Resolor

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Prucalopride succinate

Available from:

Takeda Pharmaceuticals International AG Ireland

ATC code:

A06AX05

INN (International Name):

prucalopride

Therapeutic group:

Other drugs for constipation

Therapeutic area:

Constipation

Therapeutic indications:

Resolor is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.

Product summary:

Revision: 29

Authorization status:

Authorised

Authorization date:

2009-10-14

Patient Information leaflet

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE USER
RESOLOR 1 MG FILM-COATED TABLETS
RESOLOR 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 Resolor is and what it is used for
2.
What you need to know before you take Resolor
3.
How to take Resolor
4.
Possible side effects
5.
How to store Resolor
6.
Contents of the pack and other information
1.
WHAT RESOLOR IS AND WHAT IT IS USED FOR
Resolor contains the active substance prucalopride.
Resolor 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. Resolor 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 RESOLOR
DO NOT TAKE RESOLOR:
-
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 Resolor.
Take special care with Resolor and tell your doctor if you:
-
suffer from severe kidney disease,
-
suffer from severe liver disease,
-
are currently under supervision by a doctor for a serious medic

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Resolor 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 142.5
mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
White to off-white, round, biconvex tablets marked “PRU 1” on one
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Resolor 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