Granisetron 2mg Film-Coated Tablets
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, pharmacist or nurse.
- 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Granisetron Film-coated Tablets are and what they are used for
2. What you need to know before you take Granisetron Film-coated Tablets
3. How to take Granisetron Film-coated Tablets
4. Possible side effects
5. How to store Granisetron Film-coated Tablets
6. Contents of the pack and other information
1. What Granisetron Film-coated Tablets are and what they are used for
Granisetron belongs to a group of medicines called ‘5-HT3 receptor antagonists’ or ‘anti-emetics’. These tablets are only for use in adults.
Granisetron Film-coated Tablets are 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 Film-coated Tablets Do not take Granisetron Film-coated Tablets:
• 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, pharmacist or nurse before taking these tablets.
Warnings and precautions
Check with your doctor, pharmacist or nurse 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 antagonist’ medicines. These include dolasetron, ondansetron used like Granisetron Film-coated Tablets in the treatment and prevention of nausea and vomiting.
Children
Children should not take these tablets.
Other medicines and Granisetron Film-coated Tablets
Tell your doctor, pharmacist or nurse 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, pharmacist or nurse 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 Film-coated Tablets” 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
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.
Driving and using machines
Granisetron Film-coated Tablets have no or negligible affect on your ability to drive or use any tools or machines.
Granisetron Film-coated Tablets 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 Film-coated Tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.
The dose of Granisetron Film-coated Tablets 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 Film-coated Tablets 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 Film-coated Tablets 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 Film-coated Tablets
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 Film-coated Tablets
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 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: 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 Film-coated Tablets
Keep this medicine out of the sight and reach of children
Do not use this medicine after the expiry date which is stated on the carton and blister foil (EXP). The expiry date refers to the last day of that month.
Granisetron Film-coated Tablets do 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 Film-coated Tablets contain
Granisetron Film-coated Tablets are available in two different strengths.
The active substance is granisetron. Each tablet contains 1 mg or 2 mg of granisetron (as hydrochloride).
The other ingredients are:
Tablet Core Lactose anhydrous Microcrystalline cellulose Sodium starch glycolate Hypromellose Magnesium stearate
Film Coating Polyvinyl alcohol Titanium dioxide (E171)
Macrogol 3350 Talc
What Granisetron Film-coated Tablets look like and contents of the pack
engraved on engraved on
Granisetron 1 mg Film-coated Tablets are triangular, white and biconvex. They have “G1” one side.
Granisetron 2 mg Film-coated Tablets are triangular, white and biconvex. They have “G2” one side.
Pack sizes:
*(only the actual marketed pack sizes will be stated on the leaflet)
Both strengths are available in blister packs of 1, 2, 5, 10 and 20 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aptil Pharma Limited 9th Floor, CP House 97-107 Uxbridge Road, Ealing London W5 5TL
Manufacturer:*
Actavis hf Reykjavikurvegi 78 IS-222 Hafnarfjordur Iceland Or
Actavis Ltd
BLB016 Bulebel Industrial Estate Zejtun ZTN 3000 Malta
*(the actual leaflet will only refer to the batch release site that is utilized)
This leaflet was last revised in 04/2012