Medicinal Products

ACARBOSE SANDOZ 100 mg

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

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 SANDOZ 100 mg tablet box of 90

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

Against indications

· Hypersensitivity to acarbose or any of the constituents.

· Digestive system: Due to its possible digestive side effects, ACARBOSE SANDOZ 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).

Adverse effects Acarbose Sandoz

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.

System
Organ class
(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.

Potentially serious hepatitis

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 SANDOZ is not clearly established (see Warnings and Precautions section ).

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 SANDOZ 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 SANDOZ (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. Health 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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