Granisetron 2 Mg Film-Coated Tablets
Out of date information, search anotherPACKAGE LEAFLET: INFORMATION FOR THE USER Granisetron 2 mg Film-coated Tablets (Granisetron)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 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 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
The name of your medicine is Granisetron 2 mg Tablets. Granisetron tablets are film-coated and contain the active ingredient granisetron. The tablets are available in two strengths. Each Granisetron tablet contains either 1 milligram or 2 milligrams of granisetron as the hydrochloride.
Granisetron is one of a group of drugs called 5-HT3 receptor antagonists which act as anti-emetics.
Granisetron tablets are used to prevent nausea (feeling sick) and vomiting (being sick) after certain types of treatment, such as chemotherapy or radiotherapy.
These tablets can stop you feeling or being sick, and are especially useful when you need to have medical treatment that may cause you to feel or be sick, for example, chemotherapy or radiotherapy.
2. BEFORE YOU TAKE GRANISETRON
Do not take Granisetron if you are allergic (hypersensitive) to:
- granisetron or other ingredients in these tablets
- other similar medicines (5-HT3receptor antagonists), such as dolasteron, ondansetron, palonosetron and tropisetron.
If you are not sure, talk to your doctor or pharmacist before taking Granisetron.
Take special care with Granisetron
Check with your doctor or pharmacist before taking Granisetron if:
- you are having problems with your bowel movements because of a blockage in your bowels (intestines).
- it has been prescribed for a child under 12 years of age as Granisetron is not recommended for children.
- you have been told by your doctor that you have an intolerance to some sugars as these tablets contain lactose.
- you are having blood tests, because Granisetron can sometimes affect liver function tests.
Taking other medicines
- Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines bought without a prescription and herbal medicines. This is because Granisetron can affect the way some medicines work. Also, some medicines can affect the way Granisetron works.
- If you go into hospital, let the medical staff know you are taking Granisetron.
Pregnancy and breast-feeding
You should not take Granisetron if you are pregnant or are breast-feeding unless your doctor has specifically recommended it. If you are required to take Granisetron you should stop breast-feeding during treatment with this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Your medicine is unlikely to affect your ability to drive or to operate machinery.
Important information about some of the ingredients of Granisetron
This medicinal product 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. Also read the label. You should check with your doctor or pharmacist if you are not sure.
Take Granisetron Tablets within one hour before the start of chemotherapy or radiotherapy. Swallow the tablet whole with a drink of water.
The usual dosages are either:
Adults and children over 12 years of age
- One 1 mg tablet within one hour before the start of chemotherapy or radiotherapy and another 1 mg tablet 12 hours later. Or
- One 2 mg tablet within one hour before the start of chemotherapy or radiotherapy treatment only.
Children under 12 years of age
Granisetron is not recommended in this age group
If you take more Granisetron than you should
If you take more Granisetron than you should, contact your doctor. In the case of an overdose, contact the nearest hospital casualty department immediately.
If you forget to take Granisetron
It is important to take your tablets as directed to prevent you feeling sick. If you forget to take a dose, and feel sick, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose. If you are worried, ask your doctor or pharmacist for advice.
If you stop taking Granisetron
Do not stop taking your tablets, even if you are feeling well, unless your doctor tells you.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Cipla Inventory Code
Font : Times New Roman Bodytext: 9pt Heading text: 10pt Main Heading text: 12pt
4. POSSIBLE SIDE EFFECTS
Like all medicines, Granisetron can cause some side effects, although not everybody gets them.
Contact your doctor or seek medical help immediately if you experience any of the following:
- swelling of the face, lips, tongue or throat or difficulty breathing or swallowing. It may be accompanied by a rash or itching.
This is a serious but very rare side effect (affecting fewer than one in every 10,000 users) due to a severe allergic reaction to this medicine.
Very rarely, less severe allergic reactions causing mild skin rashes may also occur.
In addition, the following side effects have been reported with this medicine.
Very common (affecting more than 1 in 10 users):
- headache
- nausea (feeling sick)
- constipation
Common (affecting more than 1 in 100, but fewer than 1 in 10 users):
- reduced appetite
- diarrhoea
- vomiting (being sick)
- abdominal pain
- weakness and fatigue
- pain
- fever
Rare (affecting fewer than 1 in 1000, but more than 1 in 10,000 users):
- effects on the liver and liver function tests
- effects on heart rhythm which may cause palpitations or an irregular heart beat
- chest pain
Very rare (affecting fewer than 1 in 10,000 users):
- loss of appetite (anorexia)
- coma
- fainting
- dizziness
- insomnia
- movement disorders which may affect walking
- agitation
If any of the side effects gets serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE GRANISETRON
Keep out of the reach and sight 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.
Keep the tablets in the original package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. FURTHER INFORMATION
What Granisetron contains
- The active substance is Granisetron.
- The other ingredients of the tablet core are microcrystalline cellulose, lactose monohydrate, sodium starch glycollate, maize starch, magnesium stearate.
- The film coat contains hypromellose 15cP, titanium dioxide (E171), macrogol 6000.
Remember: These tablets have been prescribed just for you. Never offer your tablets to other people. They may not be suitable for them, even if their symptoms seem the same as yours.
What Granisetron looks like and contents of the pack
Granisetron 2 mg Film-coated Tablets are white to off white, barrel shaped, film coated, biconvex tablets with ‘G2’ debossed on one side and plain on the other side.
Granisetron 2 mg Film-coated Tablets are available in packs of 5 tablets.
Granisetron tablets are also available as 1 mg Tablets in a pack of 10 tablets.
Marketing Authorisation Holder
Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW.
Manufacturer:
Recipharm Limited, Vale of Bardsley, Ashton-Under-Lyne, Lancashire, OL7 9RR, United Kingdom.
Marketed and Distributed By:
APC Pharmaceuticals & Chemicals (Europe) Limited, 9th floor, C.P. House, 97 - 107 Uxbridge Road, Ealing, London, W5 5TL. This leaflet was last revised in November 2012.
in
it
XXXXX <
<v
T3
O
d
CD
_d
TO
Q.
O