Mistacor AM Adverse Reactions

Fixed Dose Combination: The safety and tolerability of Telmisartan + Amlodipine besilate has been evaluated in five controlled clinical studies with over 3500 patients, over 2500 of whom received telmisartan in combination with amlodipine. Adverse reactions reported in clinical trials with telmisartan plus amlodipine are shown as follows according to system organ class.
Infections and infestations: Cystitis.
Psychiatric disorders: Depression, anxiety, insomnia.
Nervous system disorders: Dizziness, somnolence, migraine, headache, paraesthesia, syncope, peripheral neuropathy, hypoaesthesia, dysgeusia, tremor.
Ear and labyrinth disorders: Vertigo.
Cardiac disorders: Bradycardia, palpitations.
Vascular disorders: Hypotension, orthostatic hypotension, flushing.
Respiratory, thoracic and mediastinal disorders: Cough.
Gastrointestinal disorders: Abdominal pain, diarrhea, nausea, vomiting, gingival hypertrophy, dyspepsia, dry mouth.
Skin and subcutaneous tissue disorders: Pruritus, eczema, erythema, rash.
Musculoskeletal and connective tissue disorders: Arthralgia, muscle spasms (cramps in legs), myalgia, back pain, pain in extremity (leg pain).
Renal and urinary disorders: Nocturia.
Reproductive system and breast disorders: Erectile dysfunction.
General disorders: Peripheral oedema, asthenia (weakness), chest pain, fatigue, oedema, malaise.
Investigations: Hepatic enzymes increased, blood uric acid increased.
Additional information on the combination: Peripheral oedema, a recognised dose dependent side effect of amlodipine, was generally observed at a lower incidence in patients who received the telmisartan/amlodipine combination than in those who received amlodipine alone.
Additional information on individual components: Side effects previously reported with one of the individual components (amlodipine or telmisartan) may be potential side effects with Telmisartan + Amlodipine besilate as well, even if not observed in clinical trials or during the post-marketing period.
Telmisartan: Infections and infestations: Urinary tract infections, upper respiratory tract infections, sepsis including fatal outcome.
Blood and lymphatic system disorders: Anaemia, eosinophilia, thrombocytopenia.
Immune system disorders: Anaphylactic reaction, hypersensitivity.
Metabolism and nutrition disorders: Hyperkalaemia, hypoglycaemia (in diabetic patients).
Eye disorders: Visual disturbance.
Cardiac disorders: Tachycardia.
Respiratory, thoracic and mediastinal disorders: Dyspnoea.
Gastrointestinal disorders: Flatulence, stomach discomfort.
Hepotobiliary disorders: Hepatic function abnormal/liver disorder*.
* Most cases of hepatic function abnormal/liver disorder from post-marketing experience with telmisartan occurred in patients in Japan, who are most likely to experience these adverse reactions.
Skin and subcutaneous tissue disorders: Angioedema (with fatal outcome), hyperhidrosis, urticaria, drug eruption, toxic skin eruption.
Musculoskeletal and connective tissue disorders: Tendon pain (tendinitis like symptoms).
Renal and urinary disorders: Renal impairment including acute renal failure.
General disorders: Influenza-like illness.
Investigations: Blood creatinine increased, haemoglobin decreased, blood creatine phosphokinase (CPK) increased.
Amlodipine: Blood and lymphatic system disorders: Leucopenia, thrombocytopenia.
Immune system disorders: Hypersensitivity.
Metabolism and nutrition disorders: Hyperglycaemia.
Psychiatric disorders: Mood change, confusional state.
Nervous system disorders: Extrapyramidal disorder.
Eye disorders: Visual impairment.
Ear and labyrinth disorders: Tinnitus.
Cardiac disorders: Myocardial infarction, arrhythmia, ventricular tachycardia, atrial fibrillation.
Vascular disorders: Vasculitis.
Respiratory, thoracic and mediastinal disorders: Dyspnoea, rhinitis.
Gastrointestinal disorders: Change of bowel habit, pancreatitis, gastritis.
Hepatobiliary disorders: Hepatitis, jaundice, hepatic enzyme elevations (mostly consistent with cholestasis).
Skin and subcutaneous tissue disorders: Hyperhidrosis, angioedema, urticaria, alopecia, purpura, skin discolouration, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, photosensitivity reaction.
Renal and urinary disorders: Micturition disorder, pollakiuria.
Reproductive system and breast disorders: Gynaecomastia.
General disorders: Pain, weight increased, weight decreased.