Gliclazide 80mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gliclazide

Available from:

Medreich Plc

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; GTIN: 05060292740676 05060292740683

Patient Information leaflet

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0070/O/PIL/001/I
•
take other medicines or natural remedies at the same time,
•
take too high doses of gliclazide,
•
suffer from particular hormone-induced disorders (Functional disorders
of the thyroid
gland, of the pituitary gland or adrenal cortex),
•
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 heartbeat, 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 convulsions, lose self-control, your breathing may
be shallow and your
heart beat slowed down, you may become unconscious. In most cases the
symptoms of
low blood sugar vanish very quickly when you consume some form of
sugar, e.g. glucose
tablets, sugar cubes, sweet juice, sweetened tea.
You should therefore always carry some form of sugar with you (glucose
tablets, sugar
cubes). Remember that artificial sweeteners are not effective.
Please contact your doctor or the nearest hospital if taking sugar
does not help or if the
symptoms recur.
Symptom of low blood sugar may be absent, less obvious or develop very
slowly or you are not
aware in time that your blood sugar level has dropped. This may happen
if you are an elderly
patient taking certain medicines (those acting on the central nervous
system and ß-blockers).
Symptoms of high blood sugar (Hypeglycaemia) may occur when Gliclazide
has not yet
sufficiently reduced the blood sugar, when you have not complied with
the treatment plan
prescribed by your doctor or in special stress situations. These m

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gliclazide 80mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80mg Gliclazide
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Gliclazide 80mg Tablets are presented as white round tablets with ‘G
80’ on
one side and score line on other side.
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 - 80mg daily (½ to 1 tablets) and increasing until adequate
control is
achieved. A single dose should not exceed 160mg (2 tablets). When
higher
dose is required, Gliclazide 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
alone,
additional therapy may be required.
• Switching from another oral antidiabetic agent to Gliclazide 80 mg
tablets:
Gliclazide 80 mg tablets 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 80 mg tablets.
A transitional period is not generally necessary. A starting dose of
40-80 mg
(½ to 1 tablet) 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 80 mg tablets can be given in combination with biguanides,
alpha
glucosidase inhibitors or insulin.
In
pat