Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Summary of the safety profile
The adverse reactions reported with Levitra film-coated tablets or 10 mg orodispersible 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         (≥1/10,000 to               (cannot be (≥1/10)    <1/10)       <1/100)              <1/1,000)                   estimated from the available data)
Infection and                                                   Conjunctivitis infestations
Immune system                              Allergic oedema      Allergic reaction disorders                                  and angioedema
Psychiatric                                Sleep disorder       Anxiety disorders
Nervous system     Headache   Dizziness    Somnolence           Syncope                     Cerebral haemorrhage disorders                                  Paraesthesia and     Seizure dysaesthesia         Amnesia
Transient ischaemic attack
Eye disorders                              Visual disturbance   Increase in intraocular     Non-arteritic anterior Ocular hyperaemia    pressure                    ischemic optic
Visual colour        Lacrimation increased       neuropathy distortions                                      Visual defects
Eye pain and eye discomfort
Photophobia
Ear and                                    Tinnitus                                         Sudden deafness labyrinth                                  Vertigo disorders
Cardiac                                    Palpitation          Myocardial infarction       Sudden death disorders                                  Tachycardia          Ventricular tachy- arrhythmias
Angina pectoris
Vascular                      Flushing                          Hypotension disorders                                                       Hypertension Respiratory,                  Nasal        Dyspnoea             Epistaxis thoracic and                  congestion   Sinus congestion mediastinal disorders
Gastrointestinal              Dyspepsia     Gastro- disorders                                  oesophageal reflux disease
Gastritis
Gastrointestinal and abdominal pain
Diarrhoea
Vomiting
Nausea
Dry mouth
Hepatobiliary                              Increase in          Increase in gamma- disorders                                  transaminases        glutamyl transferase Skin and                                   Erythema             Photosensitivity reaction subcutaneous                               Rash tissue disorders
System Organ       Very           Common         Uncommon               Rare                      Not known Class              common         (≥1/100 to     (≥1/1,000 to           (≥1/10,000 to             (cannot be (≥1/10)        <1/10)         <1/100)                <1/1,000)                 estimated from the available data)
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 Haemorrhage system and                                                                                        Haematospermia breast disorders
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 Levitra 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/