Granisetron 2mg 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 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. 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 other information
1. 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 (hypersensitive) to granisetron or any of the other ingredients of this medicine (listed in section 6 Further information and “Important information about some of the ingredients of granisetron film-coted tablets” below).
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 haveing 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 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 “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 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 affect on your ability to drive or use any tools or machines.
Granisetron contains lactose
This medicine 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..
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::
- 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):
- Diarrhoea,
- Problems sleeping (insomnia)
- Changes in how your liver is working shown by blood tests.
Uncommon (affects 1 to 10 users 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 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 as follows:
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 Sante S.A., Rue Bellocier, 89107 Sens, France OR
Marketing Authorisation holder: TEVA UK Limited, Eastbourne, BN22 9AG. Company responsible for manufacture: TEVA Pharmaceutical Works Private Limited Company, Pallagi ut 13, 4042 Debrecen, Hungary OR
Marketing Authorisation holder: TEVA UK Limited, Eastbourne, BN22 9AG. Company responsible for manufacture: TEVA Pharmaceutical Works Private Limited Company, Tancsics Mihaly ut 82, H-2100 Godollo, 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 July 2013
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Only the paragraph containing the details of the current batch release site will be included in the printed version of the PIL