Glucovance

Glucovance Adverse Reactions

glibenclamide + metformin

Manufacturer:

Merck

Distributor:

Zuellig Pharma
Full Prescribing Info
Adverse Reactions
During treatment initiation, the most common adverse reactions are nausea, vomiting, diarrhoea, abdominal pain and loss of appetite which resolve spontaneously in most cases. To prevent them, it is recommended to take Glucovance in 2 or 3 daily doses and to increase slowly the doses.
Transient visual disturbances may occur at the start of treatment due to a decrease in glycaemia levels.
The following undesirable effects may occur under treatment with 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).
Blood and lymphatic system disorders: These are reversible upon treatment discontinuation.
Rare: Leukopenia, thrombocytopenia. Very rare: Agranulocytosis, haemolytic anaemia, bone marrow aplasia and pancytopenia.
Metabolism and nutrition disorders: Hypoglycaemia (see Precautions).
Common: Vitamin B12 decrease/deficiency (see Other Precautions under Precautions). Uncommon: Crises of hepatic porphyria and porphyria cutanea. Very rare: Lactic acidosis (see Precautions).
Disulfiram-like reaction with alcohol intake.
Nervous system disorders: Common: Taste disturbance.
Eye disorders: Transient visual disturbances may occur at the start of treatment due to a decrease in glycaemia levels.
Gastrointestinal disorders: Very common: Gastrointestinal disorders such as nausea, vomiting, diarrhoea, 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 Glucovance be taken in 2 or 3 daily doses. A slow increase of the dose may also improve gastrointestinal tolerability.
Skin and subcutaneous tissue disorders: A cross reactivity to sulphonamide(s) and their derivatives may occur.
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 sulphonamide(s) and their derivatives may occur.
Hepatobiliary disorders: Very rare: Liver function test abnormalities or hepatitis requiring treatment discontinuation.
Investigations: Uncommon: Average to moderate elevations in serum urea and creatinine concentrations. Very rare: Hyponatremia.
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