Ziclaseg 30mg modified-release tablets

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Gliclazide

제공처:

Lupin Healthcare (UK) Ltd

ATC 코드:

A10BB09

INN (International Name):

Gliclazide

복용량:

30mg

약제 형태:

Modified-release tablet

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 06010201; GTIN: 8901107021597 8901107023126

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZICLASEG 30MG PROLONGED RELEASE TABLET
GLICLAZIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again
-
If you have any further questions, ask your doctor or pharmacist
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Ziclaseg Tablets are and what they are used for
2.
What you need to know before you take Ziclaseg Tablets
3.
How to take
_ _
Ziclaseg Tablets
4.
Possible side effects
5.
How to store Ziclaseg Tablets
6.
Contents of the pack and other information
1.
WHAT ZICLASEG TABLETS ARE AND WHAT THEY ARE USED FOR
Gliclazide-Lupin 30mg prolonged-release tablet.
Each tablet contains 30 mg Gliclazide.
Pharmacotherapeutic group: Sulfonamides, urea derivatives, ATC code:
A10BB09
Ziclaseg is a medicine which
REDUCES BLOOD SUGAR LEVELS
(oral antidiabetic medicine
belonging to the sulphonylurea group).
Ziclaseg 30mg prolonged release tablets are used to keep blood sugar
at the correct level in
adults with
DIABETES
(type 2 diabetes mellitus)
when it is not controlled by dietary measures,
physical exercise and weight loss alone.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZICLASEG TABLETS
DO NOT TAKE ZICLASEG 30MG PROLONGED RELEASE TABLETS:

if you are ALLERGIC
(hypersensitive)
TO GLICLAZIDE
or any of the other ingredients in this
medicine (see section 6,“Further Information”) or to any other
medicines of the same
group (sulphonylureas or sulphonamides).

if you have insulin-dependent (Type 1)
DIABETES;

if you have ketone bodies and sugar in your urine (this may mean you
have
DIABETIC
KETO-ACIDOSIS
), diabetic pre-coma or coma

if you have
SEVERE KIDNEY OR LIVER DISEASE;
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제품 특성 요약

OBJECT 1
ZICLASEG 30MG PROLONGED-RELEASE TABLETS.
Summary of Product Characteristics Updated 17-Aug-2016 | Lupin
Healthcare (UK) Ltd
1. Name of the medicinal product
Ziclaseg 30mg prolonged-release tablet.
2. Qualitative and quantitative composition
Each tablet contains 30mg gliclazide.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet.
White to off-white capsule shaped, biconvex tablet debossed with
“30“ on one side, and plain on the
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
Adults:
The daily dose may vary from 1 to 4 tablets per day i.e 30 “ 120mg
taken orally in a single intake at
breakfast time.
It is recommended that the tablet(s) are swallowed whole without
chewing.
If a dose is forgotten, there must be no increase in the dose taken
the next day.
As with any hypoglycaemic agent, the dose should be adjusted according
to the individual patients
metabolic response (blood glucose, HbAlc).
Initial Dose:
The recommended starting dose is 30mg daily.
If blood glucose is effectively controlled, this dose may be used for
maintenance treatment.
If blood glucose is not adequately controlled, the dose may be
increase to 60, 90 or 120mg daily, in
successive steps. The interval between each dose increment should be
at least 1 month except in patients
whose blood glucose has not reduced after two weeks of treatment. In
such cases, the dose may be
increased at the end of the second week of treatment.
The maximum recommended daily dose is 120mg.
_Switching from Gliclazide 80mg tablets to Ziclaseg 30mg prolonged
release tablets:_
1 tablet of Gliclazide 80mg is comparable to 1 tablet of Ziclaseg 30mg
prolonged release tablets.
Consequently the switch can be performed provided a careful blood
monitoring.
_Switching from another oral antidiabetic agent t