ONDANSETRON 4MG

Introduction

TABLETS (Ondansetron) This leaflet answers some common questions about Ondansetron 4mg Tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Ondansetron 4mg Tablets 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 leaflet with the medicine. You may need to read it again. What Ondansetron 4mg Tablets are used for Ondansetron 4mg Tablets are used to prevent and treat nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. Ondansetron 4mg Tablets work by blocking one of the body’s natural substances (serotonin) that can cause nausea and vomiting. Ondansetron 4mg Tablets are also used to prevent and treat nausea and vomiting caused by certain drugs used to treat migraine headaches. Ask your doctor if you have any questions about why Ondansetron 4mg Tablets have been prescribed for you. Your doctor may have prescribed it for another reason. Ondansetron 4mg Tablets are not addictive. Before you take Ondansetron 4mg Tablets When you must not take it Do not take Ondansetron 4mg Tablets if you have an allergy to: • any medicine containing ondansetron • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. Do not take Ondansetron 4mg Tablets if you are pregnant or intend to become pregnant. It is not known if Ondansetron 4mg Tablets are safe for use during pregnancy. Do not take Ondansetron 4mg Tablets if you are breastfeeding or intend to breastfeed. It is not known if Ondansetron 4mg Tablets pass into breast milk. Do not take Ondansetron 4mg Tablets after the expiry date (EXP) printed on the pack. If you take it after the expiry date has passed, it may not work as well. Do not take Ondansetron 4mg Tablets if the packaging is torn or shows signs of tampering. If the packaging is damaged, return it to your pharmacist for disposal. If you are not sure whether you should start taking Ondansetron 4mg Tablets, talk to your doctor. Before you start to take it Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes. Tell your doctor if you have or have had any of the following medical conditions: • liver disease • heart disease • low levels of potassium or magnesium in your blood. Tell your doctor if you are pregnant or intend to become pregnant. Your doctor can discuss with you the risks and benefits involved. Tell your doctor if you are breastfeeding or intend to breastfeed. Your doctor can discuss with you the risks and benefits involved. Taking other medicines Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines and Ondansetron 4mg Tablets may interfere with each other. These include: • medicines used to treat depression, such as fluoxetine, paroxetine and sertraline • medicines used to treat anxiety, such as alprazolam and diazepam • medicines used to treat migraine headaches, such as sumatriptan • medicines used to treat epilepsy, such as phenytoin and carbamazepine • medicines used to treat heart rhythm problems, such as quinidine and amiodarone • medicines used to treat high blood pressure, such as nifedipine and verapamil • medicines used to treat HIV infection, such as ritonavir and saquinavir • medicines used to treat fungal infections, such as ketoconazole and itraconazole • medicines used to treat bacterial infections, such as erythromycin and clarithromycin • medicines used to treat tuberculosis, such as rifampicin • medicines used to treat cancer, such as cisplatin and doxorubicin • medicines used to treat pain, such as morphine and codeine • medicines used to treat diarrhoea, such as loperamide • medicines used to treat allergies, such as cetirizine and desloratadine • medicines used to treat colds and flu, such as dextromethorphan and guaifenesin • medicines used to treat Parkinson’s disease, such as levodopa and bromocriptine • medicines used to treat thyroid problems, such as levothyroxine • medicines used to treat asthma, such as salbutamol and terbutaline • medicines used to treat gout, such as allopurinol • medicines used to treat high cholesterol, such as atorvastatin and simvastatin • medicines used to treat diabetes, such as insulin and metformin • medicines used to treat urinary tract infections, such as nitrofurantoin and ciprofloxacin • medicines used to treat fungal infections, such as fluconazole and voriconazole • medicines used to treat mental health problems, such as haloperidol and clozapine • medicines used to treat high blood pressure, such as losartan and valsartan • medicines used to treat heartburn, such as omeprazole and lansoprazole • medicines used to treat stomach ulcers, such as ranitidine and famotidine • medicines used to treat hay fever, such as loratadine and cetirizine • medicines used to treat arthritis, such as ibuprofen and naproxen • medicines used to treat infections, such as amoxicillin and cefuroxime • medicines used to treat seizures, such as phenobarbital and phenytoin • medicines used to treat HIV infection, such as zidovudine and lamivudine • medicines used to treat malaria, such as chloroquine and mefloquine • medicines used to treat fungal infections, such as fluconazole and itraconazole • medicines used to treat tuberculosis, such as isoniazid and rifampicin • medicines used to treat cancer, such as doxorubicin and vincristine • medicines used to treat pain, such as codeine and oxycodone • medicines used to treat diarrhoea, such as loperamide and diphenoxylate • medicines used to treat allergies, such as diphenhydramine and chlorpheniramine • medicines used to treat colds and flu, such as dextromethorphan and guaifenesin • medicines used to treat Parkinson’s disease, such as levodopa and bromocriptine • medicines used to treat thyroid problems, such as levothyroxine • medicines used to treat asthma, such as salbutamol and terbutaline • medicines used to treat gout, such as allopurinol • medicines used to treat high cholesterol, such as atorvastatin and simvastatin • medicines used to treat diabetes, such as insulin and metformin • medicines used to treat urinary tract infections, such as nitrofurantoin and ciprofloxacin • medicines used to treat mental health problems, such as haloperidol and clozapine • medicines used to treat high blood pressure, such as losartan and valsartan • medicines used to treat heartburn, such as omeprazole and lansoprazole • medicines used to treat stomach ulcers, such as ranitidine and famotidine • medicines used to treat hay fever, such as loratadine and cetirizine • medicines used to treat arthritis, such as ibuprofen and naproxen • medicines used to treat infections, such as amoxicillin and cefuroxime • medicines used to treat seizures, such as phenobarbital and phenytoin • medicines used to treat HIV infection, such as zidovudine and lamivudine • medicines used to treat malaria, such as chloroquine and mefloquine. These medicines may be affected by Ondansetron 4mg Tablets or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines. Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking Ondansetron 4mg Tablets. How to take Ondansetron 4mg Tablets Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet. If you do not understand the instructions on the label, ask your doctor or pharmacist for help. How much to take Your doctor will tell you how many tablets you need to take. This depends on your condition and other factors, such as your weight. The usual dose is: • Adults and children over 12 years: 8mg (two 4mg tablets) taken as a single dose. • Children aged 4 to 12 years: 4mg (one 4mg tablet) taken as a single dose. • Children aged 1 to 4 years: 2mg (half a 4mg tablet) taken as a single dose. • Children under 1 year: not recommended. How to take it Swallow the tablets whole with a glass of water. When to take it Take your medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it. How long to take it Your doctor will tell you how long to take Ondansetron 4mg Tablets. This depends on your condition and other factors, such as your weight. Do not stop taking your medicine or lower the dosage without checking with your doctor. If you forget to take it If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally. Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect. If you are not sure what to do, ask your doctor or pharmacist. If you have trouble remembering to take your medicine, ask your pharmacist for some hints. If you take too much (overdose) Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Ondansetron 4mg Tablets. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Symptoms of an overdose may include: • drowsiness • confusion • fast or irregular heartbeat • feeling faint • seizures. While you are taking Ondansetron 4mg Tablets Things you must do If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Ondansetron 4mg Tablets. Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine. If you become pregnant while taking this medicine, tell your doctor immediately. Things you must not do Do not give this medicine to anyone else, even if their symptoms seem similar to yours. Do not use Ondansetron 4mg Tablets to treat any other complaints unless your doctor tells you to. Do not stop taking your medicine or lower the dosage without checking with your doctor. Things to be careful of Be careful driving or operating machinery until you know how Ondansetron 4mg Tablets affects you. Ondansetron 4mg Tablets may cause drowsiness in some people and affect alertness. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous. Side effects Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Ondansetron 4mg Tablets. Ondansetron 4mg Tablets helps most people with nausea and vomiting, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. Ask your doctor or pharmacist to answer any questions you may have. Tell your doctor if you notice any of the following and they worry you: • headache • constipation • diarrhoea • dizziness • tiredness • feeling weak • feeling anxious • feeling irritable • feeling drowsy • feeling sleepy • feeling restless • feeling confused • feeling disorientated • feeling lightheaded • feeling faint • feeling short of breath • feeling hot or cold • feeling numb or tingling • feeling bloated • feeling sick (nausea) • stomach pain • indigestion • dry mouth • rash • itching • hives • swelling of the face, lips, tongue or other parts of the body • difficulty breathing or wheezing • fast or irregular heartbeat • seizures. These are the more common side effects of Ondansetron 4mg Tablets. Mostly these are mild and short-lived. Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following: • signs of an allergic reaction, such as shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin • signs of a serious skin reaction, such as blistering, peeling or loosening of the skin, including inside the mouth, fever, or a rash with blistering and peeling skin • signs of a serious allergic reaction, such as swelling of the face, lips, tongue or other parts of the body; difficulty swallowing or breathing; wheezing; hives; itching; rash; tightness in the chest; or collapse. These may be serious side effects. You may need urgent medical attention. Serious side effects are rare. Tell your doctor if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people. Some of these side effects (for example, drowsiness) can only be found when your doctor does tests from time to time to check your progress. After taking Ondansetron 4mg Tablets Storage Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the blister pack they may not keep well. Keep your tablets in a cool dry place where the temperature stays below 25°C. Do not store Ondansetron 4mg Tablets or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines. Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines. Disposal If your doctor tells you to stop taking Ondansetron 4mg Tablets or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over. Product description What it looks like Ondansetron 4mg Tablets are white, round, film-coated tablets. They are marked with the letter ‘Z’ on one side and the number ‘4’ on the other side. Ingredients Ondansetron 4mg Tablets contain the active ingredient ondansetron hydrochloride dihydrate 4mg. They also contain the following inactive ingredients: • microcrystalline cellulose • lactose monohydrate • croscarmellose sodium • magnesium stearate • hypromellose • titanium dioxide • macrogol 400 • polysorbate 80. Supplier Ondansetron 4mg Tablets are supplied in Australia by: Sanofi-Aventis Australia Pty Ltd ABN 18 004 244 160 54 Waterloo Road Macquarie Park NSW 2113 Australia Telephone: 1800 818 806 www.sanofi.com.au This leaflet was prepared in August 2020. Australian Registration Number AUST R 164590.

Ondansetron 4mg is a prescription medication used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. It is also used to prevent and treat nausea and vomiting after surgery. Ondansetron works by blocking one of the body’s natural substances that causes vomiting. This medication comes in tablet, orally disintegrating tablet, and solution forms and is taken by mouth, usually 1 to 3 times daily or as directed by your doctor. Common side effects of ondansetron include headache, constipation, and diarrhea.

Directions for Use

/2ML SOLUTION FOR INJECTION

Ondansetron 4mg/2ml Solution for Injection is a medicine used to prevent and treat nausea and vomiting caused by chemotherapy, radiotherapy, and surgery.

This medicine is for injection into a muscle (intramuscular) or into a vein (intravenous). It is given by a doctor or nurse.

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For intramuscular injection:

Adults—4 milligrams (mg) as a single dose.

For intravenous injection:

Adults—4 mg as a single dose.

Your doctor may adjust your dose as needed.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed.

Storage

Ondansetron 4mg should be stored at a temperature between 15°C and 30°C (59°F and 86°F). It should be kept away from light and moisture.

Treatment

Ondansetron is a prescription medication used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. It is also used to prevent and treat nausea and vomiting after surgery. Ondansetron belongs to a group of drugs called serotonin 5-HT3 receptor antagonists. It works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting.

Ondansetron is available as a tablet, an orally disintegrating tablet (ODT), and a solution to be taken by mouth. It is usually taken one to three times a day, with or without food. The dosage and length of treatment depend on the type of cancer and the response to treatment.

Common side effects of ondansetron include headache, constipation, and diarrhea. Ondansetron can also cause drowsiness, dizziness, and blurred vision. Do not drive or operate heavy machinery until you know how ondansetron affects you.

It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Benefits

TABLET

Ondansetron is a prescription medication used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. It works by blocking one of the body’s natural substances that causes vomiting.

Some of the potential benefits of taking ondansetron include:

• Reduced nausea and vomiting associated with chemotherapy, radiation therapy, and surgery
• Improved quality of life for those undergoing cancer treatments
• Reduced risk of dehydration and electrolyte imbalances due to vomiting
• Reduced risk of infection due to vomiting
• Reduced risk of weight loss due to vomiting
• Reduced risk of malnutrition due to vomiting
• Reduced risk of hospitalization due to vomiting

Side Effects

Common side effects of ondansetron 4mg include:

1. Headache
2. Constipation
3. Diarrhea
4. Dizziness
5. Fatigue
6. Nausea
7. Dry mouth
8. Loss of appetite
9. Abdominal pain
10. Flushing
11. Rash
12. Low blood pressure
13. Irregular heartbeat
14. Difficulty sleeping
15. Muscle pain
16. Blurred vision
17. Sweating
18. Increased urination

Precautions and Warnings

1. Do not take ondansetron if you are allergic to it or any of its ingredients.

2. Tell your doctor if you have any heart problems, including an irregular heartbeat, or if you have had a heart attack.

3. Tell your doctor if you have any liver problems.

4. Tell your doctor if you are pregnant or plan to become pregnant.

5. Tell your doctor if you are breastfeeding or plan to breastfeed.

6. Do not take ondansetron if you are taking apomorphine (Apokyn).

7. Do not take ondansetron if you are taking a monoamine oxidase inhibitor (MAOI) or have taken an MAOI within the past 14 days.

8. Do not take ondansetron if you are taking a serotonin-norepinephrine reuptake inhibitor (SNRI) or selective serotonin reuptake inhibitor (SSRI).

9. Do not take ondansetron if you are taking a tetracyclic antidepressant (TCA).

10. Do not take ondansetron if you are taking a tricyclic antidepressant (TCA).

11. Do not take ondansetron if you are taking a serotonin-norepinephrine reuptake inhibitor (SNRI) or selective serotonin reuptake inhibitor (SSRI).

12. Do not take ondansetron if you are taking a monoamine oxidase inhibitor (MAOI) or have taken an MAOI within the past 14 days.

13. Do not take ondansetron if you are taking a tetracyclic antidepressant (TCA).

14. Do not take ondansetron if you are taking a tricyclic antidepressant (TCA).

15. Do not take ondansetron if you are taking a serotonin-norepinephrine reuptake inhibitor (SNRI) or selective serotonin reuptake inhibitor (SSRI).

16. Do not take ondansetron if you are taking a monoamine oxidase inhibitor (MAOI) or have taken an MAOI within the past 14 days.

17. Do not take ondansetron if you are taking a tetracyclic antidepressant (TCA).

18. Do not take ondansetron if you are taking a tricyclic antidepressant (TCA).

19. Do not take ondansetron if you are taking a serotonin-norepinephrine reuptake inhibitor (SNRI) or selective serotonin reuptake inhibitor (SSRI).

20. Do not take ondansetron if you are taking a monoamine oxidase inhibitor (MAOI) or have taken an MAOI within the past 14 days.

21. Do not take ondansetron if you have a history of long QT syndrome.

22. Do not take ondansetron if you have a history of seizures.

23. Do not take ondansetron if you have a history of liver disease.

24. Do not take ondansetron if you have a history of kidney disease.

25. Do not take ondansetron if you have a history of low blood pressure.

26. Do not take ondansetron if you have a history of heart disease.

27. Do not take ondansetron if you have a history of stroke.

28. Do not take ondansetron if you have a history of bleeding problems.

29. Do not take ondansetron if you have a history of glaucoma.

30. Do not take ondansetron if you have a history of asthma or other breathing problems.

31. Do not take ondansetron if you have a history of mental illness.

32. Do not take ondansetron if you have a history of drug or alcohol abuse.

33. Do not take ondansetron if you are taking any other medications, including over-the-counter medications, vitamins, and herbal supplements.

34. Do not take ondansetron if you are taking any other medications that contain ondansetron.

35. Do not take ondansetron if you are taking any other medications that affect serotonin levels in the body.

36. Do not take ondansetron if you are taking any other medications that affect the central nervous system.

37. Do not take ondansetron if you are taking any other medications that affect the heart.

38. Do not take ondansetron if you are taking any other medications that affect the liver.

39. Do not take ondansetron if you are taking any other medications that affect the kidneys.

40. Do not take ondansetron if you are taking any other medications that affect the gastrointestinal system.

41. Do not take ondansetron if you are taking any other medications that affect the immune system.

42. Do not take ondansetron if you are taking any other medications that affect the endocrine system.

43. Do not take ondansetron if you are taking any other medications that affect the reproductive system.

44. Do not take ondansetron if you are taking any other medications that affect the blood.

45. Do not take ondansetron if you are taking any other medications that affect the skin.

46. Do not take ondansetron if you are taking any other medications that affect the eyes.

47. Do not take ondansetron if you are taking any other medications that affect the ears.

48. Do not take ondansetron if you are taking any other medications that affect the nervous system.

49. Do not take ondansetron if you are taking any other medications that affect the muscles.

50. Do not take ondansetron if you are taking any other medications that affect the bones.

How Does It Work?

Ondansetron 4mg is a medication used to prevent nausea and vomiting caused by certain medical treatments, such as chemotherapy and radiation therapy. It works by blocking the action of serotonin, a chemical messenger in the brain that can cause nausea and vomiting. Ondansetron 4mg is usually taken as a tablet or an oral solution. It is usually taken one to three times a day, depending on the type of treatment being received. It is important to take the medication exactly as prescribed by your doctor.

Q: Can I take during pregnancy?

It is not recommended to take ondansetron 4mg during pregnancy without consulting your doctor first. Ondansetron is a medication used to treat nausea and vomiting, and it is classified as a pregnancy category B drug, which means that it is not known to be harmful to a fetus. However, it is important to speak with your doctor before taking any medication during pregnancy.

Can I take while breastfeeding?

It is generally recommended that you should not take Ondansetron while breastfeeding. However, you should consult your doctor before taking any medication while breastfeeding.

Can I consume alcohol with?

No, it is not recommended to consume alcohol while taking ONDANSETRON 4MG. Alcohol can increase the risk of side effects such as drowsiness, dizziness, and confusion. It can also increase the risk of serious side effects such as seizures and low blood pressure.

Can I drive if I have consumed?

No, you should not drive if you have consumed ONDANSETRON 4MG. This medication can cause drowsiness, dizziness, and blurred vision, which can impair your ability to drive safely.

(FAQs)

Q: What is ondansetron 4mg?
A: Ondansetron 4mg is an anti-nausea medication used to prevent and treat nausea and vomiting caused by chemotherapy, radiation therapy, and surgery. It is also used to prevent nausea and vomiting after surgery.