Stercore 2 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

PRUCALOPRIDESUCCINAAT 2,6 mg/stuk SAMENSTELLING overeenkomend met ; PRUCALOPRIDE 2 mg/stuk

INN (Algemene Internationale Benaming):

PRUCALOPRIDESUCCINAAT 2,6 mg/stuk SAMENSTELLING overeenkomend met ; PRUCALOPRIDE 2 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
STERCORE1 MG
filmomhulde tabletten
STERCORE 2 MG
filmomhulde tabletten
prucalopride
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 Stercore is and what it is used for
2.
What you need to know before you take Stercore
3.
How to take Stercore
4.
Possible side effects
5.
How to store Stercore
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
Stercore contains the active substance prucalopride. Prucalopride
belongs to a group of gut motility
enhancing medicines (gastrointestinal prokinetics). It acts on the
muscle wall of the gut, helping to
restore the normal functioning of the bowel.
Stercore is used for the treatment of chronic constipation in adults
in whom laxatives do not work well
enough.
Not for use in children and adolescents younger than 18 years.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE STERCORE
DO NOT TAKE STERCORE
-
if you are allergic to prucalopride or any of the other ingredients of
this medicine (listed in section
6).
-
if you are on renal dialysis.
-
if you suffer from perforation or obstruction of the gut wall, severe
inflammation of the intestinal
tract, such as Crohn’s disease, ulcerative colitis or toxic
megacolon/megarectum.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Stercore
-
if you suffer from severe kidney disease.
-
if you suffer from severe liver disease.
-
if you are currently under supervision by a doctor for a serious
medical probl

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Stercore1 mg filmomhulde tabletten
Stercore 2 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains either 1 mg or 2 mg prucalopride (as
succinate).
Excipient with known effect: lactose.
Each tablet of 1 mg contains 78.02 mg lactose monohydrate.
Each tablet of 2 mg contains 156.012 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
1 mg: White, round, bioconvex, film-coated tablets embossed ‘10’
on one side, plain on the other side,
with diameter of nucleus 6 mm.
2 mg:
Pink, round, bioconvex, film-coated tablets embossed ‘20’ on one
side, plain on the other side,
with diameter of nucleus 8 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Stercore is indicated for symptomatic treatment of chronic
constipation in adults in whom laxatives
fail to provide adequate relief.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
2 mg once daily with or without food, at any time of the day.
Due to the specific mode of action of prucalopride (stimulation of
propulsive motility), exceeding the
daily dose of 2 mg is not expected to increase efficacy.
If the intake of once daily prucalopride is not effective after 4
weeks of treatment, the patient should
be re-examined and the benefit of continuing treatment reconsidered.
The efficacy of prucalopride has been established in double-blind,
placebo-controlled studies for up to
3 months. Efficacy beyond three months has not been demonstrated in
placebo-controlled studies (see
section 5.1). In case of prolonged treatment, the benefit should be
reassessed at regular intervals.
_Special populations _
_Older people (>65 years) _
Start with 1 mg once daily (see section 5.2); if needed the dose can
be increased to 2 mg once daily.
_Patients with renal impairment _
2
The dose for patients with severe renal impairment (GFR <30
ml/min/1.73 m2) is 1 mg once daily (see
sections 4.3 and 5.2). No