Adverse reactions : תופעות לוואי

 4.8 Undesirable effects
Summary of the safety profile
The adverse reactions reported with Vardenafil Inovamed film-coated tablets in clinical trials were generally transient and mild to moderate in nature. The most commonly reported adverse drug reaction occurring in ≥ 10% of patients is headache.

Tabulated list of adverse reactions
Adverse reactions are listed according to the MedDRA frequency convention: 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) and not known (can not be estimated from available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.


The following adverse reactions have been reported:
System Organ       very         Common       Uncommon                 Rare                 Not known Class              common       (≥1/100 to   (≥1/1,000 to <1/100)     (≥1/10,000 to        (cannot be (≥1/10)      <1/10)                                <1/1,000)            estimated from the available data)
Infection and                                                         Conjunctivitis infestations
Immune system                                Allergic                 Allergic reaction disorders                                    oedema and angioedema
Psychiatric                                  Sleep disorder           Anxiety disorders
Nervous system     Headache     Dizziness    Somnolence               Syncope              Cerebral disorders                                    Paraesthesia             Seizure              haemorrhage and                      Amnesia dysaesthesia             Transient ischaemic attack
Eye disorders                                Visual disturbance       Increase in          Non-arteritic Ocular hyperaemia        intraocular          anterior
Visual colour            pressure             ischemic distortions                                   optic
Eye pain and eye         Lacrimation          neuropathy discomfort               increased            Visual
Photophobia                                   defects
Ear and                                      Tinnitus                                      Sudden labyrinth                                    Vertigo                                       deafness disorders
Cardiac                                      Palpitation              Myocardial           Sudden death disorders                                    Tachycardia              infarction Ventricular tachy- arrhythmias
Angina pectoris
Vascular                         Flushing                              Hypotension disorders                                                              Hypertension Respiratory,                     Nasal      Dyspnoea                   Epistaxis thoracic and                     congestion Sinus congestion mediastinal disorders
Gastrointestinal                 Dyspepsia    Gastro-oesophageal disorders                                     reflux disease
Gastritis
Gastrointestinal and abdominal pain
Diarrhoea
Vomiting
Nausea
Dry mouth
Hepatobiliary                                 Increase in              Increase in disorders                                     transaminases            gamma-glutamyl transferase
Skin and                                      Erythema                 Photosensitivity subcutaneous                                  Rash                     reaction tissue disorders
Musculoskeletal                               Back pain and connective                                Increase in creatine tissue disorders                              phosphokinase
Myalgia
Increased muscle tone and cramping
Renal and                                                                                    Haematuria urinary disorders
Reproductive                                  Increase in erection     Priapism              Penile system and                                                                                   Haemorrhage breast disorders                                                                             Haematosper- mia
General                                       Feeling unwell           Chest pain disorders and administration site conditions

Description of selected adverse reactions
Penile haemorrhage, haematospermia and haematuria have been reported in clinical trials and spontaneous post-marketing data with the use of all PDE5 inhibitors, including vardenafil. At a dose of 20 mg Vardenafil Inovamed film-coated tablets, elderly (≥65 years old) patients had higher frequencies of headaches (16.2% versus 11.8%) and dizziness (3.7% versus 0.7%) than younger patients (<65 years old).
In general, the incidence of adverse reactions (especially “dizziness”) has been shown to be slightly higher in patients with a history of hypertension.

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/