Kytril 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Granisetron hydrochloride

Available from:

Waymade Healthcare Plc

ATC code:

A04AA02

INN (International Name):

Granisetron hydrochloride

Dosage:

1mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04060000

Patient Information leaflet

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.
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 prevention
of nausea and vomiting.
CHILDREN
Children should not take these tablets.
OTHER MEDICINES AND KYTRIL
PREGNANCY AND BREAST-FEEDING
You should not take these tablets if you are
pregnant, trying to get pregnant or are breast-
feeding,
unless your doctor has told you to.
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor, nurse or pharmacist for advice
before taking this medicine.
DRIVING AND USING MACHINES
Kytril has no or negligible effect on your ability
to drive or use any tools or machines.
KYTRIL CONTAINS
Kytril contains lactose (a type of sugar). If you
have been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicinal product.
Kytril is ess

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Kytril 1 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 mg granisetron (as the
hydrochloride).
Excipients with known effect:
_ _
Each tablet contains 69.38 mg 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
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.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As gran