Glucobay

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Acarbose 100mg

Available from:

Bayer New Zealand Limited

INN (International Name):

Acarbose 100 mg

Dosage:

100 mg

Pharmaceutical form:

Tablet

Composition:

Active: Acarbose 100mg Excipient: Colloidal silicon dioxide Magnesium stearate Maize starch Microcrystalline cellulose

Units in package:

Blister pack, polypropylene, 90 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Bayer AG

Therapeutic indications:

Glucobay is indicated for the additional treatment of insulin dependant and non-insulin dependant diabetes mellitus in association with diet.

Product summary:

Package - Contents - Shelf Life: Blister pack, PA/Alu/PVC - 90 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Polypropylene/Alu - 90 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Alu - 90 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1993-12-16

Patient Information leaflet

GLUCOBAY
®
CMI
1
GLUCOBAY
®
(GLUE·CO·BAY)
_acarbose_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Glucobay. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Glucobay
against the benefits they expect it
will have for you.
As Glucobay is a prescription
medicine, it should only be used
under medical supervision.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT GLUCOBAY IS
USED FOR
Glucobay tablets contain the active
drug acarbose. They are used for
the treatment of diabetes .
Glucobay helps to control your
blood sugar levels in conjunction
with diet, exercise, weight loss and
other measures by slowing down
the digestion of carbohydrates
(complex sugars) from your diet.
This reduces the abnormally high
blood sugar levels that occur after
each meal.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU TAKE
GLUCOBAY
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE GLUCOBAY IF YOU HAVE
AN ALLERGY TO:
• acarbose, the active ingredient in
Glucobay
• any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue
or other parts of the body
• rash, itching or hives on the skin.
DO NOT TAKE GLUCOBAY IF:
•
you have a severe kidney
disorder (creatinine clearance
< 25 mL/min).
•
you suffer from intestinal
obstruction, inflammation or
ulceration of the bowel, e.g.
ulcerative colitis or Crohn’s
disease.
•
you have a hernia or have had
previous abdominal surgery.
If so, consult your doctor first.
DO NOT GIVE THIS MEDICINE TO A
CHILD UNDER THE AGE OF

Summary of Product characteristics

DATA SHEET
GLUCOBAY
®
_ACARBOSE TABLETS 50 MG AND 100 MG OBLONG _
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glucobay 50
1 tablet contains 50 mg acarbose
Glucobay 100
1 tablet contains 100 mg acarbose
PHARMACEUTICAL FORM
Glucobay 50
Tablets
Glucobay 100
Tablets
TABLETS 50 MG
: White to yellow-tinged round, convex tablets of 7 mm diameter and 10
mm radius of
curvature. On one side the tablet code is “G” and “50” and on
the other side “Bayer cross”.
OBLONG TABLETS 100 MG
: White to yellow-tinged oval oblong, convex tablets of 13 mm length,
6 mm width
and 5.5 mm radius of curvature. On one side the tablet code is
“G”, ”score” and “100” and on the other
side “score”.
INDICATIONS
Glucobay is indicated for the additional treatment of insulin
dependant and non-insulin dependant diabetes
mellitus in association with diet.
POSOLOGY AND METHOD OF ADMINISTRATION
_RECOMMENDED USUAL DOSE FOR ADDITIONAL THERAPY IN ASSOCIATION WITH
DIET IN PATIENTS WITH DIABETES _
_MELLITUS _
Because efficacy and tolerability vary, the dosage must be adjusted by
the doctor to suit each individual
patient.
_DOSAGE REGIMEN _
Unless otherwise prescribed the recommended dosage is as follows:
Initially
3 x 1 tablet of
50 mg Glucobay/day
or
3 x ½ tablet of
100mg Glucobay/day
Up to
3 x 2 tablets of
50 mg Glucobay/day
or
3 x 1 tablet of
100mg Glucobay/day
A further increase in dosage to 3 x 200 mg Glucobay/day may
occasionally be necessary.
The dose may be increased after 4 – 8 weeks. An increase can also be
made later in the course of the
treatment if the patient shows an inadequate clinical response. If
side effects occur in spite of strict
adherence to the diet, the dose should not be increased, and if
necessary should be reduced. The average
Glucobay Data Sheet
1
dose is 300mg Glucobay/day (corresponding to 3 x 2 tablets of Glucobay
50 /day, or 3 x 1 tablet of
Glucobay 100 /day).
_METHOD OF ADMINISTRATION _
Glucobay tablets are effective only if swallowed whole with a little
liquid directly before the meal or
chewed wi