Gliclazide 80mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Gliclazide

Διαθέσιμο από:

Actavis UK Ltd

Φαρμακολογική κατηγορία (ATC):

A10BB09

INN (Διεθνής Όνομα):

Gliclazide

Δοσολογία:

80mg

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 06010201; GTIN: 5012617003508 5012617013309

Φύλλο οδηγιών χρήσης

Actavis BST - Packing Technical
[e-mail]
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Gliclazide Tablets 80mg
x 28 & 60’s (UK)
148x210 (Reel Fed)
50814133
Leaflet for Blisters
6668
R.Wrey
27/06/14
148x210 Leaflet Reel Fed Profile (BST)
_Continued top of next column_
Gliclazide 80mg tablets PIL - UK
item no:
print proof no:
origination date:
originated by:
revision date:
revised by:
dimensions:
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1.
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1. Profile
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date sent:
supplier:
technically app. date:
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TECHNICAL APPROVAL
Black
AAAH0158
2
02.07.14
DR
05.09.14
DR
Actavis UK
148x210
7pt
02.07.14
50814133 AAAH0158
GLICLAZIDE 80MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your
doctor or pharmacist.
•
This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
INDEX
1
WHAT GLICLAZIDE TABLETS ARE AND WHAT
THEY ARE USED FOR
2
BEFORE YOU TAKE
3
HOW TO TAKE
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE
6
FURTHER INFORMATION
1
WHAT GLICLAZIDE TABLETS ARE AND WHAT
THEY ARE USED FOR
Gliclazide is one of a group of medicines called
sulfonylureas that are used to lower the blood sugar level.
Gliclazide tablets are used to treat maturity onset
diabetes in patients that is not controlled by diet alone.
They are not for use in children or in patients with
diabetes requiring insulin.
2
BEFORE YOU TAKE
DO NOT TAKE Gliclazide tablets AND TELL YOUR
DOCTOR if you:
•
have ever had AN ALLERGIC REACTION to Gliclazide
tablets or any of the ingredients in the tablet (Please
refer to section 6, further information) An allergic
reaction may include a rash, itching, difficulty
breathing or swelling of the face, lips, throat or
tongue
•
are BREAST FEEDING.
•
have SEVERE LIVER or KIDNEY disease.
•
have PORPHYRIA (

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gliclazide 80 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg of gliclazide.
Excipient(s) with known effect:
This product contains lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White, flat, round tablets marked with a double score line on one side
and
‘3G5’ on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gliclazide tablets are indicated for the treatment of non insulin
dependent
diabetes mellitus.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
_Adults _
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 (½-1 tablets) and increasing until adequate
control is
achieved. A single dose should not exceed 160 mg (2 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.
_Children _
Gliclazide, as with other sulphonylureas, is not indicated for the
treatment of
juvenile onset diabetes mellitus.
_Older people _
Plasma clearance of gliclazide is not altered in the older people and
steady
state plasma levels can therefore be expected to be similar to those
in adults
under 65 years. Clinical experience in the older people to date shows
that
gliclazide is effective and well tolerated. Care should be exercised,
however,
when prescribing sulphonylureas in the older people due to a possible
age-
related risk of hypoglycaemia.
In patients with mild to moderate renal impairment
In these patients, the same dosing regimen can be used as in patients
with
normal renal function with careful patient monitoring. These data have
been
confirmed in clinical trials.
In patients at risk of hypoglycaemia
Higher risk of hypoglycaemia exists in follo