Source: European Medicines Agency (EU)
Diastabol is recommended as an adjunct to diet or diet and sulfonylureas for the treatment of noninsulin-dependent diabetes mellitus (NIDDM) in patients inadequately controlled on diet alone, or on diet and sulfonylureas.
Diastabol tablets are taken orally and should be chewed with the first mouthful of food, or swallowed whole with a little liquid directly before the meal.
The recommended initial dose is 50 mg three times a day. Depending upon tolerability, the dose should normally be increased to the recommended maintenance dose of 100 mg three times a day after four or twelve weeks' treatment.
No modification of the normal adult dosage regimen is necessary.
No dosage adjustment is necessary.
No dosage adjustment is necessary for patients with mild to moderate renal insufficiency (creatinine clearance >25 ml/min).
No case of overdose has been reported. No specific antidotes to miglitol are known. In the event of overdosing, patients are likely to suffer from gastro-intestinal symptoms, for example, flatulence, diarrhoea and abdominal pain. Abdominal distension, softer stools, borborygmi (meteorism) and a feeling of fullness may also occur.
Intake of carbohydrate-containing meals or beverages should be avoided for 4-6 hours. Diarrhoea should be treated by standard conservative measures. Further treatment is supportive and symptomatic.
This medicinal product does not require any special storage conditions.
Blister strips in hard cardboard outers comprising:
Pack sizes: 15, 20, 30, 50, 60, 90, 120, 240 tablets.
Not all pack sizes may be marketed.
No special requirements.
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