Cardiplot Adverse Reactions

A number of undesirable effects have been observed during treatment with Cardiplot and other dihydropyridines, with the following frequencies: 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, including isolated cases; Not known cannot be estimated from the available data.
The common undesirable effects are dose-dependent and usually disappear later on during treatment.
Investigations: Uncommon: reversible increases in SGPT, SGOT, LDH, gamma-GT, alkaline phosphatase, BUN and serum creatinine.
Rare: bilirubin increased.
Cardiac disorders: Common: palpitations, oedema.
Uncommon: tachycardia.
Rare: chest pain, angina.
Very rare: myocardial stroke and, in isolated cases, patients with pre-existent angina may experience increased frequency, duration and severity of these incidents.
Nervous system disorders: Common: headache, dizziness and vertigo.
Uncommon: paresthesia.
Rare: somnolence and drowsiness.
Not known: extrapyramidal syndrome has been reported with some calcium inhibitors.
Respiratory, thoracic and mediastinal disorders: Uncommon: dyspnea.
Gastrointestinal disorders: Uncommon: nausea, vomiting, constipation, dry mouth, digestive disorders.
Rare: stomachache, abdominal pain, diarrhoea, anorexia.
Very rare: gingivitis and gingival hyperplasia, which generally disappeared with the withdrawal of the drug and need careful dental care.
Skin and subcutaneous disorders: Uncommon: rash, eczema.
Rare: erythema, itching.
Not known: erythema multiforme, exfoliative dermatitis.
Vascular disorders: Common: hot flushes.
Uncommon: hypotension.
Rare: hypertension.
Hepatobiliary disorders: Rare: jaundice.
Musculoskeletal and connective tissue disorders: Not known: myalgia.
Reproductive system and breast disorder: Not known: gynaecomastia.
General disorders and administration site conditions: Uncommon: asthenia.
Rare: irritability.
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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.