Kytril 1mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Granisetron hydrochloride

Available from:

Atnahs Pharma UK Limited

ATC code:

A04AA; A04AA02

INN (International Name):

Granisetron hydrochloride

Dosage:

1 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Serotonin (5HT3) antagonists; granisetron

Authorization status:

Marketed

Authorization date:

1994-02-15

Patient Information leaflet

YOU START TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this
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
See section 4.
:
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
calcium, in your body (electrolyte
abnormalities)
● are taking other ‘5-HT
3
receptor antagonist’
medicines. These include
dolasetron, ondansetron
used like Kytril in the
treatment and prev

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kytril 1mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1mg granisetron (as the
hydrochloride).
Excipients with known effect:
Each tablet contains 69.38mg of lactose monohydrate
Sodium starch glycolate
For the 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 ‘K1’ 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
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