Gliclazide 40mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gliclazide

Available from:

A A H Pharmaceuticals Ltd

ATC code:

A10BB09

INN (International Name):

Gliclazide

Dosage:

40mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06010201; GTIN: 5025903009177

Patient Information leaflet

SAME SIZE ARTWORK
400 x 160 mm
Front
400 mm
160 mm
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist 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, to 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 (hypoglycaemia) 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 diet,
•
if you increase your physical activity and carbohydrate intake does
not match this increase,
•
if you drink alcohol, especially in combination with skipped meals,
•
if you take other medicines or natural remedies at the same time,
•
if you take too high doses of gliclazide,
•
if you suffer from particular hormone-induced disorders (functional
disorders of the thyroid gland, of the
pituitary gland or adrenal cortex),
•
if your kidney function or liver function is severely decreased.
If you have low blood sugar you may have the following symptoms:
headache, intense hunger, nausea, vomiting,
weariness, sleep disorders, restlessness, aggressiveness, poor
concentration, reduced alertness and reaction
time, depression, confusion, speech or visual disorders, tremor,
sensory disturbances, dizziness and
helplessness.
The following signs and symptoms may also occur: sweating, clammy
skin, anxiety, fast or irregular heart beat,
high blood pressure, sudden strong pain in the chest that may radiate
into nearby areas (angina pectoris).
If blood sugar levels continue to drop you may suffer from
considerable confusion (delirium), develop conv

Summary of Product characteristics

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