Gliclazide 80mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Gliclazide

Verfügbar ab:

Viatris UK Healthcare Ltd

ATC-Code:

A10BB09

INN (Internationale Bezeichnung):

Gliclazide

Dosierung:

80mg

Darreichungsform:

Oral tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 06010201; GTIN: 5016695330075

Gebrauchsinformation

BEFORE YOU TAKE YOUR MEDICINE PLEASE
READ THIS LEAFLET CAREFULLY
This leaflet contains a summary of the information
about your medicine, Gliclazide Tablets BP 80 mg.
YOUR MEDICINE
Your medicine is in the form of a white, round,
scored tablet, marked 'GZ 80' on one side with a 'G'
on the other. Each tablet contains 80 mg of the
active ingredient Gliclazide. Each tablet also
contains lactose monohydrate, microcrystalline
cellulose, povidone, sodium starch glycollate, talc
and magnesium stearate.
Gliclazide Tablets are available in blister packs of 7,
10, 28, 30, 56, 60, 100, 120 and 250 tablets.
*Your pharmacist will dispense the number of
tablets prescribed by your doctor.
_(*Only the marketed pack sizes will feature on the _
_printed leaflet)_
Product Licence Holder and Manufacturer:
Generics [UK] Limited, Potters Bar, Herts EN6 1TL
Distributed by: Sovereign Medical, Sovereign
House, Miles Gray Road, Basildon, Essex. SS14 3FR.
HOW DOES YOUR MEDICINE WORK?
GLICLAZIDE TABLETS are a medicine which your
doctor may prescribe for you, together with diet,
to help reduce your blood sugar if you suffer from
NON INSULIN DEPENDENT DIABETES MELLITUS.
This condition is also called maturity onset
diabetes mellitus or Type II diabetes mellitus. This
type of diabetes can occur if your pancreas does
not produce enough insulin or if your body
becomes resistant to insulin. Insulin is a natural
chemical, which is released by the pancreas and
which helps your body to use sugar in your food
for energy. Gliclazide Tablets, which belong to the
group of medicines called Sulphonylureas, act on
the pancreas to help it release more insulin and so
reduce your blood sugar. Your doctor will prescribe
Gliclazide Tablets for you if your diabetes cannot
be controlled by diet alone. If you take Gliclazide
Tablets it is important that you should still
continue with your diabetic diet.
WHAT SHOULD YOU DO BEFORE TAKING YOUR
MEDICINE?
YOU MUST TELL YOUR DOCTOR BEFORE TAKING
YOUR MEDICINE IF:
• YOU HAVE TAKEN GLICLAZIDE TABLETS OR A SIMILAR
MEDICINE

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gliclazide Tablets BP 80mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Gliclazide Tablets BP contain Gliclazide 80 mg.
3.
PHARMACEUTICAL FORM
Tablets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Gliclazide Tablets are used for the treatment of maturity onset
diabetes
mellitus.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Gliclazide Tablets are for oral administration.
Adults
The total daily dose may vary from 40-320 mg taken orally. The dose
should
be adjusted according to the 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) and when higher doses are
required
a twice daily split dosage is advised and should be divided according
to the
main meals of the day.
In obese patients or those not showing adequate response to Gliclazide
alone
additional therapy should be considered.
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. There is evidence to indicate that Gliclazide is effective
and well
tolerated in elderly patients. Care should be exercised however, when
prescribing sulphonylureas in the elderly due to a possible age
related
increased tendency for hypoglycaemia.
Children
Gliclazide as with other sulphonylureas is not indicated for the
treatment of
juvenile onset diabetes mellitus.
4.3.
CONTRA-INDICATIONS
Gliclazide should not be used in juvenile onset diabetes, diabetes
complicated
by ketosis and acidosis, porphyria, during pregnancy and breast
feeding,
diabetics undergoing surgery, after severe trauma or during
infections, patients
with known hypersensitivity to Gliclazide or chemically related drugs
(including other sulphonylureas), diabetic pre-coma and coma and
severe renal
or hepatic insufficiency.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Care should be exercised in patients with hepatic