Medicinal Products

DAONIL LOW 1.25 mg

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

Compressed
Box of 60
All forms

Indication

Noninsulin-dependent diabetes, in combination with the appropriate diet, when the prescribed diet is not sufficient to restore the glycemic balance alone.

Dosage DAONIL LOW 1.25 mg Tablet Box of 60

Reserved for adults.

Like any hypoglycemic agent, dosages should be tailored to each particular case. In case of transient glucose imbalance, a short period of administration of the product may be sufficient in a patient usually well balanced by the diet.

Subject under 65

Initial dose:

The recommended starting dose is 1 tablet a day, administered before breakfast.

Bearings:

Dosage adjustments are usually made in increments of 1 tablet depending on the glycemic response, by dividing the doses before the 2 or 3 main meals. At least several days must separate each dose level.

If dosages greater than 3 tablets are required, it is possible to use H emmi-Daonil 2.5 mg.

The maximum dosage is 15 mg glibenclamide.

Risk topics

· Subject over 65 years of age: Start with a weak Daonil 1.25 mg tablet once a day. This dose may be gradually increased until satisfactory glycemic control of the patient, respecting minimum 7-day stages and under close glycemic surveillance.

· In other patients at risk : In patients who are malnourished or have a marked deterioration of the general state, or whose caloric intake is irregular and in patients with renal or hepatic insufficiency, treatment should be initiated at the same dose. the dose levels must be scrupulously respected, so as to avoid hypoglycaemic reactions (see Warnings and Precautions ).

· In patients receiving other oral hypoglycemic agents: As with any hypoglycaemic sulfonylurea, this medication may take over from an antidiabetic treatment without a transition period. When switching from a long-acting hypoglycemic sulfonylurea (such as chlorpropamide) to this medication, patients will be closely monitored (for several weeks) to avoid hypoglycemia due to the possibility of overlapping therapeutic effects.

Against indications

This medicine is contraindicated in case:

· Hypersensitivity to glibenclamide, other sulphonylureas or sulphonamides or to any of the excipients used (in particular yellow-orange S),

· Insulin-dependent diabetes, particularly juvenile diabetes, keto-ketotic diabetes, diabetic pre-coma,

· Severe renal or hepatic impairment,

Porphyries,

· Treatment with miconazole (see section 4.5 Interaction with other medicinal products and other forms of interaction ),

· Breastfeeding.

Adverse effects Daonil Low

Metabolism and nutrition disorders

· Hypoglycaemia: (see sections Warnings and precautions for use and Overdose ). These hypoglycaemia can be prolonged and severe and are not always easy to correct.

Skin and subcutaneous tissue disorders

· Mucocutaneous rash: pruritus, urticaria, maculopapular rash.

· Some cases of photosensitization have been reported.

Immune system disorders

· Manifestations of hypersensitivity to bronchospasm type, hypotension or shock.

Gastrointestinal disorders

· Nausea, diarrhea, epigastric discomfort.

Hepatobiliary disorders

· Hepatic impairment: An increase in liver enzymes has been noted with the possibility of occurrence of cytolytic or cholestatic hepatitis requiring discontinuation of treatment.

These attacks can progress to life-threatening liver failure

Blood and lymphatic system disorders

Hematologic disorders usually reversible upon discontinuation of treatment:

· Hypereosinophilia, leukopenia, moderate or severe thrombocytopenia may manifest as purpura.

· More rarely: agranulocytosis, haemolytic anemia, medullary aplasia and pancytopenia.

investigations

· Cases of hyponatremia (isolated cases).

· Moderate to moderate occasional elevations of uremia and creatinine.

Eye disorders

Transient visual disturbances with visual blur or accommodation difficulties, especially at the beginning of treatment, with or without glycemic variation

General disorders

· Antabuse effect in case of ingestion of alcohol during meals.

· Clinical expression of porphyria (hepatic or cutaneous) in porphyritic patients (see section 4.3 ).

· Exceptionally, cutaneous or visceral allergic vasculitis that may be life-threatening.

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