Glucovance Adverse Reactions

The following undesirable effects may occur under treatment with metformin + glibenclamide (Glucovance). Frequencies are defined as follows: 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; not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Investigations: Uncommon: Average to moderate elevations in serum urea and creatinine concentrations; Very rare: Hyponatremia.
Blood and lymphatic system disorders: These are reversible upon treatment discontinuation. Rare: Leukopenia, thrombocytopenia; Very rare: Agranulocytosis, hemolytic anemia, bone marrow aplasia and pancytopenia.
Nervous system disorders: Common: Taste disturbance.
Eye disorders: Transient visual disturbances may occur at the start of treatment due to a decrease in glycemia levels.
Gastrointestinal disorders: Very common: Gastrointestinal disorders such as nausea, vomiting, diarrhea, abdominal pain and loss of appetite. These undesirable effects occur more frequently during treatment initiation and resolve spontaneously in most cases. To prevent them, it is recommended that metformin + glibenclamide (Glucovance) be taken in 2 or 3 daily doses. A slow increase of the dose may also improve gastrointestinal tolerability. Should these symptoms continue, the patient should stop taking metformin + glibenclamide (Glucovance) and the doctor must be consulted.
Skin and subcutaneous tissue disorders: Rare: Skin reactions such as pruritus, urticaria, maculopapular rash; Very rare: Cutaneous or visceral allergic angiitis, erythema multiforme, exfoliative dermatitis, photosensitization, urticaria evolving to shock. A cross reactivity to sulfonamide(s) and their derivatives may occur.
Metabolism and nutrition disorders: Hypoglycemia (see Precautions); Common: Vitamin B₁₂ decrease/deficiency (See Precautions); Uncommon: Crises of hepatic porphyria and porphyria cutanea; Very rare: Lactic acidosis (See Precautions), Disulfiram-like reaction with alcohol intake.
Hepatobiliary disorders: Very rare: Liver function test abnormalities or hepatitis requiring treatment discontinuation.
ADR Reporting Statement: At the first sign of any adverse drug reaction, patient must seek medical attention immediately.