Adverse reactions : תופעות לוואי

4.8   Undesirable effects
Frequency estimates: Very common ≥ / ; common ≥ /               to <1/10); u o      o ≥ / ,     to < /      ; rare ≥ / ,     to < / ,     ; very rare (<1/10,000); not known (cannot be estimated from the available data) System      Very     Common          Uncom    Rare         Very rare Not Organ       comm      ≥ /     to     mon        ≥ / ,      (<1/10,0       known Class       on       <1/10)           ≥ / ,   00 to        00)            (cannot ≥ /                     00 to    <1/1,000                    be
0)                       <1/100) )                            estimate d from the available data)
Blood                                                      Thrombo and                                                        cytopeni lymphat                                                    a,
ic                                                         agranulo system                                                     cytosis disorder s
Psychiat                                      Depressi     Hallucin ric                                           on,          ations,
disorder                                      nightmar     personali s                                             es,          ty
Nervous      disorder,
ness,        Amnesia anxiety,     / impotenc memory e            impairm ent
Nervous              Dizziness,               Alertness system               headache                 decrease disorder                                      d,
s                                             somnole nce or insomnia
,
paraesthe sia
Eye                                                        Visual disorder                                                   disturban s                                                          ce (e.g.
blurred vision,
dry eyes and/or eye irritation
Ear and                                  Tinnitus,
labyrint h                               and, in disorder                                 doses s                                        exceedin g those recomme nded,
"hearing disorders
(eg.
hypoacus is or deafness)
Cardiac      Bradycard      Heart        Cardiac       Increase disorder     ia             failure,     conducti      in existing s                           cardiac      on            intermitt arrhythm     disorders     ent ias,         ,             claudicat palpitatio   precordia     ion n            l pain
Vascula r    Orthostatic    Oedema,      Gangren disorder     hypotensio     Raynaud'     e in s            n (occasiona   s            patients lly with       phenome      with pre syncope)       non          existing severe periphera l circulato ry disorders

Respirat     Exertional     Broncho      Rhinitis ory,         dyspnoea       spasm thoracic                    (which and                         may mediasti                    occur in nal                         patients disorder s                  without a history of obstructi ve lung disease)
Gastroi      Nausea         Diarrhoe     Dry           Retroperi ntestinal    and            a or         mouth         toneal disorder     vomiting,      constipat                  fibrosis* s            abdominal      ion pain
Hepatobil                                                                Hepatitis iary disorder s
Skin and                                        Skin rash    Photosen    Occurren Subcutan                                        (in the      sitivity,   ce of eous                                            form of      hyperhid    antinucle tissue                                          urticaria,   rosis,      ar disorder s                                      psoriasif    alopecia,   antibodie orm and      worsenin    s (not dystrophi    g of        associate c            psoriasis   d with skin                     SLE) lesions) s
Musculo                                         Muscle       Arthritis skelet al                                       cramps and connecti ve tissue disorder s
Reprod                                                       Disturba    Peyronie' uctive                                                       nces of     s disease* system                                                       Libido and                                                          and breast                                                       potency disorder s
General               Fatigue                                Dysgeusi disorder                                                     a (Taste s and                                                        disturban adminis                                                      ces) tration site conditio ns
Investig                                                     Weight ations                                                       increase, liver function test abnormal


* (relationship to Metoprolol has not been definitely established).
Beta-blockers may mask the symptoms of thyrotoxicosis or hypoglycaemia.
Post Marketing Experience
The following adverse reactions have been reported during post-approval use of metoprolol: confusional state, an increase in blood triglycerides and a decrease in high density lipoprotein (HDL). Because these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency.

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/( 
Additio ally, you a report to Unipharm Ltd