GRANISETRON 1 MG FILM COATED TABLETS
Active substance(s): GRANISETRON HYDROCHLORIDE / GRANISETRON HYDROCHLORIDE / GRANISETRON HYDROCHLORIDE
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.
- 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse
In this leaflet:
1. What Granisetron is and what it is used for
2. Before you take Granisetron
3. How to take Granisetron
4. Possible side effects
5. How to store Granisetron
6. Further information
1. WHAT GRANISETRON IS AND WHAT IT IS USED FOR
Granisetron belongs to a group of medicines called ‘5-HT3 receptor antagonists’ or ‘antiemetics’. Granisetron tablets are only
for use in adults.
Granisetron is used to prevent nausea and vomiting (feeling and being sick) caused by other medical treatments, such as
chemotherapy or radiotherapy for cancer.
2. BEFORE YOU TAKE GRANISETRON
Do not take Granisetron tablets
- If you are allergic (hypersensitive) to granisetron or any other ingredients of Granisetron (listed in Section 6: Further
information and “Important Information about some of the ingredients of Granisetron below”).
If you are not sure, talk to your doctor, nurse or pharmacist before taking these tablets.
Warnings and precautions
Check with your doctor, nurse or pharmacist before using these tablets, 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 antagonists’ medicines. These include dolasetron, ondansetron used like granisetron in the
treatment and prevention of nausea and vomiting.
Children should not take these tablets.
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, setraline, fluvoxamine, citalopram, escitalopram, venlafaxine, duloxetine.
Other medicines and Granisetron
Please tell your doctor, nurse 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, 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 “Take special care with Granisetron” 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
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. 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.
Important information about some of the ingredients of Granisetron
This medicine contains lactose monohydrate (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.
3. HOW TO TAKE GRANISETRON
Always take Granisetron 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 forgot 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 dose.
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
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, Granisetron can cause side effects, although not everyone gets them. If you notice the following problem
you must see a doctor straight away:
- allergic reaction (anaphylaxis). The signs may include swelling of the throat, face, lips and mouth, difficulty in breathing or
Other side effects that may be experienced while taking this medicine are:
Very common: affects more than 1 user in 10
- constipation. Your doctor will monitor your condition.
Common: affects 1 to 10 users in 100
- problems sleeping (insomnia)
- changes in how your liver is working shown by blood tests
Uncommon: affects 1 to 10 users in 1,000
- 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 diarrhoea, nausea, vomiting, high temperature and blood pressure,
excessive sweating and rapid heartbeat, agitation, confusion, hallucination, shivering, muscle shakes, jerks or stiffness,
loss of coordination and restlessness.
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 after EXP. The expiry date refers to the last day of
This medicinal product 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 to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Granisetron contains
The active substance is granisetron.
Each 1 mg film-coated tablet contains 1 mg of granisetron as granisetron hydrochloride.
Each 2 mg film-coated tablet contains 2 mg of granisetron as granisetron hydrochloride.
The other ingredients are:
Cellulose Microcrystalline (E460),
Sodium Starch Glycolate (Type A),
Magnesium stearate (E572).
HPMC 2910/ Hypromellose 6 cP (E464)
Titanium Dioxide (E171)
Macrogol/ PEG 6000
Polysorbate 80 (E433)
For 2 mg: Iron Oxide Yellow (E172)
What Granisetron looks like and contents of the pack
Granisetron 1 mg: White to off-white film coated triangular shaped biconvex tablet debossed with “G1” on one side and plain
on the other side.
Granisetron 2 mg: pale yellow to yellow colour triangular shaped biconvex film coated tablet debossed with “104” on
one side and logo on other side.
Packed in PVC/PVdC/Aluminium blister pack of 5 or 10 film-coated tablets.
Not all pack sizes may be marketed.
Manufacturer and Marketing Authorisation Holder
Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED. United Kingdom
This leaflet was last revised on
Source: Medicines and Healthcare Products Regulatory Agency