Ondansetron 4mg Tablets
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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 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 you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
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
WHAT ONDANSETRON IS AND - WHAT IT IS USED FOR
Ondansetron belongs to a group of medicines called anti-emetics, drugs against feeling sick (nausea) or being sick (vomiting).
This medicine is used for
• Preventing nausea (feeling sick) and vomiting (being sick) caused by chemotherapy or radiotherapy for cancer in adults and in children aged a 6 months.
• Preventing nausea and vomiting after surgery in adults and in children aged a 1 month.
WHAT YOU NEED TO KNOW 2. BEFORE YOU TAKE ONDANSETRON
Other medicines and Ondansetron
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
• If you are taking phenytoin, carbamazepine (used to treat epilepsy or other illnesses), or rifampicin (used to treat certain infections): the ondansetron blood concentrations are decreased.
• If you are taking tramadol (used to treat pain): the effect of tramadol may be reduced.
• If you are taking medicines used to treat heart problems such as anti-arrhythmic medicines (e.g. quinidine or lidocaine) and beta-blockers (e.g. propranolol or atenolol).
• If you are taking any cancer medicines which are known to have toxic effects on the heart (especially anthracyclines e.g. Daunorubicin, Epirubicin). These medicines may not be used together with ondansetron as they may increase the risk of irregular heartbeat.
• If you are taking serotonergic drugs (including SSRIs and SNRIs), used to treat major depression and other mental disorders.
• If you are taking apomorphine, used to treat Parkinson's disease.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor or pharmacist for advice before taking this medicine.
• Because of insufficient experience the use of ondansetron during pregnancy is not recommended.
• Ondansetron enters the breast milk, so you should not breast-feed while you are having this medicine.
Driving and using machines
Ondansetron has no or negligible effect on the ability to drive or use machines.
Ondansetron contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Ondansetron is not suitable for everyone.
Do not take Ondansetron
• If you are allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6).
• If you already take apomorphine, a medicine used to treat Parkinson’s disease.
Ask your doctor or pharmacist if you are not sure about anything before you take Ondansetron.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ondansetron:
• if you are allergic to similar medicines to ondansetron such as granisetron or dolasetron.
• if you suffer from any blockage in your gut or if you have severe constipation.
• if you have liver problems.
• if you are having your tonsils out.
• if you have a heart problem or are taking medicines used to treat a heart problem
• if your child is being treated with medicines which are toxic to the liver, he/she should be closely monitored for damaged liver function.
• if your blood levels of potassium or magnesium are reduced.
Children
This medicine should not be used in children under 2 years of age, or in very small children, because insufficient experience is available.
3. HOW TO TAKE ONDANSETRON
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
• Swallow each tablet whole with a little water.
Your doctor will decide on the correct dose of ondansetron therapy for you. The dose varies depending on why you are being given ondansetron and on your liver function. It may also be recommended to be given ondansetron by injection. A separate ondansetron injection solution is available for this purpose.
Patients receiving chemotherapy and/or radiotherapy that causes nausea and vomiting:
• Adults (including the elderly): The
recommended dose is 8 mg to be taken 1 to 2 hours before chemotherapy followed by 8 mg 12 hours later.
• After the first 24 hours following chemotherapy, ondansetron tablets can be given to prevent nausea and vomiting. The usual dose is 8 mg twice a day which can be taken up to 5 days.
• Children aged over 6 months and adolescents (less than 18 years of age):
Ondansetron may be given by injection immediately before chemotherapy, followed by 2 or 4 mg given by mouth twelve hours later (depending on the size of the child). Following this, the dose taken will depend on the size of the child and will be worked out by the doctor. The usual dose is 4 mg or 8 mg every twelve hours, which may be taken up to 5 days.
To prevent nausea and vomiting after an
operation:
• Adults (including the elderly): The usual adult dose is 16 mg before the operation, or 8 mg before the operation followed by two further doses of 8 mg at eight hourly intervals.
• Children aged over 1 month and adolescents (less than 18 years of age): It is recommended that ondansetron is given as an intravenous injection.
Uncommon side effects (may affect up to 1 in
100people) include: low blood pressure, slow heart beat, hiccups, increases in liver blood test results.
Rare side effects (may affect up to 1 in 1,000 people) include: dizziness, blurred vision.
Very rare side effects (may affect up to 1 in
10,000people) include: transient blindness.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effect not listed in this leaflet.
HOW TO STORE - ONDANSETRON
Keep this medicine out of the sight and reach of children.
To treat nausea and vomiting after an operation:
• Adults: Intravenous administration is recommended.
• Children aged over 1 month and adolescents: the doctor will decide the dose. A single dose of ondansetron may be administered by slow intravenous injection (not less than 30 seconds) at a dose
0.1 mg/kg up to a maximum of 4 mg either prior to, at or after induction of anaesthesia.
Patients with moderate or severe liver problems:
• The total daily dose should not be more than 8 mg.
If you notice that the effect of ondansetron is too strong or too weak, talk to your doctor or pharmacist.
If you take more Ondansetron than you should
If you take too many ondansetron tablets or if someone else has taken some tablets by accident, you should see a doctor at once or go to the hospital emergency department. Take any remaining tablets or the package with you to show the doctor.
If you forget to take Ondansetron
If you forget 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 on the label.
If you stop taking Ondansetron
Do not stop taking your tablets, even if you are feeling well, unless your doctor tells you.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Do not use Ondansetron after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This 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 protect the environment.
CONTENTS OF THE PACK AND - OTHER INFORMATION
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
You should seek medical attention immediately if you experience any of the following:
• Serious allergic reaction which causes swelling of the face or throat, difficulty in breathing or dizziness, or severe itching of the skin with raised lumps.
• Chest pain or irregular heart beat.
• fits (seizures).
• unusual body movements or shaking.
• problems with eye movements.
• spasms in the muscles or the head and neck.
Other side effects
Very common side effects (may affect more than 1 in 10 people) include: headache.
Common side effects (may affect up to 1 in 10 people) include: constipation, feeling flushed or warm.
What Ondansetron contains
Ondansetron 4 mg Tablets:
The active substance is ondansetron hydrochloride dihydrate. Each film-coated tablet contains ondansetron hydrochloride dihydrate equivalent to 4 mg ondansetron.
Ondansetron 8 mg Tablets:
The active substance is ondansetron hydrochloride dihydrate. Each film-coated tablet contains ondansetron hydrochloride dihydrate equivalent to 8 mg ondansetron.
• The other ingredients are:
Core: lactose anhydrous, cellulose
microcrystalline, starch (maize) pregelatinised, magnesium stearate. Coating: hypromellose, lactose monohydrate, titanium dioxide (E171), glycerol triacetate, iron oxide yellow (E172).
What Ondansetron looks like and contents of the pack
Ondansetron tablets are yellow, oval shaped, film-coated tablets, plain on both sides.
Ondansetron tablets are packed in PVC/PVDC//Aluminium blisters.
Pack sizes:
Blisters containing 2, 4, 6, 10, 15, 30, 50 and 100 film-coated tablets.
Unit dose blisters containing 10, 30 and 50 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer
Salutas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen, Germany or Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia or Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria or Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany or S.C. Sandoz, S.R.L., Str. Livezeni nr 7A, 540472, Targu Mures, Jud. Mures, Romania.
This leaflet was last revised in 02/2013.
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