The overall incidence of adverse events reported with MICARDIS PLUS was comparable to those reported with telmisartan alone in randomised controlled trials involving 1471 patients receiving telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636). There was no dose-relationship to undesirable effects and there was no correlation with gender, age or race of the patients.
Adverse reactions reported in clinical trials with telmisartan plus hydrochlorothiazide are shown as follows according to system organ class. Adverse reactions not observed in clinical trials with telmisartan plus hydrochlorothiazide but expected during treatment with MICARDIS PLUS based on the experience with telmisartan or hydrochlorothiazide alone have been included and are detailed in separate sections as follows: Infections and infestations: Bronchitis, pharyngitis, sinusitis.
Immune system disorders: Exacerbation or activation of systemic lupus erythematosus*.
* based on post-marketing experience.
Metabolism and nutrition disorders: Hypokalaemia, hyponatraemia, hyperuricaemia.
Psychiatric disorders: Anxiety, depression.
Nervous system disorders: Dizziness, syncope/faint, paraesthesia, sleep disturbances, insomnia.
Eye disorders: Abnormal vision, transient blurred vision.
Ear and labyrinth disorders: Vertigo.
Cardiac disorders: Cardiac arrhythmias, tachycardia.
Vascular disorders: Hypotension (including orthostatic hypotension).
Respiratory, thoracic and mediastinal disorders: Dyspnoea, respiratory distress (including pneumonitis and pulmonary oedema).
Gastrointestinal disorders: Diarrhoea, dry mouth, flatulence, abdominal pain, constipation, dyspepsia, vomiting, gastritis.
Hepato-biliary disorders: Abnormal hepatic function / liver disorder*.
*Most cases of hepatic function abnormal / liver disorder from post-marketing experience with telmisartan occurred in patients in Japan, who are more likely to experience these adverse reactions.
Skin and subcutaneous tissue disorders: Angiooedema (with fatal outcome), erythema, pruritus, rash, sweating increased, urticaria.
Musculoskeletal, connective tissue and bone disorders: Back pain, muscle spasm, myalgia, arthralgia, leg pain, cramps in legs.
Reproductive system and breast disorders: Impotence.
General disorders and administration site conditions: Chest pain, influenza-like symptoms, pain.
Investigations: Increase in uric acid, increase in creatinine, increase in liver enzymes, increase in blood creatine phosphokinase.
Telmisartan: Additional side effects reported in clinical trials with telmisartan monotherapy in the indication hypertension or in patients 50 years or older at high risk of cardiovascular events were as follows: Infections and Infestations: Upper respiratory tract infections, urinary tract infections (including cystitis), sepsis including fatal outcome.
Blood and lymphatic system disorders: Anaemia, thrombocytopenia, eosinophilia.
Immune system disorders: Anaphylactic reaction, hypersensitivity.
Metabolism and nutrition disorders: Hyperkalaemia, hypoglycaemia (in diabetic patients).
Cardiac disorders: Bradycardia.
Gastrointestinal disorders: Stomach upset.
Skin and subcutaneous tissue disorders: Eczema, drug eruption, toxic skin eruption.
Musculoskeletal, connective tissue and bone disorders: Arthrosis, tendon pain (tendinitis like symptoms).
Renal and urinary disorders: Renal impairment including acute renal failure (see also under Precautions).
General disorders and administration site conditions: Asthenia (weakness).
Investigations: Decrease in haemoglobin.
Hydrochlorothiazide: Additional side effects reported with hydrochlorothiazide monotherapy were as follows: Infections and infestations: Sialadenitis.
Neoplasms Benign, malignant and unspecified (incl. cysts and polyps): Non-melanoma skin cancer (Basal cell carcinoma and Squamous cell carcinoma of skin or lip).
Blood and the lymphatic system disorders: Thrombocytopenia (sometimes with purpura), aplastic anaemia, haemolytic anaemia, bone marrow depression, leukopenia, neutropenia/agranulocytosis.
Immune system disorders: Anaphylactic reactions, allergy.
Endocrine disorders: Loss of diabetic control.
Metabolism and nutrition disorders: Cause or exacerbate volume depletion, electrolyte imbalance, anorexia, loss of appetite, hyperglycaemia, hypercholesterolaemia, hypomagnesaemia, hypercalcaemia, hypochloraemic alkalosis.
Psychiatric disorders: Restlessness.
Nervous system disorders: Headache, light-headedness.
Eye disorders: Xanthopsia, acute myopia, acute angle-closure glaucoma.
Vascular disorders: Necrotizing angiitis (vasculitis).
Gastro-intestinal disorders: Nausea, stomach upset, pancreatitis.
Hepato-biliary disorders: Jaundice (hepatocellular or cholestatic jaundice).
Skin and subcutaneous tissue disorders: Toxic epidermal necrolysis, erythema multiforme, cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, cutaneous vasculitis, photosensitivity reactions.
Musculoskeletal, connective tissue and bone disorders: Weakness.
Renal and urinary disorders: Interstitial nephritis, renal dysfunction, glycosuria.
General disorders and administration site conditions: Fever.
Investigations: Increase in triglycerides.
Description of selected adverse reactions: Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dose-dependent association between HCTZ and NMSC has been observed (see also Precautions and Pharmacology: Pharmacodynamics under Actions).