GLUCOBAY 50mg Tablet Ref.[6049] Active ingredients: Acarbose

Hypoglycaemia

Glucobay has an antihyperglycaemic effect, but does not itself induce hypoglycaemia. If Glucobay is prescribed in addition to other blood glucose lowering drugs (e.g sulphonylureas metformin, or insulin) a fall of the blood glucose values into the hypoglycaemic range may require a dose adaption of the respective co-medication. If acute hypoglycemia develops glucose should be used for rapid correction of hypoglycaemia (see section 4.5).

Episodes of hypoglycaemia occurring during therapy must, where appropriate, be treated by the administration of glucose, not sucrose. This is because acarbose will delay the digestion and absorption of disaccharides, but not monosaccharides.

Transaminases

Cases of fulminant hepatitis have been reported during Glucobay therapy. The mechanism is unknown, but Glucobay may contribute to a multifactorial pathophysiology of liver injury. It is recommended that liver enzyme monitoring is considered during the first 6 to 12 months of treatment (see section 4.8). If elevated liver enzymes are observed, a reduction in dosage or withdrawal of therapy may be warranted, particularly if the elevations persist. In such circumstances, patients should be monitored at weekly intervals until normal values are established.

The administration of antacid preparations containing magnesium and aluminium salts, e.g. hydrotalcite, has been shown not to ameliorate the acute gastrointestinal symptoms of Glucobay in higher dosage and should, therefore, not be recommended to patients for this purpose.

When administered alone, Glucobay does not cause hypoglycaemia. It may, however, act to potentiate the hypoglycaemic effects of insulin, metformin and sulphonylurea drugs, and the dosages of these agents may need to be modified accordingly. In individual cases hypoglycaemic shock may occur (i.e. clinical sequelae of glucose levels <1 mmol/L such as altered conscious levels, confusion or convulsions).

Episodes of hypoglycaemia occurring during therapy must, where appropriate, be treated by the administration of glucose, not sucrose. This is because acarbose will delay the digestion and absorption of disaccharides, but not monosaccharides.

Sucrose (cane sugar) and foods containing sucrose often cause abdominal discomfort or even diarrhoea during treatment with Glucobay tablets as a result of increased carbohydrate fermentation in the colon.

Intestinal adsorbents (e.g. charcoal) and digestive enzyme preparations containing carbohydrate splitting enzymes (e.g. amylase, pancreatin) may reduce the effect of Glucobay and should not therefore be taken concomitantly.

The concomitant administration of neomycin may lead to enhanced reductions of postprandial blood glucose and to an increase in the frequency and severity of gastro-intestinal side-effects. If the symptoms are severe, a temporary dose reduction of Glucobay may be warranted.

The concomitant administration of colestyramine may enhance the effects of Glucobay, particularly with respect to reducing postprandial insulin levels. Simultaneous administration of Glucobay and colestyramine should, therefore, be avoided. In the rare circumstance that both Glucobay and colestyramine therapy are withdrawn simultaneously, care is needed as a rebound phenomenon has been observed with respect to insulin levels in non-diabetic subjects.

In individual cases Glucobay may affect digoxin bioavailability, which may require dose adjustment of digoxin. Monitoring of serum digoxin levels should be considered.

In a pilot study to investigate a possible interaction between Glucobay and nifedipine, no significant or reproducible changes were observed in the plasma nifedipine profiles.

Glucobay should not be administered during pregnancy as no information is available from clinical studies on its use in pregnant women.

After the administration of radioactively marked acarbose to nursing rats, a small amount of radioactivity was recovered in the milk. To date there have been no similar findings in humans.

Nevertheless, as the possibility of drug induced effects on nursing infants can not be excluded, the prescription of Glucobay is not recommended during breast-feeding.

None known.

The frequencies of adverse drug reactions (ADRs) reported with Glucobay, based on placebo-controlled studies (Glucobay N=8,595; placebo N=7,278), are summarised in the table below.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000).

The ADRs identified during postmarketing surveillance only and for which a frequency could not be estimated, are listed under “Not known”.

Blood and lymphatic system disorders

Not known: Thrombocytopenia

Immune system disorders

Not known: Drug hypersensivity and hypersensivity (rash, erythema, exanthema, urticaria) h3. Vascular disorders

Rare: Oedema

Gastrointestinal disorders

Very common: Flatulence

Common: Diarrhoea, Gastrointestinal and abdominal pains

Uncommon: Nausea, Vomiting, Dyspepsia

Not known: Subileus/Ileus, Pneumatosis cystoides intestinalis

Hepatobiliary disorders

Uncommon: Increase in transaminases

Rare: Jaundice

Not known: Hepatitis

Skin and subcutaneous tissue disorders

Not known: Acute generalised exanthematous pustulosis

In postmarketing, cases of liver disorder, hepatic function abnormal, and liver injury have been reported. Individual cases of fulminant hepatitis with fatal outcome have also been reported, particularly from Japan.

In patients receiving the recommended daily dose of 150 to 300 mg Glucobay, clinically relevant abnormal liver function tests (three times above upper limit of normal range) were rarely observed. Abnormal values may be transient under ongoing Glucobay therapy (see section 4.4).

If the prescribed diabetic diet is not observed the intestinal side effects may be intensified. If strongly distressing symptoms develop in spite of adherence to the diabetic diet prescribed, the doctor must be consulted and the dose temporarily or permanently reduced.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

None stated.