Gliclazide 80mg tablets

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Gliclazide

Հասանելի է:

Sovereign Medical Ltd

ATC կոդը:

A10BB09

INN (Միջազգային անվանումը):

Gliclazide

Դոզան:

80mg

Դեղագործական ձեւ:

Oral tablet

Կառավարման երթուղին:

Oral

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 06010201

Տեղեկատվական թերթիկ

READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS
MEDICINE.
•
Please 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.
•
If any of the side effects becomes severe, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
IN THIS LEAFLET:
1.
What Gliclazide 80 mg Tablets are and what they are used
for
2.
Before you take Gliclazide 80 mg Tablets
3.
How to take Gliclazide 80 mg Tablets
4.
Possible side effects
5.
How to store Gliclazide 80 mg Tablets
6.
Further information
1.
WHAT GLICLAZIDE 80 MG TABLETS ARE AND WHAT
THEY ARE USED FOR
The name of your medicine is Gliclazide 80 mg Tablets. The
active ingredient is gliclazide. Gliclazide is one of a group of
medicines called sulphonylureas. It works by lowering the
amount of sugar in your blood.
Gliclazide 80 mg Tablets are used to treat type II diabetes
mellitus in adults.
2.
BEFORE YOU TAKE GLICLAZIDE 80 MG TABLETS
DO NOT TAKE THIS MEDICINE IF:
•
you have ever had an allergic reaction (allergic reactions
include mild symptoms such as itching and/or rash. More
severe symptoms include swelling of the face, lips, tongue
and/or throat with difficulty in swallowing or breathing) to
any of the ingredients of Gliclazide 80 mg Tablets or any
other medicines that you may have taken to treat diabetes
mellitus;
•
you suffer from severe liver or kidney problems;
•
you suffer from type I diabetes;
•
you suffer from diabetes complications such as ketoacidosis
(excessive acid and ketones in your blood);
•
you are pregnant, trying to become pregnant or
breast-feeding;
•
you are under 14 years of age;
•
you are suffering from severe injury, infection or
undergoing major surgery;
•
you are taking miconazole (a treatment for fungal
infections)(see TAKING OTHER MEDICINES).
TAKE SPECIAL CARE WITH THIS M

Ապրանքի հատկությունները

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gliclazide 80 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg gliclazide.
For a full list of excipients, see 6.1
3
PHARMACEUTICAL FORM
Tablet.
White, round tablet, scored on one side and embossed “G03” on the
reverse
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of maturity onset diabetes mellitus.
4.2
POSOLOGY AND METHOD OF 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 tablet) and increasing until adequate
control is
achieved.
A single dose should not exceed 160 mg (2 tablets). When higher doses
are
required, Gliclazide 80 mg tablets should be taken twice daily
according to the
main meals of the day.
In obese patients or those not showing adequate response to Gliclazide
80 mg
tablets alone, additional therapy may be required.
Elderly:
Plasma clearance of gliclazide is not altered in the elderly and
steady state plasma
levels can therefore be expected to be similar to those in adults
under 65 years.
Clinical experience in the elderly to date shows that gliclazide is
effective and well
tolerated. Care should be exercised, however, when prescribing
sulphonylureas in the
elderly due to a possible age-related increased risk of hypoglycaemia.
Children:
Gliclazide, as with other sulphonylureas, is not indicated for the
treatment of juvenile
onset diabetes mellitus.
4.3.
CONTRAINDICATIONS
Gliclazide 80 mg tablets are contraindicated in:
•
Juvenile onset diabetes.
•
Type 1 diabetes.
•
Diabetes complicated by ketosis and acidosis.
•
Pregnancy and lactation (see section 4.6 Pregnancy and lactation).
•
Diabetics undergoing surgery after severe trauma or during
infections.
•
Patients known to have hypersensitivity to gliclazide or to any of
the excipients, other sulphonylureas, sulphonamides and related
drugs.
•
Diabetics p