The safety of Normetec was investigated in controlled clinical trials in 2892 patients receiving olmesartan medoxomil in combination with amlodipine.
The following terminologies arranged by system organ class have been used in order to classify the occurrence of undesirable effects: 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); not known (cannot be estimated from the available data).
Immune System Disorders:
Rare: Drug hypersensitivity.
Metabolism and Nutrition Disorders:
Uncommon: Decreased libido.
Nervous System Disorders:
Common: Dizziness, headache. Uncommon: Postural dizziness, lethargy, paraesthesia, hypoaesthesia. Rare: Syncope.
Ear and Labyrinth Disorders:
Uncommon: Palpitations, tachycardia.
Uncommon: Hypotension, orthostatic hypotension.
Respiratory, Thoracic and Mediastinal Disorders:
Uncommon: Dyspnoea, cough.
Uncommon: Nausea, vomiting, dyspepsia, diarrhoea, constipation, dry mouth, upper abdominal pain.
Skin and Subcutaneous Tissue Disorders:
Uncommon: Rash. Rare: Urticaria.
Musculoskeletal and Connective Tissue Disorders:
Uncommon: Muscle spasm, pain in extremity, back pain.
Renal and Urinary Disorders:
Reproductive System and Breast Disorders:
Uncommon: Erectile dysfunction.
General Disorders and Administration Site Conditions:
Common: Oedema; peripheral and pitting oedema; fatigue. Uncommon: Asthenia. Rare: Face oedema.
Uncommon: Decreased blood potassium; increased blood creatinine, blood uric acid and γ-glutamyl transferase.
Additional Information on the Individual Components:
Adverse reactions previously reported with 1 of the individual components may be potential adverse reactions with Normetec, even if not observed in clinical trials with Normetec.
Further adverse events reported in clinical studies with olmesartan medoxomil monotherapy in hypertension were as follows: Angina pectoris, bronchitis, pharyngitis, rhinitis, abdominal pain, gastroenteritis, arthritis, skeletal pain, haematuria, urinary tract infection, chest pain, influenza-like symptoms, pain.
Further laboratory adverse events reported in clinical studies with olmesartan medoxomil monotherapy (irrespective of causality) were: Increased creatine phosphokinase, hypertriglyceridaemia, liver enzyme elevations.
In post-marketing experience with olmesartan medoxomil, additional adverse reactions reported, all at very rare frequency, were as follows: Thrombocytopenia, pruritus, exanthema, angioneurotic oedema, face oedema, allergic dermatitis, myalgia, acute renal failure, renal insufficiency, increased blood urea, malaise.
Single cases of rhabdomyolysis have been reported in temporal association with the intake of angiotensin II receptor blockers. A causal relationship, however, has not been established.
Additional Information on Special Populations:
In elderly patients the frequency of hypotension is slightly increased from rare to uncommon.
Further adverse reactions reported with amlodipine monotherapy were as follows: Common additional adverse reactions are facial flushing and abdominal pain. Less common adverse reactions include: Leukocytopenia, thrombocytopenia, gynaecomastia, hyperglycaemia, sleep disorder, irritability, depression, confusion, mood changes including anxiety, malaise, tremor, increased sweating, taste changes, peripheral neuropathy, visual disturbances, tinnitus, chest pain, aggravation of angina pectoris, vasculitis, rhinitis, gingival hyperplasia, gastritis, elevated liver enzymes, jaundice, hepatitis, pancreatitis, increased micturition frequency, impotency, exanthema, pruritus, alopecia, skin discolouration, purpura, isolated cases of allergic reactions (pruritus, rash, angio-oedema, erythema exsudativum multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, Quincke oedema), myalgia, arthralgia, increase or decrease in weight. Isolated cases of myocardial infarction and arrhythmias (including extrasystole, ventricular tachycardia, bradycardia and atrial arrhythmias) and angina pectoris have been reported in patients with coronary artery disease, but a clear association with amlodipine has not been established.