ONDANSETRON 0.08 mg/ml Solution

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. You should carefully read the contents of the leaflet before receiving the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
2. What is Ondansetron B. Braun and what is it used for
3. Important information before using Ondansetron B. Braun
   1. When not to use Ondansetron B. Braun
   2. Warnings and precautions
   3. Ondansetron B. Braun and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Ondansetron B. Braun contains sodium
4. How to use Ondansetron B. Braun
   1. Dosage
   2. Dose adjustment
   3. Duration of treatment
   4. Method of administration
   5. Use of a higher than recommended dose of Ondansetron B. Braun
5. Possible side effects
   1. The following side effects may be serious. If the patient experiences any of the following side effects, they should immediately inform their doctor, as it may be necessary to discontinue the use of this medicine.
   2. Other side effects:
   3. Reporting side effects
6. How to store Ondansetron B. Braun
7. Package contents and other information
   1. What Ondansetron B. Braun contains
   2. What Ondansetron B. Braun looks like and package contents
   3. Marketing authorization holder:
   4. Manufacturer:
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet: 2022-04-08 -------------------------------------------------------------------------------------------------------------------------

Leaflet attached to the packaging: patient information

Ondansetron B. Braun, 0.08 mg/ml, solution for infusion
Ondansetron B. Braun, 0.16 mg/ml, solution for infusion
Ondansetronum

You should carefully read the contents of the leaflet before receiving the medicine, as it contains important information for the patient.

• ●You should keep this leaflet, so that you can read it again if necessary.
• ●If you have any doubts, you should consult a doctor or pharmacist.
• ●If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Ondansetron B. Braun and what is it 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. Package contents and other information

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

Ondansetron B. Braun belongs to a group of medicines called antiemetic medicines, which prevent nausea or vomiting. Some pharmacological methods of treating tumors (chemotherapy) or radiation therapy may cause nausea or vomiting. Nausea and vomiting can also occur in the postoperative period. Ondansetron B. Braun may help alleviate these effects in adults.
Additionally, Ondansetron B. Braun can be used in children

• over 6 months of age: for the treatment of nausea and vomiting after anticancer treatment;
• over 1 month of age: for the prevention and treatment of nausea and vomiting after surgery.

2. Important information before using Ondansetron B. Braun

When not to use Ondansetron B. Braun

This medicine must not be used (you should 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 to treat Parkinson's disease).

Warnings and precautions

Before starting to use Ondansetron B. Braun, you should discuss it with your doctor or pharmacist.
During the use of this medicine, special caution will be exercised if:

• the patient is allergic to other antiemetic medicines that prevent nausea: they may also be allergic to this medicine;
• the patient has intestinal obstruction or severe constipation. Ondansetron may worsen obstruction or constipation;
• the patient has taken cardiac medicines;
• the patient has had heart disease;
• the patient has disturbances in the balance of mineral components in the blood, such as potassium, sodium, magnesium;
• the patient has arrhythmia;
• the patient is going to have their tonsils removed;
• the patient's liver does not work properly.

If a child is receiving this medicine, as well as anticancer medicines that affect the liver, the doctor will monitor the child's liver function.

Ondansetron B. Braun and other medicines

You should tell your doctor about all medicines that the patient is currently taking or has recently taken, as well as any medicines that the patient plans to take.
In particular, it is important to inform your doctor if the patient is taking:

• certain medicines used to treat epilepsy (e.g. phenytoin, carbamazepine);
• an antibiotic called rifampicin;
• a strong pain reliever called tramadol;
• medicines used to treat depression (such as fluoxetine, sertraline, duloxetine, venlafaxine);
• apomorphine (a medicine used to treat Parkinson's disease), as significant drops in blood pressure and loss of consciousness have been reported after concomitant administration with this medicine;
• medicines that affect heart rhythm or heart function, such as.
• anticancer medicines from the anthracycline group (e.g. doxorubicin, daunorubicin or trastuzumab);
• antibiotics (e.g. erythromycin, ketoconazole) or
• beta-blockers (e.g. atenolol, timolol);
• antiarrhythmic medicines (such as amiodarone).

Pregnancy and breastfeeding

Ondansetron B. Braun should not be used in the first trimester of pregnancy. This is because Ondansetron B. Braun may slightly increase the risk of cleft lip and/or palate [opening or slit in the upper lip and/or palate].
If the patient is already pregnant, suspects pregnancy or plans to become pregnant, they should consult their doctor or pharmacist before using Ondansetron B. Braun.
If the patient is a woman of childbearing age, they may be advised to use effective contraception.
It has been shown that ondansetron passes into breast milk in animals. For this reason, mothers taking ondansetron SHOULD NOT breastfeed.

Driving and using machines

Ondansetron has no influence or negligible influence on the ability to drive or use machines.

Ondansetron B. Braun contains sodium

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

3. How to use Ondansetron B. Braun

Dosage

The doctor will individually select the appropriate dose of ondansetron.
The dose depends on the method of primary treatment used (chemotherapy or surgery), liver function, and whether the medicine is administered by injection or infusion.
In the case of chemotherapy or radiation therapy, the typical dose for adults is 8 to 32 mg of ondansetron per day. In the treatment of postoperative nausea and vomiting, a single dose of 4 mg of ondansetron is usually administered.
Use in children over 1 month of age and adolescents
The dose will be determined by the doctor individually.

Dose adjustment

Patients with liver failure
In patients with liver failure, the maximum dose should not exceed 8 mg of ondansetron per day
Patients with renal failure or impaired sparteine/debrisoquine metabolism
There is no need to modify the dose, frequency, or method of administration of the medicine.
Patients of advanced age
65-74 years: the usual adult dosing schedule can be used.
> 74 years: specific dosing schedules should be used. The doctor is aware of them and may use a lower initial dose of the medicine than in younger patients.

Duration of treatment

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

Method of administration

Ondansetron B. Braun is administered by short-term intravenous infusion. The medicine is usually administered by a doctor or nurse.

Use of a higher than recommended dose of Ondansetron B. Braun

Ondansetron B. Braun will be administered by a doctor or nurse, so it is unlikely that the patient will receive too much of the medicine. If it is suspected that the patient has received too much of the medicine or has missed a dose of the medicine, they should inform their doctor or nurse.
So far, there is little data on overdose. The symptoms that occur in most patients are similar to the symptoms that occur in patients receiving the recommended doses of this medicine (see section "Possible side effects"). The following symptoms have been observed in cases of overdose: vision disturbances, severe constipation, hypotension, and loss of consciousness. In each case, the symptoms resolved completely.
This medicine may cause a change in heart rhythm, especially in the event of an overdose. In such a situation, the doctor will monitor the patient's heart function.
There is no specific antidote for ondansetron, so in case of suspected overdose, symptomatic treatment should be used.
You should inform your doctor about the occurrence of any of the above symptoms.
In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although they may not occur in everyone.

The following side effects may be serious. If the patient experiences any of the following side effects, they should immediately inform their doctor, as it may be necessary to discontinue the use of this medicine.

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

• chest pain, irregular heart rhythm (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 swallowing or breathing. Additionally, a rash or itching and hives may occur.

Frequency of side effects unknown (cannot be determined from available data):

• myocardial ischemia: symptoms include sudden chest pain or pressure in the chest.

Other side effects:

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

• headache.

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

• feeling of blood rushing or heat;
• 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, abnormal muscle contractions that can cause twisting or bending of the body, seizures (e.g. epileptic seizures);
• hypotension (low blood pressure) ;
• hiccups;
• asymptomatic increase in liver function test results. Such effects occur particularly in patients receiving anticancer treatment, e.g. cisplatin;
• allergic reactions may occur around the injection site (e.g. rash, hives, itching).

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

• dizziness when administered intravenously quickly;
• transient changes in the ECG recording (a record of the electrical processes occurring in the heart during its operation), mostly after intravenous administration of ondansetron (prolongation of the QTc interval, including torsades de pointes);
• transient visual disturbances (e.g. blurred vision) after rapid intravenous administration;

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

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

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ondansetron B. Braun

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and carton after: Expiry Date (EXP). The expiry date refers to the last day of the month stated.
There are no special precautions for storage temperature.
Store the vial in the outer packaging to protect it from light.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment .

6. Package contents and other information

What Ondansetron B. Braun contains

The active substance of the medicine is ondansetron.
Ondansetron B. Braun, 0.08 mg/ml, solution for infusion
1 ml of solution for infusion contains 0.08 mg of ondansetron in the form of ondansetron hydrochloride dihydrate.
Each 100 ml vial contains 8 mg of ondansetron.
Ondansetron B. Braun, 0.16 mg/ml, solution for infusion
1 ml of solution for infusion contains 0.16 mg of ondansetron in the form of ondansetron hydrochloride dihydrate.
Each 50 ml vial 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 package contents

Ondansetron B. Braun is a clear, colorless solution.
The medicine is supplied in LDPE plastic vials:
Each vial 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
Package 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 authorization 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 authorized in the Member States of the European Economic Area 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, roztwór do infuzji
Ondansetron B. Braun, 0,16 mg/ml, roztwór do infuzji
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

Date of last revision of the leaflet: 2022-04-08 -------------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:
Prolongation of the QT interval
Rarely and mainly after intravenous administration of ondansetron, transient changes in the ECG recording have been observed, including prolongation of the QT interval. Additionally, cases of torsades de pointeshave been reported in patients taking ondansetron. Caution is recommended in patients who may experience QTc interval prolongation. This applies to patients with electrolyte disturbances, with congenital long QT syndrome, or patients taking other medicinal products that lead to QT interval prolongation. Therefore, caution is recommended in patients with arrhythmias or conduction disorders of the heart muscle, patients taking antiarrhythmic medicines or beta-blockers, and patients with significant electrolyte disturbances.
Serotonin syndrome
There have been reports from the post-marketing period describing patients with serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular abnormalities) after concomitant use of ondansetron and 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 necessary for clinical reasons, the patient should be closely monitored.
Compatibility with other medicinal products:
The following medicines can be administered simultaneously with Ondansetron B. Braun using a three-way set for ondansetron administration. In principle, compatibility has been demonstrated for up to one hour, but the recommendations for the concomitantly administered medicine specified by the manufacturer should be taken into account.
Cisplatin:concentrations up to 0.48 mg/ml (e.g. 240 mg in 500 ml).
Carboplatin: concentrations in the range of 0.18 mg/ml to 9.9 mg/ml (e.g. 90 mg in 500 ml to 990 mg in 100 ml)
Etoposide:concentrations in the range of 0.14 mg/ml to 0.25 mg/ml (e.g. 72 mg in 500 ml to 250 mg in 1 liter)
Ceftazidime:compatibility has been demonstrated for 2000 mg reconstituted in 20 ml of NaCl 0.9% and 2000 mg reconstituted in 10 ml of water for injections.
Cyclophosphamide:compatibility has been demonstrated for 1000 mg reconstituted in 50 ml of NaCl 0.9%.
Doxorubicin:concentrations up to 2 mg/ml (e.g. 10 mg in 5 ml or 100 mg in 200 ml).
Dexamethasone:compatibility between dexamethasone sodium phosphate and ondansetron has been demonstrated when administered through the same infusion set, achieving concentrations of 32 micrograms - 2.5 mg/ml for dexamethasone sodium phosphate and 8 micrograms - 0.75 mg/ml for ondansetron.
To obtain complete information about this medicinal product, see the Summary of Product Characteristics.