Gliclazide 80mg tablets

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Gliclazide

Disponibbli minn:

Noumed Life Sciences Ltd

Kodiċi ATC:

A10BB09

INN (Isem Internazzjonali):

Gliclazide

Dożaġġ:

80mg

Għamla farmaċewtika:

Oral tablet

Rotta amministrattiva:

Oral

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 06010201; GTIN: 05060453460221 05060453465035

Fuljett ta 'informazzjoni

PREGNANCY AND BREAST-FEEDING
Gliclazide Tablets are not recommended for use during pregnancy. If
you are pregnant or
breastfeeding, think you may be pregnant or are planning to have a
baby while taking this
medicine, inform your doctor so that he may prescribe a more suitable
treatment for you.
You must not take Gliclazide Tablets while you are breastfeeding.
DRIVING AND USING MACHINES
Provided your blood glucose levels are satisfactorily controlled on
this medicine, your
ability to drive or use machines should not be affected. However, if
your blood glucose
levels become too low, this could adversely affect your concentration,
and therefore your
ability to perform these tasks.
ASK YOUR DOCTOR WHETHER YOU CAN DRIVE A CAR IF YOU:
•
have frequent episodes of low blood sugar (hypoglycaemia),
•
have few or no warning signals of low blood sugar (hypoglycaemia).
GLICLAZIDE TABLETS CONTAIN LACTOSE
If you have been told by your doctor that you have an intolerance to
some sugars contact
your doctor before taking this medicinal product
3. HOW TO TAKE GLICLAZIDE TABLETS
Always take this medicine exactly as your doctor has told you. Check
with your doctor or
pharmacist if you are not sure.
Change in external factors (e.g. weight reduction, change in life
style, stress) or
improvements in the blood sugar control may require changed gliclazide
doses.
The recommended dose is
ADULTS AND ELDERLY: The usual starting dose is 40 to 80mg (½ or 1
tablet) daily, adjusted
according to your response, up to a maximum of 320mg (four tablets)
daily. Up to 160mg
(two tablets) can be taken at one time.
Your starting dose will be reduced if you are elderly or have liver or
kidney problems.
If a combination therapy of gliclazide with metformin, an alpha
glucosidase inhibitor, a
thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1
receptor agonist or insulin is
initiated your doctor will determine the proper dose of each medicine
individually for you. If
you notice that your blood sugar levels are high although you are
taking the

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gliclazide 80mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITIONS:
Each tablet contains 80mg Gliclazide
Excipient with known effect: Lactose
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.
The tablet can be divided into equal doses.
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