KYTRIL 2 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

GRANISETRON HYDROCHLORIDE

Available from:

Roche Products Limited

ATC code:

A04AA02

INN (International Name):

GRANISETRON HYDROCHLORIDE

Dosage:

2 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

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

Therapeutic area:

Serotonin (5HT3) antagonists

Authorization status:

Authorised

Authorization date:

1998-05-01

Patient Information leaflet

1 

Kytril-PIL-clean-1407-1mg-2mg-tab 
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 
[http://www.netdoctor.co.uk/medicines/effect/cancer.shtml]or radiotherapy for cancer.
[http://www.netdoctor.co.uk/cancer/index.shtml] 

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 takin

Summary of Product characteristics

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