Granisetron 1mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Granisetron hydrochloride

זמין מ:

Torrent Pharma (UK) Ltd

קוד ATC:

A04AA02

INN (שם בינלאומי):

Granisetron hydrochloride

כמות:

1mg

טופס פרצבטיות:

Oral tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 04060000; GTIN: 5060623371258

עלון מידע

COLOUR BLACK
Reviewed By
ACTIVITIES
DEPARTMENT
NAME
SIGNATURE
DATE
Prepared By
PKG.DEV
PKG.DEV
LOCATION :
SUPERSEDES A/W NO.:
-
COUNTRY : UK
QUALITY
Approved By
REMARK :
SIZE
: 190 X 380 MM_FRONT/BACK SIDE
CODE : 8075203-7803
DATE : 01-07-2019
SUBSTRATE :
THIS COLOUR PROOF IS NOT COLOUR BINDING. FOLLOW PANTONE SHADE
REFERENCE FOR ACTUAL COLOUR MATCHING.
PACKAGE LEAFLET: INFORMATION FOR THE USER
GRANISETRON 1 MG FILM-COATED TABLETS
GRANISETRON 2 MG FILM-COATED TABLETS
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, nurse 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, nurse or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Granisetron Film-coated Tablets are and what they are used for
2.
What you need to know before you take Granisetron Film-coated Tablets
3.
How to take Granisetron Film-coated Tablets
4.
Possible side effects
5.
How to store Granisetron Film-coated Tablets
6.
Contents of the pack and other information
1.
WHAT GRANISETRON FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
Granisetron belongs to a group of medicines called ‘5-HT
3
receptor antagonists’ or ‘anti-emetics’. These tablets are only
for use in adults.
Granisetron Film-coated Tablets are 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 FILM-COATED TABLETS
DO NOT TAKE GRANISETRON FILM-COATED TABLETS:
•
if you are allergic to granisetron, or any of the other ingredients of
this medicine (listed in section 6).
If you are not sure, talk to your

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Granisetron 1 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 mg granisetron (as the
hydrochloride)
Excipients with known effect:
Each tablet contains 69.38 mg of lactose
Sodium starch glycolate
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet.
Triangular white, biconvex, film-coated tablets with G1 engraved on
one side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Granisetron film coated tablets are indicated in adults for the
prevention and
treatment of acute nausea and vomiting associated with chemotherapy
and
radiotherapy.
Granisetron film coated 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 film
coated
tablets 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.
_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
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 grani