Resolor Film-coated Tablet 2 mg

Pays: Singapour

Langue: anglais

Source: HSA (Health Sciences Authority)

Ingrédients actifs:

Prucalopride succinate 2.642mg eqv Prucalopride

Disponible depuis:

DCH AURIGA SINGAPORE

Code ATC:

A03AE04

Dosage:

2mg

forme pharmaceutique:

TABLET, FILM COATED

Composition:

Prucalopride succinate 2.642mg eqv Prucalopride 2mg

Mode d'administration:

ORAL

Type d'ordonnance:

Prescription Only

Fabriqué par:

Janssen Cilag S.p.A.

Statut de autorisation:

ACTIVE

Date de l'autorisation:

2012-02-14

Notice patient

PRODUCT NAME 
RESOLOR
®
 Film-coated tablets 

DOSAGE FORMS AND STRENGTHS 
Film-coated tablet 
- 
1 mg: white to off-white, round, biconvex tablets marked
“PRU 1” on one side 
(equivalent to 1.321 mg prucalopride succinate) 
- 
2 mg: pink, round, biconvex tablets marked  “PRU 2” on
one side  (equivalent to 
2.642 mg prucalopride succinate) 

For excipients, see _List of Excipients_. 

CLINICAL INFORMATION 
INDICATIONS 
RESOLOR
®
 is indicated for symptomatic treatment
of chronic constipation in adults in whom 
laxatives fail to provide adequate relief. 

DOSAGE AND ADMINISTRATION 
DOSAGE 
_ADULTS _
2 mg once daily 

_ELDERLY (> 65 YEARS) _
Start with 1 mg once daily (see _Pharmacokinetic
Properties_); if needed the dose can be 
increased to 2 mg once daily. 

_CHILDREN AND ADOLESCENTS _
RESOLOR
®
  is not recommended in children and adolescents younger than
18 years  (see 
_Pediatric Population_ and _Clinical Studies_). 

_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 _Contraindications_  and  _Pharmacokinetic Properties_).
No dose adjustment is 
required for patients with mild to moderate renal impairment. 

_PATIENTS WITH HEPATIC IMPAIRMENT _
The dose for patients with
severe hepatic impairment (Child-Pugh class C) is 1 mg once
daily 
(see  _Warnings  and_  _Precautions  _and  _Pharmacokinetic Properties_).
No dose adjustment is 
required for patients with mild to moderate hepatic impairment. 

Due to the specific mode of action of prucalopride (stimulation
of propulsive motility) 
exceeding the daily dose of 2mg is not expected to increase
in efficacy. It has also been 
shown in clinical trials, a doubling of the daily dose to
4mg did not lead to an  increase  in 
efficacy. 

If

Résumé des caractéristiques du produit

160 mm
800 mm
PAGE 1 OF 2
Dimension:
800 x 160 mm
PCC:
768885
Template Ref. Name:
I/I/016/V2-(800x160)
Pharma Code
(Mat. ID Code):
3949
Print Colours:
Black
Non-Print Colours:
Cutter
Min. Font Size:
9 pt
AMS Component No.:
AW-LF-0000542
(V0.3)
Product Description:
RESOLOR 1MG
28 TABL.
SING.,RESOLOR
2MG 28 TABL.
SING.
Component:
Leaflet
Product Code:
105263,105264
Country:
Singapore, Brunei
Vendor Name:
JANSSEN
PHARMACEUTICA
NV, BELGIUM
PROOF NUMBER:
0.3
Revision Date:
12-Dec-2023
Revised by:
DAJ
PRODUCT NAME
RESOLOR
®
Film-coated tablets
DOSAGE FORMS AND STRENGTHS
Film-coated tablet
-
1
mg
prucalopride:
white
to
off-white,
round, biconvex tablets marked “PRU 1”
on
one
side
(equivalent
to
1.321
mg
prucalopride succinate)
-
2 mg prucalopride: pink, round, biconvex
tablets
marked
“PRU
2”
on
one
side
(equivalent
to
2.642
mg
prucalopride
succinate)
For excipients, see _List of Excipients_.
CLINICAL INFORMATION
INDICATIONS
RESOLOR
®
is
indicated
for
symptomatic
treatment of chronic idiopathic constipation
in adults in whom laxatives fail to provide
adequate relief.
DOSAGE AND ADMINISTRATION
DOSAGE
_ADULTS_
2 mg once daily
_ELDERLY (> 65 YEARS)_
Start with 1 mg once daily (see _Pharmacokinetic_
_ _
_Properties_);
if
needed
the
dose
can
be
increased to 2 mg once daily.
_CHILDREN AND ADOLESCENTS_
RESOLOR
®
is not recommended in children
and
adolescents
younger
than
18
years
(see _Pediatric Population_ and _Clinical Studies_).
_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 _Contraindications_ and
_Pharmacokinetic _
_Properties_).
No
dose
adjustment is required for patients with mild
to moderate renal impairment.
_PATIENTS WITH HEPATIC IMPAIRMENT_
The dose for patients with severe hepatic
impairment (Child-Pugh class C) is 1 mg
once daily (see _ Warnings and_ _ Precautions _
and _ Pharmacokinetic Properties_). No dose
adjustment is required for patients with mild
to moderate hepatic impairment.
Due
to
the
specific
mode
of
act