Prucalopride Holsten 1 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PRUCALOPRIDE SUCCINATE

Available from:

Holsten Pharma GmbH Hahnstraße 31-35 60528 Frankfurt am Main , Germany

ATC code:

A06AX05

INN (International Name):

PRUCALOPRIDE SUCCINATE 1 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

PRUCALOPRIDE SUCCINATE 1 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR CONSTIPATION

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Withdrawn

Authorization date:

2022-02-11

Patient Information leaflet

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

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Prucalopride Holsten 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 Holsten 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 3 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.
2
_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 tol