Medicinal Products

DIASTABOL 50 mg

Generic drug of the therapeutic class: Metabolism and nutrition
active ingredients: Miglitol
laboratory: Sanofi-Aventis France

Compressed
Box of 90
All forms

Indication

DIASTABOL is indicated as an adjunct to the sulfonamide diet or regimen for the treatment of non-insulin-dependent diabetes mellitus (type 2 diabetes mellitus), in patients who are insufficiently balanced on a diet alone or on a sulfonamide-associated diet.

Dosage DIASTABOL 50 mg Tablet Box of 90

Oral way.

DIASTABOL tablets should be chewed with the first bite of food or swallowed with a little liquid at the beginning of the meal.

Adult :

The recommended starting dose is 1 tablet of 50 mg 3 times daily. Depending on the tolerability, the dosage will generally be increased to the recommended maintenance dose of 1 100 mg tablet 3 times daily after 4 to 12 weeks of treatment.

Elderly :

No change in dosage is required.

Hepatic insufficiency :

It is not necessary to adjust the dose.

Renal insufficiency :

There is no need to adjust the dose in mild to moderate renal impairment (creatinine clearance greater than 25 ml / min).

Against indications

Hypersensitivity to miglitol or to any of the excipients.

DIASTABOL should not be used in children and those under 18 years of age.

· Breastfeeding

· DIASTABOL is also contraindicated in patients with:

o inflammatory bowel disease,

o colonic ulceration,

o Partial bowel obstruction or predisposition to bowel obstruction.

o In addition, DIASTABOL should not be used in patients with chronic intestinal disorders associated with significant digestive or absorption disorders, or in patients whose condition may be aggravated by increased training. intestinal gas (eg important intestinal hernia).

· Miglitol clearance is reduced in patients with renal impairment and in the absence of data in patients with severe renal impairment, miglitol is contraindicated in patients with creatinine clearance <25 ml / min.

Diastabol side effects

The frequencies listed below have the following definitions: very common (≥ 1/10), common (≥ 1/100 to <1/10), and uncommon (≥ 1/1000 to <1/100).

Metabolism and nutrition disorders

When using miglitol in combination with other antidiabetic medicines (sulfonamides and insulin), hypoglycaemia has been reported frequently (see Warnings and Precautions ).

Gastrointestinal disorders

Given its mode of action, miglitol may result in some patients an increase in the amount of undigested carbohydrates in the colon. These carbohydrates can also be used by the intestinal flora, resulting in an increase in intestinal gas production.

The majority of patients are therefore likely to have one or more of the following gastrointestinal disorders:

Very common: flatulence, diarrhea and abdominal pain.

Frequent: nausea, constipation and dyspepsia.

These symptoms depend on both dose and diet and may decrease during treatment. These effects can be minimized by good adherence to the prescribed diabetic diet, and by avoiding sugar and sugary foods. If symptoms are poorly tolerated, it is recommended to reduce the dosage.

If diarrhea persists, the patient should be carefully monitored and the dosage reduced or treatment discontinued if necessary.

Hepatobiliary disorders

Frequent: elevation of transaminases.

Uncommon: abnormal liver function

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