DIASTABOL Tablet
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
DIASTABOL 50 mg tablets. DIASTABOL 100 mg tablets.
Qualitative and quantitative composition
Each Diastabol 50 mg tablet contains: miglitol 50 mg. Each Diastabol 100 mg tablet contains: miglitol 100 mg. For a full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White to slightly pale yellow, round biconvex tablet. Diastabol 50 mg tablets are blank on one side and imprinted with MIG 50 on the other side. Diastabol 100 mg tablets are blank on one side and ...
Therapeutic indications
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 ...
Posology and method of administration
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. Adults The recommended initial dose is 50 mg three ...
Contraindications
Hypersensitivity to miglitol or to any of the excipients. Miglitol should not be used in children and individuals less than 18 years of age. Breast-feeding woman. Patients with inflammatory bowel disease, ...
Special warnings and precautions for use
Hypoglycaemia Miglitol may act to potentate the hypoglycaemic effects of sulfonylureas, and the dosages of these agents may need to be adjusted accordingly. However, this effect has not been seen in clinical ...
Interaction with other medicinal products and other forms of interaction
The bioavailability of glibenclamide and metformin is slightly reduced when administered concomitantly with miglitol, but the results of clinical trials with these combinations indicate that any pharmacokinetic ...
Pregnancy and lactation
Pregnancy No data concerning the use of miglitol during pregnancy in humans is available. Animal studies do not indicate harmful effects with respect to pregnancy, embryonal or fœtal development, parturition ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Patients should be alerted to the possible risk of hypoglycaemia when miglitol is used in combination with a sulfonylurea. ...
Undesirable effects
The frequencies listed below are defined as: very common (≥1/10), common (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100). Metabolism and nutrition disorders When used in combination with other antidiabetic ...
Overdose
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 ...
Pharmacodynamic properties
Pharmacotherapeutic group: ALPHA-GLUCOSIDASE INHIBITOR ATC code: A10BF02 Miglitol is a reversible inhibitor of intestinal alpha-glucosidases. Under the influence of miglitol, the digestion of complex carbohydrates ...
Pharmacokinetic properties
The pharmacodynamic action of miglitol is local in the gastro-intestinal tract. Following oral administration of low doses of miglitol (12.5 to 25mg), the compound is almost quantitatively absorbed. Increasing ...
Preclinical safety data
In chronic toxicity studies weight loss was the dose-limiting toxicity. Specific target organs for toxicity could not be determined. Miglitol had no genotoxic potential in a battery of genotoxicity tests, ...
List of excipients
Microcrystalline cellulose Magnesium stearate Maize starch
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Blister strips in hard cardboard outers comprising: Polypropylene foil (colourless) sealed with aluminium foil PVC/PVDC foil (colourless) and aluminium foil Polyamide/aluminium/PVC foil and aluminium foil ...
Special precautions for disposal and other handling
No special requirements.
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
