MINIDIAB 5MG TABLET

Maa: Malesia

Kieli: englanti

Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiivinen ainesosa:

GLIPIZIDE

Saatavilla:

PFIZER (MALAYSIA) SDN. BHD.

INN (Kansainvälinen yleisnimi):

GLIPIZIDE

Kpl paketissa:

0.05gm030Tablet Tablets; 0.05 gm 0 30 Tablet Tablets; 0.05 gm 0 160 Tablet Tablets

Valmistaja:

Pfizer Italia S.r.l.

Pakkausseloste

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
MINIDIAB
® TABLET
Glipizide (5 mg)
WHAT IS IN THIS LEAFLET
1.
What Minidiab is used for
2.
How Minidiab works
3.
Before you use Minidiab
4.
How to use Minidiab
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Minidiab
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of Revision
11. Serial Number
WHAT MINIDIAB IS USED FOR
Minidiab is indicated as an adjunct to
diet and exercise to improve glycemic
control in adults with type 2 diabetes
mellitus.
HOW MINIDIAB WORKS
Minidiab stimulates insulin secretion
from the pancreas in response to a meal
and potentiates insulin action.
BEFORE YOU USE MINIDIAB
-
_When you must not use it_
Minidiab is contraindicated in patients
with:
1. Hypersensitivity to glipizide or any
excipients in the tablets.
2. Type 1 diabetes mellitus, diabetic
ketoacidosis, diabetic coma.
_Pregnancy and lactation: _
Minidiab should be used during
pregnancy only if the potential benefit
justifies the potential risk to the fetus.
Although it is not known whether
Minidiab is excreted in human milk,
some sulfonylurea drugs are known to
be excreted in human milk.
Do not take Minidiab if you are
pregnant, trying to get pregnant or
think you may be pregnant.
Do not take Minidiab
_ _
if you are
breast-feeding. Ask your doctor or
pharmacist for advice before taking
any medicine.
-
_Before you start to use it _
Be sure to tell your doctor if:
•
You have been told you are
allergic to glipizide or any of
the ingredients in Minidiab.
•
You have insulin dependent
(Type I) diabetes.
•
You suffer from Glucose-6-
Phosphate Dehydrogenase
deficiency (abnormal
destruction of your red blood
cells).
•
You have ketone bodies and
sugar in your urine (this may
mean you have ketoacidosis).
•
You have liver or kidney
problems.
•
You have thyroid problems.
•
You are about to have major
surgery or you have recently
suffered a severe illness or
infection. At such times
diabetic control may be lost

Valmisteyhteenveto

Pfizer Confidential
PFIZER
MINIDIAB
®
Glipizide
1.
NAME OF THE MEDICINAL PRODUCT
MINIDIAB
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glipizide is available as 5 mg scored tablets containing glipizide as
the active ingredient.
3.
PHARMACEUTICAL FORM
Scored tablets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Glipizide is indicated as an adjunct to diet and exercise to improve
glycemic control in adults
with type 2 diabetes mellitus.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
As for any hypoglycemic agent, dosage must be adapted for each
individual case.
Short-term administration of glipizide may be sufficient during
periods of transient loss of control
in patients usually controlled well on diet.
In general, glipizide should be given approximately 30 minutes before
a meal to achieve the
greatest reduction in postprandial hyperglycemia.
_Initial Dose _
The recommended starting dose is 5 mg/day, given before breakfast or
the mid-day meal. Elderly
patients and other patients at risk for hypoglycemia may be started on
2.5 mg (see
_Use in Elderly _
_and High-Risk Patients_
).
_Titration _
Dosage adjustments should ordinarily be in increments of 2.5 mg or 5
mg, as determined by blood
glucose response. At least several days should elapse between
titration steps.
_Maintenance _
Some
patients
may
be
effectively
controlled
on
a
once-a-day
regimen.
The
maximum
recommended single dose is 15 mg. If this is not sufficient, splitting
the daily dosage may prove
effective. Doses above 15 mg should ordinarily be divided. Total daily
dosage above 15 mg
should ordinarily be divided. Total dosage above 30 mg has been safely
given on a twice-a-day
basis to long-term patients. Patients can usually be stabilized on a
dosage ranging from 2.5 mg
to 30 mg daily. The maximum recommended daily dosage is 40 mg.
Pfizer Confidential
1
_Use in Children _
Safety and effectiveness in children have not been established.
_ _
_Use in Elderly and High-Risk Patients _
To decrease the risk of hypoglycemia in patients at risk including
elderly,