GLIMEPIRIDE SANDOZ glimepiride 1 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

glimepiride, Quantity: 1 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Glimepiride

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; sodium starch glycollate; povidone; iron oxide red; magnesium stearate

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

As an adjunct to diet, exercise and weight loss, to lower the blood glucose in patients with noninsulin dependant diabetes mellitus (type 2 diabetes).

Product summary:

Visual Identification: A light red, flat, modified oblong, scored tablet encoded G 1 on one side. Size: Approx. 4.0 x 8.0 mm.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2006-07-10

Patient Information leaflet

GLIMEPIRIDE SANDOZ
®
_glimepiride tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Glimepiride Sandoz.
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 this medicine
against the benefits they expect it
will have for you.
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 GLIMEPIRIDE
SANDOZ IS USED FOR
This medicine is used to control
blood glucose (sugar) in patients with
type 2 diabetes mellitus.
It contains the active ingredient
glimepiride.
Glimepiride belongs to a group of
medicines called sulfonylureas.
It works by increasing the amount of
insulin produced by your pancreas.
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.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
GLIMEPIRIDE SANDOZ
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
glimepiride, the active ingredient,
or to any of the other ingredients
listed at the end of this leaflet
under Product description
•
other sulfonylureas (e.g.
Minidiab, Diamicron or Daonil)
•
any other similar medicines such
as sulfonamides (e.g. sulphur
antibiotics or thiazide diuretics).
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 THIS MEDICINE IF YOU
HAVE OR HAVE HAD ANY OF THE
FOLLOWING MEDICAL CONDITIONS:
•
a previous reaction to
glimepiride, other sulfonylureas
or sulphonamides
•
type 1 diabetes mellitus
•
diabetic ketoacidosis
•
diabetic coma or pre-com

Summary of Product characteristics

181113-Glimepiride Sandoz-pi
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
CLIMEPIRIDE SANDOZ TABLETS (GLIMEPIRIDE)
1
NAME OF THE MEDICINE
Glimepiride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glimepiride is a white odourless, crystalline powder, practically
insoluble in methanol and
water, slightly soluble in ethanol and sparingly soluble in methylene
chloride.
_Active_
: glimepiride 1 mg / 2 mg / 3 mg / 4 mg
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Glimepiride Sandoz 1 mg tablets: A light red, flat, modified oblong,
scored tablet encoded G|1
on one side: 30’s.
Glimepiride Sandoz 2 mg tablets: A light green, flat, modified oblong,
scored tablet encoded
G|2 on one side: 30’s.
Glimepiride Sandoz 3 mg tablets: A light yellow, flat, modified
oblong, scored tablet encoded
G|3 on one side: 30’s.
Glimepiride Sandoz 4 mg tablets: A light blue, flat, modified oblong,
scored tablet encoded
G|4 on one side: 30’s.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
As an adjunct to diet, exercise and weight loss, to lower the blood
glucose in patients with non-
insulin dependent diabetes mellitus (type 2 diabetes).
_ _
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
In the management of type 2 diabetes mellitus, administration of an
oral antidiabetic agent is
not a substitute for appropriate dietary control.
In initiating treatment for non-insulin dependent diabetes mellitus
(NIDDM), 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
sulfonylurea should be considered. Use of Glimepiride Sandoz must be
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