GRANISETRON 2 MG FILM-COATED TABLETS - Patient leaflet, side effects, dosage

u.o i: 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, nurse 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, pharmacist or nurse. 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

3. 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. what you need to know before you take granisetron

Do not take Granisetron tablets

1 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.

Warnings and precautions

Talk to your doctor, nurse or pharmacist before using these tablets, if you:

1 are having problems with your bowel movements because of a blockage of your gut (intestines).

1 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.

Serotonin syndrome is an uncommon but potentially ife-threatening reaction that can occur with granisetron (see section 4).

The reaction can occur if you take granisetron alone out it is more likely to occur if you take granisetron with certain other medicines (in particular fluoxetine, oaroxetine, setraline, fluvoxamine, citalopram, sscitalopram, venlafaxine, duloxetine. Be sure to tell /our doctor, nurse or pharmacist all the medicines /ou are taking.

Children

Children should not take these tablets

Other medicines and Granisetron

Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, ncluding 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 /ou 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.

• ■ SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety. Examples are fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram.

• SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety. Examples are venlafaxine, duloxetine.

Pregnancy, Breast-feeding and Fertility

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. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before taking any medicine.

Driving and using machines

Granisetron has no or negligible effect on your ability to drive or use any tools or machines.

Granisetron Tablets contain lactose

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.

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium free”.

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.

Swallow the tablets with a glass of water.

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

Children

Granisetron is not suitable for children.

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.

Margin 10 mm

Margin 10 mm

Do not take a double dose to make up for a forgotten The other ingredients are: dose. Tablet Core: If you stop taking Granisetron Cellulose Microcrystalline (E460), Do not stop taking your medicine before the Sodium Starch Glycolate (Type A), treatment is finished. If you do stop taking your Lactose Monohydrate, medicine, your symptoms may return. Hypromellose (E464), If you have any further questions on the use of this Magnesium stearate (E572). medicine, ask your doctor, nurse or pharmacist. Film Coating: HPMC 2910/ Hypromellose 6 cP (E464),

4. possible side effects                      titanium dioxide (e171),

Like all medicines, Granisetron can cause side Macrogol/ PEG 6000,

effects, although not everybody gets them. If you Polysorbate 80 (E433),

notice the following problem you must see a doctor For 2 mg: Iron Oxide Yellow (E172).

straight away: What Granisetron looks like and contents of the

• ■ allergic reaction (anaphylaxis). The signs may pack

include swelling of the throat, face, lips and mouth, Granjsetron 1 mg: White to off-white film coated difficulty in breathing or swallowing. triangular shaped biconvex tablet debossed with

Other side effects that may be experienced while ” on one side and plain on the other side,

taking this medicine are: Granisetron 2 mg: pale yellow to yellow colour

Very common: may affect more than 1 in 10 people triangular shaped biconvex film coated tablet ■ headache debossed with “104” on one side and logo on other

• constipation. Your doctor will monitor your condition, side.

Common: may affect up to 1 in 10 people Packed in PVC/PVdC/Aluminium blister pack of 5 or

• ■ problems sleeping (insomnia) 10 f^-coated tablets.

• changes in how your liver is working shown by Not all pack sizes may be marketed.

blood tests Marketing Authorisation Holder and Manufacturer

• diarrhoea. Crescent Pharma Limited,

Uncommon: may affect up to 1 in 100 people Units 3 & 4,

• skin rashes or an allergic skin reaction or Quidhampton Business Units,

“nettle-rash” or “hives” (urticaria). The signs may Polhampton Lane, Overton,

include red, raised itchy bumps Hants, RG25 3ED, United Kingdom

• changes in the heartbeat (rhythm) and changes This |eaflet was |ast revised in 06/2021

seen on ECG readings (electrical recordings of the heart)

• ■ abnormal involuntary movements, such as shaking, muscle rigidity and muscle contractions.

• Serotonin Syndrome. The signs may include diarrhoea, nausea, vomiting, high temperature and blood pressure, excessive sweating and rapid heartbeat, agitation, confusion, hallucination, shivering, muscle shakes, jerks or stiffness, loss of coordination and restlessness.

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.

Th is 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.

M.L.N0. TN00002222/2006

948026743

P17797

Margin 10 mm

Margin 10 mm