Granisetron Actavis Coated Tablets 2mg

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

GRANISETRON HYDROCHLORIDE

Prieinama:

Actavis Group PTC ehf

ATC kodas:

A04AA02

INN (Tarptautinis Pavadinimas):

GRANISETRON HYDROCHLORIDE

Vaisto forma:

COATED TABLET

Sudėtis:

GRANISETRON HYDROCHLORIDE 2.24 mg

Recepto tipas:

POM

Gydymo sritis:

ANTIEMETICS AND ANTINAUSEANTS

Autorizacija statusas:

Authorised

Leidimo data:

2009-03-16

Pakuotės lapelis

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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.
-
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. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What Granisetron Actavis is and what it is used for
2.
Before you take Granisetron Actavis
3.
How to take Granisetron Actavis
4.
Possible side effects
5.
How to store Granisetron Actavis
6.
Further 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.
BEFORE YOU TAKE GRANISETRON ACTAVIS
DO NOT TAKE GRANISETRON ACTAVIS
•
if you are allergic
(hypersensitive) to granisetron or any of the other ingredients of
Granisetron
Actavis (listed in section 6: Further information and “Important
Information about some of the
ingredients of Granisetron Actavis” below).
TAKE SPECIAL CARE WITH GRANISETRON ACTAVIS
Check with your doctor, nurse or pharmacist before using these
tablets, if you:
•
are having problems with your bowel movements because of a blockage in
your gut (intestines)
•
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 body
(electrolyte abn

Prekės savybės

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SUMMARY OF PRODUCT CHARACTERISTICS
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: lactose (69.38 mg per film-coated tablet) (138.76 mg per
tablet)
For a 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
embossed with “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 group (see
section 5.2).
Meth