Resotrans

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Prucalopride succinate 2.642mg equivalent to 2 mg prucalopride

Disponibil de la:

Boucher & Muir (NZ) Ltd t/a Mercury Pharma (NZ)

INN (nume internaţional):

Prucalopride succinate 2.642 mg (equivalent to 2 mg prucalopride)

Dozare:

2 mg

Forma farmaceutică:

Film coated tablet

Compoziție:

Active: Prucalopride succinate 2.642mg equivalent to 2 mg prucalopride Excipient: Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry pink 33G34847 Purified water

Unități în pachet:

Blister pack, Al/Al, 7 tablets

Clasă:

Prescription

Tip de prescriptie medicala:

Prescription

Produs de:

Janssen Pharmaceutica NV

Indicații terapeutice:

Treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.

Rezumat produs:

Package - Contents - Shelf Life: Blister pack, Al/Al - 7 tablets - 36 months from date of manufacture stored at or below 30°C protect from moisture - Blister pack, Al/Al - 28 tablets - 36 months from date of manufacture stored at or below 30°C protect from moisture

Data de autorizare:

2010-11-08

Prospect

RESOTRANS
®
(210804) CMI
1
RESOTRANS
®
_1 MG AND 2 MG TABLETS _
_Prucalopride succinate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about RESOTRANS. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking RESOTRANS
against the benefits this medicine is
expected to have for you.
If you have any concerns about
taking this medicine, ask your doctor
or pharmacist.
Keep this leaflet while being treated.
You may need to read it again.
WHAT RESOTRANS IS
USED FOR
RESOTRANS tablets are used for
the treatment of long-standing
constipation in adults in whom
conventional medicines used to treat
constipation (laxatives) fail to
provide adequate relief.
RESOTRANS is not used to treat
constipation due to other medical
conditions including disorders which
involve the over-production or under-
production of hormones from the
endocrine gland, disorders that
involve an alteration in normal
metabolism, disorders of the nervous
system and constipation due to use of
medicines including opioid
medicines such as codeine,
oxycodone and morphine.
RESOTRANS contains the active
ingredient prucalopride succinate. It
acts on the muscle wall of the gut,
helping to restore the normal
functioning of the bowel.
Your doctor may have prescribed this
medicine for another reason. Ask
your doctor if you have any questions
about why it has been prescribed for
you.
There is no evidence that this
medicine is addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
RESOTRANS
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE RESOTRANS IF YOU
HAVE AN ALLERGY TO:
•
prucalopride, the active
ingredient in the medicine
•
any of the ingredients listed at the
end of this leaflet.
RESOTRANS contains lactose. If
you have been told by your doctor
that you have an intolerance to some
sugars, contact your doctor before
taking this medicin

Caracteristicilor produsului

1
RESOTRANS
PRUCALOPRIDE (AS SUCCINATE) TABLET FILM COATED 1MG AND 2MG
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
RESOTRANS 1 mg film-coated tablet
RESOTRANS 2 mg film-coated tablet
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
RESOTRANS is available as film-coated tablets containing 1 mg or 2 mg
of prucalopride (as
prucalopride succinate).
Excipient(s) with known effect:
Sugars as lactose.
Each 1 mg film-coated tablet contains 151.3 mg lactose monohydrate.
Each 2 mg film-coated tablet contains 167 mg lactose monohydrate.
For the full list of excipients, see
SECTION 6.1
.
3
PHARMACEUTICAL FORM
Film-coated tablets
1 mg – white to off-white, round, biconvex tablets marked “PRU
1” on one side
2 mg – pink, round, biconvex tablets marked “PRU 2” on one side.
4
CLINICAL PARTICULARS
4.1 INDICATIONS
RESOTRANS is indicated for the treatment of chronic constipation in
adults in whom laxatives
fail to provide adequate relief.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
RESOTRANS film-coated tablets are for oral use and can be taken with
or without food.
_ADULTS_
: 2 mg once daily.
_ELDERLY (>65 YEARS):_
Start with one 1 mg tablet once daily (see
SECTION 5.2
); if needed the dose
can be increased to 2 mg once daily.
2
RESOTRANS
PRUCALOPRIDE (AS SUCCINATE) TABLET FILM COATED 1MG AND 2MG
_CHILDREN AND ADOLESCENTS_
: RESOTRANS is not recommended in children and adolescents
younger than 18 years.
_PATIENTS WITH RENAL IMPAIRMENT_
: The dose for patients with severe renal impairment (GFR
< 30 mL/min/1.73m
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_
: The dose for patients with severe hepatic impairment (Child-
Pugh class C) is 1 mg once daily (see
SECTIONS 4.4
and
5.2
). No dose adjustment is required for
patients with mild to moderate hepatic impairment.
Due to the specific mode of action of RESOTRANS (stimulation of
propulsive motility),
exceeding the daily dose of 2 mg is not expected to increase e