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:



Not known
System Organ                   Common          Uncommon                Rare          (cannot be Very common
Class                     (≥1/100 to    (≥1/1,000 to         (≥1/10,000 to       estimated from (≥1/10)
<1/10)     <1/100)                  <1/1,000)       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 disorders                                    Paraesthesia and     Seizure             haemorrhage dysaesthesia         Amnesia
Transient ischaemic attack


Eye disorders                                Visual disturbance Increase in           Non-arteritic Ocular hyperaemia intraocular            anterior ischemic pressure              optic neuropathy
Visual colour distortions        Lacrimation           Visual defects increased
Eye pain and eye discomfort
Photophobia
Ear and                                      Tinnitus                                 Sudden deafness labyrinth                                    Vertigo 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- disorders                                    oesophageal 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 tissue disorders                                    creatine phosphokinase
Myalgia
Increased muscle tone and cramping


Renal and                                                                                   Haematuria urinary disorders
Reproductive                                        Increase in          Priapism           Penile system and                                          erection                                Haemorrhage breast disorders
Haematospermia
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/