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Granisetron 2mg Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

GRANISETRON 1 mg TABLETS GRANISETRON 2 mg 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 get 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

Granisetron belongs to a group of medicines known as '5-HT3 receptor antagonists' or anti-emetics or anti-sickness medicines. These tablets are only for use in adults. It is used to prevent or treat nausea (feeling sick) and vomiting (being sick) caused by other medical treatments, such as chemotherapy or radiation treatment for cancer.

2.    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). If you are not sure, talk to your doctor, nurse or pharmacist before taking these tablets.

Take special care with Granisetron

You should tell your doctor before taking this medicine if you:

•    have a blockage in the intestine (gut) causing symptoms such as stomach ache, wind, feeling or being sick, or difficulty passing stools.

•    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 in the treatment and prevention of nausea and vomiting.

Children

Children should not take these tablets.

Taking other medicines

Please tell your doctor 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 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

Granisetron should not be given to pregnant or breast-feeding mothers unless the benefits to the mother outweigh the risks to the baby. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Granisetron should not affect your ability to drive or operate machinery.

Important information about some of the ingredients of Granisetron

This medicine contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicine.

3.HOW TO TAKE GRANISETRON

Always take Granisetron exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Swallow the tablets with a glass of water.

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.

Your doctor may also give you another medicine called dexamethasone to take as well.

Children

Granisetron is not suitable for children.

If you take more Granisetron than you should

Contact your doctor or go to the nearest hospital casualty department immediately. Take the container and any remaining tablets with you. The symptoms of overdose include mild headaches. You will be treated depending on your symptoms.

If you forget to take Granisetron

Take it as soon as you remember unless it is nearly time for your next dose. Do not take two doses together to make up for the one you have missed.

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. Speak to your doctor first if you wish to stop taking this medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Granisetron 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, difficultly 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 get serious or you notice any side effects not mentioned in this leaflet, please tell your pharmacist or doctor.

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 or label after 'EXP. The expiry date refers to the last day of that month. There are no special storage conditions for this medicine. 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 to protect the environment.

6. FURTHER INFORMATION

What Granisetron contains

The active substance is 1 mg or 2 mg of granisetron as the hydrochloride. The other ingredients are lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate, magnesium stearate, titanium dioxide (E171), hypromellose, macrogol, polysorbate.

What Granisetron looks like and contents of the pack - Your medicine comes as a film-coated tablet. The tablets are white to off-white. The 1 mg strength Tablets are marked 'GS' on one side and the 2 mg strength are marked 'GS2' on one side. Granisetron is available in plastic bottles or blister packs of 1, 2, 4, 5, 6, 7, 10, 14, 20, 28, 30, 50, 90, 100, 150, 200, 250 and 500 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Generics [UK] Ltd t/a Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

Manufacturers

Generics [UK] Limited, Potters Bar,

Hertfordshire, EN6 1TL, United Kingdom.

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

This leaflet was last

revised in: 02/2015    571822