Consumer Medicine Information

ZOFRAN ZYDIS™

Ondansetron hydrochloride dihydrate wafers 4mg and 8mg

What is in this leaflet?

Please read this leaflet carefully before you start taking Zofran Zydis.

This leaflet answers some common questions about Zofran Zydis. It does not contain all of the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Sometimes new risks are found even when a medicine has been used for many years. Your doctor has weighed the risks of you taking Zofran Zydis against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this information with your medication. You may need to read it again.

What Zofran Zydis are used for

Zofran Zydis is used to help stop the nausea (sick feeling) and vomiting which can occur after certain treatments such as chemotherapy and radiotherapy. They are also used for the prevention of nausea and vomiting, which can occur after an operation. Zofran Zydis wafers should only be used to treat the nausea and vomiting for which they have been prescribed.

Zofran Zydis wafers are not addictive.

Zofran Zydis is only available on the prescription of a doctor.

Before you use Zofran Zydis

When you must not use them

• Do not take Zofran Zydis if you have ever had an allergic reaction to ondansetron or any of the other ingredients in Zofran Zydis which are listed at the end of this leaflet.
• Do not use Zofran Zydis after the expiry or "use by" date (EXP) printed on the pack. If you take it after the expiry date it may not work as well.
• Do not use Zofran Zydis if the packaging is torn or shows signs of tampering or if the wafers look damaged or discoloured.

Before you take Zofran Zydis

• Tell your doctor if you are pregnant, trying to become pregnant or breast feeding. Your doctor can discuss the risks and benefits of using Zofran Zydis with you.
• If you have had to stop taking another medicine for your nausea or vomiting, tell your doctor.
• If you are allergic to any foods, dyes, preservatives or any other medicine, tell your doctor.
• If you have or used to have liver problems, tell your doctor
• Tell your doctor if you are constipated
• If you have a condition called phenylketonuria because Zofran Zydis contain aspartame.

Taking other medicines

Tell your doctor the names of any medicines you are taking, including those you buy without a prescription from a pharmacy, supermarket or health food shop.

In particular, tell your doctor if you are taking:

• Carbamazepine (Tegretol™, Teril™) - a medicine for epilepsy, bipolar disorder and some pain conditions
• Rifampicin (Rifadin™, Rifanah™) - an antibiotic used for tuberculosis and other infections
• Phenytoin (Dilantin™) - a medicine for epilepsy
• Tramadol (Tramal™, Zytram™) - a medicine for pain

Some medicines may affect the way other medicines work. Your doctor or pharmacist will be able to tell you what to do when taking Zofran with other medicines.

Taking Zofran Zydis

How to take them

The Pharmacist's label on the pack will tell you how many Zofran Zydis wafers to take and how often to take them. If there is anything that you do not understand, ask your doctor or pharmacist.

DO NOT take MORE Zofran Zydis than your doctor or pharmacist tells you.

If you vomit within one hour of taking your first Zofran Zydis wafer of each course prescribed for you, you should take the same dose again. If you continue to vomit, tell your doctor.

Place the Zofran Zydis on top of the tongue, where it will dissolve within seconds, then swallow.

If your nausea (feeling of sickness) or vomiting does not go away, ask your doctor what to do.

If you forget to take them

If you miss your dose and you do not feel sick take your next dose when you are meant to.

If you miss your dose, and you feel sick, take the missed dose as soon as possible, then go back to taking your Zofran Zydis as you would normally. If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Do not double the dose.

Things to be careful of

• Do not give your Zofran Zydis to anyone else.
• Only take your Zofran Zydis for the reason they have been prescribed. Do not use them for anything else, including nausea from other causes.
• Zofran should not affect your ability to drive or operate machinery.

Overdose

If you accidentally take more Zofran Zydis than you have been told, immediately contact your nearest Accident and Emergency department or poison centre (phone 0800 POISON or 0800 764 766), or tell your doctor without delay. Do this even if you feel well.

Keep telephone numbers for these places handy.

If you are not sure what to do, contact your doctor or pharmacist.

Side-Effects

Like all medicines, Zofran Zydis may cause some side effects. Sometimes they are serious, most of the time they are not. Your doctor or pharmacist will be able to answer any questions you may have.

Tell your doctor if you notice any of the following side effects and they worry you:

• headache
• a sensation of warmth or flushing
• constipation
• hiccups.

These are all mild side effects. There is no immediate reason to stop taking your medication unless you are concerned.

Tell your doctor immediately or go to your nearest Accident and Emergency department if you notice any of the following side effects:

• 'wheezy' symptoms
• chest pain or tightness of chest
• changes in the way your heart beats eg if you notice it beating faster or slower than normal, or if it beats irregularly or if it 'throbs'
• low blood pressure
• fits or convulsions
• swelling of the eyelids, face, lips, mouth or throat which may cause difficulty in swallowing or breathing
• skin rash, skin lumps or hives
• problems with muscles or movement.

These are all serious side effects. You may need urgent medical attention. Serious side effects are rare.

If you feel unwell or have any symptoms that you do not understand, you should tell your doctor immediately.

Storage

Keep your Zofran Zydis:

• In a place where children cannot reach them. A locked cupboard at least one- and-a half metres above the ground is a good place to store medicines.
• In the pack until it is time to take them.
• In a cool, dry place (below 30°C). Do not leave them in the car on hot days.
• Away from bright sunlight.
• Do not store the medicine in a bathroom or near a sink. Humidity and heat can destroy some medicines.

Disposal

Return any unused medicine or medicine which is past its expiry date to your pharmacist.

Product description

What Zofran Zydis looks like

Your Zofran Zydis wafers come as white, round, fast dissolving wafers. The wafers are packed in foil blisters. There are 10 wafers in a pack.

Ingredients

Each wafer contains either 4 or 8 milligrams of ondansetron. Your doctor will decide which strength you need.

Your wafer also contains the following inactive ingredients which help to form the wafer: gelatin, mannitol, aspartame,sodium methyl hydroxybenzoate, sodium propyl hydroxybenzoate,and strawberry flavour.

Manufacturer

Your Zofran Zydis is supplied by:

GlaxoSmithKline NZ
Quay Tower
Cnr Albert and Customs St
Private Bag 106600
Downtown Auckland
New Zealand

Ph: (09) 367 2900
Fax: (09) 367 2910

Further Information

Your doctor or pharmacist is the best person to give you advice on the treatment of your condition. You may also be able to find general information about your illness and its treatment from other sources, for example from books in public libraries.

Do not throw this leaflet away. You may want or need to read it again.

The information provided applies only to:
Zofran Zydis.

Zofran™ Tablets are a registered trademark of the GlaxoSmithKline Group of Companies. Zydis™ is a trademark of RP Scherer Corporation.

This leaflet is copyrighted to GlaxoSmithKline and may be reproduced but not altered in any way.

Issue 2, Jan 2004.