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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Ondansetron 4 mg & 8 mg Tablets

{Ondansetron hydrochloride dihydrate}

Read all of this leaflet carefully before you start taking this medicine as it contains information useful 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. Do not pass it on to others. It may harm them, even if their symptoms 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 Ondansetron is and what it is used for

2.    What you need to know before you take Ondansetron

3.    How to take Ondansetron

4.    Possible side effects

5.    How to store Ondansetron

6.    Contents of the pack and other information

The active ingredient in your tablets, Ondansetron, belongs to a group of medicines known as anti-emetics. Ondansetron tablets are used for:

•    Preventing nausea and vomiting caused by chemotherapy or radiotherapy for cancer (in adults and children)

•    Preventing nausea and vomiting after surgery (adults only).

Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ONDANSETRON

Do not take Ondansetron Tablets:

•    If you are taking apomorphine (used to treat Parkinson's disease).

•    If you are allergic (hypersensitive) to ondansetron or any of its ingredients.

•    If you have been told that you have an intolerance to some sugars. These tablets contain lactose.

Warnings and Precautions.

Talk to your doctor or pharmacist before taking ondansetron.

•    If you are allergic (hypersensitive) to medicines similar to ondansetron known as 5HT3 antagonists

•    If you suffer from severe constipation, or have you been told you have a blockage in your gut.

•    If you have heart problems (heart rhythm or conduction disorders) and are being treated with other medicines known as anti-arrhythmic or beta-blockers at the same time.

•    If you suffer from any liver problems

•    If you have problems with the levels of salts in your blood, such as potassium, sodium and magnesium.

Children and adolescents

Children receiving ondansetron with drugs that are harmful to liver should undergo regular check up for liver problems.

Other medicines and Ondansetron

Ondansetron may have an effect on other drugs or other drugs may have an effect on Ondansetron.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, natural supplements or vitamins or minerals.

You must tell your doctor that you are taking Ondansetron, if he/she starts treating you with any of the following medicines:

•    Anti-arrhythmics medicines such as amiodarone used to treat an uneven heart beat

•    Phenytoin or carbamazepine, used to treat epilepsy

•    Rifampicin, an antibiotic used to treat infections

•    Tramadol, a pain relieving medicine.

•    Beta-blocker medicines used to treat certain heart or eye problems, anxiety or prevent migraines

•    Medicines that affect the heart

•    Cancer medicines (especially anthracyclines and trastuzumab).

•    Serotonergic drugs (selective serotonin reuptake inhibitors and serotonin noradrenaline reuptake inhibitors); which are used to treat psychiatric conditions.

Contact your doctor. It may be necessary to adjust the dose.

Taking Ondansetron Tablets with food and drink

You may take Ondansetron tablets with food and drinks. The tablets should be taken with a glass of water. Pregnancy:

Do not take Ondansetron Tablets if you are pregnant. This is because safety of ondansetron for use in human pregnancy has not been established.

Breast-feeding:

Do not take Ondansetron Tablet if you are breast-feeding, because it is excreted into the milk.

Driving and using machines

Ondansetron may cause problems with your vision. If affected do not drive or operate machinery.

Psychomotor testing (testing of brain and body coordination) does not impair performance nor cause sedation.

Ondansetron contains lactose monohydrate

Ondansetron Tablet contains lactose monohydrate. Contact your doctor before taking this medicine if your doctor has told you that you do not tolerate certain types of sugar.

3. HOW TO TAKE ONDANSETRON

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

To prevent nausea and vomiting from chemotherapy or radiotherapy

On the day of chemotherapy or radiotherapy

•    The usual adult dose is 8 mg taken one or two hours before treatment and another 8 mg twelve hours after.

On the following days

•    The usual adult dose is 8 mg twice a day

•    This may be given for up to 5 days.

Children aged over 6 months and adolescents

The doctor will decide the dose. Look at the label for more information.

•    The usual dose for a child is up to 4 mg twice a day

•    This can be given for up to 5 days.

To prevent nausea and vomiting after an operation The usual adult dose is 16 mg before your operation or

•    8mg before the operation, then

•    8mg after the operation, then

•    8mg after a further eight hours.

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PACKAGING DEVELOPMENT

Children aged over 1 month and adolescents

It is recommended that Ondansetron is given as an injection.

Patients with moderate or severe liver problems The total daily dose should not be more than 8 mg.

Ondansetron Tablets should start to work within one or two hours of taking a dose.

If you are sick (vomit) within one hour of taking a dose

•    Take the same dose again but ensuring that you do not take more Ondanseron Tablets than the label says.

If you continue to feel sick, tell your doctor or nurse.

If you take more Ondansetron Tablets than you should

If you take more Ondansetron Tablets than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to take Ondansetron Tablets If you miss a dose and feel sick or vomit:

•    Take Ondansetron Tablets as soon as possible, then

•    Take your next tablet at the usual time (as shown on the label)

•    Do not take a double dose to make up for a forgotten dose.

If you miss a dose but do not feel sick

•    Take the next dose as shown on the label do not take a double dose to make up for a forgotten dose.

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

Like all medicines, Ondansetron can cause side effects, although not everybody gets them.

Allergic reactions

If you have an allergic reaction, stop taking it and see a doctor straight away. The signs may include:

•    Sudden wheezing and chest pain or chest tightness

•    Swelling of your eyelids, face, lips, mouth or tongue

•    Skin rash - red spots or lumps under your skin (hives) anywhere on your body

•    collapse.

Other side effects include:

Very common (may affect more than 1 in 10 people)

•    Headache.

Common (may affect up to 1 in 10 people)

•    A feeling of warmth or flushing

•    Constipation

Uncommon (may affect up to 1 in 100 people)

•    Hiccups

•    Low blood pressure, which can make you feel faint or dizzy

•    Uneven heart beat

•    Chest pain

•    Fits

•    Unusual body movements or shaking.

•    Changes to liver function test results (this side effect may be "common'' if Ondansetron tablets are taken with cisplatin)

Rare (may affect up to 1 in 1,000 people)

•    Feeling dizzy or light headed

•    Blurred vision.

Very rare (may affect up to 1 in 10,000 people)

•    Poor vision or temporary loss of eyesight, which usually comes back within 20 minutes.

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.

•    Keep this medicine out of the sight and reach of children.

•    Do not use Ondansetron Tablets after the expiry date which is stated on the pack after ‘Exp’.

•    Store in the original package. Keep blister in the outer carton.

•    If your doctor tells you to stop taking Ondansetron Tablets, it is important to return any which are left over to your pharmacist.

What Ondansetron contains

The active substance is Ondansetron hydrochloride dihydrate

The other ingredients are: Lactose monohydrate, Microcrystalline cellulose, Maize starch Magnesium stearate.

Tablet coat: Hypromellose, Titanium dioxide E171, Macrogol What Ondansetron Tablets looks like and contents of the pack

Ondansetron 4 mg Tablets are white, circular, biconvex, film coated tablet marked '4' on one side, plain on the other Ondansetron 8 mg Tablets are white, circular, biconvex, film coated tablet marked '8' on one side and with a deep breakline on the other.

Blister strips comprising PVC/PVdC/Aluminium foil enclosed in an outer carton. Pack sizes of 10, 30 or 100 tablets (not all packs may be marketed).

Marketing Authorisation Holder: Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey,

KT10 9NW, United Kingdom.

Manufacturer: Cipla (EU) Limited, 4^th Floor, 1 Kingdom Street, London, W2 6BY, United Kingdom This leaflet was last revised in March 2015.

Cipla

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