Granisetron 2mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Granisetron hydrochloride

Available from:

Colorama Pharmaceuticals Ltd

ATC code:

A04AA02

INN (International Name):

Granisetron hydrochloride

Dosage:

2mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04060000

Patient Information leaflet

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 doctor, pharmacist or nurse before
taking these tablets.
WARNINGS AND PRECAUTIONS
Check with your doctor, pharmacist or nurse before using these
tablets, if you:
•
are having problems with your
BOWEL MOVEMENTS
because of a blockage of your gut
(intestines)
•
have
HEART PROBLEMS
, are being treated for cancer with a medicine that is known to
damage

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Granisetron 2 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2 mg granisetron (as the
hydrochloride)
Excipients with known effect:
Each tablet contains 138.76 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 G2 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 gra