Treatment of non-insulin-dependent diabetes, in addition to the diet, as monotherapy and in combination with other antidiabetic therapies

The recommended starting dose is 1 tablet 50 mg 3 times a day.
Depending on the effect on glycemic parameters, the dose may be increased to 100 mg 3 times daily (use ACARBOSE SANDOZ 100 mg tablet). Br>
In rare cases, the dose may be increased to 200 mg, 3 times a day.
The tablets of ACARBOSE SANDOZ should be swallowed with a little water at the beginning, meals or crushed with the first ones, bite-sized

White-to-white, round, biconvex tablet engraved "ACA 50" on one side

Pharmacotherapeutic group: ALPHA INHIBITORS - GLUCOSIDASE, ATC code, A10BF01.

Acarbose is a pseudotetrasaccharide, of microbial origin. At the brush border of the intestine, acarbose acts by competitive inhibition of alpha-glucosidases. It thus reduces the degradation of carbohydrates (di-oligo- and polysaccharides) and of absorbable monosaccharides. Acarbose therefore decreases, postprandial hyperglycemia, without causing hyperinsulinemia or weight modification.

A multicenter, randomized, double-blind, placebo-controlled study evaluated the effects of acarbose on 1429 subjects at risk of developing type 2 diabetes. After a follow-up of an average duration of 3 , 3%, 32% of patients in the acarbose group developed diabetes, versus 42% in the placebo group (statistically significant difference). >
However, three months later, the discontinuation of treatment, the incidence of diabetes, was similar in both treatment groups.

The clinical benefit of long-term results is not known.


No data are available on the effects of ACARBOSE SANDOZ treatment on fitness to drive and use machines

· Hypersensitivity to acarbose or to any of the constituents

· Digestive system: ACARBOSE SANDOZ should not be prescribed in case of due to its possible undesirable digestive effects

O Chronic diseases associating digestion and absorption disorders

Inflammatory bowel diseases

O colon ulcerations

O major intestinal hernia

O Partial intestinal obstruction or predisposition to intestinal obstruction

In patients with severe renal impairment, acarbose should not be used in patients with creatinine clearance
· Severe hepatic impairment (eg, liver cirrhosis).
Acarbose reduces hyperglycaemia but does not induce hypoglycemia itself When combined with other oral antidiabetic agents (eg sulphonylurea, metformin) or insulin Blood glucose lowering may require a decrease in the dosage of the associated drugs.


· Due to the increased fermentation of carbohydrates in the colon during treatment with ACARBOSE, SANDOZ, digestive disorders may occur (see section 4.3 Undesirable effects). They can improve with time, spreading, gradual dosing up to the desired dose, helps prevent or decrease this symptomatology.

· ACARBOSE SANDOZ may induce an asymptomatic increase in liver enzymes, reversible at stop, treatment. If the level of transaminases is elevated, treatment should be discontinued (see section Undesirable effects).

· Monitoring of liver enzymes should be considered during the first 6 to 12 months, especially in patients with hepatic impairment

· If there is suspicion of sub-occlusion or occlusion, the treatment should be discontinued immediately (see section Undesirable effects)

· The efficacy and safety of ACARBOSE SANDOZ has not been established in children under the age of 18.

During treatment with ACARBOSE, SANDOZ, sucrose (cane sugar) as well as sucrose-containing foods can sometimes cause intestinal discomfort or diarrhea due to the increased fermentation of carbohydrates in the body; Colon.

ACARBOSE SANDOZ decreases hyperglycemia but does not induce itself hypoglycemia

If ACARBOSE SANDOZ is combined with a sulphonylurea, metformin, or insulin, blood glucose may decrease and lead to hypoglycaemia, adjustment of the dosage of associated drugs may be necessary.

Isolated cases of hypoglycaemic shock have been reported

In the event of a severe hypoglycemia, the biotransformation of sucrose to fructose and glucose being slower, during treatment, glucose should be used instead of sucrose for rapid improvement, glycemia

In some cases, ACARBOSE SANDOZ may interfere with the bioavailability of digoxin, requiring dosage adjustment.
Concurrent administration of colestyramine, intestinal absorbents or medicinal products based on digestive enzymes should be avoided (possible change in ACARBOSE SANDOZ activity)
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Concomitant use of ACARBOSE SANDOZ and oral neomycin may lead to a greater reduction in blood glucose, postprandial as well as an increase in the frequency and severity of gastrointestinal adverse effects. If the symptoms are severe, a temporary dose reduction of ACARBOSE SANDOZ may be considered.
Not applicable.

Overdosage of ACARBOSE SANDOZ, associated with the intake of drinks and / or food containing carbohydrates (polysaccharides, oligosaccharides or disaccharides) may result in meteorism, flatulence and diarrhea. Digestive (diarrhea). However, in case of overdose outside meals, no excessive intestinal symptoms are expected. Avoid the absorption of drinks and / or food containing carbohydrates (poly-oligo-disaccharides) for 4 to 6 hours after overdose.


Pregnancy

Risk associated with diabetes

Diabetes (gestational or permanent), when not balanced, is responsible for an increase in congenital malformations and perinatal mortality. In the periconceptional period, a balance, as good as possible, of diabetes must be achieved, in order to reduce the risk, malformative.
Risk associated with acarbose

Studies in animals have not shown any teratogenic effect. In the absence of teratogenic effect in animals, a malformative effect in the human species is not expected. Indeed, to date, the substances responsible for malformations in the human species have been found to be teratogenic in animals in well-conducted studies of two species

In clinical studies, there is currently no adequate data on a possible malformative or fetotoxic effect of acarbose when administered during pregnancy. >
What to do

The re-equilibration of diabetes makes it possible to standardize the course of pregnancy in this category of patients.

It is imperative to appeal to insulin, irrespective of the type of diabetes, I or II, gestational or permanent.

In the latter case, ACARBOSE SANDOZ should be discontinued and insulin should be taken as soon as pregnancy is contemplated or in case of accidental discovery of an exposed pregnancy To this medication: in this case this does not constitute the systematic argument to advise an interruption of pregnancy but leads to an attitude of caution and prenatal surveillance oriented

Neonatal blood glucose monitoring is recommended.

Breastfeeding

After administration of radiolabelled acarbose in the lactating spleen, a small amount was detected in the milk. To date, there are no similar data in humans.

However, the risk of ACARBOSE and SANDOZ effects on the breastfed child can not be excluded, this medication is not recommended in case of breastfeeding
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The adverse reactions described in the placebo-controlled studies evaluating the effect of acarbose are presented below by CIOMS III (acarbose N '= 8595, placebo N' = 7278, status as of February 10 2006).

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


Adverse reactions from pharmacovigilance reports (status as at 31 December 2005), for which frequencies can not be estimated, are listed on a non-determined frequency.
Organ-class system (MedDRA)

Very common

Common

Little, frequent

Rare

No, determined

Hematologic 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 pneumonia,

Hepatobiliary disorders.

Increase in liver enzymes.

Ictere

Potentially serious hepatitis.

The most appropriate term MedDRA is used to describe a certain type of reaction as well as its synonyms and pathologies related to
In addition, liver damage (hepatic disorders, abnormal liver function and liver damage) has been reported in particular 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)

Gastrointestinal adverse reactions depend on dosage and diet. These effects decrease, usually during treatment. They decrease, also when the prescribed hypoglucidal diet is respected. If the symptoms persist, the dosage should be temporarily or permanently reduced.
3 times the normal limit) were rarely observed. Abnormal values ​​may be transient during treatment with ACARBOSE SANDOZ (see Warnings and Precautions for Use).

Reporting of suspected adverse reactions

The reporting of suspected adverse effects after authorization of the drug is important. It provides continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Pharmacovigilance Centers -
Treatment of non-insulin-dependent diabetes, in addition to the diet, as monotherapy and in combination with other antidiabetic therapies