Gliclazide 40mg tablets

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktīvā sastāvdaļa:

Gliclazide

Pieejams no:

Flamingo Pharma (UK) Ltd

ATĶ kods:

A10BB09

SNN (starptautisko nepatentēto nosaukumu):

Gliclazide

Deva:

40mg

Zāļu forma:

Oral tablet

Ievadīšanas:

Oral

Klase:

No Controlled Drug Status

Receptes veids:

Valid as a prescribable product

Produktu pārskats:

BNF: 06010201; GTIN: 5060464500824

Produkta apraksts

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gliclazide 40 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40 mg of Gliclazide
Excipient(s) with known effect: Lactose monohydrate
Each tablet contains 21.250 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White to off white, circular, flat faced beveled edge uncoated tablets
plain on both
sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non insulin dependent diabetes (type 2) in adults when dietary
measures,
physical
exercise and weight loss alone are not sufficient to control blood
glucose.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Posology
•
Initial dose
The total daily dose may vary from 40 to 320 mg taken orally. The dose
should be
adjusted according to the individual patient's response, commencing
with 40-80 mg
daily (1 - 2 tablets) and increasing until adequate control is
achieved. A single dose
should not exceed 160 mg (4 tablets). When higher doses are required,
gliclazide
should be taken twice daily and according to the main meals of the
day.
In
obese
patients
or
those
not
showing
adequate
response
to
gliclazide
alone,
additional therapy may be required.
_ _
_Switching from another oral antidiabetic agent to Gliclazide 40 mg
Tablets: _
Gliclazide 40 mg Tablets can be used to replace other oral
antidiabetic agents.
The dosage and the half-life of the previous antidiabetic agent should
be taken into
account when switching to Gliclazide 40 mg Tablets.
A transitional period is not generally necessary. A starting dose of
40-80 mg (1 to 2
tablet) should be used and this should be adjusted to suit the
patient’s blood glucose
response, as described above.
When switching from a hypoglycaemic sulfonylurea with a prolonged
half-life, a
treatment free period of a few days may be necessary to avoid an
additive effect of the
two products, which might cause hypoglycaemia.
_Combination treatment with other antidiabetic agents:_
_ _