Granisetron Actavis Tablet, film coated 2mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GRANISETRON HYDROCHLORIDE

Available from:

Sigillata Limited

ATC code:

A04AA02

INN (International Name):

GRANISETRON HYDROCHLORIDE

Pharmaceutical form:

FILM-COATED TABLET

Composition:

GRANISETRON HYDROCHLORIDE 2.24 milligram(s)

Prescription type:

POM

Therapeutic area:

ANTIEMETICS AND ANTINAUSEANTS

Authorization status:

Authorised

Authorization date:

2009-03-16

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
GRANISETRON ACTAVIS 1 MG FILM-COATED TABLETS
GRANISETRON ACTAVIS 2 MG, FILM-COATED TABLETS
Granisetron
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Granisetron Actavis is and what it is used for
2.
What you need to know before you take Granisetron Actavis
3.
How to take Granisetron Actavis
4.
Possible side effects
5.
How to store Granisetron Actavis
6.
Contents of the pack and other information
1.
WHAT GRANISETRON ACTAVIS IS AND WHAT IT IS USED FOR
Granisetron Actavis contains a medicine called granisetron. This
belongs to a group of medicines
called ‘5-HT
3
receptor antagonists’ or ‘anti-emetics’. These tablets are only
for use in adults.
Granisetron Actavis is used to prevent or treat nausea and vomiting
(feeling and being sick) caused
by other medical treatments, such as chemotherapy or radiotherapy for
cancer.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GRANISETRON ACTAVIS
DO NOT TAKE GRANISETRON ACTAVIS
-
if you are allergic to granisetron or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Granisetron
Actavis
-
if you are having problems with your bowel movements because of a
blockage in your gut
(intestines)
-
if you have heart problems, are being treated for cancer with a
medicine that is known to
damage your heart or have problems with levels of salts, such as
potassium, sodium or
calcium, in your bo

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Granisetron Actavis 1 mg film-coated tablets
Granisetron Actavis 2 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 mg granisetron as granisetron
hydrochloride.
Each film-coated tablet contains 2 mg granisetron as granisetron
hydrochloride.
Excipient with known effect:
Lactose (69.38 mg per film-coated tablet) (138.76 mg per tablet)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Appearance:
1 mg tablets: triangular, white, biconvex, film-coated tablets
embossed with “G1” on one side.
2 mg tablets: triangular, white, biconvex, film-coated tablets
embossedwith “G2” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Granisetron tablets are indicated in adults for the prevention and
treatment of acute nausea and
vomiting associated with chemotherapy and radiotherapy.
Granisetron tablets are indicated in adults for prevention of delayed
nausea and vomiting associated
with chemotherapy and radiotherapy.
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 Granisetron Actavis 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 granisetron tablets in children have not
yet been established.
No data are available.
_Elderly and renal impairment _
There are no special precautions required for its use in either
elderly patients or those patients with
renal or hepatic impairment.
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_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