesthesia,         Balance            Syndrome Dysgeusia             disorder*,         (NMS)*,
Coordination       Serotonin abnormal*,         syndrome*,
Dyskinaesia*       Convulsion,
Dystonia*
Eye disorders                      Visual impairment,                       Angle-closure Accommodation                            glaucoma* disorder, including vision blurred,
Mydriasis
Ear and                            Tinnitus*                                                                   Vertigo labyrinth disorders
Cardiac                            Tachycardia,                             Torsade de                         Stress disorders                          Palpitations*                            pointes*,                          cardiomyopath Ventricular                        y (takotsubo tachycardia*,                      cardiomyopath
Ventricular                        y)* fibrillation,
Electrocardio- gram QT prolonged*
Vascular                           Hypertension, Hot     Orthostatic disorders                          flush                 hypotension, Hypotension*
Respiratory,                       Dyspnoea*,                               Interstitial lung thoracic and                       Yawning                                  disease*, mediastinal                                                                 Pulmonary disorders                                                                   eosinophilia* Gastrointestinal   Nausea, Dry     Diarrhoea*,           Gastrointestinal   Pancreatitis* disorders          mouth,          Vomiting              haemorrhage* Constipation
Hepatobiliary                                            Liver function     Hepatitis* disorders                                                test abnormal* Skin and           Hyperhidrosi    Rash, Pruritus*       Urticaria*,        Stevens- subcutaneous       s* (including                         Alopecia*,         Johnson tissue disorders   night                                 Ecchymosis,        syndrome*, sweats) *                             Angioedema*,       Toxic epidermal Photosensitivity   necrolysis*,
reaction           Erythema multiforme*
Musculoskeleta                     Hypertonia                               Rhabdomyoly- l and                                                                       sis* connective tissue disorders
Renal and                          Urinary hesitation,   Urinary urinary                            Urinary retention ,   incontinence* disorders                          Pollakiuria*
Reproductive                 Menorrhagia*,                                                          Postpartum system and                   Metrorrhagia*,                                                         haemorrhage* breast                       Erectile                                                               d  disorders                    dysfunctionb,
Ejaculation disorderb
General                      Fatigue, Asthenia,                                       Mucosal disorders and                Chills*                                                  haemorrhag administration                                                                        e* site conditions
Investigations               Weight decreased,                                        Bleeding Weight increased,                                        time
Blood cholesterol                                        prolonged* increased


*ADR identified post-marketing.
a Cases of suicidal ideation and suicidal behaviours have been reported during venlafaxine therapy or early after treatment discontinuation (see section 4.4).
 b See section 4.4
 c In pooled clinical trials, the incidence of headache with venlafaxine and placebo were similar.
 d This event has been reported for the therapeutic class of SSRIs/SNRIs (see sections 4.4 and 4.6).

Discontinuation of treatment
Discontinuation of venlafaxine (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, vertigo, headache, flu syndrome, visual impairment and hypertension 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 venlafaxine treatment is no longer required, gradual discontinuation by dose tapering should be carried out. However, in some patients severe aggression and suicidal ideation occurred when the dose was reduced or during discontinuation (see sections 4.2 and 4.4).

Paediatric population
In general, the adverse reaction profile of venlafaxine (in placebo-controlled clinical trials) in children and adolescents (ages 6 to 17) was similar to that seen for adults. As with adults, decreased appetite, weight loss, increased blood pressure, and increased serum cholesterol were observed (see section 4.4).

In paediatric clinical trials the adverse reaction suicidal ideation was observed. There were also increased reports of hostility and, especially in major depressive disorder, self-harm.
Particularly, the following adverse reactions were observed in paediatric patients: abdominal pain, agitation, dyspepsia, ecchymosis, epistaxis, and myalgia.
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