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GRANISETRON 2MG FILM-COATED TABLETS

Active substance(s): GRANISETRON HYDROCHLORIDE / GRANISETRON HYDROCHLORIDE / GRANISETRON HYDROCHLORIDE

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Package leaflet: Information for the user
Granisetron 1 mg Film-coated Tablets
Granisetron 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 or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.
2.
3.
4.
5.
6.
1.

What Granisetron is and what it is used for
What you need to know before you take Granisetron
How to take Granisetron
Possible side effects
How to store Granisetron
Contents of the pack and other information
What Granisetron is and what it is used for

- Granisetron belongs to a group of drugs called ‘5-HT3 receptor antagonists’ or ’antiemetics’. These
tablets are only for use in adults.
- Granisetron 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 Granisetron

Do not take Granisetron:
- If you are allergic 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 or pharmacist before taking Granisetron:
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 antagonists’ medicines. These include dolasetron,
ondansetron used like granisetron in the treatment and prevention of nausea and vomiting.
Serotonin syndrome is an uncommon but potentially life-threatening reaction that can occur with
granisetron (see section 4). The reaction can occur if you take granisetron alone but it is more likely to
occur if you take granisetron with certain other medicines (in particular fluoxetine, paroxetine,
sertraline, fluvoxamine, citalopram, escitalopram, venlafaxine, duloxetine).

Children and adolescents
Children should not take these tablets.
Other medicines and Granisetron
Tell your doctor or pharmacist if you are taking have recently taken or might take any other medicines.
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, nurse or pharmacist if you are taking the following:
medicines to treat an irregular heartbeat
other ‘5-HT3 receptor antagonist’ medicines such as dolasetron or ondansetron (see “Warning
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.
Examples are fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram.
SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety.
Examples are venlafaxine, duloxetine.
Pregnancy and breast-feeding
You should not take these tablets if you are pregnant, trying to get pregnant or are breastfeeding,
unless your doctor has told you to.
Ask your doctor, nurse or pharmacist for advice before taking any medicine.
Driving and using machines
Granisetron has no or negligible effect on your ability to drive or use any tools or machines.

Granisetron contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
3.

How to take Granisetron

Always take Granisetron exactly as your doctor has told you. You should check with your doctor,
nurse or pharmacist if you are not sure.
The 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.
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
radio- or 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 up to nine 1 mg tablets a day.

If you take more Granisetron 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 Granisetron
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 Granisetron
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:
Uncommon: may affect up to 1 in 100 people
- Allergic reaction (anaphylaxis). The signs may include swelling of the throat, face, lips and mouth,
difficulty in breathing or swallowing.
- Serotonin Syndrome. The signs may include diarrhoea, nausea, vomiting, high temperature and
blood pressure, excessive sweating and rapid heartbeat, agitation, confusion, hallucination,
shivering, muscles shakes, jerks or stiffness, loss of coordination and restlessness.

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
- Diarrhoea,
- Problems sleeping (insomnia)
- Changes in how your liver is working shown by blood tests.
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 heartbeat (rhythm) and changes seen on ECG readings (electrical recordings of the
heart)
- Abnormal involuntary movements, such as shaking, muscle rigidity and muscle contractions
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 this medicine after the expiry date that is stated on the carton or blister pack. The expiry
date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Granisetron contains
- The active ingredient is granisetron. The 1 mg film-coated tablets contain 1 mg granisetron as
granisetron hydrochloride. The 2 mg film-coated tablets contain 2 mg granisetron as granisetron
hydrochloride.
- The other ingredients are:
Tablet core: lactose monohydrate, hypromellose (E464), microcrystalline cellulose, sodium starch
glycolate, magnesium stearate (E572)
Film-coat: titanium dioxide (E171), polysorbate 80 and macrogol.
What Granisetron looks like and contents of the pack:
- Granisetron 1 mg Film-coated Tablets are white to off white, film coated, capsule shaped tablets,
debossed with “93” on one side of the tablet and with “7485” on the other side of the tablet
- Granisetron 2 mg Film-coated Tablets are white to off white, film coated, capsule shaped tablets,
scored and debossed with “G2” on the left side of the score and smooth on the right side of the
score. The other side of the tablet is smooth. The scoreline is only to facilitate breaking for ease of
swallowing and not to divide the tablet into equal doses.
- The 1 mg tablets are available in pack sizes of 1, 2, 5, 6, 10, 14, 50 and 100 tablets. Hospital packs
of 50 x 1, 10 x 1 and 100 x 1 tablets
- The 2 mg tablets are available in pack sizes of 1, 2, 5, 6, 10, 50 and 100 tablets. Hospital packs of
50 x 1, 10 x 1 and 5 x 1 tablets.
- Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited,
Eastbourne, BN22 9AG.
OR *
Marketing Authorisation holder: TEVA UK Limited, Eastbourne, BN22 9AG. Company responsible
for manufacture: Pharmachemie B.V., Swensweg 5, Postbus 552, 2003 RN Haarlem, The Netherlands
OR
Marketing Authorisation holder: TEVA UK Limited, Eastbourne, BN22 9AG. Company responsible
for manufacture: TEVA Pharmaceutical Works Private Limited Company, Pallagi ùt 13, 4042
Debrecen, Hungary
OR

Marketing Authorisation holder: TEVA UK Limited, Eastbourne, BN22 9AG. Company responsible
for manufacture: TEVA Pharmaceutical Works Private Limited Company, Táncsics Mihály út 82, H2100 Gödöllo, Hungary

Product Licence numbers:
Granisetron 1 mg Film-coated Tablets: PL 00289/0960
Granisetron 2 mg Film-coated Tablets: PL 00289/0961
This leaflet was last revised in April 2017
*

Only the paragraph containing the details of the current batch release site will be included in the printed version of the PIL

Expand Transcript

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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