Granisetron Sigillata 1mg film-coated Tablets

Страна: Малта

Език: английски

Източник: Medicines Authority

Активна съставка:

GRANISETRON HYDROCHLORIDE

Предлага се от:

Sigillata Limited (Ireland) Inniscarra, Main Street, Rathcoole, Co. Dublin D24 E029 , Ireland

АТС код:

A04AA02

INN (Международно Name):

GRANISETRON HYDROCHLORIDE 1 mg

Лекарствена форма:

FILM-COATED TABLET

Композиция:

GRANISETRON HYDROCHLORIDE 1 mg

Вид предписание :

POM

Терапевтична област:

ANTIEMETICS AND ANTINAUSEANTS

Статус Оторизация:

Authorised

Дата Оторизация:

2009-03-16

Листовка

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
GRANISETRON SIGILLATA 1 MG FILM-COATED TABLETS
GRANISETRON SIGILLATA 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, pharmacist or
nurse.
-
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 you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
IN THIS LEAFLET
:
1.
What Granisetron Sigillata is and what it is used for
2.
What you need to know before you take Granisetron Sigillata
3.
How to take Granisetron Sigillata
4.
Possible side effects
5.
How to store Granisetron Sigillata
6.
Contents of the pack and other information
1.
WHAT GRANISETRON SIGILLATA IS AND WHAT IT IS USED FOR
Granisetron Sigillata contains the active substance 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 Sigillata 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 SIGILLATA
DO NOT TAKE GRANISETRON SIGILLATA
•
if you are allergic
(hypersensitive) to granisetron or any of the other ingredients of
Granisetron Sigillata
(listed in section 6: Further information and “Important Information
about some of the ingredients of
Granisetron Sigillata” below).
If you are not sure, talk to your doctor, nurse or pharmacist before
taking these tablets.
WARNINGS AND PRECAUTIONS
Talk to your doctor, nurse or pharmacist before using these tablets,
especially if you:
•
are having problems with your bowel movements because of a blockage

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Granisetron Sigillata 1 mg film-coated tablets
Granisetron Sigillata 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.
Excipients with known effect:
Each tablet contains 69.38 mg of lactose.
Each tablet contains 138.76 mg of lactose.
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
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 Sigillata 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.
_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