Prucalopride Medichem 1mg film-coated Tablets

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

PRUCALOPRIDE SUCCINATE

Dostępny od:

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

Kod ATC:

A06AX05

INN (International Nazwa):

PRUCALOPRIDE SUCCINATE 1 mg

Forma farmaceutyczna:

FILM-COATED TABLET

Skład:

PRUCALOPRIDE SUCCINATE 1 mg

Typ recepty:

POM

Dziedzina terapeutyczna:

DRUGS FOR CONSTIPATION

Podsumowanie produktu:

Licence number in the source country: NOT APPLICAPABLE

Status autoryzacji:

Authorised

Data autoryzacji:

2020-01-14

Ulotka dla pacjenta

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

Charakterystyka produktu

1.
NAME OF THE MEDICINAL PRODUCT
Prucalopride Medichem 1 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 mg prucalopride (as succinate).
Excipients
with
known
effect:
Each
film-coated
tablet
contains
150
mg
lactose
(as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, round biconvex, film-coated tablets embossed with
“P1” 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 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_
: 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.
_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 is well