Gliclazide 40mg tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Gliclazide

可用日期:

Almus Pharmaceuticals Ltd

ATC代码:

A10BB09

INN（国际名称）:

Gliclazide

剂量:

40mg

药物剂型:

Oral tablet

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 06010201; GTIN: 05055382301486

资料单张

1. WHAT GLICLAZIDE TABLETS ARE AND WHAT THEY ARE USED FOR
Gliclazide tablets contain the active substance
gliclazide, one of a group of medicines called
sulfonylureas. It is an oral hypoglycaemic
medicine (blood sugar lowering drug). Gliclazide
tablets are 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 TABLETS
DO NOT TAKE GLICLAZIDE TABLETS:
• If you are allergic to gliclazide or any of the
other ingredients of this medicine (listed
in section 6), to other medicines of the same
group (sulfonylureas), to other related
medicines (hypoglycaemic sulfonamides),
•
If you have insulin-dependent diabetes (type 1),
• If you have ketone bodies and sugar in your
urine (this may mean you have
keto-acidosis), a diabetic pre-coma or coma,
• If you have severe kidney or liver disease,
• If you are taking miconazole (a treatment for
fungal infections) (see OTHER MEDICINES AND GLICLAZIDE TABLETS),
• If you are breast-feeding (see PREGNANCY AND BREAST-FEEDING).
CHILDREN AND ADOLESCENTS
Gliclazide tablets are not recommended for use
in children.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Gliclazide
tablets. You should observe the treatment plan
prescribed by your doctor to achieve proper
blood sugar levels. This means, apart from
regular tablet intake, you observe the dietary
regimen, have physical exercise and, where
necessary, reduce weight.
During gliclazide treatment regular monitoring of
your blood (and possibly urine) sugar level and
also your glycated haemoglobin (HbA1c) is
necessary.
In the first few weeks of treatment the risk of
having reduced blood sugar levels (hypo-
glyceamia) may be increased. So particularly
close medical monitoring is necessary.
Low blood sugar (Hypoglycaemia) may occur:
• if you take meals irregularly or skip meals
altogether, if you are fasting,
• if you are malnourished,
• if you change your d

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gliclazide 40mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40 mg of Gliclazide.
Excipient with known effect: Also Contains Lactose Monohydrate Ph. Eur
55
mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White to off-white, circular, flat, bevelled edged, uncoated tablets
with “40” on one
side, plain on reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non insulin dependent diabetes (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
INITIAL DOSE: 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 (1 – 2 tablets) and increasing until
adequate
control is achieved. A single dose should not exceed 160 mg (4
tablets). When
higher doses are required, Gliclazide Tablets 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
Tablets
alone, additional therapy may be required.
SWITCHING FROM ANOTHER ORAL ANTIDIABETIC AGENT TO GLICLAZIDE 40 MG:
Gliclazide 40 mg can be used to replace other oral antidiabetic
agents.
The dosage and the half-life of the previous antidiabetic agent should
be taken
into account when switching to Gliclazide 40 mg.
A transitional period is not generally necessary. A starting dose of
40-80 mg
(1 to 2 tablets) should be used and this should be adjusted to suit
the patient's
blood glucose response, as described above.
When switching from a hypoglycaemic sulfonylurea with a prolonged
half-
life, a treatment free period of a few days may be necessary to avoid
an
additive effect of the two products, which might cause hypoglycaemia.
COMBINATION TREATMENT WITH OTHER ANTIDIABETIC AGENTS:
Gliclazide 40 mg can be given in combination wit