SETRON 1 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

GRANISETRON AS HYDROCHLORIDE

Available from:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC code:

A04AA02

Pharmaceutical form:

TABLETS

Composition:

GRANISETRON AS HYDROCHLORIDE 1 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

WAVELENGTH ENTEPRISES LTD., ISRAEL

Therapeutic group:

GRANISETRON

Therapeutic area:

GRANISETRON

Therapeutic indications:

Prevention of nausea and vomiting induced by cytostatic therapy.

Authorization date:

2022-12-31

Patient Information leaflet

PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
)PREPARATIONS(-1986
This medicine can be sold with a
physician’s prescription only.
SETRON 1 MG
Tablets
EACH TABLET CONTAINS GRANISETRON 1
MG )AS HYDROCHLORIDE(
Inactive
ingredients
and
allergens
in
the
medicine
-
see
section
2
"
IMPORTANT INFORMATION ABOUT SOME
OF THE INGREDIENTS OF THIS MEDICINE
"
and section 6 in the leaflet.
READ THIS ENTIRE LEAFLET CAREFULLY
BEFORE USING THIS MEDICINE. This
leaflet contains concise information
about the medicine. If you have any
further questions, ask the physician
or pharmacist.
This medicine has been prescribed to
treat you. Do not pass it on to others.
It may harm them, even if you think
that their medical condition is the same
as yours.
1. WHAT IS THE MEDICINE INTENDED
FOR?
For the prevention of nausea and
vomiting arising from cytostatic-anti-
cancer treatments )chemotherapy or
radiation(.
THERAPEUTIC GROUP: 5-HT
3
)serotonin(
receptor antagonists - anti-sickness
and anti-emetic.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• You are hypersensitive )allergic( to
the active ingredient )granisetron(, or
to any of the other ingredients this
medicine contains )see section 6(. If
you are not sure, refer to the physician,
nurse, or pharmacist before taking the
medicine.
SPECIAL
WARNINGS
REGARDING
THE
USE OF THE MEDICINE
{
BEFORE THE TREATMENT WITH SETRON
1 MG, TELL THE PHYSICIAN IF:
• you have a blockage in the intestines
causing symptoms such as stomach
ache, wind, nausea or vomiting, or
constipation.
• you have heart problems, you are
taking a medicine for the treatment of
cancer that is known to damage the
heart or you have problems with levels
of salt in the body such as: potassium,
sodium or calcium )electrolyte level
abnormalities(.
• you
are
taking
other
medicines
from the ‘5-HT
3
)serotonin( receptor
antagonist’ group. These medicines
include for example the medicines
ondansetron and dolasetron and are
used, like Setron, in the prevention of
nausea and vomiting.
• The

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Setron 1 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg granisetron (as hydrochloride)
Excipients with known effect:
Each tablet contains 55.78 mg of lactose monohydrate. Patients with
rare hereditary problems of
galactose intolerance, total lactase deficiency or glucose galactose
malabsorption should not take this
medicine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White to off white round tablets with embossment 'GS' on one side and
plain on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Setron 1 mg tablets are indicated for the prevention of nausea and
vomiting induced by cytostatic therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
1 mg twice a day or 2 mg once a day for up to one week following
radiotherapy or chemotherapy. The first
dose of Setron should be administered within 1 hour before the start
of therapy.
Dexamethasone has been used concomitantly at doses up to 20 mg once a
day orally.
_Paediatric population _
The safety and efficacy of Setron tablets in children have not yet
been established.
No data are available.
_Older people and renal impairment _
There are no special precautions required for its use in either
elderly patients or those patients with renal
impairment.
_Hepatic impairment _
There is no evidence to date for an increased incidence of adverse
events in patients with hepatic disorders.
On the basis of its kinetics, whilst no dosage adjustment is
necessary, granisetron should be used with a
certain amount of caution in this patient group (see section 5.2).
Method of administration
The tablets should be swallowed whole with water.
4.3
CONTRAINDICATIONS
Granisetron is contra-indicated in patients hypersensitive to the
active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As granisetron may reduce lower bowel motility, patients with signs of
sub-acute intestinal obstr