GLUCOBAY acarbose 100mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

acarbose

Available from:

Bayer Australia Ltd

Authorization status:

Registered

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

180703 GLUCOBAY PI
1
PRODUCT INFORMATION
GLUCOBAY
®
(acarbose)
1. NAME OF THE MEDICINE
Acarbose
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
GLUCOBAY tablets contain acarbose 50 mg or 100 mg.
For the list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
GLUCOBAY 50 mg tablets are round, biconvex, white to yellow-tinged
tablets, marked with the Bayer
cross on the one side and “G” and “50” on the reverse side.
GLUCOBAY 100 mg tablets are round, convex, white to yellow-tinged
tablets, marked with “G” and
“100”.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an adjunct to prescribed diet and exercise for the management of
blood glucose concentrations in
non-insulin dependent diabetic patients who are inadequately
controlled by diet alone or by diet and oral
hypoglycaemic agents.
4.2 DOSE AND METHOD OF ADMINISTRATION
Since the activity and the tolerability of GLUCOBAY varies from
individual to individual, the optimal
dosage must be individualised.
GLUCOBAY tablets should be swallowed whole with a little liquid
directly before a meal or chewed
with the first few mouthfuls of the meal.
In adults, GLUCOBAY should be started at a low initial dose and be
increased slowly to minimise the
gastrointestinal side effects. Treatment is usually commenced at 50 mg
once daily for the first week, 50
mg twice daily for the second week and 50 mg three times a day for the
third week. A further increase
of the dose may be necessary after 4 - 8 weeks on the basis of the
blood glucose level. The average
adult dose is 100 mg GLUCOBAY three times daily. A further increase to
200 mg GLUCOBAY three
times
daily
may
occasionally
be
necessary
(see
Section
4.4
SPECIAL
WARNINGS
AND
PRECAUTIONS FOR USE).
If gastrointestinal symptoms are not tolerated despite close adherence
to the prescribed diet, a reduction
in the dose should be considered.
No modification of the adult dosage regimen is necessary in the
elderly.
180703 GLUCOBAY PI
2
4.3 CONTRAINDICATIONS
Hypersensitivity to acarbose and/or any of t