PALOXI CAPSULES

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PALONOSETRON AS HYDROCHLORIDE

Available from:

RAFA LABORATORIES LTD

ATC code:

A04AA05

Pharmaceutical form:

CAPSULES

Composition:

PALONOSETRON AS HYDROCHLORIDE 0.5 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

HELSINN BIREX PHARMACEUTICALS, LTD., IRELAND

Therapeutic area:

PALONOSETRON

Therapeutic indications:

Paloxi is indicated in adult for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Authorization date:

2019-07-14

Patient Information leaflet

1
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is sold with a doctor's prescription only
PALOXI
® CAPSULES
ACTIVE INGREDIENT:
Each capsule contains 0.5 mg (=500 micrograms) of palonosetron as
hydrochloride salt.
For the list of the other ingredients, please see section 6. See also
'Important information about some
of the medicine's ingredients' in section 2.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further questions,
refer to your doctor or pharmacist.
This medicine has been prescribed for treating your condition. Do not
pass it on to others. It may
harm them, even if you think their medical condition is similar to
yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for prevention of nausea and vomiting in
adults as a result of
chemotherapy treatment for cancer.
THERAPEUTIC GROUP:
Anti-nausea and vomiting agent (antiemetic): serotonin receptor
blocker (5-HT3).
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF:
You are sensitive (allergic) to the active ingredient or to any of the
other ingredients this
medicine contains (for the list of the other ingredients, please see
section 6).
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
BEFORE TREATMENT WITH THE MEDICINE TELL YOUR DOCTOR IF:

You suffer from a blocked bowel or if you suffer or have suffered in
the past from
recurring constipation.

You or someone in your family suffers or has suffered in the past from
heart problems, such as
changes in heartbeat (QT interval prolongation).

You suffer from an imbalance of certain minerals in your blood (which
is not treated) - such as
potassium and magnesium.
CHILDREN AND ADOLESCENTS:
Do not give this medicine to children.
DRUG INTERACTIONS: IF YOU ARE TAKING, OR HAVE RECENTLY TAKEN ANY OTHER
MEDICINES, INCLUDING
NON-PRESCRIPTION MEDICINES AND NUTRITION SUPPLEMENTS, PLEASE TELL YOUR
DOCTOR OR
PHARMACIST. In particular if you are taking

Summary of Product characteristics

16
Paloxi Capsules-DL-July 2019-01
This Leaflet format has been determined by the Ministry of Health and
the content has been checked and approved in July 2019
1.
NAME OF THE MEDICINAL PRODUCT
Paloxi
®
Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0.5 mg (=500 micrograms) palonosetron (as
hydrochloride).
Excipient(s):
Each capsule contains 7 mg sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Soft capsule.
Plain, light beige, opaque, round to oval, soft gelatine capsules,
filled with a clear yellowish solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Paloxi is indicated in adults for the prevention of nausea and
vomiting associated with
moderately emetogenic cancer chemotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Paloxi should be used only before chemotherapy administration.
Posology
_U_
_Adults _
_ _
500 micrograms palonosetron administered orally approximately one hour
before the start of
chemotherapy.
_E_
_U_
_ lderly population _
_ _
No dose adjustment is necessary for the elderly.
_U_
_Paediatric population _
_ _
The safety and efficacy of Paloxi in children have not been
established. Currently available data are
described in section 5.1 and section 5.2, but no recommendation on
posology can be made.
_U_
_Hepatic impairment _
_ _
No dose adjustment is necessary for patients with impaired hepatic
function.
17
_U_
_Renal impairment _
_ _
No dose adjustment is necessary for patients with impaired renal
function.
No data are available for patients with end stage renal disease
undergoing haemodialysis.
Method of administration
For oral use.
Paloxi 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