Prucalopride Aristo 1 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Prucalopride Succinate

Available from:

Aristo Pharma GmbH

ATC code:

A06AX05

INN (International Name):

Prucalopride Succinate

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

prucalopride

Authorization status:

Marketed

Authorization date:

2021-11-05

Patient Information leaflet

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

Summary of Product characteristics

Health Products Regulatory Authority
12 July 2023
CRN00DD2M
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prucalopride Aristo 1 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains prucalopride succinate equivalent to 1 mg
prucalopride.
Excipients with known effect
Each 1 mg film-coated tablet contains 136 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets
White to off-white, 8.2 mm diameter, round film-coated tablets
debossed with 'S30' on one side and plain on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prucalopride 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 m2) 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-