Prucalopride Dexcel 2mg film-coated Tablets

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

PRUCALOPRIDE SUCCINATE

Tilgængelig fra:

Dexcel Pharma GmbH Carl-Zeiss-Straße 2 63755 Alzenau, Germany

ATC-kode:

A06AX05

INN (International Name):

PRUCALOPRIDE SUCCINATE 2 mg

Lægemiddelform:

FILM-COATED TABLET

Sammensætning:

PRUCALOPRIDE SUCCINATE 2 mg

Recept type:

POM

Terapeutisk område:

DRUGS FOR CONSTIPATION

Produkt oversigt:

Licence number in the source country: NOT APPLICAPABLE

Autorisation status:

Authorised

Autorisation dato:

2020-01-14

Indlægsseddel

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

Produktets egenskaber

1
1.
NAME OF THE MEDICINAL PRODUCT
Prucalopride Dexcel 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 Dexcel 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 4.4 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 tolerated (see secti