ALOXI 500mcg Soft Capsules

Country: Malasja

Lingwa: Ingliż

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

Ingredjent attiv:

Palonosetron Hydrochloride

Disponibbli minn:

JUNIPER BIOLOGICS SDN. BHD.

INN (Isem Internazzjonali):

Palonosetron Hydrochloride

Unitajiet fil-pakkett:

5capsule Capsules; 1capsule Capsules

Manifatturat minn:

Catalent Pharma Solutions

Fuljett ta 'informazzjoni

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
ALOXI
® 500MCG SOFT CAPSULES
PALONOSETRON (500MCG)
1
WHAT IS IN THIS LEAFLET
1.
What
ALOXI
®
is used for
2.
How
ALOXI
®
works
3.
Before you use
ALOXI
®
4.
How to use
ALOXI
®
5.
While you are taking it
6.
Side effects
7.
Storage and Disposal of
ALOXI
®
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT ALOXI
®
IS USED FOR
ALOXI
®
is used for the
prevention of nausea and
vomiting associated with cancer
chemotherapy in adult patients.
HOW ALOXI
®
WORKS
ALOXI
®
belongs to a group of
medicines called serotonin
(5HT3) antagonists. These have
the ability to block the action of
the chemical, serotonin, which
can cause nausea and vomiting.
BEFORE YOU TAKE ALOXI
®
_-When you must not use it _

If you are allergic to
palonosetron or any of the
other ingredients of this
medicine (listed in Product
Description).

If you are pregnant or think
you might be, your doctor
will not use Aloxi unless it is
clearly necessary. It is not
known whether Aloxi will
cause any harmful effects
when used during pregnancy.
Ask your doctor or
pharmacist for advice before
using any medicine if you
are pregnant or think you
might be.

Tell your doctor if you are
breast-feeding or intend to
breast-feed while taking
ALOXI
®
soft capsules. It is
not known if ALOXI
®
is
found in breast milk.
_-Before you start take it _
Tell your doctor or pharmacist if
you:

have acute bowel obstruction
or a history of repeated
constipation;

are using Aloxi in addition to
other medicines that may
induce an abnormal heart
rhythm such as amiodarone,
nicardipine, quinidine,
moxifloxacin, erhthromycin,
haloperidol, quetiapine,
chlorpromazine thioridazine,
domperidone;

have personal or family
history of alterations in heart
rhythm (QT prolongation);

have other heart problems;

have an imbalance of certain
minerals in your blood such
as potassium and magnesium
which has not been treated.
It is not recommended to take
ALOXI
®
in the days f

Karatteristiċi tal-prodott

1
Aloxi 500micrograms soft capsules
1. Name of the medicinal product
Aloxi 500 micrograms soft capsules
2. Qualitative and Quantitative composition
Each capsule contains 500 micrograms palonosetron (as hydrochloride).
Excipient(s):
Each capsule contains 14.21 milligrams sorbitol. For the full list of excipients, see section 6.
3. Pharmaceutical form
Soft capsule.
Light beige, opaque, oval, soft gelatine capsules, imprinted with black logo “AlO”, filled with a clear
yellowish solution
4. Clinical particulars
4.1 Therape utic indications
Aloxi is indicated in adults for the prevention of nausea and vomiting associated with moderately
emetogenic cancer chemotherapy.
4.2 Posology and method of administration
Aloxi should be used only before chemotherapy administration.
Posology
Adults
500 micrograms palonosetron administered orally approximately one hour before the start of
chemotherapy.
Elderly population
No dose adjustment is necessary for the elderly.
Paediatric population
The safety and efficacy of Aloxi in children have not been established. No recommendation on
posology can be made.
Hepatic impairment
No dose adjustment is necessary for patients with impaired hepatic function.
Renal impairment
No dose adjustment is necessary for patients with impaire d renal function.
No data are available for patients with end stage renal disease undergoing haemodialysis.
Method of administration
For oral use.
Aloxi can be taken with or without food.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
As palonosetron may increase large bowel transit time, patients with a history of constipation or
signs of subacute intestinal obstruction should be monitored following administration. Two cases
of constipation with faecal impaction requiring hospitalisation have been reported in association
with palonosetron 750 micrograms.