Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Summary of safety profile
The safety of lercanidipine at a dose of 10-20 mg once daily has been evaluated in double-blind, placebo- controlled clinical trials (with 1200 patients receiving lercanidipine and 603 patients receiving placebo) and in active-controlled and uncontrolled long term clinical trials on a total of 3676 hypertensive patients receiving lercanidipine.
The most commonly reported adverse reactions in clinical trials and in the post-marketing experience are: peripheral oedema, headache, flushing, tachycardia and palpitations.


Tabulated list of adverse reactions
In the table below, adverse reactions reported in clinical trials and in the worldwide post-marketing experience for which a reasonable causal relationship exists are listed by MedDRA system organ class classification and frequency: 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); very rare (<1/10,000), not known (cannot be estimated from available data). Within each frequency grouping the observed adverse reactions are presented in order of decreasing seriousness.


MedDRA                Common               Uncommon                Rare                   Not known System Organ
Class
Immune system                                                      Hypersensitivity disorders
Nervous               Headache             Dizziness               Somnolence system disorders                                                   Syncope Cardiac disorders     Tachycardia                                  Angina pectoris Palpitations
Vascular disorders    Flushing             Hypotension
Gastrointestinal                           Dyspepsia               Vomiting               Gingival disorders                                  Nausea                  Diarrhoea              hypertrophy1 Abdominal pain                                 Peritoneal cloudy upper                                          effluent1
Hepatobiliary
Serum disorders transaminase increased1
Skin and                                   Rash                    Urticaria              Angioedema1 subcutaneous                               Pruritus tissue disorders
Musculoskeletal                            Myalgia and connective tissue disorders
Renal and urinary                          Polyuria                Pollakiuria disorders
General disorders     Oedema               Asthenia                Chest pain and                   peripheral           Fatigue administration site conditions
1   adverse reactions from spontaneous reporting in the worldwide post-marketing experience Description of selected adverse reactions
In placebo controlled clinical trials the incidence of peripheral oedema was 0.9% with lercanidipine 10-20 mg and 0.83% with placebo. This frequency reached 2% in the overall study population including long term clinical trials.
Lercanidipine does not appear to influence adversely blood sugar or serum lipid levels.
Some dihydropyridines may rarely lead to precordial pain or angina pectoris.
Very rarely patients with pre-existing angina pectoris may experience increased frequency, duration or severity of these attacks. Isolated cases of myocardial infarction may be observed.

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/