Metformine HCl/Glibenclamide Sandoz 500/2,5 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

GLIBENCLAMIDE ; METFORMINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; METFORMINE

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

A10BD02

INN (Algemene Internationale Benaming):

GLIBENCLAMIDE ; METFORMINEHYDROCHLORIDE COMPOSITION corresponding to ; METFORMIN

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; IJZEROXIDE BRUIN (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 25 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Metformin and sulfonylureas

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROLOSE (E 463); HYPROMELLOSE (E 464); IJZEROXIDE BRUIN (E 172); MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); POVIDON K 25 (E 1201); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2009-11-16

Bijsluiter

Sandoz B.V.
Page 1
Metformine HCl/Glibenclamide Sandoz 500/2,5 en 500/5 mg
1313-v6
1.3.1.3. Bijsluiter
Juni 2019
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
METFORMINE HCL/GLIBENCLAMIDE SANDOZ
® 500/2,5 MG, FILMOMHULDE TABLETTEN
METFORMINE HCL/GLIBENCLAMIDE SANDOZ
® 500/5 MG, FILMOMHULDE TABLETTEN
metformin hydrochloride and glibenclamide
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 [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] contains two antidiabetic medicines,
belonging to groups of medicines
called biguanides (metformin hydrochloride) and sulphonylureas
(glibenclamide).
Insulin is a hormone that enables body tissues to take up glucose
(sugar) from the blood and to use it
for producing energy or to store it for future use. Patients with type
2 diabetes mellitus (i.e. non-
insulin dependent diabetes) do not produce enough insulin in their
pancreas or their body does not
respond properly to the insulin it produces. This causes an increased
level of glucose in the blood.
This medicine helps to reduce their blood sugar towards a normal
level.
[NATIONALLY COMPLETED NAME] IS USED FOR THE ORAL TREATMENT OF TYPE 2
DIABETES MELLITUS IN ADULT
PATIENTS.
You have rece

Productkenmerken

Sandoz B.V.
Page 1
Metformine HCl/Glibenclamide Sandoz 500/2,5mg en
500/5 mg, filmomhulde tabletten
1311-v6
1.3.1.1. Samenvatting van de Productkenmerken
Juni 2019
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Metformine HCl/Glibenclamide Sandoz 500/2,5 mg, filmomhulde tabletten
Metformine HCl/Glibenclamide Sandoz 500/5 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg metformin hydrochloride,
equivalent to 390 mg metformin,
and 2.5 mg glibenclamide.
Each film-coated tablet contains 500 mg metformin hydrochloride,
equivalent to 390 mg metformin,
and 5 mg glibenclamide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
[Nationally completed name] 500mg/2.5mg film-coated tablet is an
almost white, oval, biconvex film-
coated tablet.
[Nationally completed name] 500mg/5mg film-coated tablet is a dark
pink, oval, biconvex film-coated
tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment
of
type 2
diabetes
in
adults,
as
replacement
for
previous
combination
therapy
with
metformin and glibenclamide in patients whose glycaemia is stable and
well-controlled.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Oral route.
For use in adults only.
_Adults with normal renal function (GFR≥ 90 mL/min)_
As for all hypoglycaemic agents, the dosage should be adapted
according to the individual metabolic
response (glycaemia, HbA1c).
[Nationally completed name, 500mg/5mg, film-coated tablets]:
Sandoz B.V.
Page 2
Metformine HCl/Glibenclamide Sandoz 500/2,5mg en
500/5 mg, filmomhulde tabletten
1311-v6
1.3.1.1. Samenvatting van de Productkenmerken
Juni 2019
[Nationally completed name, 500mg/5mg, film-coated tablets] should
preferably be used in patients
who cannot be sufficiently controlled with [Nationally completed name,
500mg/2,5mg, film-coated
tablets]
INITIATION OF TREATMENT:
Treatment should be initiated with a dose of the combination product
equivalent to previous individual
doses of metfor