Daonil

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Glibenclamide 5mg;  ; Glibenclamide 5mg

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Glibenclamide 5 mg

Dosage:

5 mg

Pharmaceutical form:

Tablet

Composition:

Active: Glibenclamide 5mg   Excipient: Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Maize starch Pregelatinised maize starch Purified talc Active: Glibenclamide 5mg Excipient: Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Maize starch Purified talc

Units in package:

Blister pack, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Aventis Pharma Limited

Product summary:

Package - Contents - Shelf Life: Blister pack, - 100 tablets - 36 months unopened stored at or below 25°C protect from light

Authorization date:

1969-12-31

Patient Information leaflet

DAONIL
®
1
DAONIL
®
_glibenclamide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Daonil. It does not
contain all the available information.
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 Daonil 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 THE MEDICINE.
You may need to read it again.
WHAT DAONIL IS USED
FOR
Daonil is used to control blood
glucose levels in patients with type 2
diabetes mellitus. This type of
diabetes is also known as non-
insulin-dependent diabetes (NIDDM)
or maturity onset diabetes.
Daonil is used in conjunction with
diet control and exercise to control
blood sugar.
Daonil can be used alone, or in
combination with insulin or other
anti-diabetes medicines.
Daonil lowers high blood glucose by
increasing the amount of insulin
released by your pancreas.
Daonil belongs to a group of
medicines called sulphonylureas.
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.
Low blood glucose can occur
suddenly. Signs may include:
•
weakness, trembling, shaking
•
sweating
•
light headedness, dizziness,
headache or lack of concentration
•
tearfulness, crying or depression
•
irritability
•
hunger
•
numbness around the lips and
tongue
•
restlessness or disturbed sleep
If not treated promptly, these may
progress to:
•
loss of co-ordination
•
slurred speech
•
confusion
•
loss of consciousness or seizures
High blood glucose usually occurs
more slowly than low blood glucose.
Signs of high blood glucose may
include:
•
lethargy or tiredness
•
headache
•
severe thirst
•
passing large amou

Summary of Product characteristics

New Zealand Data Sheet
Daonil - glibenclamide
daonil-ccdsv10-1-dsv8-20jun22
Page 1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Daonil 5mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg of glibenclamide.
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Each tablet of Daonil is white, biplane, oblong, with a score-line on
both sides. LDI is engraved
each side of the score-line and inverted. The other side is plain.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non insulin dependent (type 2 diabetes mellitus), whenever blood
glucose levels cannot be
controlled adequately by diet, physical exercise, and weight reduction
alone.
When the efficacy of Daonil decreases (partial secondary failure) it
can be given together with
insulin.
Daonil can also be combined with other, non-betacytotropic oral
antidiabetics.
4.2
DOSE AND METHOD OF ADMINISTRATION
In principle, the dosage of Daonil is governed by the desired blood
glucose level. The dosage of
glibenclamide must be the lowest possible dose which is effective.
Treatment with Daonil must be initiated and monitored by a physician.
The patient must take
Daonil at the times and in the doses prescribed by the physician.
New Zealand Data Sheet
Daonil - glibenclamide
daonil-ccdsv10-1-dsv8-20jun22
Page 2
Mistakes, e.g. forgetting to take a dose, must never be corrected by
subsequently taking a larger
dose. Measures for dealing with such mistakes (in particular
forgetting a dose or skipping a meal)
or in the event that a dose cannot be taken at the prescribed time
must be discussed and agreed
between physician and patient beforehand.
If it is discovered that too high a dose or an extra dose of Daonil
has been taken, a physician must
be notified immediately.
INITIAL DOSE AND DOSE TITRATION
Usual initial dose: ½ to 1 tablet Daonil once daily.
It is recommended that treatment be started with the smallest possible
dose. This applies in
particular to patients who are prone to hypoglycaemia (see Section
4.4) or who weigh less than 50
kg.
If