PHARMACOR GLICLAMIRON gliclazide 30 mg modified release tablet bottle pack

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

gliclazide, Quantity: 30 mg

Tilgængelig fra:

Pharmacor Pty Ltd

Lægemiddelform:

Tablet, modified release

Sammensætning:

Excipient Ingredients: magnesium stearate; hypromellose; sodium acetate; silicon dioxide; mannitol; lactose monohydrate

Indgivelsesvej:

Oral

Enheder i pakken:

60's, 100's

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

Type II diabetes in association with dietary measures when dietary measures alone are inadequate to control blood glucose.,During controlled clinical trials in patients with type II diabetes, a modified release formulation of gliclazide (30 mg - 120 mg), taken as a single daily dose, was shown to be effective long term in controlling blood glucose levels, based on monitoring of HbA1c.

Produkt oversigt:

Visual Identification: White to off-white, round tablets, engraved with G3 on one face and plain on the other face.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Autorisation status:

Registered

Autorisation dato:

2020-04-29

Indlægsseddel

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_PHARMACOR GLICLAMIRON _
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PHARMACOR GLICLAMIRON TABLETS
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
PHARMACOR GLICLAMIRON contains the active ingredient gliclazide.
PHARMACOR GLICLAMIRON is used so control blood glucose (sugar) in
patients with Type II diabetes mellitus. For more
information, see Section 1. Why am I using PHARMACOR GLICLAMIRON? in
the full CMI.
Do not use if you have ever had an allergic reaction to PHARMACOR
GLICLAMIRON, macrolide antibiotics, or any of the ingredients listed
at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT
OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
PHARMACOR GLICLAMIRON ? in the full CMI.
Some medicines may interfere with PHARMACOR GLICLAMIRON and affect how
it works.
Tell your doctor, pharmacist or diabetes educator if you are taking
any other medicines, including medicines you buy without a
prescription
from a pharmacy, supermarket or health food shop.
See Section 3. What if I am taking other medicines? in the full CMI
for information.
Your doctor will tell you how many tablets to take each day. They may
increase or decrease the dose, depending on your blood glucose
levels.
More instructions can be found in Section 4. How do I use PHARMACOR
GLICLAMIRON? in the full CMI.
Tell all doctors, dentists, pharmacists and diabetes educators who are
involved with your treatment that you are taking PHARMACOR
GLICLAMIRON.
If you are about to start taking any new medicines, tell you doctor
and pharmacist that you are taking.
For more information, see Section 5. What should I know while using
PHARMACOR GLICLAMIRON? in the full CMI.
There are a number of side effects associated with this medicine. It
is important to be aware of them so that you can identify any symptoms
if
they occur (see the full CMI for more details). The serious s

Produktets egenskaber

PHARMACOR GLICLAMIRON
Ver 03
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
PHARMACOR GLICLAMIRON TABLETS
(GLICLAZIDE)
1.
NAME OF THE MEDICINE
Gliclazide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PHARMACOR GLICLAMIRON 30 mg: Each modified release tablet contain 30
mg
Gliclazide._ _
Excipient with known effect: Lactose Monohydrate 39 mg
PHARMACOR GLICLAMIRON 60 mg: Each modified release tablet contain 60
mg Gliclazide._ _
Excipient with known effect: Lactose Monohydrate 78 mg
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Tablet, Modified Release
PHARMACOR GLICLAMIRON 30 mg: White to off-white, round tablets,
engraved with
“G3” on one face and plain on the other face.
PHARMACOR GLICLAMIRON 60 mg: White to off-white, oblong shaped
tablets, scored
with a break bar on both sides, engraved with “G L” on one face
and plain on the other face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Type II diabetes in association with dietary measures when dietary
measures alone are
inadequate to control blood glucose.
During
controlled
clinical
trials
in
patients
with
type
II
diabetes,
a
modified
release
formulation of gliclazide (30 mg - 120 mg), taken as a single daily
dose, was shown to be
effective long term in controlling blood glucose levels, based on
monitoring of HbA1c.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
For adult use only.
PHARMACOR GLICLAMIRON
Ver 03
Page 2 of 14
PHARMACOR GLICLAMIRON 60 mg have a break bar and may be administered
as whole
or as half tablets (see section 5.2 Pharmacokinetic properties).
PHARMACOR GLICLAMIRON are modified release tablets; tablets should not
be chewed
or crushed to maintain the modified release properties of the product.
A single daily dose provides an effective blood glucose control. The
daily dose may vary
from 30 mg to 120 mg taken orally. The initial recommended dose is 30
mg, even in elderly
patients (≥ 65 years). The daily dose should not exceed 120 mg.
As with all hypoglycaemic agents, the dose should be titrated