Metformin Bluefish 1000 mg, film-coated tablets

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Metformin Hydrochloride

متاح من:

Bluefish Pharmaceuticals AB

ATC رمز:

A10BA; A10BA02

INN (الاسم الدولي):

Metformin Hydrochloride

جرعة:

1000 milligram(s)

الشكل الصيدلاني:

Film-coated tablet

نوع الوصفة الطبية :

Product subject to prescription which may be renewed (B)

المجال العلاجي:

Biguanides; metformin

الوضع إذن:

Marketed

تاريخ الترخيص:

2009-03-27

نشرة المعلومات

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
METFORMIN BLUEFISH 500 MG/ 850 MG/ 1000 MG FILM-COATED 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 Metformin Bluefish is and what it is used for
2.
What you need to know before you take Metformin Bluefish
3.
How to take Metformin Bluefish
4.
Possible side effects
5.
How to store Metformin Bluefish
6.
Contents of the pack and further information
1.
WHAT METFORMIN BLUEFISH IS AND WHAT IT IS USED FOR
Metformin Bluefish contains metformin
,
a medicine to treat diabetes. It belongs to a group of
medicines called biguanides.
Insulin is a hormone produced by the pancreasthat makes your body take
in glucose (sugar) from the
blood. Your body uses glucose to produce energy or stores it for
future use.
If you have diabetes, your pancreas does not make enough insulin or
your body is not able to use
properly the insulin it produces. This leads to a high level of
glucose in your blood. Metformin
Bluefish helps to lower your blood glucose to as normal a level as
possible.
If you are an overweight adult, taking Metformin Bluefish over a long
period of time also helps to
lower the risk of complications associated with diabetes. Metformin
Bluefish is associated with either
a stable body weight or modest weight loss.
Metformin Bluefish is used to treat patients with type 2 diabetes
(also called 'non-insulin dependent
diabetes') when diet and exercise alone have not been enough to
control your blood glucose levels. It is
used particular

خصائص المنتج

Health Products Regulatory Authority
25 January 2024
CRN00DS9H
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Metformin Bluefish 1000 mg, film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1000 mg metformin hydrochloride
corresponding to 780 mg metformin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, oval, biconvex, film-coated tablets dimensions of 19.2 x 9.2
mm, with ‘A’ debossed on one side and ‘62’ debossed on the
other side. The score line is not intended for breaking the tablet.
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, Metformin Bluefish film-coated tablets 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, Metformin Bluefish
film-coated tablets 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 (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 ANTIDIABETIC AGENTS:
The usual starting dose is 500mg or 850mg 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.
In patients receiving a high metformin hydrochloride dose (2 to 3
grams per day), it is possible to replace two Metformin HCl
Bluefish 500 mg film-coated tablets with one Metformin HCl Bluefish
1000 mg film-coated tablet.
The maximum recommended dose of metformin hydrochlo