Gliclazide 80mg tablets

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Gliclazide

Tersedia dari:

Bristol Laboratories Ltd

Kode ATC:

A10BB09

INN (Nama Internasional):

Gliclazide

Dosis:

80mg

Bentuk farmasi:

Oral tablet

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 06010201; GTIN: 5060013941894 5060013941900

Selebaran informasi

SAME SIZE ARTWORK
430 x 140 mm
Front
430 mm
140 mm
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,
-
you are malnourished,
you change your diet,
-
you increase your physical activity and carbohydrate intake does not
match this increase,
-
you drink alcohol, especially in combination with skipped meals,
-
you take high doses of gliclazide,
-
you suffer from particular hormone-induced disorders (functional
disorders of the thyroid gland, of the
pituitary gland or adrenal cortex),
-
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
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

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gliclazide 80mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80mg of Gliclazide
Excipient with known effect: 110mg of Lactose Monohydrate
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 “80” on one
side and a breakline on the 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 - 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
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:
Gliclazide 80 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 80 mg.
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 can be given in combination with biguanides, alpha
glucosidas