Kytril 2mg film-coated tablets

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Granisetron hydrochloride

Disponibbli minn:

Atnahs Pharma Netherlands B.V.

Kodiċi ATC:

A04AA; A04AA02

INN (Isem Internazzjonali):

Granisetron hydrochloride

Dożaġġ:

2 milligram(s)

Għamla farmaċewtika:

Film-coated tablet

Żona terapewtika:

Serotonin (5HT3) antagonists; granisetron

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

1998-05-01

Fuljett ta 'informazzjoni

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
KYTRIL 1 MG FILM-COATED TABLETS
KYTRIL 2 MG FILM-COATED TABLETS
Granisetron
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. 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.
IN THIS LEAFLET
:
1.
What Kytril is and what it is used for
2.
What you need to know before you take Kytril
3.
How to take Kytril
4.
Possible side effects
5.
How to store Kytril
6.
Contents of the pack and information
1.
WHAT KYTRIL IS AND WHAT IT IS USED FOR
Kytril contains the active substance granisetron. This belongs to a
group of medicines called ‘5-HT
3
receptor antagonists’ or ‘anti-emetics’. These tablets are only
for use in adults.
Kytril is 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 KYTRIL
DO NOT TAKE KYTRIL TABLETS
•
if you are allergic (hypersensitive) to granisetron or any of the
other ingredients of Kytril (listed in
section 6: Further information and “Important Information about some
of the ingredients Kytril
below”).
If you are not sure, talk to your doctor, nurse or pharmacist before
taking these tablets.
WARNINGS AND PRECAUTIONS
Talk to your doctor, nurse or pharmacist before using these tablets,
especially 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 your
heart or have problems with levels of salts, such as potassium, sodium
or

Karatteristiċi tal-prodott

Health Products Regulatory Authority
23 March 2021
CRN009X9N
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kytril 2mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2mg granisetron (as the
hydrochloride).
Excipients with known effect:
Each tablet contains 138.76 of lactose monohydrate
Sodium starch glycolate
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
The tablets are white to almost-white, triangular, biconvex tablets
imprinted with ‘K2’ on one side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Kytril film-coated tablets are indicated in adults for the prevention
and treatment of acute nausea and vomiting associated with
chemotherapy and radiotherapy.
Kytril 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 Kytril
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.
_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
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4