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GRANISETRON 2MG TABLETS

Active substance(s): GRANISETRON HYDROCHLORIDE

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Package leaflet: Information for the user

Granisetron 1 mg film-coated tablets
Granisetron 2 mg film-coated tablets
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
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.

What is in this leaflet:
1. What Granisetron is and what it is used for
2. What you need to know before you take
Granisetron
3. How to take Granisetron
4. Possible side effects
5. How to store Granisetron
6. Contents of the pack and information

1. What Granisetron is and what it is used for
Granisetron belongs to a group of medicines known
as ‘5-HT3 receptor antagonists’ or anti-emetics or
anti-sickness medicines. These tablets are only for
use in adults. It is used to prevent or treat nausea
(feeling sick) and vomiting (being sick) caused by
other medical treatments, such as chemotherapy or
radiation treatment for cancer.

2. What you need to know before you
take Granisetron
Do not take granisetron
• if you are allergic (hypersensitive) to granisetron or
any of the other ingredients of this medicine (listed
in section 6). 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:
• have a blockage in the intestine (gut) causing
symptoms such as stomach ache, wind, feeling or
being sick, or difficulty passing stools.
• 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 granisetron in the treatment and
prevention of nausea and vomiting.

It can cause serious changes in how your brain, muscles,
and digestive system work. The reaction can occur if you
take Granisetron alone but is more likely to occur if you
take Granisetron 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 granisetron
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
This is because granisetron can affect the way some
medicines work. Also some other medicines can affect
the way these tablets work.
In particular, tell your doctor 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)
• 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.
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
Granisetron should not affect your ability to drive or
operate machinery.
Granisetron tablets contain lactose
This medicine contains lactose (a type of sugar).
If your doctor has told you that you have an
intolerance to some sugars, such as lactose, contact
your doctor before taking this medicine.

3. How to take Granisetron
Always take Granisetron exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
Swallow the tablets with a glass of water.
The recommended dose of granisetron 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.

Serotonin Syndrome is a rare but potentially
life-threatening reaction that can occur with granisetron.

Description Granisetron Hydrochloride 1 mg 10

Date: 24 Jul 2015

Component Type Leaflet

Pharma Code N/A

No. of colours

Affiliate Item Code 648481

SAP No. N/A

Colours

Superceded Affiliate Item Code 571822
TrackWise PR No. 648481
MA No. N/A
Packing Site/Printer N/A
Supplier Code N/A

Sign-offs

Vendor Job No. 255944
Trackwise Proof No. 3
Glams Proof No. N/A
Client Market United Kingdom

1

Time:

12:49

Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with

Keyline/Drawing No. N/A

Main Font

Barcode Info N/A

Dimensions

Myriad Pro
183 x 266 mm

Body Text Size 10 pt
Min Text Size used 10 pt

Prevention of feeling or being sick
Your first dose of granisetron will usually be given an
hour before your radio- or chemotherapy. The dose
will be either one or two 1 mg tablets or one 2 mg
tablet once a day for up to a week after your radioor chemotherapy.
Treatment of feeling or being sick
The dose will usually be either one or two 1 mg tablets or
one 2 mg tablet once a day, but your doctor may decide
to increase your dose to upto nine 1 mg tablets a day.
Your doctor may also give you another medicine
called dexamethasone to take as well.

Children
Granisetron is not suitable for children.
If you take more Granisetron than you should
Contact your doctor or go to the nearest hospital
casualty department immediately. Take the container
and any remaining tablets with you. The symptoms of
overdose include mild headaches. You will be treated
depending on your symptoms.
If you forget to take Granisetron
If you think you have forgotten to take your medicine
speak to your doctor or nurse. Do not take two doses
together to make up for the one you have missed.
If you stop taking Granisetron
Do not stop taking your medicine before the
treatment is finished. If you do stop taking your
medicine, your symptoms may return. Speak to your
doctor first if you wish to stop taking this medicine.
If you have any further questions on the use of this
medicine, ask your doctor 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 to 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.

Description Granisetron Hydrochloride 1 mg 10

• Serotonin Syndrome. The signs may include fever,
sweating, shivering, diarrhoea, 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.

5. How to store Granisetron
Keep this medicine out of the sight and reach of children.
Do not use Granisetron after the expiry date which is
stated on the carton or label after EXP. The expiry date
refers to the last day of that month.
There are no special storage conditions for this medicine.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.

6. Contents of the pack and other information
What Granisetron contains
• The active substance is 1 mg or 2 mg of granisetron,
as hydrochloride.
• The other ingredients are lactose monohydrate,
microcrystalline cellulose, hypromellose, sodium
starch glycolate, magnesium stearate, titanium
dioxide (E171), macrogol and polysorbate.
What Granisetron looks like and contents of the pack

Your medicine comes as a film-coated tablet. The
tablets are white to off-white. The 1 mg strength
tablets are marked ‘GS’ on one side and the 2 mg
strength are marked ‘GS2’ on one side.

Granisetron is available in plastic bottles or blister
packs of 1, 2, 4, 5, 6, 7, 10, 14, 20, 28, 30, 50, 90, 100,
150, 200, 250 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan
Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Manufacturers
Generics [UK] Limited
Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13,
Ireland.
This leaflet was last revised in 06/2015.
648481

Date: 24 Jul 2015

Component Type Leaflet

Pharma Code N/A

No. of colours

Affiliate Item Code 648481

SAP No. N/A

Colours

Superceded Affiliate Item Code 571822
TrackWise PR No. 648481
MA No. N/A
Packing Site/Printer N/A
Supplier Code N/A

Sign-offs

Vendor Job No. 255944
Trackwise Proof No. 3
Glams Proof No. N/A
Client Market United Kingdom

1

Time:

12:49

Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with

Keyline/Drawing No. N/A

Main Font

Barcode Info N/A

Dimensions

Myriad Pro
183 x 266 mm

Body Text Size 10 pt
Min Text Size used 10 pt

Expand view ⇕

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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