1 Adverse Reaction Overview DIAMICRON® MR 30 mg (gliclazide) has been evaluated for safety in controlled clinical trials in 955 patients, of which 728 were treated in long-term studies for up to 10 months, in comparison with gliclazide 80 mg tablets.
The most frequent adverse drug reactions are hypoglycaemia and gastrointestinal disturbances (including abdominal pain, nausea, vomiting, dyspepsia, diarrhea, constipation). Serious adverse drug reactions that resulted in hospitalization during clinical trials were malaise, acute renal failure, and thrombophlebitis.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Hypoglycemia (see 8 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism) Severe hypoglycemia which mimics acute CNS disorders may occur.
Hepatic and/or renal impairment, malnutrition, debility, advanced age, alcoholism, adrenal or pituitary insufficiency may be predisposing factors. 1%). 8). 1). Other adverse events Adverse events reported during controlled clinical trials with DIAMICRON® MR 30 mg were those expected in the population of interest, a population whose underlying disease is recognized atheromatous risk factor.
0% of diabetic patients in long-term controlled studies, whatever their relationship to treatment, are listed by body system in Table 2. The most frequent adverse events were unspecific of the disease as respiratory infections or back pain.
Table 2 – Adverse events reported in ≥1% of type 2 diabetic patients in long-term controlled studies with DIAMICRON® MR 30 mg vs. 4 Analysis of adverse events in sub-populations led to similar pattern as in the whole population and showed that sex, age and renal insufficiency had no significant influence on the safety profile of 30 mg.
3 Less Common Clinical Trial Adverse Reactions Adverse events other than those already specifically mentioned in this product monograph and that have been reported with DIAMICRON® MR 30 mg during long-term studies in more than one patient and/or that have been previously reported with gliclazide 80 mg tablets or with other sulfonylurea drugs include the following (drug relationship has not been proved for all cases): Cardiovascular disorders: arteritis, cardiac failure, cerebrovascular disorder, coronary artery disorder, epistaxis, hypotension, myocardial infarction, palpitation, tachycardia, thrombophlebitis, vein disorder.
Ear/Nose/Throat disorders: hearing decreased, tinnitus. Endocrine disorders: hypothyroidism. A decrease in the uptake of radioactive iodine by the thyroid gland has been reported with other sulfonylurea drugs. This has not been shown with gliclazide 80 mg tablets during a study involving 15 patients.
Gastrointestinal disorders: abdominal pain, anal fissure, appetite increased, colitis, duodenal ulcer, epigastric fullness, faecal incontinence, flatulence, gastric irritation, gastroesophageal reflux, GI neoplasm benign, hemorrhoids, melena, dry mouth, oesophagitis, saliva increased, tooth ache, tooth disorder, vomiting.
These reactions are generally dose-related and may disappear when the dose is reduced. General disorders: allergy, carpal tunnel syndrome, chest pain, fever, infection, fungal infection, leg pain, malaise, pain, weight increase. Hepatobiliary Disorders: increased liver enzymes, hepatitis, hepatomegaly.
Metabolic and nutritional disorders: gout, glycosuria, hypercholesterolemia, […]