Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Summary of the safety profile
RELERT® has been administered in clinical trials to over 5000 subjects, taking one or two doses of RELERT® 20 or 40 or 80 mg. The most common adverse reactions noted were asthenia, somnolence, nausea and dizziness. In randomised clinical studies using doses of 20 40 and 80 mg, a trend for a dose-dependency of the incidence of adverse events has been shown.

Tabulated list of adverse reactions

The following adverse reactions (with an incidence ≥1% and higher than placebo) were reported in patients treated with therapeutic doses in clinical trials. Events are categorized by frequency as common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), or rare (≥1/10,000 to <1/1,000).

System Organ Class               Common                   Uncommon                        Rare Infections and           pharyngitis, and rhinitis                            respiratory tract infection infestations:

Blood and the                                                                 lymphadenopathy lymphatic system disorders:

Metabolism and                                        anorexia nutrition disorders:

Psychiatric disorders:                                thinking abnormal,      emotional lability agitation, confusion,
depersonalisation,
euphoria, depression,
and insomnia

Nervous system           somnolence, headache,        tremor,
disorders:               dizziness, tingling or       hyperaesthesia, abnormal sensation,          ataxia, hypokinesia,
hypertonia, hypoaesthesia,   speech disorder,
and myasthenia               stupor, and taste perversion
Eye disorders:                                        abnormal vision, eye    conjunctivitis pain, photophobia,
and lacrimation disorder
Ear and labyrinth        vertigo                      ear pain, tinnitus disorders:

Cardiac disorders:       palpitation, and                                     bradycardia tachycardia
Vascular disorders:      flushing                     peripheral vascular     shock disorder
Respiratory, thoracic    throat tightness             dyspnea, respiratory    asthma and voice alteration and mediastinal                                       disorder and yawning disorders:

Gastrointestinal         abdominal pain, nausea,      diarrhoea, and          constipation, oesophagitis, disorders:               dry mouth, and dyspepsia     glossitis               tongue oedema and eructation
Hepato-biliary                                                                hyperbilirubinaemia, and disorders:                                                                    increased AST 
Skin and subcutaneous    sweating                       rash and pruritis       skin disorder and urticaria tissue disorders:

Musculoskeletal,         back pain, myalgia             arthralgia, arthrosis   arthritis, myopathy and connective tissue and                                   and bone pain           twitching bone disorders:

Renal and urinary                                       increased urinary disorders:                                              frequency, urinary tract disorder and polyuria
Reproductive system                                                             breast pain and and breast disorders:                                                           menorrhagia 
General disorders and    feeling hot, asthenia, chest   malaise, face administration site      symptoms (pain, tightness,     oedema, thirst, conditions:              pressure), chills and pain     oedema and peripheral oedema

The common adverse events seen with eletriptan are typical of adverse events reported with 5-HT1 agonists as a class.

In post-marketing experience, the following undesirable effects have been reported: 
Immune system disorders: allergic reactions, some of which may be serious including angioedema 
Nervous system disorders: serotonin syndrome, rare cases of syncope, cerebrovascular accident 
Vascular disorders: hypertension

Cardiac disorders: myocardial ischaemia or infarction, arteriospasm coronary 
Gastrointestinal disorders: as with some other 5HT 1B/1D agonists, rare reports of ischaemic colitis have been received, vomiting.

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/