Minodiab 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Glipizide

Available from:

Pfizer Ltd

ATC code:

A10BB07

INN (International Name):

Glipizide

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06010201; GTIN: 5012882008277

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MINODIAB
 5 MG TABLETS
Glipizide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Minodiab is and what it is used for
2. What you need to know before you take Minodiab
3. How to take Minodiab
4. Possible side effects
5. How to store Minodiab
6. Contents of the pack and other information
1. WHAT MINODIAB IS AND WHAT IT IS USED FOR
This medicine contains glipizide which is one of a group of medicines
called sulfonylureas.
Minodiab is used to treat diabetes (Type II, non-insulin-dependent
diabetes) and helps to lower
your blood glucose (sugar) levels, when a change in diet alone is not
enough to control the
condition.
Diabetics produce too much glucose due to a lack of insulin in the
body. This can be
controlled by Minodiab, which reduces high blood glucose (sugar)
levels by increasing insulin
production.
You must talk to a doctor if you do not feel better or if you feel
worse after taking this medicine.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MINODIAB
DO NOT TAKE MINODIAB:
•
If you are allergic to glipizide, similar antidiabetic medicines or
any of the other
ingredients of this medicine (listed in section 6).
•
If you have insulin-dependent diabetes (also called juvenile or Type I
diabetes) which
would have probably started in your childhood.
•
If you have ketone bodies and sugar in your urine (this may mean you
may have
diabetic ketoacidosis).
•
If you suffer from episodes of unconsciousness (this may mean you may
have
diabetic coma).
�

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Minodiab 5 mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 mg Glipizide.
Excipient with known effect:
Each tablet contains 153 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White biconvex tablets scored on both sides.
The score line is not intended for breaking the tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Glipizide is indicated as an adjunct to diet and exercise to improve
glycaemic control
in adults with type 2 diabetes mellitus.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
As for any hypoglycaemic 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 shortly before a meal to achieve
the greatest
reduction in post-prandial hyperglycaemia.
Initial Dose
The recommended starting dose is 5 mg, given before breakfast or the
midday meal.
Mild diabetics, geriatric patients or those with liver disease may be
started on 2.5 mg.
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. 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.
Maintenance
Some patients may be effectively controlled on a once-a-day regimen.
Total daily
dosage above 15 mg should ordinarily be divided.
The maximum recommended daily dosage is 20 mg_._
Paediatric population
Safety and effectiveness in children have not been established.
Use in Elderly and High-Risk Patients
In elderly, debilitated and malnourished patients or patients with an
impaired renal or
hepatic function, the initial and maintenance dosing should be
conservative to avoid
hypoglycaemic reactions (see In