Gliclazide 160mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Gliclazide

זמין מ:

Zentiva Pharma UK Ltd

קוד ATC:

A10BB09

INN (שם בינלאומי):

Gliclazide

כמות:

160mg

טופס פרצבטיות:

Oral tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 06010201; GTIN: 8594739261624

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GLICLAZIDE 160 MG TABLETS
gliclazide
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 heartbeat 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.
Symptoms 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 (e.g. those acting on the central
nervous system and beta blockers).
If you are in stress-situations (e.g. accidents, surgical operations,
fever etc.) your doctor may temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia) 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,
if you take St John’s Wort (
_Hypercium perforatum_
) preparations (see
section
OTHER MEDICINE AND GLICLAZIDE TABLETS
) or in special stress
situations. These may include thirst, frequent urination, dry mouth,
dry itchy skin, skin infections and reduced performance.
If these symptoms occur, you must contact your doctor, pharmacist
or nurse.
While taking Gliclazide tablets you should:
•
Follow a regular diet: it is important to eat regular meals, including
breakfast and never to miss or delay a meal
•
Take your medicine regularly (see
HOW TO TAKE GLICLAZIDE TABLETS
)
•
Check your blood glucose regularly as recommended by your doctor
Blood glucose disturbance (low blood sugar

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Gliclazide 160 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each uncoated tablet contains 160 mg Gliclazide.
Excipient with known effect: Each uncoated tablet contains 77 mg of
lactose
monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Gliclazide tablets are 12.5mm X 7.2mm, White to off-white, flat-faced,
oval-shaped,
beveled-edged, uncoated tablet, debossed “160” on one side and
score line on the
other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide
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
For oral 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 and increasing until adequate control is achieved. A single dose
should not
exceed 160 mg (1 tablet). 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 tablets
Gliclazide 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 tablets.
A transitional period is not generally necessary. A starting dose of
40-80 mg 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 necessa