Ondansetron 8 Mg Film-Coated Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Ondansetron 4 mg Film-coated Tablets Ondansetron 8 mg Film-coated Tablets
Ondansetron (as hydrochloride dihydrate)
Read all of this leaflet carefully before you start taking this medicine.
- 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Ondansetron Tablets are and what they are used for
2. Before you take use Ondansetron Tablets
3. How to take Ondansetron Tablets
4. Possible side effects
5. How to store Ondansetron Tablets
6. Further information
1. What Ondansetron Tablets are and what they are 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 > 6 months.
• Preventing nausea and vomiting after surgery in adults and in children aged > 1 month.
2. Before you take Ondansetron Tablets
Ondansetron Tablets are not suitable for everyone.
Do not use Ondansetron Tablets if you are allergic (hypersensitive) to:
- ondansetron
- any of the other ingredients of Ondansetron Tablets (see section 6)
Ask your doctor or pharmacist if you are not sure about anything before you take Ondansetron Tablets
Take special care with Ondansetron and tell your doctor:
- 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
This medicine should not be used in children under 2 years of age, or in very small children, because insufficient experience is available.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
• 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 and 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.
Pregnancy and breast-feeding
• Because of insufficient experience the use of ondansetron during pregnancy is not recommended.
• Ondansetron enters the breast milk, so you should not breastfeed while you are having this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Ondansetron has no or negligible effect on the ability to drive or use machines.
Important information about some of the ingredients of Ondansetron Tablets
This medicine 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.
3. How to take Ondansetron Tablets
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
Patients receiving chemotherapy and/or radiotherapy that causes nausea and vomiting:
• Adults (including the elderly): The recommended dose is 8 mg 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 agedover 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 three times a day, 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.
To treat nausea and vomiting after an operation:
• Adults: Intravenous administration is recommended.
• Children aged over 1 monthand 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 Tablets 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 Tablets
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 not feel sick take the next dose as on the label.
If you stop taking Ondansetron Tablets
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.
4. Possible side effects
Like all medicines, ondansetron 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
Tell your doctor or pharmacist if any of the following side effects bother you:
Very common side effects (affects more than 1 in 10people) include: headache
Common side effects (affects less than 1 in 10people) include:, constipation,, feeling flushed or warm.
Uncommon side effects (affects less than 1 in 100people) include: low blood pressure, slow heart beat, hiccups,, increases in liver blood test results.
Rare side effects (affects less than 1 in 1000people) include: dizziness, blurred vision,
Very rare side effects (affects less than 1 in 10,000people) include: transient blindness
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Ondansetron Tablets
Keep out of the reach and sight of children.
Do not use Ondansetron Tablets 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
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Ondansetron Tablets contains
Ondansetron 4 mg Film-coated Tablets
The active substance is ondansetron hydrochloride dihydrate. Each film-coated tablet contains ondansetron hydrochloride dihydratre equivalent to 4 mg ondansetron.
Ondansetron 8 mg Film-coated 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 Tablets look like and contents of the pack
Ondansetron 4 mg Film-coated Tablets are yellow, oval shaped, film-coated tablets, plain on both sides.
Ondansetron 8 mg Film-coated 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 6, 8, 10, 12, 15, 20, 30, 50, 60 and 100 film-coated tablets.
Not all pack sizes may be marketed.
Ondansetron 4 mg/8 mg film-coated tablets Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder Sandoz Ltd
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR.
United Kingdom
Manufacturer
Salutas Pharma GmbH DieselstraPe 5 70839 Gerlingen Germany
Lek Pharmaceuticals d.d. Verovskova 57 1526 Ljubljana Slovenia
Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben Germany
LEK S.A.
ul. Domaniewska 50C 02-672 Warsaw Poland
or
S.C. Sandaz S.R.L.
Str. Livezeni nr. 7A RO-540472 Targu-Mures Romania