Gliclazide 40mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Gliclazide

Inapatikana kutoka:

DE Pharmaceuticals

ATC kanuni:

A10BB09

INN (Jina la Kimataifa):

Gliclazide

Kipimo:

40mg

Dawa fomu:

Oral tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 06010201

Taarifa za kipeperushi

296x210 Leaflet Reel Fed Bi Fold Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Gliclazide Tablets 40mg x 28’s (UK)
296x210 (Reel Fed)
50965118
Leaflet for Blisters
4266
R.Wrey
18/02/19
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DATE RECEIVED:
Item no:
ORIGINATOR:
ORIGINATION DATE:
REVISION DATE:
REVISED BY:
DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
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GLICLAZIDE 40MG 28 TABLES PIL - UK
Black
Profile
BBBA4382
R.Wrey
01/04/19
05/04/19
R.Wrey
296 x 210
9pt
Accord Barnstaple
n/a
n/a
02
page 4
page 1
50965118
GLICLAZIDE 40MG TABLETS
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_Continued over page_
BBBA4382
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it
again.
•
If you have any further questions, ask your
doctor, pharmacist or nurse.
•
This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them, even if their signs of illness are
the same as yours.
•
If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1 WHAT GLICLAZIDE TABLETS ARE AND WHAT
THEY ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU
TAKE GLICLAZIDE TABLETS
3 HOW TO TAKE GLICLAZIDE TABLETS
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE GLICLAZIDE TABLETS
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1 WHAT GLICLAZIDE TABLETS ARE AND WHAT
THEY ARE USED FOR
Gliclazide belongs to a group of medicines called
sulfonylureas that are used to lower the blood
sugar level.
Gliclazide tablets are used in the treatment of
di

Tabia za bidhaa

OBJECT 1
GLICLAZIDE 40MG TABLETS
Summary of Product Characteristics Updated 17-May-2019 | Accord-UK Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Gliclazide 40mg Tablets
2. Qualitative and quantitative composition
Each tablet contains 40mg gliclazide
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Tablet
White, circular, flat, bevelled-edge uncoated tablet plain on one face
and the identifying letters “GU” on
the reverse
4. Clinical particulars
4.1 Therapeutic indications
Non insulin dependent diabetes mellitus (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
Posology
_Adults _
The total daily dose may vary from 40-320mg. The dose should be
adjusted according to the individual's
response, commencing with 40-80mg (1 - 2 tablets) daily and increasing
until adequate control is
achieved. A single dose should not exceed 160m