Granisetron 1mg tablets

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Granisetron hydrochloride

MAH:

Viatris UK Healthcare Ltd

ATC_code:

A04AA02

INN:

Granisetron hydrochloride

dosage:

1mg

pharmaceutical_form:

Oral tablet

administration_route:

Oral

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 04060000; GTIN: 5016695000237

PIL

V2 Oct 2022
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Granisetron Hydrochloride, 1 mg, 10
Leaflet/IFU - Folded
119
ART-4777-02
400001092
2072227
N.A.
ART-4777-02
1
PL 04569/0688
United Kingdom
Haupt Pharma Muenster
GmbH (Muenster - DE)
N.A.
51752228
51742819
N.A.
N.A.
10 JAN 2022
12:52
1
1 of 2
10 pt
10 pt
Myriad Pro
180 x 300 mm
Black
Keyline
N.A.
pharmacode
direction
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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

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Granisetron 1 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg granisetron (as hydrochloride).
Excipient with known effect:
Each tablet contains 55.78 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white tablet embossed "GS" on one side and plain on the
reverse
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 should be administered
within one hour
before the start of therapy.
Dexamethasone has been used concomitantly at doses up to 20 mg once a
day orally.
Maximum Dose and Duration of Treatment
Granisetron is also available as ampoules for intravenous
administration. The
maximum dose of granisetron administered orally and/or intravenously
over 24 hours
should not exceed 9 mg.
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 section 5.2).
Method of administration
The tablets should be swallowed whole with water.
4.3
CONTRAINDICATIONS
Gr