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1. Ondansetrone Accord Healthcare 2 mg/ml injectable solution or infusion
   1. What is Ondansetrone Accord Healthcare and what is it used for?
   2. How to use Ondansetrone Accord Healthcare
   3. Possible side effects
   4. How to store Ondansetrone Accord Healthcare
   5. Contents of the pack and other information

Ondansetrone Accord Healthcare 2 mg/ml injectable solution or infusion

Generic medicine

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

The name of the medicine is Ondansetrone Accord Healthcare 2 mg/ml injectable solution or infusion, but

Contents of this leaflet:

• 1. What Ondansetrone Accord Healthcare is and what it is used for
• 2. What you need to know before you use or give Ondansetrone Accord Healthcare to your child
• 3. How to use Ondansetrone Accord Healthcare
• 4. Possible side effects
• 5. How to store Ondansetrone Accord Healthcare
• 6. Contents of the pack and other information

1. What is Ondansetrone Accord Healthcare and what is it used for?

Ondansetrone Accord Healthcare contains the active ingredient ondansetron, which belongs to a group of
medicines called antiemetics. Some operations may make you feel sick or vomit. Antiemetics
are prescribed to prevent nausea and vomiting after treatment.
In adults, Ondansetrone Accord Healthcare is used for

• To prevent nausea and vomiting caused by or Chemotherapy (a cycle of chemo) or radiation (radiotherapy) during treatment for cancer

To prevent and treat nausea and vomiting following an operation under general anesthesia.
In children over 1 month of age, Ondansetrone Accord Healthcare can be used to prevent and
treat nausea and vomiting that may occur after an operation.

• In children over 6 months of age, Ondansetrone Accord Healthcare can also be used for the treatment of nausea and vomiting during chemotherapy.
• 2. What you need to know before you use or give Ondansetrone Accord Healthcare to your childDo not use Ondansetrone Accord Healthcare
• If you or your child are using apomorphine (medicine used to treat Parkinson's disease)
• If you or your child are allergic to ondansetron or any of the ingredients of this medicine (listed in section 6)
• If you think this is the case, contact your doctor before administration

Warnings and precautions
Talk to your doctor or pharmacist before using Ondansetrone Accord Healthcare

• if you or your child are allergic to medicines similar to ondansetron, such as medicines containing granisetron or palonosetron
• if you or your child have ever had heart problems, such as irregular heartbeat (arrhythmia)
• if you or your child have bowel problems
• if your liver is not working properly, your doctor may reduce the dose of Ondansetrone Accord Healthcare

Tell your doctor if you think this may apply to you.

Other medicines and Ondansetrone Accord Healthcare
Tell your doctor or pharmacist if you or your child are taking, have recently taken or
may take any other medicines, including medicines obtained without a prescription.
medical prescription.

phenytoin andcarbamazepine (medicines prescribed for epilepsy) can negatively affect the
concentration of ondansetron in the body

rifampicin(a medicine prescribed for itching, tuberculosis and leprosy) can affect
negatively the concentration of ondansetron in the body
the effect of tramadol(a medicine prescribed to fight pain) may be negatively affected
by the simultaneous use of ondansetron

• fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram(SSRIs) [selective serotonin reuptake inhibitors] (medicines for the treatment of depression and/or anxiety) may cause a change in your mental state
• venlafaxine, duloxetine(SNRIs [serotonin-norepinephrine reuptake inhibitors]) (medicines for the treatment of depression and/or anxiety) may cause a change in your mental state
• simultaneous use of ondansetron with medicines that act on the heart (e.g. anthracyclines such as doxorubicin,daunorubicinortrastuzumab), antibiotics (such as erythromycinorketoconazole), antiarrhythmics (such as amiodarone) and beta-blockers (such as atenolol or timolol) increase the risk of heart rhythm disturbances. Tell your doctor if you are using any of these medicines.

Pregnancy and breastfeeding:
Ondansetrone Accord Healthcare should not be used during the first trimester of pregnancy, because
Ondansetrone Accord Healthcare may slightly increase the risk that the baby is born with cleft lip
and/or cleft palate (cracks or fissures in the upper lip and/or palate). If you are already pregnant, believe you may
be pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before
taking Ondansetrone Accord Healthcare. If you are a woman of childbearing age, you may be asked to
use effective contraceptive measures.

Breastfeedingis not recommended during treatment with Ondansetrone Accord Healthcare:
Studies in animals have shown that ondansetron can be excreted in breast milk. This
may affect your baby. Talk to your doctor.

Driving and using machines:
Ondansetron does not impair the ability to drive and use machines.

Ondansetrone Accord Healthcare contains sodium:
This medicine contains 3.62 mg of sodium (the main component of table salt) in each ml.
This is equivalent to 0.18% of the recommended daily intake of salt for an adult.

3. How to use Ondansetrone Accord Healthcare

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor
or pharmacist.
Ondansetrone Accord Healthcare is normally administered by a nurse or a doctor. The
dose prescribed to you will depend on the treatment you are receiving.

To prevent nausea and vomiting caused by chemotherapy or radiotherapy
Adults
On the day of chemotherapy or radiotherapy, the recommended dose for adults is 8 mg
administered by an injection into the vein or muscle, shortly before treatment, and another 8 mg
administered twelve hours later. The usual intravenous dose for adults should not exceed 8 mg.
In the following days
after chemotherapy the medicine will usually be administered orally as 8 mg
ondansetrone tablets or 10 ml (8 mg) of ondansetrone syrup.
Oral administration can begin twelve hours after the last intravenous dose and can be continued
for a maximum of 5 days.
If chemotherapy or radiotherapy is likely to cause severe nausea and vomiting, you or your
child will be given a dose higher than the usual dose of Ondansetrone Accord Healthcare. The
dose will be decided by the doctor.

To prevent nausea and vomiting caused by chemotherapy
Children over 6 months of age and adolescents
The doctor will decide the dose based on the child's weight or size (body surface area).
On the day of chemotherapy
the first dose is administered by an injection into the vein, shortly before the
child's treatment. After chemotherapy, the medicine will generally be administered to the child orally
as a tablet or syrup.
In the following days, the oral dose can be started after twelve hours from the intravenous dose and can be
administered for a maximum of 5 days.

To prevent and treat nausea and vomiting after surgery
Adults:
The usual dose for adults is 4 mg administered by injection into the vein or injection into the
muscle. For prevention, this will be administered shortly before surgery.
Children:
For children from 1 month of age and for adolescents, the doctor will decide the dose. The dose
maximum is 4 mg administered by slow injection into the vein. For prevention, this will be
administered before surgery.

Patients with moderate or severe liver problems
The total daily dose should not exceed 8 mg.

If you or your child feel unwell or are feeling sick
This medicine should start working shortly after the injection. If you or your child continue to
experience nausea or vomiting, inform the doctor or nurse.

If you or your child have received more Ondansetrone Accord Healthcare than you should
The doctor or nurse will give you or your child ondansetrone, so it is unlikely that you or your
child have received too much. If you think that you or your child have taken too much or have
forgotten a dose, inform the doctor or nurse.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

SERIOUS SIDE EFFECTS
Allergic reactions
If you or your child have an allergic reaction, tell your doctor or a member of medical staff
immediately. Signs may include:

• Sudden shortness of breath and chest pain or tightness
• Swelling of eyelids, face, lips, mouth or tongue, which may make it difficult to breathe
• Skin rash - red spots or blisters under the skin (urticaria) anywhere on the body
• Collapse

Contact a doctor immediatelyif these symptoms occur . Stop taking this
medicine.
Other side effects:
Very common
(may affect more than 1
in 10 people)
Headache

Common
(may affect up to 1
in 10 people)
Sensations of hot flushes or heat
Constipation
Changes in liver function tests (if you receive ondansetron injection with a medicine called cisplatin, otherwise this
side effect is uncommon)
Irritation at the injection site such as pain, burning, swelling,
redness or itching
Seizures (fits or convulsions)
Unusual movements or tremors of the body (dyskinesia)
Movement disorders (including persistent muscle contraction and/or repetitive movements, dystonia)

Uncommon
(may affect up to 1
in 100 people)
Irregular or slow heartbeat
Chest pain with or without ST segment depression on ECG
Fixed gaze (oculogyric crisis)
Low blood pressure, which may make you feel weak or dizzy
Hiccups
Increased substances (enzymes) produced by the liver (these can be
detected by blood tests). These symptoms have been commonly reported
in patients taking cisplatin (a drug used for
chemotherapy).

Rare
(may affect up to 1
in 1,000 people)
Severe allergic reactions
Feelings of dizziness or lightheadedness during rapid administration into a vein
Transient visual disturbances (such as blurred or double vision) mainly
during i.v. administration
Heart rhythm disorder (which sometimes causes sudden loss of
consciousness)
Diarrhea and abdominal pain

Very rare
(may affect up to 1
in 10,000 people)
Not known
(frequency cannot be
estimated from available data)
Severe sudden allergic reaction with symptoms such as fever and blisters
on the skin and shedding of the skin (toxic epidermal necrolysis;
Lyell's syndrome) and severe allergic reaction with high fever, skin blisters, joint pain and/or eye inflammation (Stevens-Johnson syndrome)
Reduced vision or temporary loss of vision, which usually lasts less than
20 minutes. Most patients had received chemotherapeutic agents, including cisplatin. In some cases, transient blindness has been reported to be caused by a problem in the brain.
Fluid retention (edema)
Skin rash and itching
Myocardial ischemia, signs include: sudden chest pain or
chest tightness

Reporting of side effects
If you or your child gets any side effect, talk to your doctor, pharmacist or nurse. You can also report side effects
adverse reactions. By reporting side effects you can help provide more information on
the safety of this medicine.

5. How to store Ondansetrone Accord Healthcare

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial or the box after Exp. The
expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature. Keep the vials
in the outer packaging to protect the medicine from light.
Do not use this medicine if you notice that the container is damaged or if particles/crystals are visible.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ondansetrone Accord Healthcare contains:
The active ingredient in Ondansetrone Accord Healthcare is ondansetron (as hydrochloride dihydrate).
Each ml of injectable or infusion solution contains 2 mg of ondansetron (as ondansetron
hydrochloride dihydrate)
Each vial of 2 ml contains 4 mg of ondansetron (as ondansetron hydrochloride dihydrate).
Each vial of 4 ml contains 8 mg of ondansetron (as ondansetron hydrochloride dihydrate).
The other ingredients are citric acid monohydrate, sodium citrate, sodium chloride, sodium hydroxide and/or hydrochloric acid for pH adjustment and water for injections.

Description of Ondansetrone Accord Healthcare and contents of the pack:
Ondansetrone Accord Healthcare is a clear, colourless solution for injection or infusion contained in
a clear/amber glass vial.
Ondansetrone Accord Healthcare 2 mg/ml is available in packs containing 5 vials of 2 ml and 5 vials of
4 ml and in packs containing 10 vials of 2 ml and 10 vials of 4 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta
08039-Barcelona,
Spain.

Manufacturer:
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95-200 Pabianice, Poland

This medicinal product is authorised in the Member States of the European Economic Area and the United
Kingdom (Northern Ireland) under the following names:

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The following information is only for doctors or healthcare professionals:
Instructions for use:
For intravenous injection or intramuscular injection or intravenous infusion after dilution.
Prescribers intending to use ondansetron in the prevention of delayed nausea and vomiting
associated with chemotherapy or radiotherapy in adults, adolescents or children should consider
current practice and appropriate guidelines.

Chemotherapy and radiotherapy induced nausea and vomiting:

Adults:The emetogenic potential of cancer treatment varies according to the doses and combinations of
chemotherapy and radiotherapy regimens used. The route of administration and dose of ondansetron
should be flexible and within the range of 8-32 mg per day and selected as described below.

Emetogenic chemotherapy and radiotherapy:
Ondansetron can be administered by rectal, oral (tablets or syrup), intravenous or
intramuscular route.
For most patients undergoing emetogenic chemotherapy or radiotherapy, 8 mg of ondansetron
should be administered by a slow intramuscular or intravenous injection (no less than
30 seconds) or an intramuscular infusion, immediately before treatment followed by 8 mg orally every twelve hours.
To prevent delayed or prolonged emesis after the first 24 hours, oral or rectal treatment with
ondansetron should be continued for up to 5 days after a treatment cycle.
Highly emetogenic chemotherapy: For patients treated with highly emetogenic chemotherapy, for
example, high-dose cisplatin, ondansetron can be administered orally, rectally, intravenously or
intramuscularly. Ondansetron has been shown to be equally effective at the following doses during the first 24
hours of chemotherapy.

• A single dose of 8 mg by intramuscular or slow intravenous injection (no less than 30 seconds) immediately before chemotherapy.
• A dose of 8 mg by intramuscular or slow intravenous injection (no less than 30 seconds) doses of 8 mg at two or four hour intervals, or by constant infusion of 1 mg/hour for up to 24 hours. An initial intravenous dose of up to 16 mg diluted in 50-100 ml of physiological saline or other compatible infusion fluid (see section 6.6) and administered by infusion, for at least 15 minutes, immediately before chemotherapy. The initial dose of ondansetron may be followed by two additional 8 mg intravenous doses (no less than 30 seconds) or intramuscular doses 4 hours later.
• The choice of dosage regimen should be determined by the severity of the emetogenic potential. A single intravenous dose greater than 16 mg should not be administered due to the dose-dependent increase in the risk of QT interval prolongation (see sections 4.4, 4.8 and 5.1 of the Summary of Product Characteristics).

The efficacy of ondansetron in highly emetogenic chemotherapy may be increased by the addition of a single intravenous dose of desamethasone sodium phosphate, 20 mg administered before
chemotherapy.
To prevent delayed or prolonged emesis after the first 24 hours, oral or rectal treatment with
ondansetron should be continued for up to 5 days after a treatment cycle.

Paediatric population:
Chemotherapy induced nausea and vomiting in children ≥ 6 months of age and adolescents:
The dose of ondansetron for chemotherapy induced nausea and vomiting can be calculated based on
body surface area (BSA) or weight. See below.
Dosage based on body surface area (BSA)
Ondansetron should be administered immediately before chemotherapy as a single
intravenous dose of 5 mg/m². The single intravenous dose should not exceed 8 mg.
Oral administration may start twelve hours later and may continue for up to 5 days. (see
the SmPC for the Dosage Table).
The total dose in 24 hours (administered as divided doses) should not exceed the adult dose of
32 mg.
Dosage based on body weight:
Weight-based dosage produces higher total daily doses than body surface area (BSA) based dosage. Ondansetron should be administered immediately before
chemotherapy in a single intravenous dose of 0.15 mg/kg. The single intravenous dose should not
exceed 8 mg.
Two additional intravenous doses may be administered at intervals of 4 hours. Oral administration may
start 12 hours later and may be continued for up to 5 days. (see the SmPC for further
details).
Ondansetron Accord Healthcare should be diluted in 5% dextrose or 0.9% sodium chloride or other
compatible infusion fluid (see the SmPC section 6.6) and infused intravenously over a
period of no less than 15 minutes.
No data are available from clinical studies on the use of Ondansetron Accord Healthcare in
the prevention of delayed or prolonged chemotherapy induced nausea and vomiting. No data are available
from controlled clinical studies on the use of Ondansetron Accord Healthcare for nausea and vomiting
induced by radiotherapy in children.

Postoperative nausea and vomiting (PONV):
Adults :For the prevention of postoperative nausea and vomiting (PONV) ondansetron can be
administered orally or by intravenous or intramuscular injection.
Ondansetron can be administered as a single dose of 4 mg by intramuscular or
slow intravenous injection at the induction of anaesthesia.
For the treatment of postoperative nausea and vomiting (PONV), a single dose of 4 mg
is recommended administered by intramuscular or slow intravenous injection.
Children (children aged ≥ 1 month and adolescents)

Oral formulation:
No studies have been conducted on the use of ondansetron administered orally in the prevention or
treatment of postoperative nausea and vomiting; for this treatment an intravenous
injection is recommended.

Injection:
For the prevention of PONV in paediatric patients undergoing surgery under general anaesthesia,
a single dose of ondansetron may be administered by slow intravenous injection
(duration of no less than 30 seconds) at a dose of 0.1 mg/kg up to a maximum of 4 mg or before or
after induction of anaesthesia.
For the prevention of PONV after surgery in paediatric patients undergoing surgery
performed under general anaesthesia, a single dose of ondansetron may be administered
by slow intravenous injection (duration of no less than 30 seconds) at a dose of 0.1 mg/kg up to
a maximum of 4 mg.
No data are available on the use of Ondansetron Accord Healthcare for the treatment of postoperative
vomiting in children under 2 years of age.
Elderly: Experience is limited in the use of ondansetron in the prevention and treatment of postoperative nausea and
vomiting (PONV) in the elderly; ondansetron is however well tolerated in patients over 65
years of age receiving chemotherapy.
Patients with renal impairment: No adjustments to the daily dose, frequency or
route of administration are required.
Patients with hepatic impairment: The clearance of ondansetron is significantly reduced and the serum half-life
is significantly prolonged in subjects with moderate to severe hepatic insufficiency. In these
patients the total daily dose of more than 8 mg should not be exceeded and therefore parenteral or oral administration is recommended.
Patients with sparteine/debrisoquin metabolism slow: The elimination half-life of ondansetron
is not altered in subjects classified as sparteine and debrisochine slow metabolisers.
Therefore in these patients the administration of repeated doses results in exposure levels that do not differ from those of the general population. Therefore no changes to the daily dose or frequency of administration are required.

Incompatibilities:
This medicine should not be mixed with other medicines except those recommended
below.
The solution should not be autoclaved.
Ondansetron Accord Healthcare should only be mixed with the recommended infusion solutions:
Sodium Chloride 0.9% w/v intravenous infusion solution, BP
Glucose 5% w/v intravenous infusion solution, BP
Mannitol 10% w/v intravenous infusion solution, BP
Ringer’s intravenous infusion solution
Potassium Chloride 0.3% w/v and Sodium Chloride 0.9% w/v intravenous infusion solution, BP
Potassium Chloride 0.3% w/v and Glucose 5% w/v intravenous infusion solution, BP
The stability of Ondansetron Accord Healthcare after dilution with the recommended infusion fluids
has been demonstrated at concentrations of 0.016 mg/ml and 0.64 mg/ml.
Only clear and colourless solutions should be used.
Diluted solutions should be stored protected from light.

Shelf life and storage
Intact package
3 years
This medicine does not require any particular storage temperature.
Store the vials in the outer packaging to protect the medicine from light.
Injection
After initial opening, the drug must be used immediately.
Infusion
After dilution with the recommended diluents, chemical and physical stability during use has been demonstrated
for 7 days at 25°C and 2-8°C.
From a microbiological point of view, the product must be used immediately. If not used
immediately, the in-use storage time and conditions prior to use are the responsibility
of the user and normally should not exceed 24 hours at a temperature of 2-8°C, unless the
dilution has been carried out under controlled and validated aseptic conditions.