The undesirable effects observed in the course of using active ingredients separately are to be give according to the following frequency grouping: Very common (≥ 1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1000 to <1/100); Rare (≥1/10,000 to < 1/1000); Very rare (<1/10,000); Frequency not known (cannot be estimated from the available data).
In connection with amlodipine:
During placebo-controlled studies with patients suffering of hypotension and angina pectoris, most frequently reported adverse effects were as follow: headache, oedemas (especially ankle oedema), increased fatigue, somnolence, nausea, abdominal pain, flush, palpitation and dizziness.
In these clinical trials clinically significant laboratory abnormalities in relation with amlodipine have not been observed.
Blood and lymphatic system disorders:
Very rare: Leukopenia, thrombocytopenia.
Immune system disorders:
Rare: Allergic reactions, mainly affecting the skin.
Metabolism and nutrition disorders:
Very rare: Hyperglycaemia.
Uncommon: Insomnia, mood changes (including anxiety), depression, sleep disorders.
Rare: Nightmare, hallucinations, confusion.
Nervous system disorders:
Common: Headache, dizziness, somnolence. These symptoms especially occur at the beginning of therapy. There are generally mild and often disappear within 1-2 weeks.
Uncommon: Hypoesthesia, paraesthesia, dysgeusia, tremor.
Very rare: Peripheral neuropathy.
Uncommon: Visual disturbance (including diplopia).
Rare: Decreased tear secretion (to be considered if the patient uses contact lenses).
Very rare: Conjunctivitis.
Ear and labyrinth disorders:
Rare: Hearing disorders.
Uncommon: Atrioventricular-conduction disturbances, worsening of pre-existing heart failure, bradycardia.
Very rare: Myocardial infarction, arrhythmia.
Common: Flushing, feeling of coldness and numbness in the extremities.
Uncommon: Hypotension, syncope.
Very rare: Vasculitis.
Respiratory, thoracic and mediastinal disorders:
Uncommon: Dyspnoea, bronchospasm in patients with bronchial asthma or a history of obstructive pulmonary disease, rhinitis.
Rare: Allergic rhinitis.
Very rare: Cough.
Common: Gastrointestinal complaints such as nausea, vomiting, diarrhoea, constipation, abdominal pain.
Uncommon: Dyspepsia, dry mouth.
Very rare: Gastritis, gingival hyperplasia, pancreatitis.
Rare: Hepatitis (in most cases with cholestasis).
Very rare: Jaundice (in most cases with cholestasis).
Skin and subcutaneous tissue disorders:
Uncommon: Alopecia, purpura, skin discolouration, hyperhydrosis, pruritus, exanthema.
Very rare: Angio-oedema, erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, psoriasis (psoriasis like skin disorders or aggravated psoriasis), photosensitivity.
Frequency not known: Toxic epidermal necrolysis.
Musculoskeletal and connective tissue disorders:
Uncommon: Arthralgia, myalgia, muscular weakness, muscle cramps, back pain.
Very rare: Muscular hypertonia.
Renal and urinary disorders:
Uncommon: Micturition disorder, nocturia, pollakiuria.
Reproductive system and breast disorders:
Uncommon: Potency disorders, gynaecomastia.
Common: Oedema (e.g. ankle oedema), fatigue (especially at the beginning of therapy; generally mild and often disappear within 1-2 weeks).
Uncommon: Asthenia (especially at the beginning of therapy; generally mild and often disappear within 1-2 weeks), chest pain, pain, malaise.
Uncommon: Weight increase, weight decrease.
Rare: Increased triglycerides, increased liver enzymes (ALAT, ASAT).