Zexitor 500mg prolonged release tablets

国家: 马耳他

语言: 英文

来源: Medicines Authority

可用日期:

Novatin Limited 230, second floor, Eucharistic Congress Road, Mosta MT 9039 , Malta

ATC代码:

A10BA02

INN（国际名称）:

METFORMIN HYDROCHLORIDE 500 mg

药物剂型:

PROLONGED-RELEASE TABLET

组成:

METFORMIN HYDROCHLORIDE 500 mg

处方类型:

POM

治疗领域:

DRUGS USED IN DIABETES

授权状态:

Authorised

授权日期:

2023-12-22

资料单张

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
ZEXITOR 500 MG, 750 MG, 1000 MG PROLONGED RELEASE TABLETS
metformin hydrochloride
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 only. 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 Zexitor is and what it is used for
2.
What you need to know before you take Zexitor
3.
How to take Zexitor
4.
Possible side effects
5.
How to store Zexitor
6.
Contents of the pack and other information
1.
WHAT ZEXITOR IS AND WHAT IT IS USED FOR
Zexitor contains the active ingredient metformin hydrochloride and
belong to a group of medicines called
biguanides, used in the treatment of diabetes.
Zexitor is used for the treatment of Type 2 (also known as non-insulin
dependent) diabetes mellitus in
adults when diet and exercise changes alone have not been enough to
control blood glucose (sugar).
Insulin is a hormone that enables body tissues to take glucose from
the blood and to use it for energy
or for storage for future use. People with Type 2 diabetes do not make
enough insulin in their pancreas
or their body does not respond properly to the insulin it does make.
This causes a build-up of glucose
in the blood which can cause a number of serious long-term problems so
it is important that you
continue to take your medicine, even though you may not have any
obvious symptoms. Zexitor makes
the body more sensitive to insulin and helps return to normal the way
your body uses glucose.
Zexitor is associated with either a stable body weight or modest
weight loss.
Zexitor is specially made to rele

产品特点

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Zexitor 500 mg prolonged release tablets
Zexitor 750 mg prolonged release tablets
Zexitor 1000 mg prolonged release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release tablet contains 500 mg metformin hydrochloride
corresponding to 390 mg
metformin base.
Each prolonged release tablet contains 750 mg metformin hydrochloride
corresponding to 585 mg
metformin base.
Each prolonged release tablet contains 1000 mg metformin hydrochloride
corresponding to 780 mg
metformin base.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged release tablet.
Zexitor 500 mg prolonged release tablets are white to off-white,
capsule shaped uncoated
tablets, 16.50 mm in length, 8.20 mm in width, debossed with 'XR500'
on one side and plain on
the other side.
Zexitor 750 mg prolonged release tablets are white to off-white,
capsule shaped, uncoated
tablets, 19.60 mm in length, 9.30 mm in width, debossed with 'XR 750'
on one side and plain on
the other side
Zexitor 1000 mg prolonged release tablets are white to off-white,
capsule shaped, uncoated
tablets, 21.10 mm in length, 10.10 mm in width, debossed with 'XR
1000' on one side and plain
on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of type 2 diabetes mellitus in adults, particularly in
overweight patients, when dietary
management and exercise alone does not result in adequate glycaemic
control. Metformin
prolonged release tablets may be used as monotherapy or in combination
with other oral
antidiabetic agents, or with insulin.
For study results with respect to effects on glycaemic control and
diabetic complications, see
section 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults with normal renal function (GFR ≥ 90 ml/min) _
_ _
_Monotherapy and combination with other oral anti-diabetic agents _
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The usual starting dose is one Zexitor 500 mg prolonged release tablet
once daily, taken