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KYTRIL 2MG FILM-COATED TABLETS

Active substance(s): GRANISETRON HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

GB IL

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-HT3 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.

The recommended dose of Kytril varies from
one patient to another. It depends on your age,
weight, and whether you are being given the
medicine to prevent, or treat, nausea and
vomiting. The doctor will work out how much
to give you.
Prevention of feeling or being sick
Your first dose of Kytril will usually be given an
hour before your radio- or chemotherapy. The
dose will be taken either as:
- one 1 mg tablet twice a day or
- two 1 mg tablets once a day or
- one 2 mg tablet once a day
for up to a week after your radio- or
chemotherapy.
Treatment of feeling or being sick
The dose will usually be taken either as:
- one 1 mg tablet twice a day or
- two 1 mg tablets once a day or
- one 2 mg tablet once a day.
If you take more Kytril than you should
If you think you have taken too many of the
tablets talk to your doctor or nurse. The
symptoms of overdose include mild headaches.
You will be treated depending on your
symptoms.
If you forget to take Kytril

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-HT3
receptor antagonist’
medicines. These include
dolasetron, ondansetron
used like Kytril in the
treatment and prevention
of nausea and vomiting.
Serotonin Syndrome is a rare but potentially
life-threatening reaction that can occur with
Kytril. It can cause serious changes in how your
brain, muscles, and digestive system work. The
reaction can occur if you take Kytril alone but is
more likely to occur if you take Kytril with
certain other medications. Be sure to tell your
doctor, nurse or pharmacist all the medicines
you are taking.
Children
Children should not take these tablets.
Other medicines and Kytril
Please tell your doctor, nurse or pharmacist if
you are taking or have recently taken or might
take any other medicines, including medicines
obtained without a prescription. This is because
Kytril can affect the way some medicines work.
Also some other medicines can affect the way
these tablets work.
In particular, tell your doctor, nurse or pharmacist
if you are taking the following medicines:
● medicines used to treat an irregular heartbeat,
other ‘5-HT3 receptor antagonist’ medicines
such as dolasetron or ondansetron (see
“Warnings and precautions” above)
● phenobarbital, a medicine used to treat
epilepsy
● a medicine called ketoconazole used in the
treatment of fungal infections
● the antibiotic erythromycin used to treat
bacterial infections
● SSRIs (selective serotonin reuptake
inhibitors) used to treat depression and/or
anxiety including fluoxetine, paroxetine,
sertraline, fluvoxamine, citalopram,
escitalopram
● SNRIs (serotonin noradrenaline reuptake
inhibitors) used to treat depression and/or
anxiety including venlafaxine, duloxetine.

If you think you have forgotten to take your
medicine speak to your doctor or nurse.
Do not take a double dose to make up for a
forgotten tablet.
If you stop taking Kytril
Do not stop taking your medicine before the
treatment is finished. If you do stop taking your
medicine, your symptoms may return.
If you have any further questions on the use of
this medicine, ask your doctor, nurse or
pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them. If
you notice the following problem you must see
a doctor straight away:
● allergic reactions
(anaphylaxis). The signs
may include swelling of
the throat, face, lips and
mouth, difficulty in
breathing or swallowing.
Other side effects that may be experienced
while taking this medicine are:
Very common: may affect more than 1 in
10 people
● headache
● constipation. Your doctor will monitor your
condition.
Common: may affect up to 1 in 10 people
● problems sleeping (insomnia)
● changes in how your liver is working shown
by blood tests
● diarrhoea.
Uncommon: may affect up to 1 in 100 people
● skin rashes or an allergic skin reaction or
“nettle-rash” or “hives” (urticaria). The signs
may include red, raised itchy bumps
● changes in the heartbeat (rhythm) and
changes seen on ECG readings (electrical
recordings of the heart)
● abnormal involuntary movements, such as
shaking, muscle rigidity and muscle
contractions
● Serotonin Syndrome. The signs may include
fever, sweating, shivering, diarrhea, nausea,
vomiting, muscle shakes, jerks, twitches or
stiffness, overactive reflexes, loss of
coordination, fast heartbeat, changes in blood
pressure,confusion, agitation, restlessness,
hallucinations, mood changes,
unconsciousness and coma.
Reporting of side effects
If you get any side effects, talk to your doctor,
nurse or pharmacist. This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly via the Yellow
Card Scheme at www.mhra.gov.uk/yellowcard .
By reporting side effects you can help provide
more information on the safety of this medicine.

Pregnancy and breast-feeding

5. How to store Kytril

You should not take these tablets if you are
pregnant, trying to get pregnant or are breastfeeding, unless your doctor has told you to.

Keep this medicine out of the reach and sight of
children.

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.

Do not use this medicine after the expiry date
which is stated on the blister and carton after
EXP. The expiry date refers to the last day of
that month.

Driving and using machines

This medicinal product does not require any
special storage conditions.

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 essentially ‘sodium free’ as it contains
less than 1 mmol sodium (23 mg) per dose (2 mg).

Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no
longer use. These measures will help to protect
the environment.

6. Contents of the pack and other
information
What Kytril contains

3. How to take Kytril
Always take this medicine exactly as your
doctor has told you. Check with your doctor,
nurse or pharmacist if you are not sure.
10154879_NPIL9344.indd 1

The active substance is granisetron.
Each 1 mg film-coated tablet contains 1 mg
granisetron (as the hydrochloride).
Each 2 mg film-coated tablet contains 2 mg
granisetron (as the hydrochloride).
10.11.2014 17:05:24

The other ingredients are:
Lactose monohydrate
Hypromellose
Sodium starch glycolate
Cellulose, microcrystalline
Magnesium stearate
Film-coat:
Hypromellose
Titanium dioxide (E171)
Macrogol 400
Polysorbate 80
What Kytril looks like and contents of the
pack
The tablets are white to almost white triangular
biconvex tablets imprinted with K1 on one side.
The tablets are white to almost white triangular
biconvex tablets imprinted with K2 on one side.
Opaque PVC blisters sealed with an aluminium
foil containing 2 or 10 tablets (1 mg) or 1, 5 or
10 tablets (2 mg). Not all pack sizes may be
marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
Manufacturer
Roche Pharma AG
Emil-Barell-Str. 1
D-79639 Grenzach-Wyhlen
Germany
This medicinal product is authorised in the
Member States of the EEA under the
following names:
Austria, Belgium, Bulgaria, Czech Republic,
Estonia, Finland, France, Ireland, Italy,
Luxembourg, Netherlands, Portugal, Slovenia,
Spain, Sweden and United Kingdom: Kytril
Germany: Kevatril
This leaflet was last revised in October 2014.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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