Granisetron 1mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Granisetron hydrochloride

Prieinama:

Alliance Healthcare (Distribution) Ltd

ATC kodas:

A04AA02

INN (Tarptautinis Pavadinimas):

Granisetron hydrochloride

Dozė:

1mg

Vaisto forma:

Oral tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

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
N/A
102837246/0020
2
United Kingdom
N/A
13 Sep 19
17:38
1
183 x 266 mm
Black
1 / 2
3D Render ID
N/A
v3/Jul 2017
N/A
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

Prekės savybės

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