Glucovance Tablet 1000mg/5mg

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv bestanddel:

Glibenclamide

Tilgængelig fra:

MERCK PTE. LTD.

ATC-kode:

A10BD02

Dosering:

5.0mg

Lægemiddelform:

TABLET, FILM COATED

Indgivelsesvej:

ORAL

Recept type:

Prescription Only

Fremstillet af:

Merck Santé s.a.s

Autorisation dato:

2013-03-18

Indlægsseddel

5
2
2
140
140
5
5
5
2
2
10
MC-1528-2014
M
C-
152
8-
20
14
M
C-
152
8-
20
14
_Other precautions_
_Because this medicinal product contains lactose, it is
contraindicated in case of _
_congenital galactosemia, glucose and galactose malabsorption syndrome
or in _
_case of lactase deficiency._
_Hypoxic states--_-Cardiovascular collapse (shock) from whatever
cause, acute 
congestive heart failure, acute myocardial infarction, and other
conditions 
characterized by hypoxemia have been associated with lactic
acidosis and 
may also cause prerenal azotemia. When such events occur in patients
on 
GLUCOVANCE therapy, the drug should be promptly discontinued.
_Alcohol intake_---Alcohol is known to
potentiate the effect of metformin on 
lactate metabolism. Patients, therefore, should be warned against
excessive 
alcohol intake, acute or chronic, while receiving GLUCOVANCE. Due to
its effect 
on the gluconeogenic capacity of the liver, alcohol may also increase
the risk of 
hypoglycemia.
_Impaired hepatic function_--Since impaired hepatic function has
been associated 
with some cases of lactic acidosis, GLUCOVANCE should generally be
avoided in 
patients with clinical or laboratory evidence of hepatic disease.
_Vitamin B_
_12_
_ levels_---In controlled clinical trials with metformin of 29
weeks 
duration, a decrease to subnormal levels of previously normal serum
Vitamin B
12

without clinical manifestations, was observed in approximately 7%
of patients. 
Such decrease, possibly due to interference with B
12
 absorption from the 
B
12
-intrinsic factor complex, is, however, very rarely associated with anemia (see 
ADVERSE REACTIONS) and appears to be rapidly reversible with discontinuation 
of metformin or Vitamin B
12
 supplementation. Measurement of hematologic 
parameters on an annual basis is advised in patients on metformin and
any 
apparent abnormalities should be appropriately investigated and
managed (see 
PRECAUTIONS: Laboratory Tests)