Granisetron 1mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Granisetron hydrochloride

Verfügbar ab:

APC Pharmaceuticals & Chemicals (Europe) Ltd

ATC-Code:

A04AA02

INN (Internationale Bezeichnung):

Granisetron hydrochloride

Dosierung:

1mg

Darreichungsform:

Oral tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 04060000

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Myriad Pro
10 pt
10 pt
Granisetron_Hydrochloride_1mg_10
Leaflet
N/A
N/A
1958859
PL 04569/0688
TBC
TBC
TBC
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102837246/0020
2
United Kingdom
N/A
13 Sep 19
17:38
1
183 x 266 mm
Black
1 / 2
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v3/Jul 2017
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PACKAGE LEAFLET: INFORMATION FOR THE USER
GRANISETRON 1 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
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 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 is and what it is used for
2. What you need to know before you take
Granisetron
3. How to take Granisetron
4. Possible side effects
5. How to store Granisetron
6. Contents of the pack and information
1. WHAT GRANISETRON IS AND WHAT IT IS USED FOR
Granisetron belongs to a group of medicines known
as ‘5-HT3 receptor antagonists’ or anti-emetics or
anti-sickness medicines. These tablets are only for
use in adults. It is used to prevent or treat nausea
(feeling sick) and vomiting_ _(being sick) caused by
other medical treatments, such as chemotherapy or
radiation treatment for cancer.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE GRANISETRON
DO NOT TAKE GRANISETRON
•
if you are allergic (hypersensitive) to granisetron or
any of the other ingredients of this m

Fachinformation

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