Granisetron 1 Mg Film-Coated Tablets
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.
- 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 or pharmacist.
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.
Take special care with Granisetron
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 use like granisetron in the treatment and prevention of nausea and vomiting.
Children
Children should not take these tablets.
Taking other medicines
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.
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 affect 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 upto 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 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, 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 swallowing.
Other side effects that may be experienced while taking this medicine are:
Very common: affects more than 1 user in 10
- headache
- 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
- diarrhoea.
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.
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 or pharmacist.
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 that month.
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:
Tablet Core:
Cellulose Microcrystalline (E460),
Sodium Starch Glycolate (Type A),
Lactose Monohydrate,
Hypromellose (E464),
Magnesium stearate (E572).
Film Coating:
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.
Marketing Authorisation Holder
DAWA Limited.
5 Sandridge Close,
Harrow, Middlesex HA1 1XD,
United Kingdom.
Manufacturer
Orchid Europe Ltd.
Building 3, Chiswick Park,
566 Chiswick High Road,
Chiswick, London W4 5YA United Kingdom.
This medicinal product is authorised in the Member states of the EEA under the following names:
Portugal - Granissetrom Orchid Europe 1 mg & 2 mg Comprimidos revestido por pelfcula
Romania - Granored 1 mg & 2 mg Comprimate filmate
United Kingdom - Granisetron 1 mg & 2 mg Film-coated tablets