Medicinal Products

DAONIL 5 mg

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

Tablet breackable
Box of 20
All forms

Indication

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

Dosage DAONIL 5 mg scored tablet Box of 20

RESERVED FOR THE ADULT.

As with 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 ½ tablet daily, administered before breakfast.

bearings

Dose adjustments are usually made in ½ tablet increments depending on the glycemic response by dividing doses before the 2 or 3 main meals. At least several days must separate each dose level.

Maintenance treatment

The maximum dosage is 3 tablets per day, to be divided into 2 or 3 doses before the main meals.

Risk topics

Subject aged over 65

· Do not initiate treatment with a DAONIL tablet. Start with a ½ tablet of HEMI-DAONIL 2.5 mg or 1 tablet of weak DAONIL 1.25 mg once a day.

· This dose may be gradually increased until satisfactory glycemic control of the patient, respecting levels of 7 days minimum and under close glycemic surveillance.

In other patients at risk

· In patients who are malnourished or have marked changes in general health, or whose caloric intake is irregular and in patients with renal or hepatic impairment, treatment should be initiated at the lowest dose and dosage levels should be be scrupulously respected, so as to avoid hypoglycemic reactions (see Warnings and precautions for use ).

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 sulfonylureas or sulfonamides or any of the excipients used,

· 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.

Daonil side effects

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

Visual transient visual blurred or accommodation disturbances, 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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