Converide Adverse Reactions

The frequency of adverse reactions listed as follows is defined using the following convention: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Irbesartan/hydrochlorothiazide combination: In placebo-controlled trials in patients with hypertension, the overall incidence of adverse events did not differ between the irbesartan/hydrochlorothiazide and the placebo groups. Discontinuation due to any clinical or laboratory adverse event was less frequent for irbesartan/hydrochlorothiazide treated patients than for placebo-treated patients. The incidence of adverse events was not related to gender, age, race, or dose within the recommended dose range. In placebo-controlled trials in which 898 hypertensive patients received various doses (range: 37.5mg/6.25mg to 300 mg/25mg irbesartan/hydrochlorothiazide), the following adverse reactions were reported: Neoplasms benign, malignant and unspecified (incl cysts and polyps): Frequency 'not known': Non-melanoma skin cancer (Basal cell carcinoma and Squamous cell carcinoma).
Non-melanoma skin cancer: Based on available data from epidemiological studies, cumulative dose-dependent association between hydrochlorothiazide and non-melanoma skin cancer has been observed.
Nervous system disorders: Common: dizziness.
Uncommon: orthostatic dizziness.
Cardiac disorders: Uncommon: hypotension, oedema, syncope, tachycardia.
Vascular disorders: Uncommon: flushing.
Gastrointestinal disorders: Common: nausea/vomiting.
Uncommon: diarrhoea.
Musculoskeletal, connective tissue and bone disorders: Uncommon: swelling extremity.
Renal and urinary disorders: Common: abnormal urination.
Reproductive system and breast disorders: Uncommon: libido changes, sexual dysfunction.
General disorders and administration site conditions: Common: fatigue.
Investigations: patients treated with irbesartan/hydrochlorothiazide had changes in laboratory test parameters which were rarely clinically significant.
Common: increases in BUN, creatinine and creatine kinase.
Uncommon: decreases in serum potassium and sodium.
In addition, since introduction of irbesartan/hydrochlorothiazide in the market the following adverse reactions have also been reported: Immune system disorders: Rare: as with other angiotensin-II receptor antagonists, rare cases of hypersensitivity reactions such as angioedema, rash, urticaria have been reported.
Metabolism and nutrition disorders: Very rare: hyperkalaemia.
Nervous system disorders: Very rare: headache.
Ear and labyrinth disorders: Very rare: tinnitus.
Respiratory, thoracic and mediastinal disorders: Very rare: cough.
Gastrointestinal disorders: Very rare: dysgeusia, dyspepsia.
Hepato-biliary disorders: Uncommon: jaundice.
Very rare: abnormal liver function, hepatitis.
Musculoskeletal, connective tissue and bone disorders: Very rare: arthalgia, myalgia.
Renal and urinary disorders: Very rare: impaired renal function including isolated cases of renal failure in patients at risk (see Precautions).
Additional information on individual components: In addition to the adverse reactions listed previously for the combination product, other adverse events previously reported with one of the individual components may be potential undesirable effects with Converide.
Irbesartan: Adverse events reported with the use of irbesartan alone include: General disorders and administration site conditions: Uncommon: chest pain.
Hydrochlorothiazide: Adverse events (regardless of relationship to medicinal product) reported with the use of hydrochlorothiazide alone include: Blood and lymphatic system: Aplastic anemia, bone marrow depression, haemolytic anaemia, leucopenia, neutropenia/agranulocytosis, thrombocytopenia.
Psychiatric disorders: Depression, sleep disturbances.
Nervous system disorders: Light-headedness, paraesthesia, restlessness, vertigo.
Eye disorders: Transient blurred vision, xanthopsia, acute myopia and secondary acute angle-closure glaucoma.
Cardiac disorders: Cardiac arrhythmias.
Vascular disorders: Postural hypotension.
Respiratory, thoracic and mediastinal disorders: Respiratory distress (including pneumonitis and pulmonary oedema).
Gastrointestinal disorders: Pancreatitis, anorexia, constipation, diarrhoea, gastric irritation, loss of appetite, sialadenitis.
Hepatobiliary disorders: Jaundice (intrahepatic cholestatic jaundice).
Skin and subcutaneous tissue disorders: Anaphylactic reactions, toxic epidermal necrolysis, cutaneous lupus erythematosus-like reactions, necrotising angitis (vasculitis, cutaneous vasculitis), photosensitivity reactions, rash, reactivation of cutaneous lupus erythematosus, urticaria.
Musculoskeletal, connective tissue and bone disorders: Muscle spasm, weakness.
Renal and urinary disorders: Interstitial nephritis, renal dysfunction.
General disorders and administration site conditions: Fever.
Investigations: Electrolyte imbalance (including hypokalaemia and hyponatremia, (see Precautions), glycosuria, hyperglycemia, hyperuricemia, increases in cholesterol and triglycerides.
The dose dependent adverse events of hydrochlorothiazide (particularly electrolyte disturbances) may increase when titrating the hydrochlorothiazide.