Medicinal Products

ACARBOSE MYLAN 50 mg

Generic drug of Glucor
Therapeutic class: Metabolism and nutrition
active ingredients: Acarbose
laboratory: Mylan

Compressed
Box of 90
All forms

Indication

Treatment of noninsulin-dependent diabetes, in addition to diet, as monotherapy as in combination with other antidiabetic therapies.

Dosage ACARBOSE MYLAN 50 mg Tablet Box of 90

The recommended starting dose is 1 tablet at 50 mg 3 times daily.

Depending on the effect observed on the glycemic parameters, the dose may be increased to 100 mg 3 times daily (use ACARBOSE MYLAN 100 mg, scored tablet).

In some rare cases, the dose may be increased up to 200 mg, 3 times daily.

ACARBOSE MYLAN tablets should be swallowed with a little water at the beginning of the meal or chewed with the first bites.

Against indications

· Hypersensitivity to acarbose or any of the constituents.

· Digestive system: because of its possible digestive side effects, acarbose should not be prescribed in case of:

o chronic diseases associating disorders of digestion and absorption,

o inflammatory bowel diseases,

o ulcerations of the colon,

o major intestinal hernia,

o Partial intestinal obstruction or predisposition to intestinal obstruction.

· Severe renal impairment: In the absence of data in patients with severe renal impairment, acarbose should not be used in patients with creatinine clearance <25 ml / min.

· Severe hepatic insufficiency (eg hepatic cirrhosis).

Acarbose Mylan side effects

The adverse effects reported in the placebo-controlled studies evaluating the effect of acarbose are presented below by CIOMS III frequency category (acarbose N = 8595, placebo N = 7278, status as of February 10, 2006).

Within each frequency group, adverse effects are presented in order of decreasing severity.

Frequencies are defined as follows: very common (≥ 1/10), frequent (≥ 1/100, <1/10), infrequent (≥ 1/1000, <1/100), rare (≥ 1/10 000), <1/1000).

Adverse effects from pharmacovigilance reports (status as at 31 December 2005) for which frequencies can not be estimated are listed as unspecified frequency.

Body-class system (MedDRA)

Very common

Frequent

Rare

Rare

Not determined

Blood and lymphatic system disorders

Thrombocytopenia.

Immune system disorders

Hypersensitivity to the drug and hypersensitivity (rash, erythema, exanthema, urticaria).

Vascular disorders

Edema

Gastrointestinal disorders

Flatulence.

Diarrhea.
Gastrointestinal and abdominal pain.

Nausea.
Vomiting.
Dyspepsia.

Occlusions.
Subocclusions.
Intestinal cystic pneumatosis.

Hepatobiliary disorders.

Increased liver enzymes

Jaundice.

Hepatitis potentially serious.

The term most appropriate MedDRA is used to describe a certain type of reaction as well as its synonyms and related pathologies.

In addition, liver damage (liver disorders, abnormal liver function and liver damage) has been reported, particularly in Japan.

Isolated cases of fulminant hepatitis with fatal outcome have been reported in Japan. The link with acarbose is unclear. (See section Warnings and precautions for use )

Gastrointestinal side effects depend on dosage and diet. These effects usually decrease during treatment. They also decrease when the prescribed low carbohydrate diet is respected. If symptoms persist, the dosage should be temporarily or permanently reduced.

In patients treated with acarbose at the recommended daily dose of 150 mg to 300 mg, clinically significant liver function abnormalities (liver test values ​​greater than 3 times the normal limit) were rarely observed. Abnormal values ​​may be transient during treatment with acarbose (see Warnings and Precautions ).

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr

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