GLUCOMIN

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

METFORMIN HYDROCHLORIDE

متاح من:

DEXCEL LTD, ISRAEL

ATC رمز:

A10BA02

الشكل الصيدلاني:

CAPLETS

تركيب:

METFORMIN HYDROCHLORIDE 850 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

DEXCEL LTD, ISRAEL

المجال العلاجي:

METFORMIN

الخصائص العلاجية:

Treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control.• In adults, Glucomin may be used as monotherapy or in combination with other oral anti-diabetic agents or with insulin.• In children from 10 years of age and adolescents, Glucomin may be used as monotherapy or in combination with insulin.A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with metformin as first-line therapy after diet failure.

تاريخ الترخيص:

2015-01-26

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Glucomin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each caplet contains 850 mg metformin hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Caplet.
White caplets, scored on both sides.
The caplet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of type 2 diabetes mellitus, particularly in overweight
patients, when dietary management and exercise alone
does not result in adequate glycaemic control.
• In adults, Glucomin may be used as monotherapy or in combination
with other oral antidiabetic agents or with
insulin.
• In children from 10 years of age and adolescents, Glucomin may be
used as monotherapy or in combination with
insulin.
A reduction of diabetic complications has been shown in overweight
type 2 diabetic adult patients treated with metformin
as first-line therapy after diet failure.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Glucomin can be halved. There is no information regarding crushing or
chewing of the caplets. The caplets are coated to
avoid the bitter taste of the medicine.
In case of need, the medicine can be divided to halves (425 mg). A
dose of 425 mg can be an alternative to a 500
_ _
mg dose.
_ _
_Posology _
_ _
_Adults with normal renal function (GFR≥ 90 mL/min) _
MONOTHERAPY AND COMBINATION WITH OTHER ORAL ANTIDIABETIC AGENTS
The usual starting dose is 500 mg or 850 mg metformin hydrochloride 2
or 3 times daily given during or after meals.
After 10 to 15 days the dose should be adjusted on the basis of blood
glucose measurements. A slow increase of dose
may improve gastrointestinal tolerability.
The maximum recommended dose of metformin hydrochloride is 2550 mg
daily, taken as 3 divided doses.
If transfer from another oral antidiabetic agent is intended:
discontinue the other agent and initiate metformin at the dose
indicated above.
COMBINATION WITH INSULIN
Metformin and insulin may be used in combination therapy to achieve
better bl