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10mm I    24mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ondansetron 4mg Film-coated Tablets Ondansetron 8mg Film-coated Tablets

Read all of this leaflet carefully before you start to take your 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1.    What Ondansetron Tablets are and what they are used for

2.    What you need to know before you take Ondansetron Tablets

3.    How to take Ondansetron Tablets

4.    Possible side effects

5.    How to store Ondansetron Tablets

6.    Contents of the pack and other information_

11. What Ondansetron Tablets are and what they are used for|

The name of your medicine is Ondansetron 4mg or 8mg film-coated tablets, which will be referred as Ondansetron tablets throughout the leaflet. The active ingredient is Ondansetron hydrochloride dihydrate.

Ondansetron belongs to a group of medicines called anti-emetics.

Ondansetron tablets are used for:

•    preventing nausea and vomiting caused by chemotherapy or radiotherapy for cancer (in adults only)

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

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

| 2. What you need to know before you take Ondansetron Tablets |

Do not take Ondansetron Tablets if you:

•    are allergic to Ondansetron or to any of the other ingredients in the tablet (listed in Section 6)

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

If you are not sure, talk to your doctor or pharmacist before taking Ondansetron tablets.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Ondansetron tablets if you:

•    have a blockage in your gut

•    have liver problems

•    have ever had ‘heart problems' (e.g. congestive heart failure which causes shortness of breath and swollen ankles)

•    have an uneven heartbeat (arrhythmia)

•    are allergic to medicines similar to Ondansetron such as Granisetron (known as 'Kytril')

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

•    have liver problems

Other medicines and Ondansetron tablets

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, or might take any other medicines. This is because Ondansetron can affect the way some medicines work. Also some other medicines can affect the way Ondansetron works.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

•    medicines used to treat epilepsy e.g. phenytoin, carbamazepine

•    medicines used to treat infection e.g. rifampicin

•    pain killer e.g. tramadol

•    anti-arrhythmic medicines used to treat an uneven heart beat

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

•    cancer medicines especially anthracyclines and trastuzumab

•    antibiotics such as erythromycin or ketoconazole

•    medicines that affect the heart (such as haloperidol or methadone)

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

•    SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine. Pregnancy and breast feeding and fertility

•    It is not known if Ondansetron is safe during pregnancy. However, the use of Ondansetron is not recommended during pregnancy.

•    Ondansetron may pass into the mother's milk. DO NOT take these tablets if you are breast-feeding.

•    Always ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or think you may be pregnant. Driving and using machines

•    Ondansetron has no or negligible influence on the ability to drive and use machines.

Ondansetron tablets contain Lactose

•    If you have been previously told by your doctor that you have intolerance to some sugars (such as lactose), contact your doctor before taking this medicine.

| 3. How to take Ondansetron Tablets]

•    Always take these tablets exactly as your doctor has told you.

•    You should check with your doctor or pharmacist if you are not sure.

•    The number of tablets you need will depend on your condition.

•    The tablets should be swallowed whole with a little glass of water.

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 to 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.

SAME SIZE ARTWORK

150 x 260 mm

Front

10mm    24mm

Children aged over 6 months and adolescents:

The doctor will decide the dose depending on the child's size (body surface area) or weight. 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 Children aged over 1 month and adolescents

It is recommended that Ondansetron is given as an intravenous injection (medicines given into one of your veins).

Patients with moderate or severe liver disease

•    Total daily dose should not be more than 8 mg. Ondansetron tablets should start 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 otherwise, do not take more Ondansetron tablets than the label says. If you continue to feel sick, tell your doctor or nurse.

If you forget to take Ondansetron tablets

•    If you miss a dose and feel sick or vomit take a tablet as soon as possible and then carry on as before.

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 take more tablets than you should

It is important to stick to the dose on the label. Taking more than this could make you ill. If you accidentally take too many tablets, tell your doctor immediately or contact your nearest Hospital Casualty/Accident and Emergency Department even if there are no signs of discomfort. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily.

I 4. Possible Side Effects I

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

Stop taking this medicine and tell your doctor immediately if you suffer from any of the following:

•    Allergic reaction: Symptoms of which may include sudden wheeziness and chest pain or dizziness; swelling of the eyelids face or lips; skin rash - red spots or hives (also known as nettle rash or urticaria); or collapse.

Other side effects include:

Very common (affects more than 1 in 10 people)

•    Headache

Common (affects less than 1 in 10 people)

•    A feeling of warmth or flushing

•    Constipation

Uncommon (affects less than 1 in 100 people)

•    Hiccups

•    Slow or uneven heart beat

•    Low blood pressure which can make you feel lightheaded or dizzy

•    Changes to liver function blood test results (This side effect is common if you take ondansetron with a chemotherapy medicine called Cisplatin).

•    Chest pain

•    Fits, unusual body movements or shaking Rare (affects less than 1 in 1,000 people)

•    Feeling dizzy or light headed

•    Blurred vision

•    Disturbance in heart rhythm (sometimes causing a sudden loss of consciousness)

Very rare (affects less than 1 in 10,000 people)

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

If you feel unwell or have any other unusual discomfort you don't understand, it is important to tell your doctor as soon as possible.

If your sickness does not get better whilst taking Ondansetron, then tell your doctor.

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 Cara Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

15. How to Store Ondansetron Tablets!

•    Keep out of the sight and reach of children

•    Do not store above 25°C. Store in the original package.

•    Do not use the tablets after the expiry date shown on the carton or label after (EXP). The expiry date refers to the last date of that month.

•    Do not throw away    any medicines via waste water or household waste. Ask your pharmacist how    to dispose of medicines you no longer

use. These measures will help protect the environment._

| 6. Contents of the pack and other information |

What Ondansetron tablets contain

•    The active substance in Ondansetron tablets is Ondansetron (as Ondansetron hydrochloride dihydrate).

•    The other ingredients in Ondansetron tablets are - lactose, pregelatinised starch, microcrystalline cellulose, magnesium stearate, hypromellose, titanium dioxide (E171) and ferric oxide yellow (E172).

What Ondansetron tablets look like and contents of the pack.

•    Ondansetron 4 mg    tablets are yellow coloured, oval biconvex, film coated tablets embossed with    'BL' on one face and '4' on the other.

•    Ondansetron 8 mg    tablets are yellow coloured, oval biconvex, film coated tablets embossed with    'BL' on one face and '8' on the other.

•    The tablets are supplied in packs containing 10, 30 or 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Name ana    address:    Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom Telephone:    0044 (0)1442 200922

Fax:    0044 (0)1442 873717

Email:    info@bristol-labs.co.uk

Ondansetron 4mg Film-Coated Tablets; PL 17907/0058 Ondansetron 8mg Film-Coated Tablets; PL 17907/0059 This leaflet was last revised in August 2014

To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.    vi 22-08-14 do

SAME SIZE ARTWORK

150 x 260 mm

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