GLUCOMIN

Country: Israel

Bahasa: Inggeris

Sumber: Ministry of Health

Bahan aktif:

METFORMIN HYDROCHLORIDE

Boleh didapati daripada:

DEXCEL LTD, ISRAEL

Kod ATC:

A10BA02

Borang farmaseutikal:

CAPLETS

Komposisi:

METFORMIN HYDROCHLORIDE 850 MG

Laluan pentadbiran:

PER OS

Jenis preskripsi:

Required

Dikeluarkan oleh:

DEXCEL LTD, ISRAEL

Kumpulan terapeutik:

METFORMIN

Kawasan terapeutik:

METFORMIN

Tanda-tanda terapeutik:

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.

Tarikh kebenaran:

2023-09-30

Risalah maklumat

PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS’ REGULATIONS
(PREPARATIONS)
– 1986
This medicine can be sold without a physician’s prescription
GLUCOMIN® 850 MG, CAPLETS
Each caplet contains 850 mg metformin hydrochloride.
Inactive ingredients and allergens in the medicine - see section 6
"Additional information'.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. This leaflet
contains concise information about the medicine. 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 you think that their medical condition is the same as yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for the treatment of type 2 diabetes
mellitus, particularly in
overweight patients, when change in diet and exercise alone are not
sufficient to stabilize
blood glucose levels.

In adults, GLUCOMIN is indicated as monotherapy or in combination with
other oral
medicines for the treatment of diabetes or with insulin.

In children from 10 years of age and adolescents, GLUCOMIN is
indicated as monotherapy
or in combination with insulin.
A reduction of diabetic complications has been shown in overweight
adult patients with type
2 diabetes who were treated with metformin as first-line therapy after
diet failure.
THERAPEUTIC GROUP: Medicines to lower blood glucose levels. The active
ingredient is part of
the biguanide group.
Insulin is a hormone produced by the pancreas, that causes the body to
absorb glucose
(sugar) from the blood. Your body uses glucose to create energy or
stores it for future use.
If you have diabetes, your pancreas does not produce enough insulin or
your body is unable
to properly use the insulin produced by it. This causes a high blood
level of glucose.
GLUCOMIN helps to reduce the blood level of glucose to as normal as
possible.
If you are an adult with excess weight, taking GLUCOMIN long term
helps to reduce the risk of
complications associated with diabetes

Ciri produk

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