What Zofran orally soluble is and what it is used for
Adults
Zofran orally soluble is given preventively and as a treatment for nausea and vomiting in connection with chemotherapy, radiotherapy, or surgery.
Children
Zofran orally soluble is given preventively and as a treatment for nausea and vomiting in connection with chemotherapy for children who are 6 months and older and in connection with surgery for children who are 1 month and older.
The ondansetron found in Zofran oral solution may also be approved to treat other conditions not listed in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Zofran oral solution
Do not use Zofran orally
- if you are allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6).
- if you are using apomorphine, a medicine used for Parkinson’s disease.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Zofran oral solution:
- if you have impaired liver function, blockage, or obstruction in the intestine (intestinal obstruction)
- if you have heart problems and if you are taking any medicines for this problem
- if you are hypersensitive to other anti-nausea and vomiting medicines
- if you are elderly, then experience in treating the elderly is limited.
Talk to your doctor or pharmacist immediately if you develop any of the following symptoms during or after treatment with Zofran:
- if you experience sudden chest pain or pressure in the chest (myocardial ischemia).
Contact your doctor if you experience breathing problems, as breathing problems can be a precursor to a hypersensitivity reaction.
Other medicines and Zofran are orally soluble
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, including (traditional) herbal medicines and herbal medicines. The effect of the treatment can be affected if Zofran is orally soluble and other medicines are taken at the same time.
You must inform your doctor if you are using any of the following medicines as they may affect the effectiveness of the treatment:
- phenytoin , carbamazepine – used in epilepsy
- tramadol – pain reliever drug
- rifampicin – used for tuberculosis
- fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram ( SSRI drugs) – used to treat depression and/or anxiety
- venlafaxine, duloxetine ( SNRI medicines) – used to treat depression and/or anxiety.
Concomitant use of Zofran oral solution and drugs that can cause ECG changes may lead to more pronounced ECG changes.
Concomitant use of Zofran orally soluble and medicines that can cause heart problems (eg anthracyclines ) can increase the risk of rhythm disturbances.
Therefore, consult your doctor if you are using other medicines before starting treatment with Zofran orally soluble.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
You should not use Zofran during the first three months of pregnancy (first trimester). The reason is that Zofran may slightly increase the risk of a child being born with a cleft lip and/or cleft palate (opening or splitting in the upper lip or palate). If you are already pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking Zofran. If you are a woman of childbearing age, you may be advised to use contraception.
Breast-feeding
A breastfed child may be affected. Therefore, do not use Zofran orally soluble during breastfeeding, unless specifically prescribed by a doctor.
Driving ability and use of machinery
Some side effects (impaired vision and feeling dizzy) may occur that affect driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Zofran orally soluble contains aspartame
Zofran orally soluble 4 mg contains 0.625 mg of aspartame per tablet.
Zofran orally soluble 8 mg contains 1.25 mg of aspartame per tablet.
Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in the body.
Zofran orally soluble contains sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate (E219 and E217) respectively
These preservatives can cause an allergic reaction (possibly delayed).
Zofran orally soluble contains alcohol
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Zofran orally soluble contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How to use Zofran orally soluble
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Your hands must be dry when you take the tablet. When the tablet is placed on the tongue, it dissolves and can be swallowed without water.
Nausea and vomiting caused by chemotherapy or radiotherapy
Adults: The dose of ondansetron can vary within the range of 8-32 mg per day, either by injection or orally. The usual starting dose is 8 mg of ondansetron as a slow intravenous injection directly before chemotherapy and then you can receive an additional dose of 8 mg to a maximum daily dose of 32 mg.
After one day, you can receive 8 mg of Zofran orally soluble 2 times a day for 2-5 days. In the case of radiotherapy, you can be given 8 mg 2-3 times a day during the entire treatment period and then for another 2-5 days.
Children and adolescents (aged 6 months to 17 years): Nausea and vomiting caused by chemotherapy in children and adolescents. Dose one is individual and is calculated by the doctor based on the child’s weight or body surface area.
Zofran is given as an injection immediately before chemotherapy and must not exceed 8 mg. Oral dosing can be started 12 hours later and continued for up to 5 days. The total daily dose must not exceed the maximum adult dose of 32 mg.
Treatment and prevention of nausea and vomiting after surgery
Adults, prevention and treatment: Usual dose is 4-8 mg one hour before anesthesia. Your doctor may have decided to give the medicine as an injection.
Elderly, prevention and treatment: Experience in the treatment of postoperative nausea in elderly patients is limited. However, Zofran orally soluble is well tolerated by patients over 65 years of age during chemotherapy and radiotherapy.
Children and adolescents (aged 1 month to 17 years), prevention and treatment: No studies have been conducted on the use of Zofran oral solution to prevent or treat nausea or vomiting after surgery. Slow intravenous injection is recommended for this purpose.
Impaired liver function: The daily dose should not exceed 8 mg if you have moderate to severely impaired liver function.
If you have used too much Zofran oral solution
If you or your child has taken too much medicine or if e.g. a child has accidentally ingested the medicine, you must immediately contact a doctor or hospital for an assessment of the risk and advice. Take the medicine package with you if you go to the hospital.
Symptoms of overdose:
Possible are blurred vision, double vision, dizziness, headache, fatigue, fast or slow heartbeat, low blood pressure, severe constipation, involuntary muscle spasms, muscle twitching, restlessness, overactivity, and hallucinations.
If you forget to use Zofran oral solution
Do not take a double dose to make up for a missed dose.
If you stop using Zofran oral solution
Do not stop taking your medicine without consulting your doctor, even if you feel well.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious
STOP taking Zofran and contact your doctor immediately or go to the nearest emergency department if you or your child experience the following symptoms:
Serious allergic reactions:
- hypersensitivity reaction with fever, rash, swelling, and sometimes a drop in blood pressure (anaphylactic shock, rare).
- severe widespread skin damage (skin peeling of the epidermis and superficial mucous membranes), ( toxic epidermal necrolysis, very rare occurrence).
Myocardial ischemia
Signs include:
- sudden chest pain or
- pressure over the chest
Other possible side effects:
Other side effects that may occur are listed below. Tell the doctor, pharmacist, or nurse if these side effects become severe.
Very common (may affect more than 1 in 10 users):
- headache.
Common (may affect up to 1 in 10 users):
- the feeling of warmth, hot flushes
- constipation
- local reactions at the injection site (in case of intravenous administration ).
Uncommon (may affect up to 1 in 100 users):
- movement disorders, involuntary muscle twitching, and painful movements. Eye spasms when the eyes are forced in a certain direction, this can give a vertigo-like experience.
- convulsions
- irregular heartbeat or slow heartbeat
- chest pain
- low blood pressure
- hiccup
- elevated liver values in liver function tests.
Rare (may affect up to 1 in 1,000 users):
- hypersensitivity reaction
- temporary vision changes, e.g. blurred vision (occurs mainly during injection treatment)
- dizziness (in case of rapid injection administration).
Very rare (may affect up to 1 in 10,000 users):
- transient blindness, usually transient within 20 minutes (occurs mainly with injection therapy).
How Zofran orally soluble should be stored
Keep this medicine out of the sight and reach of children.
Store at a maximum of 30 o C in the original packaging. Moisture sensitive.
Use before the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is ondansetron. 1 freeze-dried tablet contains 4 mg and 8 mg ondansetron respectively.
- Other ingredients are gelatin, mannitol, aspartame, strawberry flavor (contains alcohol, less than 100 mg per dose ), and sodium methyl parahydroxybenzoate and sodium propyl parahydroxybenzoate respectively ( preservatives E219 and E217).
Appearance and package sizes of the medicine
The freeze-dried tablets are white, round, and domed.
Zofran orally soluble 4 and 8 mg freeze-dried tablets are available in blister packs of 10 tablets.