Forbetes Plus 500/5 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 this product 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 adverse reactions may occur under treatment with this product. Frequencies are defined as follows: very common: >1/10; common ≥1/100, <1/10; uncommon: ≥1/1,000; rare ≥1/10,000, <1/1,000; very rare <1/10,000.
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).
Uncommon: Crises of hepatic porphyria and porphyria cutanea. Very rare: Lactic acidosis (see Precautions). Decrease of vitamin B12 absorption with decrease of serum levels during long-term use of Metformin. Consideration of such aetiology is recommended if a patient presents with megaloblastic anaemia. 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 this product 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.
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.