Ondansetron b. braun

Package leaflet: Information for the patient

Ondansetron B. Braun, 0.08 mg/ml, solution for infusion
Ondansetron B. Braun, 0.16 mg/ml, solution for infusion
Ondansetronum
Please read the entire leaflet carefully before receiving this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Ondansetron B. Braun is and what it is used for

Ondansetron B. Braun belongs to a group of medicines called antiemetic agents, which
prevent nausea and vomiting. Certain cancer treatments (chemotherapy) or radiotherapy
may cause nausea or vomiting. Nausea and vomiting may also occur in the postoperative period. Ondansetron B. Braun may help to reduce these effects in adults.
Additionally, Ondansetron B. Braun may be used in children:

• over 6 months of age: for the treatment of nausea and vomiting following anti-cancer therapy;
• over 1 month of age: for the prevention and treatment of postoperative nausea and vomiting.

2. Important information before using Ondansetron B. Braun

When not to use Ondansetron B. Braun
This medicine must not be used (inform your doctor)

• if the patient is allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6);
• if the patient is receiving apomorphine (a medicine used in the treatment of Parkinson's disease).

Warnings and precautions
Talk to your doctor or pharmacist before using Ondansetron B. Braun.
Special caution is required if:

• the patient is allergic to other antiemetic and nausea-preventing medicines: allergy to this medicine may also occur;
• the patient has intestinal obstruction or severe constipation. Ondansetron may worsen intestinal obstruction or constipation;
• the patient is taking cardiac medications;
• the patient has ever had heart disease;
• the patient has electrolyte imbalances in the blood, such as potassium, sodium, or magnesium;
• the patient has arrhythmia;
• the patient is undergoing tonsillectomy;
• the patient's liver is not functioning properly.

If a child is receiving this medicine along with hepatotoxic anticancer drugs, the doctor will monitor the child's liver function.

Ondansetron B. Braun and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
It is particularly important to inform the doctor if the patient is taking or using:

• certain antiepileptic drugs (e.g. phenytoin, carbamazepine);
• the antibiotic rifampicin;
• the strong analgesic tramadol;
• medicines used to treat depression (such as fluoxetine, sertraline, duloxetine, venlafaxine);
• apomorphine (a medicine used in the treatment of Parkinson's disease), as significant hypotension and loss of consciousness have been reported following concomitant administration with this medicine;
• medicines affecting heart rhythm or heart function, such as:
  • anticancer drugs of the anthracycline group (e.g. doxorubicin, daunorubicin or trastuzumab);
  • antibiotics (e.g. erythromycin, ketoconazole) or
  • beta-blockers (e.g. atenolol, timolol);
  • antiarrhythmics (such as amiodarone).

Pregnancy and breastfeeding
Ondansetron B. Braun must not be used during the first trimester of pregnancy. This is because Ondansetron B. Braun may slightly increase the risk of cleft lip and/or cleft palate [an opening or fissure in the upper lip and/or palate].
If the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using Ondansetron B. Braun.
If the patient is a woman of childbearing age, effective contraception may be recommended.
It has been shown that ondansetron passes into milk in animals. For this reason, mothers taking ondansetron should NOT breastfeed.

Driving and operating machinery
Ondansetron has no effect or has a negligible effect on the ability to drive or operate machinery.

Ondansetron B. Braun contains sodium

• Ondansetron, 0.08 mg/ml: The medicine contains 357 mg of sodium (the main component of table salt) in each 100 ml bottle. This corresponds to 17.9% of the maximum recommended daily dietary intake of sodium for adults.
• Ondansetron, 0.16 mg/ml: The medicine contains 178.5 mg of sodium (the main component of table salt) in each 50 ml bottle. This corresponds to 8.9% of the maximum recommended daily dietary intake of sodium for adults.

3. How to use Ondansetron B. Braun

Dosage
Your doctor will individually determine the appropriate dose of ondansetron.
The dose depends on the type of primary treatment (chemotherapy or surgery), liver function, and whether the medicine is administered by injection or infusion.
In chemotherapy or radiotherapy, the typical daily dose for adults is 8 to 32 mg of ondansetron.
For the treatment of postoperative nausea and vomiting, a single dose of 4 mg of ondansetron is usually given.

Use in children over 1 month of age and adolescents
The dose will be determined individually by the doctor.

Dose adjustment
Patients with hepatic impairment
In patients with liver impairment, the maximum dose must not exceed 8 mg of ondansetron per day.

Patients with renal impairment or impaired sparteine/debrisoquine metabolism
There is no need to modify the dose, frequency, or method of administration of the medicine.

Elderly patients
65–74 years: the standard adult dosing regimen may be used.

74 years: specific dosing regimens should be applied. Your doctor is aware of these and may use an initial dose lower than that used in younger patients.

Duration of treatment
Your doctor will individually determine the duration of treatment with Ondansetron B. Braun.
After intravenous administration of Ondansetron B. Braun, treatment may be continued with other formulations of the medicine.

Method of administration
Ondansetron B. Braun is given as a short-term intravenous infusion. The medicine is usually administered by a doctor or nurse.

Administration of a higher than recommended dose of Ondansetron B. Braun
Ondansetron B. Braun is administered by a doctor or nurse, so receiving too high a dose is unlikely. If you think that a patient has received too high a dose or if a dose has been missed, inform the doctor or nurse immediately.
To date, there is limited data on overdose. Symptoms observed in most patients are similar to those seen in patients receiving recommended doses of this medicine (see section “Possible side effects”). The following symptoms have been observed in cases of overdose: visual disturbances, severe constipation, hypotension, and loss of consciousness. In all cases, symptoms resolved completely.
This medicine may cause changes in heart rhythm, especially in cases of overdose. In such situations, the doctor will monitor the patient’s heart function.
There is no specific antidote for ondansetron; therefore, in case of suspected overdose, symptomatic treatment should be administered.
Inform the doctor if any of the above symptoms occur.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may be serious. If any of the
following adverse reactions occur in a patient, a doctor must be informed immediately, as
it may be necessary to discontinue treatment with this medicine.
Uncommon (may occur in up to 1 in 100 patients):

• chest pain, irregular heartbeat (arrhythmia, which in individual cases may lead to death), and slow heart rate (bradycardia).

Rare (may occur in up to 1 in 1,000 patients):

• immediate allergic reactions, including life-threatening allergic reactions (anaphylactic reactions). These reactions include: swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing. Additionally, rash, itching, and urticaria may occur.

Frequency of adverse reactions unknown (cannot be estimated from available data):

• Myocardial ischaemia: symptoms include sudden chest pain or chest tightness.

Other adverse reactions:
Very common (may occur in more than 1 in 10 patients):

• headache.

Common (may occur in up to 1 in 10 patients):

• feeling of warmth or flushing;
• constipation;
• local reactions at the site of intravenous injection.

Uncommon (may occur in up to 1 in 100 patients):

• involuntary movement disorders, e.g. eye movements, unusual muscle contractions which may cause twisting or bending of the body, seizures (e.g. epileptic seizures);
• hypotension (low blood pressure);
• hiccups;
• asymptomatic increase in liver function tests. Such effects occur particularly in patients receiving anticancer therapy, e.g. cisplatin;
• hypersensitivity reactions around the injection site (e.g. rash, urticaria, itching) may occur.

Rare (may occur in up to 1 in 1,000 patients):

• dizziness with rapid intravenous administration;
• transient changes in electrocardiogram (ECG) recordings (recording of electrical activity in the heart during its function), usually after intravenous administration of ondansetron (prolongation of QTc interval, including torsades de pointes arrhythmias);
• transient visual disturbances (e.g. blurred vision) after rapid intravenous administration.

Very rare (may occur in up to 1 in 10,000 patients):

• depression;
• transient blindness has been reported in individual cases in patients also receiving chemotherapeutic agents, including cisplatin. In most reported cases, symptoms resolved within 20 minutes.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ondansetron B. Braun

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton: Expiry
date (EXP). The expiry date refers to the last day of the stated month.
There are no special temperature requirements for storing this medicine.
Store the bottle in its outer packaging to protect it from light.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Contents of the pack and other information

What Ondansetron B. Braun contains
The active substance is ondansetron.
Ondansetron B. Braun, 0.08 mg/ml, solution for infusion
1 ml of infusion solution contains 0.08 mg of ondansetron as ondansetron hydrochloride
dihydrate.
Each 100 ml bottle contains 8 mg of ondansetron.
Ondansetron B. Braun, 0.16 mg/ml, solution for infusion
1 ml of infusion solution contains 0.16 mg of ondansetron as ondansetron hydrochloride
dihydrate.
Each 50 ml bottle contains 8 mg of ondansetron.
The other ingredients are sodium chloride, sodium citrate, citric acid monohydrate and water for
injections.

What Ondansetron B. Braun looks like and contents of the pack
Ondansetron B. Braun is a clear, colourless solution.
The medicine is supplied in plastic bottles made of LDPE:
Each bottle contains:
Ondansetron B. Braun, 0.08 mg/ml, solution for infusion: 100 ml
Ondansetron B. Braun, 0.16 mg/ml, solution for infusion: 50 ml
Pack sizes:
Ondansetron B. Braun, 0.08 mg/ml, solution for infusion: 10 x 100 ml
Ondansetron B. Braun, 0.16 mg/ml, solution for infusion: 10 x 50 ml

Marketing Authorisation Holder:
B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen
Germany
Correspondence address:
34209 Melsungen
Germany

Manufacturer:
B. Braun Medical SA
Carretera de Terrassa 121
08191 Rubi, Barcelona
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Ondansetron B. Braun 0.08 mg/ml, oplossing voor infusie
Ondansetron B. Braun 0.16 mg/ml, oplossing voor infusie
Bulgaria: Ондансетрон 0,08 mg/ml инфузионен разтвор
Finland: Ondansetron B. Braun 0.08 mg/ml infuusioneste, liuos
Ondansetron B. Braun 0.16 mg/ml infuusioneste, liuos
Spain: Ondansetron B. Braun 0,08 mg/ml solución para perfusion
Ondansetron B. Braun 0,16 mg/ml solución para perfusion
Netherlands: Ondansetron B. Braun 0.08 mg/ml, oplossing voor infusie
Ondansetron B. Braun 0.16 mg/ml, oplossing voor infusie
Germany: Ondansetron B. Braun 0,08 mg/ml Infusionslösung
Ondansetron B. Braun 0,16 mg/ml Infusionslösung
Poland: Ondansetron B. Braun, 0.08 mg/ml, solution for infusion
Ondansetron B. Braun, 0.16 mg/ml, solution for infusion
Sweden: Ondansetron B. Braun 0.08 mg/ml infusionsvätska, lösning
Ondansetron B. Braun 0.16 mg/ml infusionsvätska, lösning
Italy: Ondansetron B. Braun 0.08 mg/ml soluzione per infusione
Ondansetron B. Braun 0.16 mg/ml soluzione per infusione

Information intended exclusively for healthcare professionals:

QT interval prolongation
Rarely and mainly after intravenous administration of ondansetron, transient changes in ECG recordings have been observed, including QT interval prolongation. In addition, cases of torsades de pointes have been reported in patients receiving ondansetron. Caution is recommended in patients who may be at risk of QTc interval prolongation, including patients with electrolyte imbalances, congenital long QT syndrome, or those receiving other medicinal products that lead to QT interval prolongation. Therefore, caution should be exercised in patients with cardiac rhythm or conduction abnormalities, patients receiving antiarrhythmic drugs or beta-blockers, and patients with significant electrolyte imbalances.

Serotonin syndrome
Post-marketing reports describe cases of serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular abnormalities) in patients receiving ondansetron in combination with other serotonergic active substances (including selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)). If concomitant treatment with ondansetron and other serotonergic active substances is clinically necessary, appropriate patient monitoring is recommended.

Compatibility with other medicinal products:
The following drugs may be administered simultaneously with Ondansetron B. Braun using a Y-site administration set. Compatibility has generally been demonstrated for up to one hour; however, the manufacturer's recommendations regarding the co-administered drug should be taken into account.

Cisplatin: concentrations up to 0.48 mg/ml (e.g., 240 mg in 500 ml).
Carboplatin: concentrations ranging from 0.18 mg/ml to 9.9 mg/ml (e.g., 90 mg in 500 ml to 990 mg in 100 ml).
Etoposide: concentrations ranging from 0.14 mg/ml to 0.25 mg/ml (e.g., 72 mg in 500 ml to 250 mg in 1 litre).
Ceftazidime: compatibility demonstrated for 2000 mg reconstituted in 20 ml of 0.9% NaCl and 2000 mg reconstituted in 10 ml of water for injection.
Cyclophosphamide: compatibility demonstrated for 1000 mg reconstituted in 50 ml of 0.9% NaCl.
Doxorubicin: concentrations up to 2 mg/ml (e.g., 10 mg in 5 ml or 100 mg in 200 ml).
Dexamethasone: compatibility between sodium phosphate dexamethasone and ondansetron has been demonstrated when administered via the same infusion line, achieving concentrations of 32 micrograms – 2.5 mg/ml for sodium phosphate dexamethasone and 8 micrograms – 0.75 mg/ml for ondansetron.

For complete information on this medicinal product, refer to the Summary of Product Characteristics.