Ondansetron Accord

Leaflet accompanying the packaging: patient information

Ondansetron Accord, 4 mg, solution for injection/infusion in a pre-filled syringe

Ondansetron Accord, 8 mg, solution for injection/infusion in a pre-filled syringe

Ondansetron

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

The medicine is called Ondansetron Accord, 4 mg or 8 mg, solution for injection/infusion in a pre-filled syringe and is referred to as Ondansetron Accord in the rest of the leaflet.

Table of contents of the leaflet

• 1. What is Ondansetron Accord and what is it used for
• 2. Important information before using Ondansetron Accord
• 3. How to use Ondansetron Accord
• 4. Possible side effects
• 5. How to store Ondansetron Accord
• 6. Contents of the packaging and other information

1. What is Ondansetron Accord and what is it used for

Ondansetron Accord contains the active substance ondansetron and belongs to a group of anti-emetic medicines. Ondansetron is a 5HT3 receptor antagonist. It works by blocking the action of 5HT3 receptors in the central and peripheral nervous system.
Ondansetron Accord is used:

• to prevent nausea and vomiting caused by
• cancer chemotherapy in adults and children aged ≥ 6 months;
• cancer radiotherapy in adults;
• to prevent and treat nausea and vomiting in the post-operative period in adults and children aged ≥ 1 month.

Consult a doctor, nurse, or pharmacist if additional information on the use of the medicine is needed.

2. Important information before using Ondansetron Accord

When not to use Ondansetron Accord:

• if the patient is hypersensitive to ondansetron or other selective 5HT3 receptor antagonists (e.g., granisetron, dolasetron) or any of the other ingredients of this medicine (listed in section 6),
• if the patient is taking apomorphine (a medicine used to treat Parkinson's disease).

Warnings and precautions

Before starting treatment with Ondansetron Accord, discuss with the doctor, pharmacist, or nurse:

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if the patient has had an allergic reaction to other anti-emetic or anti-vomiting medicines, such as granisetron or palonosetron.
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if the patient has intestinal obstruction or severe constipation. This medicine may worsen the peristalsis of the lower gastrointestinal tract
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if the patient has liver function disorders or is taking any medicines that may be harmful to the liver (hepatotoxic medicines used in chemotherapy). In such cases, liver function will be closely monitored, especially in children and adolescents.
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if the patient has had heart rhythm disorders, including irregular heartbeat (arrhythmia). Ondansetron prolongs the QT interval (a segment measured in the ECG, indicating delayed repolarization of the heart with a risk of life-threatening heart rhythm disorders) in a dose-dependent manner.
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if the patient is to undergo tonsillectomy. In such a case, they must be closely monitored, as ondansetron treatment may mask the symptoms of internal bleeding.
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if the patient has electrolyte imbalances, such as low potassium or magnesium levels.
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if the patient is to undergo any diagnostic tests (including blood, urine, skin tests with allergens, etc.). Inform the doctor about taking this medicine, as it may affect the results of the tests.

Inform the doctor or pharmacist immediately if any of these symptoms occur during or after treatment.

• If the patient experiences sudden chest pain or tightness (myocardial ischemia).

Ondansetron Accord with other medicines

Tell the doctor, pharmacist, or nurse about all medicines the patient is taking, has recently taken, or might take, including those available without a prescription.
Particularly inform the doctor, pharmacist, or nurse about the patient taking any of the following medicines:

• phenytoin (used to treat epilepsy and heart rhythm disorders). The effect of ondansetron may be reduced;
• carbamazepine (used to treat epilepsy and neuralgic pain). The effect of ondansetron may be reduced;
• rifampicin (used to treat infections such as tuberculosis). The effect of ondansetron may be reduced; antibiotics such as erythromycin; ketoconazole (used to treat patients with Cushing's syndrome); anti-arrhythmic medicines (used to treat irregular heartbeat), such as amiodarone; beta-adrenergic blockers, used to treat certain heart diseases, eye diseases, anxiety disorders, or to prevent migraines, such as atenolol or timolol; tramadol (used to treat pain). The analgesic effect of tramadol may be reduced; medicines affecting the heart (haloperidol, methadone); anticancer medicines (especially anthracyclines, such as doxorubicin, daunorubicin, or trastuzumab); SSRIs (selective serotonin reuptake inhibitors), used to treat depression and/or anxiety, including: fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram;
• SNRIs (serotonin and norepinephrine reuptake inhibitors), used to treat depression and/or anxiety, including venlafaxine, duloxetine.

Ondansetron Accord with food, drinks, and alcohol

Ondansetron Accord can be taken with or without food and drinks.

Pregnancy, breastfeeding, and fertility

Pregnancy
Do not use Ondansetron Accord during the first trimester of pregnancy. This is because Ondansetron Accord may slightly increase the risk of cleft lip and/or cleft palate [an opening or gap in the upper lip and/or palate]. If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult a doctor or pharmacist before using this medicine.
If the patient can become pregnant, they will be advised on effective contraception.
Breastfeeding
Ondansetron passes into breast milk. Therefore, mothers taking ondansetron SHOULD NOT breastfeed.
Consult a doctor before using any medicine.

Driving and using machines

Ondansetron does not affect the ability to drive or use machines.

Ondansetron Accord contains sodium

This medicine contains 3.6 mg of sodium (the main component of common salt) per milliliter. This corresponds to 0.18% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Ondansetron Accord

This medicine should always be administered by a healthcare professional, usually a doctor or nurse, and never by the patient themselves.

Dose

The doctor will determine the appropriate dose of ondansetron for the patient.
The dose depends on the treatment (chemotherapy or surgery), liver function, and whether the medicine is administered by injection or infusion.

Nausea and vomiting caused by chemotherapy or radiotherapy

Adults
On the day of chemotherapy or radiotherapy, it is recommended to use a dose of 8 mg, administered by slow intravenous or intramuscular injection, directly before chemotherapy or radiotherapy, and then another dose of 8 mg after 12 hours.
In subsequent days

• the usual dose for adults should not exceed 8 mg. Oral administration can be started 12 hours after chemotherapy or radiotherapy and continued for up to 5 days. The usual dose is 8 mg twice a day.

If chemotherapy or radiotherapy causes severe nausea and vomiting, a higher dose of this medicine may be necessary for the patient.
The doctor will decide whether to modify the dose.
A single dose should not exceed 16 mg due to the increased risk of heart rhythm disorders (see section 2).

Nausea and vomiting caused by chemotherapy

Children over 6 months and adolescents:
The dose of the medicine will be determined by the doctor based on the patient's weight or body surface area.
On the day of chemotherapy

• the first dose is administered by intravenous injection, directly before treatment. After chemotherapy, the medicine is usually administered orally to children, 12 hours later, in the form of a tablet or syrup. The usual dose is 4 mg twice a day and may be administered for up to 5 days.

Nausea and vomiting after surgery

Prevention of nausea and vomiting after surgery

Adults:

• the usual dose for adults is 4 mg, administered intramuscularly or by slow intravenous injection, directly before surgery.

Children over 1 month and adolescents
The doctor will determine the dose of the medicine. The maximum dose of 4 mg is administered by slow intravenous injection, directly before surgery.

Treatment of nausea and vomiting after surgery

Adults:

• the usual dose for adults is 4 mg, administered intramuscularly or by slow intravenous injection.

Children over 1 month and adolescents
The doctor will determine the dose of the medicine. The maximum dose is 4 mg, administered by slow intravenous injection.

Dose adjustment

Patients with moderate or severe liver disease

The dose should not exceed 8 mg per day.

Patients of advanced age, patients with renal impairment, and patients with slow metabolism of sparteine and debrisoquine

No modification of the daily dose, frequency, or route of administration is required.

Duration of treatment

The doctor will determine the duration of treatment with ondansetron. Do not stop treatment prematurely.
Ondansetron Accord should start working soon after injection. If the patient still experiences nausea or vomiting, inform the doctor or nurse.

Overdose of Ondansetron Accord

This medicine will be administered to the patient by a doctor or nurse, so it is unlikely that the patient will receive too much of the medicine. If it is thought that the patient has received too much of the medicine or missed a dose, inform the doctor or nurse.
Little is known about the overdose of ondansetron. In most patients, the symptoms were similar to those reported at recommended doses of this medicine (see section "Possible side effects").
After overdose, the following symptoms have been observed: vision disturbances, severe constipation, low blood pressure, and loss of consciousness. In all cases, the symptoms resolved completely.
This medicine may affect heart rhythm, especially in case of overdose. In such a case, the doctor will monitor the heart's action.
There is no specific antidote for ondansetron. Therefore, in case of suspected overdose, only symptomatic treatment should be used.
Inform the doctor if any of these symptoms occur.
In case of further doubts about the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Inform the doctor or nurse immediately if any of the following symptoms occur:

Uncommon(may affect up to 1 in 100 people)
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Chest pain, irregular heartbeat (arrhythmia, which can be life-threatening) and slow heartbeat (bradycardia)
Rare(may affect up to 1 in 1,000 people)
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Immediate allergic reactions, including life-threatening allergic reactions (anaphylaxis)
This may be: itching rash, swelling of the eyelids, face, lips, mouth, and tongue

Frequency not known (frequency cannot be estimated from the available data)

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Sudden chest pain or tightness (myocardial ischemia)
If any of these symptoms occur, stop taking the medicine and consult a doctor.

Other side effects include:

Very common (may affect more than 1 in 10 people)

• headache

Common (may affect up to 1 in 10 people)

flushing, hot flashes, constipation, irritation, and redness at the injection site

Uncommon (may affect up to 1 in 100 people)

seizures (convulsions), abnormal body movements or jerks, irregular heartbeat, chest pain, low blood pressure, which may lead to fainting or dizziness, hiccups, changes in liver function test results (in cases where the patient is taking the medicine Ondansetron Accord with a medicine called cisplatin, otherwise this side effect is uncommon)

Rare (may affect up to 1 in 1,000 people)

• dizziness or feeling of emptiness in the head
• blurred vision
• heart rhythm disorders (sometimes leading to sudden loss of consciousness)

Very rare (may affect up to 1 in 10,000 people)

• poor vision or temporary loss of vision, usually lasting no longer than 20 minutes
• widespread skin rash with blisters and peeling, covering a large area of the body (toxic epidermal necrolysis).

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, inform the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 201
Fax: +48 22 49 21 209
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Ondansetron Accord

Keep the medicine out of the sight and reach of children.

Expiry date

Do not use this medicine after the expiry date stated on the pre-filled syringe or carton after: EXP. The expiry date refers to the last day of the month stated.

Storage

No special storage precautions are required for the medicine.
Do not use this medicine if the container is damaged or if particles and/or crystals are visible.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Ondansetron Accord contains

The active substance of the medicine is ondansetron (as ondansetron hydrochloride dihydrate).
1 ml of the solution for injection/infusion in a pre-filled syringe contains 2 mg of ondansetron (as ondansetron hydrochloride dihydrate).
Each 2 ml pre-filled syringe contains 4 mg of ondansetron (as ondansetron hydrochloride dihydrate).
Each 4 ml pre-filled syringe contains 8 mg of ondansetron (as ondansetron hydrochloride dihydrate).
Other ingredients are: citric acid monohydrate, sodium citrate, sodium chloride, sodium hydroxide, and/or hydrochloric acid (for pH adjustment) and water for injections.

What Ondansetron Accord looks like and contents of the pack

Ondansetron is a clear and colorless solution in a pre-filled syringe made of orange glass.
The medicine is available in packs containing 1, 5, and 10 pre-filled syringes.
Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa 7 Street
02-677 Warsaw
Phone: +48 22 577 28 00

Manufacturer/Importer:

Accord Healthcare Polska Sp. z o.o.
Lutomierska 50 Street
95-200 Pabianice
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA3000
Malta
Laboratori Fundació Dau
C/ C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona
Spain
Accord Healthcare single member S.A.
64th Km National Road Athens
32009 Lamia, Schimatari
Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: February 2025

The following information is intended for healthcare professionals only

Instructions for use
For intravenous or intramuscular injection or intravenous infusion after dilution.
The doctor prescribing ondansetron to prevent nausea and vomiting associated with radiotherapy or chemotherapy in adults, adolescents, and children should take into account the appropriate guidelines for the use of the medicine and the practically accepted principles of its use.
Compatibility with other medicinal products
The following active substances may be administered through a three-way infusion set of ondansetron at concentrations of ondansetron from 16 to 160 micrograms/ml (8 mg/500 ml and 8 mg/50 ml):

Nausea and vomiting caused by chemotherapy and radiotherapy
Adults: The severity of vomiting caused by cancer treatment varies depending on the dose of the medicine and the combination of chemotherapy and radiotherapy used in the treatment regimens.
The route of administration and dose of Ondansetron Accord should be chosen flexibly, within the range of 8 mg to 32 mg per day, according to the following recommendations.
Chemotherapy and radiotherapy with emetogenic potential:
Directly before treatment, ondansetron should be administered in a dose of 8 mg by slow intravenous injection (lasting at least 30 seconds) or intramuscularly, and then 8 mg of the medicine should be administered orally, every 12 hours.

To prevent delayed or prolonged nausea and vomiting after the first 24 hours, continue oral or rectal treatment with ondansetron for up to 5 days after the end of the chemotherapy cycle.
Chemotherapy with high emetogenic potential:
Patients receiving chemotherapy with high emetogenic potential, e.g., high-dose cisplatin, may receive ondansetron orally, rectally, intravenously, or intramuscularly. Ondansetron given in the following dosing regimens during the first 24 hours after the start of chemotherapy showed comparable efficacy:

• A single dose of 8 mg, administered by slow intravenous injection (lasting at least 30 seconds) or intramuscularly, directly before chemotherapy.
• A dose of 8 mg, administered by slow intravenous injection (lasting at least 30 seconds) or intramuscularly, directly before the start of chemotherapy. Two additional doses of 8 mg should be administered by intravenous injection (lasting at least 30 seconds) or intramuscularly, at 4-hour intervals, or over 24 hours in continuous infusion at a rate of 1 mg/hour.
• An initial dose of up to 16 mg, diluted in 50 to 100 ml of sodium chloride 0.9% injection or other compatible infusion fluid (see section 6.6 of the Summary of Product Characteristics), and administered by intravenous infusion over at least 15 minutes, directly before chemotherapy. After the initial dose of Ondansetron Accord, two additional doses of 8 mg may be given by intravenous injection (lasting at least 30 seconds) or intramuscularly, at 4-hour intervals.
• A single dose should not exceed 16 mg due to the dose-dependent increased risk of QT interval prolongation (see sections 4.4, 4.8, and 5.1 of the Summary of Product Characteristics).

The choice of dosing regimen should be based on the degree of emetogenic potential.
The efficacy of ondansetron in chemotherapy with high emetogenic potential may be enhanced by the addition of a single intravenous dose of 20 mg of dexamethasone sodium phosphate before chemotherapy.
To prevent delayed or prolonged nausea and vomiting after the first 24 hours, continue oral or rectal treatment with ondansetron for up to 5 days after the end of the chemotherapy cycle.
Children and adolescents
Treatment of nausea and vomiting caused by chemotherapy in children aged ≥ 6 months and adolescents.
The dose of the medicine is calculated based on the patient's body surface area (BSA) or body weight.
Dose calculation based on body surface area (BSA):
Ondansetron Accord should be administered intravenously in a single dose of 5 mg/m², directly before chemotherapy. The single intravenous dose should not exceed 8 mg.
Oral administration can be started 12 hours later and continued for up to 5 days. See the dosing tables in the Summary of Product Characteristics.
The total dose administered over 24 hours (in divided doses) should not exceed 32 mg (the dose used in adults).
Dose calculation based on body weight:
Total daily doses based on body weight are higher than doses calculated based on body surface area (BSA). Ondansetron Accord should be administered intravenously in a single dose of 0.15 mg/kg, directly before chemotherapy. The single intravenous dose should not exceed 8 mg. Two additional intravenous doses may be administered at 4-hour intervals. Oral administration can be started 12 hours later and continued for up to 5 days (see the Summary of Product Characteristics for further information).
Ondansetron Accord should be diluted in glucose 5% injection or sodium chloride 0.9% injection (or other compatible infusion fluid, see section 6.6 of the Summary of Product Characteristics) and administered by intravenous infusion over at least 15 minutes.
There are no data from clinical trials with a control group on the use of Ondansetron Accord to prevent delayed or prolonged nausea and vomiting caused by chemotherapy.
There are no data from clinical trials with a control group on the use of Ondansetron Accord in the treatment of nausea and vomiting caused by radiotherapy in children.
Post-operative nausea and vomiting
Adults:For the prevention of nausea and vomiting, ondansetron can be administered in a single dose of 4 mg, given intramuscularly or by slow intravenous injection, before surgery.
For the treatment of post-operative nausea and vomiting, a single dose of 4 mg is recommended, given intramuscularly or by slow intravenous injection.
Children (over 1 month) and adolescents
Oral administration:
No studies have been conducted on the oral use of ondansetron for the prevention or treatment of post-operative nausea and vomiting. In such cases, slow intravenous injection is recommended.
Injection:
For the prevention of post-operative nausea and vomiting (PONV) in pediatric patients undergoing general anesthesia during surgery, ondansetron can be administered by slow intravenous injection (lasting at least 30 seconds) in a single dose of 0.1 mg/kg, up to a maximum of 4 mg, before, during, or after the induction of anesthesia.
For the treatment of nausea and vomiting in pediatric patients after surgery under general anesthesia, ondansetron can be administered by slow intravenous injection (lasting at least 30 seconds) in a single dose of 0.1 mg/kg, up to a maximum of 4 mg.
There are no data on the use of ondansetron in the treatment of post-operative nausea and vomiting in children under 2 years of age.
Elderly patients:Data on the use of ondansetron in the prevention and treatment of PONV in elderly patients are limited; however, ondansetron is well tolerated by patients over 65 years of age receiving chemotherapy.
Patients with renal impairment:No modification of the daily dose, frequency, or route of administration of Ondansetron Accord is required.
Patients with liver impairment:The clearance of ondansetron is significantly reduced, and the half-life in serum is significantly prolonged in patients with moderate or severe liver impairment. In such patients, the total daily dose should not exceed 8 mg. Therefore, oral or parenteral administration is recommended.
Patients with slow metabolism of sparteine and debrisoquine:The half-life of ondansetron in the elimination phase does not change in patients classified as slow metabolizers of sparteine and debrisoquine. Consequently, in such patients, multiple doses will result in the same level of exposure as in other patient groups. No modification of the daily dose or frequency of administration is required.
Incompatibilities
The solution should not be sterilized by autoclaving.
Ondansetron Accord should only be mixed with the following recommended solutions:
0.9% sodium chloride injection (9 mg/ml)
5% glucose injection (5% w/v)
10% mannitol injection (10% w/v)
Ringer's injection
0.3% potassium chloride (0.3% w/v) and 0.9% sodium chloride (9 mg/ml) injection
0.3% potassium chloride (0.3% w/v) and 5% glucose (5% w/v) injection
The stability of Ondansetron Accord after dilution with the recommended solutions has been demonstrated for concentrations of 0.016 mg/ml and 0.64 mg/ml.
Only clear and colorless solutions should be used.
Diluted solutions should be stored protected from light.
Shelf life and storage
3 years
No special storage precautions are required for the medicinal product.
Injection
The product should be used immediately after opening.
Infusion
After dilution with the recommended diluents, the chemical and physical in-use stability has been demonstrated for 7 days at 25°C and 2-8°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user. Normally, the storage time should not exceed 24 hours at 2-8°C, unless dilution has been made in controlled and validated aseptic conditions.