Minidiab

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

glipizide, Quantity: 5 mg

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: microcrystalline cellulose; maize starch; lactose monohydrate; stearic acid

Administration route:

Oral

Units in package:

20 tablets, 100 tablets

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Minidiab is indicated as an adjunct to diet and exercise for the control of hyperglycaemia and its associated symptomatology in patients with non-insulin-dependent diabetes mellitus (NIDDM; type II), formerly known as maturity-onset diabetes, after an adequate trial of dietary therapy has proved unsatisfactory. In initiating treatment for non-insulin-dependent diabetes, diet should be emphasised as the primary form of treatment. Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycaemia. The importance of regular physical activity should also be stressed, and cardiovascular risk factors should be identified and corrective measures taken where possible. If this treatment program fails to reduce symptoms and/or blood glucose the use of an oral sulphonylurea or insulin should be considered. Use of Minidiab must be viewed by both the physician and patient as a treatment in additio

Product summary:

Visual Identification: white, round, biconvex, scored tablets; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-09-23

Patient Information leaflet

MINIDIAB
®
_Glipizide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Minidiab. It does not
contain all the available information
and it does not take the place of
talking to your doctor, pharmacist or
diabetes educator.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Minidiab
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR, PHARMACIST OR DIABETES
EDUCATOR.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT MINIDIAB IS USED
FOR
_WHAT MINIDIAB DOES_
Minidiab is used in addition to diet
and exercise to control blood sugar in
patients with Type II diabetes
mellitus. This type of diabetes is also
known as non-insulin-dependent
diabetes mellitus (NIDDM) or
maturity onset diabetes.
Minidiab is used when diet and
exercise are not enough to control
blood sugar (glucose). Minidiab can
be used alone, or together with
insulin or other medicines for
treating diabetes.
_HOW MINIDIAB WORKS_
Minidiab belongs to a group of
medicines called sulphonylureas.
These medicines lower high blood
glucose by increasing the amount of
insulin produced by your pancreas.
If your blood glucose is not properly
controlled, you may experience
hypoglycaemia (low blood glucose)
or hyperglycaemia (high blood
glucose). High blood glucose can
lead to serious problems with your
heart, eyes, circulation or kidneys.
Hypoglycaemia (low blood glucose)
can occur suddenly. Signs may
include:
•
weakness, trembling or shaking
•
sweating
•
lightheadedness, dizziness,
headache or lack of concentration
•
tearfulness or crying
•
irritability
•
hunger
•
numbness around the lips and
tongue.
If not treated properly, these may
progress to:
•
loss of co-ordination
•
slurred speech
•
confusion
•
loss of consciousness or fitting.
Hyperglycaemia (high blood
glucose) usually occurs more slowly
than low blood glucose.
Signs of high blood glucose may
include:
�

Summary of Product characteristics

Version: pfpmindt10420
Supersedes: pfpmindt11019
Page 1 of 11
AUSTRALIAN
PRODUCT
INFORMATION
–
MINIDIAB (GLIPIZIDE)
1.
NAME OF THE MEDICINE
Glipizide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of glipizide.
EXCIPIENT(S) WITH KNOWN EFFECT
lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
White, round, biconvex, scored tablets.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MINIDIAB is indicated as an adjunct to diet and exercise for the
control of hyperglycaemia
and its associated symptomatology in patients with
non-insulin-dependent diabetes mellitus
(NIDDM; type II), formerly known as maturity-onset diabetes, after an
adequate trial of dietary
therapy has proved unsatisfactory. In initiating treatment for
non-insulin-dependent diabetes,
diet should be emphasised as the primary form of treatment. Caloric
restriction and weight
loss are essential in the obese diabetic patient. Proper dietary
management alone may be
effective in controlling the blood glucose and symptoms of
hyperglycaemia. The importance
of regular physical activity should also be stressed, and
cardiovascular risk factors should be
identified, and corrective measures taken where possible. If this
treatment program fails to
reduce symptoms and/or blood glucose the use of an oral sulphonylurea
or insulin should be
considered. Use of MINIDIAB must be viewed by both the physician and
patient as a treatment
in addition to diet, and not as a substitute for diet or as a
convenient mechanism for avoiding
dietary restraint. Furthermore, loss of blood glucose control on diet
alone also may be transient,
thus requiring only short-term administration of MINIDIAB. During
maintenance programs,
MINIDIAB should be discontinued if satisfactory lowering of blood
glucose is no longer
achieved. Judgments should be based on regular clinical and laboratory
evaluations.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Generally speaking, the drug should be taken about 30 minutes b