RESOLOR 1mg Film Coated Tablets

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

prucalopride succinate

Boleh didapati daripada:

DKSH MALAYSIA SDN BHD

INN (Nama Antarabangsa):

prucalopride succinate

Unit dalam pakej:

28tablet Tablets

Dikeluarkan oleh:

JANSSEN CILAG SPA

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
RESOLOR
®
FILM COATED TABLET
Prucalopride Succinate (1mg, 2mg)
WHAT IS IN THIS LEAFLET
1.
What RESOLOR
®
is used for
2.
How RESOLOR
®
works
3.
Before you use RESOLOR
®
4.
How to use RESOLOR
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of RESOLOR
®
8.
Product description
9.
Manufacturer and product registration
holder
10.
Date of revision
WHAT RESOLOR
®
IS USED FOR
RESOLOR
®
is used to treat long-term
recurring constipation in adults in whom
laxatives do not work well enough.
HOW RESOLOR
®
WORKS
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.
BEFORE YOU USE RESOLOR
®
-
_When you must not use it _
•
are allergic (hypersensitive) to
prucalopride or any of the other
ingredients of RESOLOR
®
•
have kidney disease and on dialysis,
•
have a torn (perforated) or blocked gut
(intestines) or other gut problems such
as Crohn’s disease, ulcerative colitis or
toxic megacolon/ megarectum.
_Pregnancy and lactation _
_Pregnancy _
If you are of child bearing age, you should
talk to your doctor about contraception
during treatment with RESOLOR
®
.
RESOLOR
®
is not recommended during
pregnancy. If you are, pregnant, or you
think you may be pregnant, or if you are
planning to become pregnant, talk to your
doctor about the risks and benefits of
taking RESOLOR
®
.
_Breastfeeding _
You are advised not to take RESOLOR
®
if
you are breastfeeding, because small
amounts of RESOLOR
®
can be passed on
to your baby in breast milk. If you are
breastfeeding or thinking about
breastfeeding, talk to your doctor.
_Children _
RESOLOR
®
should not be given to
children and adolescents under 18 years.
-
_Before you start use it _
Take special care with RESOLOR
®
if
you:
•
have severe kidney problems,
•
have severe liver problems,
•
have a serious medical problem such
as: lung or heart problems, nerve,
men

Ciri produk

RESOLOR
®
1. PRODUCT DESCRIPTION
RESOLOR
®
1.1 DOSAGE FORMS AND STRENGTHS
Film-coated tablets, each containing 1 mg
prucalopride as prucalopride succinate.
Film-coated tablets, each containing 2 mg
prucalopride as prucalopride succinate.
For excipients, see List of Excipients.
2. INDICATIONS
RESOLOR
®
is
indicated
for
symptomatic
treatment of chronic constipation in adults in
whom
laxatives
fail
to
provide
adequate
relief.
3. DOSAGE AND ADMINISTRATION
3.1 DOSAGE
_Adults_
2 mg once daily.
_Geriatric (> 65 years)_
Start
with
1
mg
once
daily
[_see _
_Geriatric _
_Patients (10.5)_]; 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 Patients (10.4), CLINICAL STUDIES _
_(12)_].
_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 _
_(4), _
_Renal _
_Impairment _
_(10.7)_].
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
2mg
if
required to improve efficacy and if the 1mg
dose is well tolerated (see Special Warnings
and
Special
Precautions
for
Use
and
Pharmacokinetic
Properties).
No
dose
adjustment is required for patients with mild
to moderate hepatic impairment.
In clinical trials, a doubling of the daily dose
to 4 mg did not lead to an increase in efficacy.
If the intake of once daily RESOLOR
®
is not
effective
after
4
weeks
of
treatment,
the
patient
should
be
re-examined
and
the
benefit of continuing treatment reconsidered.
If
treatment
is
continued
longer
than
3 months, the benefit should be reassessed
at regular intervals.
3.2 METHOD OF ADMINISTRATION
RESOLOR
®
film-coated tablets are for oral
use and can be taken with or without food.
4. CONTRAINDICATIONS
- Hypersensitivity to the active substance