Metformine HCl CF 1000 mg, filmomhulde tabletten

Land: Holland

Tungumál: hollenska

Heimild: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Virkt innihaldsefni:

METFORMINEHYDROCHLORIDE 1000 mg/stuk SAMENSTELLING overeenkomend met ; METFORMINE 779,9 mg/stuk

INN (Alþjóðlegt nafn):

METFORMINEHYDROCHLORIDE 1000 mg/stuk SAMENSTELLING overeenkomend met ; METFORMINE 779,9 mg/stuk

Lyfjaform:

Filmomhulde tablet

Samsetning:

HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; POVIDON K 90 (E 1201) ; TITAANDIOXIDE (E 171)

Stjórnsýsluleið:

Oraal gebruik

Leyfisdagur:

2023-04-20

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
METFORMINE HCL CF 1000 MG, FILMOMHULDE TABLETTEN
metforminehydrochloride
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 is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1. WHAT IS AND WHAT IT IS USED FOR
tablets contain the active ingredient metformin, a
medicine to treat diabetes.
It belongs to a group of medicines called biguanides.
Insulin is a hormone produced by the pancreas that enables your body
to 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.
helps to lower your blood glucose to as normal a level
as possible.
If you are an overweight adult, taking over a long
period of time also helps to
lower the risk of complications associated with diabetes. is associated with
either a stable body weight or modest weight loss.
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 particularly in overw

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SUMMARY OF THE PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Metformine HCl CF 1000 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 000 mg film-coated tablets
Each film-coated tablet contains 1 000 mg metformin hydrochloride
corresponding to 780 mg
metformin base.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
1 000 mg film-coated tablets
White to off white, oval, biconvex, film-coated tablets debossed with
“003” on one side and
“1000” on the other side and with a bisect line on both sides. The
tablet can be divided into
equal doses. Approximate dimension of the tablets are 19 mm length and
10 mm width.
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, 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, 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 hydrochloride 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 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.
1 000 mg film-coated tablets
In patients receiving a high metformin hydrochloride dose (2 to 3
grams per day), it is possible
to replace two 500 mg film-coated tablets with one 1 000 m