ONDANSETRON KALCEKS 2mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Ondansetrón Kalceks 2 mg/ml Solution for Injection and Infusion EFG

Read all of this leaflet carefully before you start 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

1. What Ondansetrón Kalceks is and what it is used for
2. What you need to know before you are given Ondansetrón Kalceks
3. How to use Ondansetrón Kalceks
4. Possible side effects
5. Storage of Ondansetrón Kalceks
6. Contents of the pack and other information

1. What Ondansetrón Kalceks is and what it is used for

Ondansetrón Kalceks contains a medicine called ondansetron. This belongs to a group of medicines called antiemetics which stop you feeling sick (nausea) or being sick (vomiting).

Adults

Ondansetron is used to prevent nausea and vomiting caused by chemotherapy and radiotherapy and to prevent and treat nausea and vomiting after an operation.

Children and Adolescents

Ondansetron is used to prevent nausea and vomiting caused by chemotherapy in children aged over 6 months and in adolescents.

Ondansetron is used to prevent and treat nausea and vomiting after an operation in children aged over 1 month and in adolescents.

2. What you need to know before you are given Ondansetrón Kalceks

Ondansetrón Kalceks must not be given to you if:

• you are allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6);
• you are using apomorphine (for the treatment of Parkinson's disease).

This medicine must not be given to you if any of the above applies to you. If you are not sure, talk to your doctor or nurse before you are given this medicine.

Warnings and Precautions

Talk to your doctor or nurse before you are given this medicine if:

• you have symptoms of an allergic reaction, such as itching, difficulty breathing or swelling of the face, lips, throat or tongue;
• you have previously been allergic to other medicines for nausea and vomiting (e.g. granisetron or palonosetron);
• you have heart problems; there may be temporary changes in your electrocardiogram (ECG);
• you are using medicines for heart rhythm problems (antiarrhythmics) or medicines that lower blood pressure and heart rate at rest (beta-blockers);
• you are constipated or have a gut problem that may cause constipation;
• you have liver problems or are using a medicine that may harm your liver (hepatotoxic chemotherapy medicines). In these cases, your liver will be closely monitored, especially in children and adolescents;
• you have had a blood test to check your liver values (ondansetron may affect the results);
• you have changes in the levels of salts in your blood, such as potassium and magnesium;
• you are going to have a tonsillectomy. In this case, you will need to be closely monitored.

If you are not sure if any of the above applies to you, talk to your doctor or nurse before you are given this medicine.

Other Medicines and Ondansetrón Kalceks

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or nurse if you are taking any of the following medicines:

• apomorphine (see Ondansetrón Kalceks must not be given to you if);
• carbamazepine or phenytoin (used to treat epilepsy);
• rifampicin (used to treat infections such as tuberculosis);
• tramadol (a painkiller);
• medicines used to treat depression and/or anxiety:

• SSRIs (selective serotonin reuptake inhibitors), such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram;
• SNRIs (serotonin-noradrenaline reuptake inhibitors) such as venlafaxine or duloxetine.

When given with medicines for certain heart conditions, changes in your ECG may occur. The use of medicines that harm the heart (e.g. anthracyclines (such as doxorubicin, daunorubicin) or trastuzumab), antibiotics (such as erythromycin), antifungals (such as ketoconazole), antiarrhythmics (such as amiodarone) and beta-blockers (such as atenolol or timolol) may increase the risk of heart rhythm problems.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

You should not use this medicine during the first trimester of pregnancy. This is because this medicine may slightly increase the risk of your baby being born with a cleft lip and/or cleft palate (an opening or split in the upper lip and/or the roof of the mouth). If you are already pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Women of Childbearing Age

If you are a woman of childbearing age, you should be advised to use effective contraception.

Breast-feeding

Breast-feeding should be stopped before treatment with ondansetron.

Fertility

Ondansetron has no effect on fertility.

Driving and Using Machines

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

Ondansetrón Kalceks contains Sodium

This medicine contains 3.52 mg of sodium (a major component of cooking/table salt) in each ml of solution. This is equivalent to 0.18% of the maximum daily intake of sodium recommended for an adult.

3. How to use Ondansetrón Kalceks

Ondansetron will be given to you by a doctor or nurse as an injection or infusion into a vein or as an injection into a muscle.

Ondansetron is also available in forms that can be taken by mouth, which allows the dose to be adjusted individually. However, this medicine is designed to be given only into a vein or muscle.

The dose you are given will depend on the treatment you are having.

Adults

To prevent nausea and vomiting caused by chemotherapy or radiotherapy

• On the day of chemotherapy or radiotherapy

Ondansetron should be given immediately before chemotherapy or radiotherapy. The usual dose for adults is 8 mg given as a slow injection into a vein or muscle, or by slow infusion into a vein.

• On subsequent days

After the initial treatment, your doctor may prescribe ondansetron for you to take by mouth. Follow the instructions in the package leaflet, as necessary. Always take ondansetron exactly as your doctor has told you.

If necessary, the dose may be increased up to 32 mg per day.

To prevent and treat nausea and vomiting after an operation

The usual dose for adults is 4 mg given as a slow injection into a vein or muscle.

Pediatric Population

To prevent nausea and vomiting caused by chemotherapy in children aged over 6 months and in adolescents

In children, this medicine is given slowly into a vein (intravenously), immediately before chemotherapy (recommended dose: 5 mg/m2 or 0.15 mg/kg). The intravenous dose should not exceed 8 mg. Oral dosing can start 12 hours later. This treatment can continue for up to 5 days after chemotherapy. The oral dose is calculated based on body weight or body surface area. The total daily dose should not exceed the adult dose of 32 mg.

To prevent and treat nausea and vomiting after an operation in children aged over 1 month and in adolescents

In children, the oral dose is calculated based on body weight or body surface area. The total daily dose should not exceed the adult dose of 32 mg. The dose is given as a slow intravenous injection before, during, or after the induction of anesthesia.

Elderly (over 65 years of age)

Ondansetron is well tolerated in patients over 65 years of age.

Chemotherapy and radiotherapy-induced nausea and vomiting

In patients aged 65 and over, all intravenous doses should be diluted and given by infusion over 15 minutes. If further doses are needed, they should be given with a minimum interval of 4 hours between them.

In patients aged 65 to 74, the initial dose is 8 mg or 16 mg. In patients over 75, the initial dose should not exceed 8 mg.

To prevent and treat nausea and vomiting after an operation

There is limited experience in elderly patients.

Patients with Liver Problems

In patients with moderate or severe liver problems, the total daily dose should not exceed 8 mg.

Patients with Kidney Problems

No dose adjustment, change of dosing frequency or route of administration is required.

If you are given more Ondansetrón Kalceks than you should

Your doctor or nurse will give you this medicine, so it is unlikely that you will be given too much. If you think you have been given too much or have missed a dose, tell your doctor or nurse.

The following symptoms may occur: changes in vision, severe constipation, low blood pressure, and slow heart beats.

If you have any further questions on 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.

The side effect profile in children and adolescents is similar to that seen in adults.

Severe Allergic Reactions. These are rare in people taking ondansetron. Complaints include:

• Raised, itchy rash (urticaria)
• Swelling, sometimes of the face or mouth (angioedema) with difficulty breathing
• Shortness of consciousness

Contact a doctor immediately if you experience any of these symptoms. Stop using this medicine.

Very Common Side Effects(may affect more than 1 in 10 people)

• Headache

Common Side Effects(may affect up to 1 in 10 people)

• Feeling of warmth or flushing
• Constipation
• Flushing
• Irritation at the injection site (after injection into a vein)

Uncommon Side Effects(may affect up to 1 in 100 people)

• Seizures
• Involuntary muscle movements or spasms
• Irregular or slow heart beats
• Chest pain
• Low blood pressure
• Hiccups
• Increased liver enzymes

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

• Changes in heart rhythm (which can sometimes cause a sudden loss of consciousness)
• Dizziness
• Blurred vision or changes in vision

Very Rare Side Effects(may affect up to 1 in 10,000 people)

• Widespread rash with blisters and peeling of the skin over much of the body surface (toxic epidermal necrolysis)
• Temporary loss of vision

Frequency Not Known(cannot be estimated from the available data)

• Dry mouth
• Heart attack (signs include: sudden chest pain or crushing sensation in the chest)

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 Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ondansetrón Kalceks

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

This medicine does not require any special storage temperature.

Keep the ampoules in the outer packaging to protect them from light.

After opening the ampoule

Use immediately after opening the ampoule.

Shelf-life after dilution

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 diluted solution should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless the dilution has been made in controlled and validated aseptic conditions.

Do not use this medicine after the expiry date which is stated on the ampoule label and carton after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Package Contents and Additional Information

Ondansetron Kalceks Composition

The active ingredient is ondansetron.

Each ml of solution contains ondansetron hydrochloride dihydrate, equivalent to 2 mg of ondansetron.

Each ampoule with 2 ml of solution contains ondansetron hydrochloride dihydrate, equivalent to 4 mg of ondansetron.

Each ampoule with 4 ml of solution contains ondansetron hydrochloride dihydrate, equivalent to 8 mg of ondansetron.

The other components are sodium chloride, citric acid monohydrate, sodium citrate dihydrate, and water for injectable preparations.

Product Appearance and Package Contents

Transparent and colorless solution, without visible particles.

Volumes of 2 ml or 4 ml of solution in transparent glass ampoules with a break point.

The ampoules are placed on a tray. The trays are packaged in a cardboard box.

Package sizes:

5, 10, or 25 ampoules

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

AS KALCEKS

Krustpils iela 71E,

Riga, LV‑1057,

Latvia

Tel.: +371 67083320

E‑mail: [email protected]

For further information about this medicinal product, please contact the local representative of the marketing authorization holder

Grindeks Kalceks España, S.L.

c/ José Abascal, 58 2º dcha

28003 Madrid

Spain

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

Latvia: Ondansetron Kalceks 2 mg/ml šķīdums injekcijām/infūzijai

Austria, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, Germany, Hungary, Iceland, Lithuania, Norway, Slovakia, Sweden: Ondansetron Kalceks

Belgium: Ondansetron Kalceks 2 mg/ml, solution injectable/pour perfusion

Ondansetron Kalceks 2 mg/ml, oplossing voor injectie/infusie

Ondansetron Kalceks 2 mg/ml, Injektions-/Infusionslösung

Greece: ONDANSETRON/KALCEKS

United Kingdom (Northern Ireland), Ireland: Ondansetron 2 mg/ml solution for injection/infusion

Italy: Ondansetrone Kalceks

Netherlands: Ondansetron Kalceks 2 mg/ml, oplossing voor injectie/infusie

Poland: ONDANSETRON KALCEKS

Romania: Ondansetron Kalceks 2 mg/ml soluție injectabilă/perfuzabilă

Slovenia: Ondansetron Kalceks 2 mg/ml raztopina za injiciranje/infundiranje

Spain: Ondansetrón Kalceks 2 mg/ml solución inyectable y para perfusión EFG

Date of the last revision of this prospect: February 2022.

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

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This information is intended only for healthcare professionals:

Consult the Summary of Product Characteristics or the Package Leaflet for more details on this medicinal product.

Overdose

Symptoms and signs

Experience with ondansetron overdose is limited, but in the event of accidental overdose, the following symptoms of intoxication may be expected: visual disturbances, severe constipation, hypotension, and a vasovagal episode with transient second-degree AV block. In all cases, the reactions experienced resolved completely. Ondansetron prolongs the QT interval with a dose-dependent trend.

Pediatric population

Cases have been reported in children with serotonin syndrome after accidental oral overdose of ondansetron (estimated excessive ingestion of 4 mg/kg) in infants and children from 12 months to 2 years.

Treatment

There is no specific antidote for ondansetron, so in cases of suspected overdose, symptomatic and supportive treatment should be provided as appropriate. ECG monitoring is recommended. Additional treatment should follow clinical guidelines or the recommendations of the National Institute of Toxicology, if available.

Ipecacuanha administration is not recommended to treat overdose, as it is unlikely that patients will respond due to the antiemetic action of ondansetron itself.

Incompatibilities

This medicinal product must not be administered in the same syringe or in the same infusion equipment as any other medicinal product.

This medicinal product must not be mixed with other medicinal products except those mentioned below.

Instructions for use, disposal, and other manipulations

For single use.

The medicinal product must be visually inspected before use. The medicinal product must not be used if it shows visible signs of deterioration (e.g., particles or color change).

This medicinal product must not be sterilized in an autoclave.

It can only be mixed with the following solutions for intravenous infusion:

• sodium chloride 9 mg/ml (0.9%) solution;
• glucose 50 mg/ml (5%) solution;
• mannitol 100 mg/ml (10%) solution;
• Ringer's solution;
• potassium chloride 3 mg/ml (0.3%) and sodium chloride 9 mg/ml (0.9%) solution;
• potassium chloride 3 mg/ml (0.3%) and glucose 50 mg/ml (5%) solution;
• lactated Ringer's solution.

This medicinal product has been shown to be compatible with polypropylene (PP) syringes, type I glass vials, polyethylene (PE) infusion bags, polyvinyl chloride (PVC), and ethylene-vinyl acetate (EVA) bags, as well as with PVC and PE tubes when diluted with the above-mentioned infusion solutions. It has been observed that this medicinal product is compatible with PP syringes.

Compatibility with other medicinal products

Ondansetron can be administered by intravenous infusion (at 1 mg/hour). The following medicinal products can be administered by intravenous infusion through a Y-device for ondansetron concentrations of 16 to 160 micrograms/ml (e.g., 8 mg/500 ml and 8 mg/50 ml, respectively).

• Cisplatin
• 5-Fluorouracil
• Carboplatin
• Etoposide
• Ceftazidime
• Cyclophosphamide
• Doxorubicin
• Dexamethasone

Instructions for opening the ampoule

1. Hold the ampoule with the colored point facing upwards. If some solution remains in the upper part of the ampoule, gently tap it with your finger to make the solution flow down to the lower part of the ampoule.
2. Use both hands to open it, and while holding the lower part of the ampoule with one hand, use the other hand to break the upper part of the ampoule in the direction opposite to the colored point (see the images below).

Disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations.