Gliclazide 80mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gliclazide

Available from:

DE Pharmaceuticals

ATC code:

A10BB09

INN (International Name):

Gliclazide

Dosage:

80mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06010201

Patient Information leaflet

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• New regulatory text
PACKAGE LEAFLET: INFORMATION FOR THE USER GLICLAZIDE 80MG TABLETS
Gliclazide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE 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, please ask your doctor or
pharmacist.
•
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 or pharmacist. This
includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Gliclazide 80mg Tablets are and what they are used for
2.
What you need to know before you take Gliclazide 80mg Tablets
3.
How to take Gliclazide 80mg Tablets
4.
Possible side effects
5.
How to store Gliclazide 80mg Tablets
6.
Contents of the pack and other information
1.
WHAT GLICLAZIDE 80MG TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Gliclazide 80mg Tablets. These tablets
contain
the active substance gliclazide, one of group of medicines called
sulphonylureas.
Gliclazide is an oral hypoglycaemic medicine (blood sugar lowering
drug), it is
used to keep blood sugar at the correct level in adults with
non-insulin
dependent diabetes when it is not controlled by diet, physical
exercise and
weight loss alone.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GLICLAZIDE 80MG TABLETS
DO NOT TAKE GLICLAZIDE 80MG TABLETS:
•
if you are allergic to gliclazide or any of the other ingredients in
Gliclazide
80mg Tablets (listed in section 6), to other medicines of the same
group
(sulphonylureas), to other related medicines (hypoglycaemic
sulphonamides)
•
if you have insulin dependent diabetes (type I)
•
if you have ketone bodies and sugar in your urine (this may mean you
have
keto-acidosis), a diabetic pre-coma or coma

Summary of Product characteristics

OBJECT 1
GLICLAZIDE 80MG TABLETS
Summary of Product Characteristics Updated 29-Mar-2017 | Wockhardt 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 80mg Tablets
2. Qualitative and quantitative composition
Each tablet contains Gliclazide 80mg
Excipients with known effect
Lactose
For the full list excipients, see section 6.1
3. Pharmaceutical form
Tablet
White, circular tablets with GZ80 and a breakline on one face and CP
on the other.
The tablet can be divided into equal doses.
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_
• Initial dose
The total daily dose may vary from 40 to 320mg taken orally. The dose
should be adjusted according to
the individual patient's response, commencing with 40-80mg daily (
1
/
2
– 1 tablet)