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:

JOHNSON & JOHNSON SDN BHD

INN (Nama Antarabangsa):

prucalopride succinate

Unit dalam pakej:

28tablet Tablets

Dikeluarkan oleh:

JANSSEN CILAG SPA

Risalah maklumat

RESOLOR
® FILM COATED TABLET
Prucalopride Succinate (1mg, 2mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
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,
m

Ciri produk

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 or to any of the exci