Prucalopride Medichem 2mg film-coated Tablets

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

PRUCALOPRIDE SUCCINATE

Tillgänglig från:

Medichem, S.A. Fructuós Gelabert 6-8, 08970, Sant Joan Despí, (Barcellona), Spain

ATC-kod:

A06AX05

INN (International namn):

PRUCALOPRIDE SUCCINATE 2 mg

Läkemedelsform:

FILM-COATED TABLET

Sammansättning:

PRUCALOPRIDE SUCCINATE 2 mg

Receptbelagda typ:

POM

Terapiområde:

DRUGS FOR CONSTIPATION

Produktsammanfattning:

Licence number in the source country: NOT APPLICAPABLE

Bemyndigande status:

Authorised

Tillstånd datum:

2020-01-14

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PRUCALOPRIDE MEDICHEM 1 MG FILM-COATED TABLETS
PRUCALOPRIDE MEDICHEM 2 MG FILM-COATED TABLETS
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 Prucalopride Medichem is and what it is used for
2.
What you need to know before you take Prucalopride Medichem
3.
How to take Prucalopride Medichem
4.
Possible side effects
5.
How to store Prucalopride Medichem
6.
Contents of the pack and other information
1.
WHAT PRUCALOPRIDE MEDICHEM IS AND WHAT IT IS USED FOR
Prucalopride Medichem contains the active substance prucalopride.
Prucalopride Medichem 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. Prucalopride 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 PRUCALOPRIDE MEDICHEM
DO NOT TAKE PRUCALOPRIDE MEDICHEM:
-
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 before taking Prucalopride Medichem.
Take special care with Prucalopride Medichem and

Produktens egenskaper

Page 1 of 10
1.
NAME OF THE MEDICINAL PRODUCT
Prucalopride Medichem 2 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2 mg prucalopride (as succinate).
Excipients with known effect. Each film-coated tablet contains 165.5
mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, round biconvex, film-coated tablets embossed with “P2” on
one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prucalopride Medichem 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 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_
: The dose for patients with severe renal impairment
(GFR < 30 ml/min/1.73 m
2
) is 1 mg once daily (see sections 4.3 and 5.2). No dose adjustment is
required for patients with mild to moderate renal impairment.
Page 2 of 10
_Patients with hepatic impairment_
: Patients with severe hepatic impairment (Child-Pugh class C)
start
with 1 mg once daily which may be increased to 2 mg if required to
improve efficacy and if
the 1 mg dose