Zofran 16mg Suppositories
Package Leaflet: Information for the User
Zofran® 16mg Suppositories (ondansetron)
Read all of this leaflet carefully before you start using 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 about your illness or your medicine, 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 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, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• The name of this medicine is Zofran 16mg Suppositories but will be referred to as Zofran suppositories throughout the remainder of this leaflet.
What is in this leaflet:
1) What Zofran suppositories are and what they are used for
2) What you need to know before you use Zofran suppositories
3) How to use Zofran suppositories
4) Possible side effects
5) How to store Zofran suppositories
6) Contents of the pack and other information
1) WHAT ZOFRAN SUPPOSITORIES ARE AND WHAT THEY ARE USED FOR
Zofran suppositories contain a medicine called ondansetron. This belongs to a group of medicines called anti-emetics. Zofran suppositories are for use in your back passage only (rectal use). They should not be swallowed.
Zofran suppositories are used for:
• preventing nausea and vomiting caused by chemotherapy or radiotherapy for cancer
Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses.
2) WHAT YOU NEED TO KNOW BEFORE YOU USE ZOFRAN SUPPOSITORIES
Do not use Zofran suppositories if:
• you are taking apomorphine (used to treat Parkinson's disease)
• you are allergic (hypersensitive) to ondansetron or Witespol S58 in Zofran suppositories.
If you are not sure, talk to your doctor, nurse or pharmacist before using Zofran suppositories.
Warnings and precautions
Check with your doctor, nurse or pharmacist before using Zofran suppositories if:
• you have ever had heart problems (e.g. congestive heart failure which causes shortness of breath and swollen ankles)
• you have an uneven heart beat (arrhythmias)
• you are allergic to medicines similar to ondansetron, such as granisetron or palonosetron
• you have liver problems
• you have a blockage in your gut
• you have problems with the levels of salts in your blood, such as potassium, sodium and magnesium.
If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before using Zofran suppositories.
Other medicines and Zofran
Please tell your doctor, nurse or pharmacist if you are taking or have recently taken or might take other medicines. This includes medicines that you buy without a prescription and herbal medicines.
This is because Zofran can affect the way some medicines work. Also some other medicines can affect the way Zofran works.
In particular, tell your doctor, nurse or pharmacist if you are taking any of the following medicines:
• carbamazepine or phenytoin used to treat epilepsy
• rifampicin used to treat infections such as tuberculosis (TB)
• antibiotics such as erythromycin or ketoconazole
• 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
• tramadol, a pain killer
• medicines that affect the heart (such as haloperidol or methadone)
• cancer medicines (especially anthracyclines and trastuzumab)
• 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.
If you are not sure if any of the above applies to you, talk to your doctor, nurse or pharmacist before using Zofran suppositories.
Pregnancy and breast-feeding
It is not known if Zofran is safe during pregnancy. If you are pregnant, think you are pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using Zofran suppositories.
Do not breast-feed if you are using Zofran. This is because small amounts pass into the mother's milk. Ask your doctor or midwife for advice.
3) HOW TO USE ZOFRAN SUPPOSITORIES
Always use Zofran suppositories exactly as your doctor has told you. You should check with your doctor, nurse or pharmacist if you are not sure.
Dosage
On the day of chemotherapy or radiotherapy:
• the usual dose is one suppository (16mg) to be inserted 1 to 2 hours before treatment.
On the following days:
• the usual dose is one suppository (16mg) each day
• this may be repeated for up to 5 days.
Children
Zofran suppositories are not recommended for children.
Patients with moderate or severe liver problems
You should use Zofran as injection or tablets because the total daily dose should not be more than 8mg.
Using Zofran suppositories
1. Empty your bowels if you need to. Wash your hands.
2. Remove the suppository from its packaging by tearing the foil (see illustration on pack).
3. You may find that inserting the suppository is easier if you squat or bend forward.
4. Gently push the pointed end of the suppository into the back passage (rectum).
5. Push the suppository in as far as possible and remain still for a little while. This allows the suppository to melt so the medicine will work.
6. Wash your hands.
7. Try not to empty your bowels within 1 hour of inserting the suppository.
8. If your suppository comes out of your back passage, push it back in as far as possible and remain still for a while. Wash your hands again.
If you keep feeling or being sick
Zofran suppositories should start to work within one or two hours of using a dose.
If you continue to feel sick or are sick then tell your doctor or nurse.
Do not use the suppositories more often than the label says.
If you use more Zofran suppositories than you should
If you or your child use more Zofran suppositories than you should, or accidentally swallow one, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
POM
If you forget to use Zofran suppositories
If you miss a dose and feel sick or vomit:
• use a Zofran suppository as soon as possible, then
• use your next suppository at the usual time (as shown on the label)
• do not use a double dose to make up for a forgotten dose.
If you miss a dose but do not feel sick
• use the next dose as shown on the label
• do not use a double dose to make up for a forgotten dose.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Zofran suppositories can cause side effects, although not everybody gets them.
Allergic reactions
If you have an allergic reaction, stop using 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
• changes to liver function test results (if you use Zofran suppositories with a medicine called cisplatin, otherwise this side effect is uncommon).
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.
Rare (may affect up to 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 (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.
5) HOW TO STORE ZOFRAN SUPPOSITORIES
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Zofran suppositories contain
• The active ingredient is ondansetron. Each Zofran suppository contains ondansetron 16mg.
• The other ingredient is Witespol S58.
What Zofran suppositories look like and contents of the pack
Zofran suppository is white and torpedo shaped. Each suppository is in an individually sealed cavity enclosed in a perforated cardboard mount and packed into a carton.
Manufactured by
Farmaclair, 440 Avenue du General de Gaulle, 14200 Herouville Saint-Clair, France.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER.
Repackaged by XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
PL: 33532/0258
Leaflet dated 21st April 2016 Leaflet coded XXXXXXXXXXX
Zofran® is a registered trademark of Novartis Pharma AG, Switzerland.
• Keep out of the sight and reach of children.
• Do not use Zofran suppositories after the expiry date which is stated on the pack after 'Exp'.
• Do not store Zofran suppositories above 30oC.
• Zofran suppositories should only be taken out of the blister immediately before use.
• If your doctor tells you to stop using Zofran suppositories, it is important to return any which are left over to your pharmacist.
• If your medicine shows any sign of deterioration, return it to your pharmacist.