DAONIL 5mg Tablets

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

glibenclamide, Quantity: 5 mg

Saadav alates:

Sanofi-Aventis Australia Pty Ltd

Ravimvorm:

Tablet, uncoated

Koostis:

Excipient Ingredients: colloidal anhydrous silica; magnesium stearate; pregelatinised maize starch; lactose monohydrate; purified talc; maize starch

Manustamisviis:

Oral

Ühikuid pakis:

30 Tablets, 90 Tablets, 60 Tablets, 10 Tablets (sample pack), 100 tablets

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

Daonil and Semi-Daonil are indicated as an adjunct to diet to lower the blood glucose in patients with non-insulin-dependent diabetes mellitus (type 2) whose hyperglycaemia cannot be controlled by diet alone. Because of its broad and predictable action, Daonil and Semi-Daonil are often suitable for the management of patients who have failed to respond to other oral antidiabetics.,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 programme fails to reduce symptoms and/or blood glucose the use of an oral sulphonylurea should be considered. Use of Daonil and Semi-Daonil 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.

Toote kokkuvõte:

Visual Identification: White, biplane oblong tablet with a score-line on both sides. 'LDI' is engraved each side of the score-line and inverted. The other side is plain.; Container Type: Blister Pack; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Volitamisolek:

Licence status A

Loa andmise kuupäev:

2000-04-27

Infovoldik

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 amounts of urine

Toote omadused

daonil-semi-daonil-ccdsv10-piv10-19jun20
Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION – DAONIL
® AND SEMI-
DAONIL
® (GLIBENCLAMIDE) TABLET
1
NAME OF THE MEDICINE
Glibenclamide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DAONIL
Each tablet contains 5 mg of glibenclamide.
Excipients of known effect: Lactose monohydrate
SEMI-DAONIL
*
Each tablet contains 2.5 mg of glibenclamide.
Excipients of known effect: Lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Uncoated tablets.
DAONIL
White, biplane oblong tablet with a score-line on both sides. LDI is
engraved each side of the
score-line and inverted. The other side is plain.
SEMI-DAONIL*
White, round, biplanar tablet with beveled edge, HOECHST logo and LDY
on either side of
score line.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Daonil
and Semi-Daonil
are indicated as an adjunct to diet to lower the blood glucose in
patients with non-insulin-dependent diabetes mellitus (type 2) whose
hyperglycaemia cannot
be controlled by diet alone. Because of its broad and predictable
action, Daonil
and Semi-
daonil-semi-daonil-ccdsv10-piv10-19jun20
Page 2 of 15
Daonil
are often suitable for the management of patients who have failed to
respond to other
oral antidiabetics.
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 programme fails to reduce
symptoms and/or blood
glucose the use of an oral sulphonylurea should be considered. Use of
Daonil
and Semi-
Daonil
must be viewed by both the physician and patient as a treatment in
addition to diet,
and not as a substitute for