Ondansetron Baxter

Package Leaflet: Information for the User

Ondansetron Baxter, 2 mg/ml, Solution for Injection

Ondansetron (as hydrochloride dihydrate)
The full name of this medicine is Ondansetron Baxter, 2 mg/ml, Solution for Injection, but it will also be referred to as Ondansetron Baxter or Ondansetron throughout this leaflet.

Read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

• 1. What Ondansetron Baxter is and what it is used for
• 2. Before you use Ondansetron Baxter
• 3. How to use Ondansetron Baxter
• 4. Possible side effects
• 5. How to store Ondansetron Baxter
• 6. Contents of the pack and other information

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

Ondansetron Baxter is a clear, colorless solution containing ondansetron as the active substance.
Ondansetron belongs to a group of medicines called antiemetics (to prevent nausea and vomiting).
Ondansetron Baxter is used:

• to prevent nausea and vomiting caused by chemotherapy (in adults and children) and radiotherapy for cancer (in adults only),
• to prevent nausea and vomiting after surgery.

2. Before you use Ondansetron Baxter

When not to use Ondansetron Baxter:

• if you are taking apomorphine (used to treat Parkinson's disease)
• if you have been told that you have an intolerance to some sugars
• if you are allergic (hypersensitive) to ondansetron or to any of the other ingredients of Ondansetron Baxter (listed in section 6). If you are not sure, consult your doctor, pharmacist, or nurse before using Ondansetron Baxter.

Warnings and precautions:

Before using Ondansetron Baxter, you should discuss this with your doctor, pharmacist, or nurse:

• if you have ever had heart problems (e.g., congestive heart failure, which causes shortness of breath and swelling of the ankles),
• if your heart beats irregularly (arrhythmia),
• if you are allergic to medicines similar to ondansetron, such as granisetron or palonosetron,
• if you have liver problems,
• if you have bowel obstruction,
• if you have disturbances in the levels of salts (electrolytes) such as potassium, sodium, and magnesium in your blood.

If you are not sure if any of the above apply to you, talk to your doctor, pharmacist, or nurse before using Ondansetron Baxter.

Ondansetron Baxter with other medicines

Tell your doctor or nurse about all the medicines you are taking, or have recently taken, including those obtained without a prescription and herbal medicines. This is because Ondansetron Baxter may affect the action of other medicines. Some other medicines may also affect the action of Ondansetron Baxter.
In particular, tell your doctor, nurse, or pharmacist if you are taking:

• carbamazepine or phenytoin, used to treat epilepsy;
• rifampicin, used to treat infections such as tuberculosis;
• antibiotics such as erythromycin or ketoconazole;
• anti-arrhythmic medicines, used to treat irregular heartbeat;
• beta-adrenergic blocking agents, used to treat certain heart conditions, eye conditions, anxiety, and to prevent migraine;
• tramadol, a pain reliever;
• medicines that affect the heart (such as haloperidol or methadone);
• cancer medicines (especially anthracyclines and trastuzumab);
• selective serotonin reuptake inhibitors (SSRIs) used to treat depression and/or anxiety disorders, including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram,
• serotonin and norepinephrine reuptake inhibitors (SNRIs) used to treat depression and/or anxiety disorders, including venlafaxine and duloxetine.

If you are not sure if any of the above apply to you, talk to your doctor, pharmacist, or nurse before using Ondansetron Baxter.
Ondansetron Baxter solution for injection must not be mixed with other medicines in the same syringe or infusion.

Pregnancy, breastfeeding, and fertility

Ondansetron Baxter should not be used during the first trimester of pregnancy. This is because Ondansetron Baxter may slightly increase the risk of cleft palate (a gap in the roof of the mouth). If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before using Ondansetron Baxter. If you are a woman of childbearing age, you may be advised to use effective contraception.
Do not breastfeed while using Ondansetron Baxter. This medicine passes into breast milk in small amounts. If you have any further questions, ask your doctor or midwife.

Driving and using machines

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

Ondansetron Baxter contains sodium:

Ondansetron Baxter contains sodium citrate and sodium chloride.
The solution contains 3.6 mg/ml of sodium. The maximum daily dose of Ondansetron Baxter contains 2.52 mmol (57.6 mg) of sodium. If you are on a low-sodium diet, talk to your doctor before using this medicine.

3. How to use Ondansetron Baxter

Ondansetron Baxter is usually given by a doctor or nurse. The prescribed dose will depend on the type of treatment you are having.

Prevention of nausea and vomiting caused by chemotherapy and radiotherapy in adults

On the day of chemotherapy or radiotherapy

• The usual dose for adults is 8 mg given as a slow injection into a vein or muscle, just before treatment, and another 8 mg 12 hours later. After chemotherapy, the medicine will usually be given by mouth in the form of a syrup or tablet.

On subsequent days

• The recommended dose for adults is one 8 mg tablet or 10 ml (8 mg) of syrup twice a day,
• This dose may be given for up to 5 days. If chemotherapy or radiotherapy is causing severe nausea and vomiting, you may be given a higher dose of Ondansetron Baxter than usual. Your doctor will decide this.

Prevention of nausea and vomiting caused by chemotherapy in children over 6 months of age and adolescents.

Your doctor will work out the dose based on the size (body surface area) or weight of the child.
More information can be found on the label.
On the day of chemotherapy

• The first dose is given by injection into a vein, just before the child's treatment. After chemotherapy, the medicine is usually given by mouth 12 hours later, in the form of a syrup or tablet.

On subsequent days

• Small children and children weighing 10 kg or less are given 2.5 ml (2 mg) of syrup twice a day,
• Older children and children weighing more than 10 kg are given a 4 mg tablet or 5 ml (4 mg) of syrup twice a day,
• Adolescents and children with a large body surface area are given two 4 mg tablets or 10 ml (8 mg) of syrup twice a day,
• These doses may be given for up to 5 days.

Prevention and treatment of post-operative nausea and vomiting

Adults

• The recommended dose for adults is 4 mg given as a slow injection into a vein or muscle. This will be given just before surgery to prevent nausea and vomiting.

Children

• Your doctor will decide the dose for children over 1 month of age and adolescents. The maximum dose is 4 mg given as a slow injection into a vein. This will be given just before surgery to prevent nausea and vomiting.

Patient with moderate or severe liver disease

For all patients with liver disease, the maximum daily dose is 8 mg.

If you continue to feel nauseous or vomit

Ondansetron Baxter should start to work soon after it is given as an injection.
If nausea or vomiting do not improve, talk to your doctor or nurse.

Using more Ondansetron Baxter than you should

An injection of Ondansetron Baxter will be given to you by a doctor or nurse. It is unlikely that you will be given too much. If you think you have been given too much Ondansetron Baxter, talk to your doctor or nurse.

4. Possible side effects

Like all medicines, Ondansetron Baxter can cause side effects, although not everybody gets them.

Severe side effects

If you get any of the following side effects, see a doctor immediately

• Chest pain

The following side effects have been reported:

Allergic reactions

If you have an allergic reaction, stop using Ondansetron Baxter and tell a doctor or other healthcare professional immediately. Symptoms may include:

• sudden wheezing, chest pain or tightness,
• swelling of the eyelids, face, lips, mouth, or tongue,
• red itchy lumps on the skin (hives),
• fainting.

Myocardial ischemia

Symptoms include:

• sudden chest pain or
• tightness in the chest

Other side effects:

Very common(affects more than 1 in 10 people)

• headache.

Common(affects up to 1 in 10 people)

• feeling warm or flushed,
• constipation,
• changes in liver function tests (if you are given Ondansetron Baxter with a medicine called cisplatin, otherwise this side effect is uncommon),
• irritation and redness at the injection site.

Uncommon(affects up to 1 in 100 people)

• hiccups,
• low blood pressure, which can cause fainting or dizziness,
• abnormal heart rhythm,
• chest pain,
• seizures,
• abnormal movements of the body or shaking,

Rare(affects up to 1 in 1,000 people)

• confusion or feeling disoriented,
• blurred vision,
• abnormal heart rhythm (which can sometimes cause sudden loss of consciousness).

Very rare(affects less than 1 in 10,000 people)

• loss of vision or temporary blindness, which usually improves within 20 minutes.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Further information" section.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ondansetron Baxter

• Keep this medicine out of the sight and reach of children.
• Do not use Ondansetron Baxter after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
• Store in the original package in order to protect from light.
• Do not use Ondansetron Baxter if you notice any visible signs of deterioration.
• 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 protect the environment.

6. Contents of the pack and other information

What Ondansetron Baxter contains

The active substance is ondansetron (as hydrochloride dihydrate).
Each 1 ml of solution contains 2 mg of ondansetron (as hydrochloride dihydrate).
Each 2 ml glass ampoule contains 4 mg of ondansetron (as hydrochloride dihydrate).
Each 5 ml glass ampoule (with 4 ml of solution) contains 8 mg of ondansetron (as hydrochloride dihydrate).
The other ingredients are citric acid monohydrate, sodium citrate, sodium chloride, and water for injections.

What Ondansetron Baxter looks like and contents of the pack

Ondansetron Baxter is a clear, colorless solution for injection, supplied in clear glass ampoules of 2 ml or 5 ml.
2 ml ampoule contains 4 mg/2 ml of solution
5 ml ampoule contains 8 mg/4 ml of solution
Each pack contains 25 glass ampoules of 2 ml or 5 ml or 5 glass ampoules of 2 ml or 5 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Baxter Holding B.V.
Kobaltweg 49
3542CE Utrecht, Netherlands

Importer:

UAB Norameda
Meistru 8a, 02189, Vilnius, Lithuania
Bieffe Medital S.p.A.
Via Nuova Provinciale 23034 Grossotto (SO) Italy

Date of last revision of the leaflet: February 2022