FRESENIUS

KABI

PACKAGE LEAFLET:

INFORMATION FOR THE PATIENT

Ondansetron Kabi 2 mg/ml

Solution for injection

Ondansetron

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 or pharmacist.

-    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.

What is in this leaflet:

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

2.    What you need to know before you use Ondansetron Kabi

3.    How to use Ondansetron Kabi

4.    Possible side effects

5.    How to store Ondansetron Kabi

6.    Contents of the pack and other information

1. WHAT ONDANSETRON KABI IS AND WHAT IT IS USED FOR

Ondansetron Kabi belongs to a group of medicines called anti-emetics, drugs against feeling sick or being sick. Some medical treatment with medicines for treatment of cancer (chemotherapy) or radiotherapy can make you feel sick (nausea) or be sick (vomiting). Also after surgical treatment you can feel sick (nausea) or be sick (vomiting). Ondansetron Kabi may help to prevent or stop these effects.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE ONDANSETRON KABI

Do not use Ondansetron Kabi:

-    if you are hypersensitive to ondansetron or to other selective 5HT3 receptor antagonists (e.g. granisetron, dolastron) or to any of the excipients (listed in section 6.)

-    if you are treated with apomorphine.

Warnings and precautions

Talk to your doctor, pharmacist or nurse

before using Ondansetron Kabi

-    if you are hypersensitive to other medicines for feeling sick or being sick.

-    if you have a blockage in your gut or suffer from severe constipation. Ondansetron can impede the mobility of the lower gut.

-    if you have any hepatic impairment.

-    if you have undergone surgery to remove tonsils situated at the back of the nose (adenotonsillar surgery.).

-    if you have ever had heart problems. Ondansetron prolongs the QT interval (ECG sign of delayed repolarization of the heart following a heartbeat with the risk of life-threatening arrhythmias) in a dose-dependent manner. In addition, cases of Torsade de Pointes (an increased heart rate) have been reported in patients using Ondansetron. The use of Ondansetron should be avoided in patients with congenital long QT-syndrome (a rare inborn long QT interval). Ondansetron should be administered with caution in patients who have or may develop the above-mentioned ECG disturbances. This includes patients with electrolyte abnormalties, congestive heart failure, slowed heartbeat, or patients taking other medicinal products that lead to QT prolongation or electrolyte abnormalities. Electrolyte disturbances will be corrected by your doctor prior to ondansetron administration.

if concomitant treatment with ondansetron and other serotonergic drugs (e.g. selective serotonin reuptake inhibitors (SSRIs) or serotonin noradrenaline reuptake inhibitors (SNRIs)) is clinically needed. If so, an appropriate observation by your doctor must be warranted as there are case reports describing patients with the so-called serotonin syndrome (e.g. hypervigilance and agitation, increased heart rate and blood pressure, tremor and overresponsive reflexes) following the concomitant use of ondansetron and other serotonergic drugs, such as SSRIs or SNRIs like sertraline or duloxetine (both are antidepressants).

Other medicines and Ondansetron Kabi

Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

If you are taking tramadol (painkiller): ondansetron may reduce the analgesic effect of tramadol.

If you are taking phenytoin, carbamazepine (anti-epileptics) or rifampicin (antibiotic): the ondansetron blood concentrations are decreased.

If you are taking cardiotoxic drugs (e.g. anthracyclines, cancer antibiotics such as doxorubicin, daunorubicin or trastuzumab), antibiotics (such as erythromycin or ketoconazole), antiarrhythmics (such as amiodarone) and beta blockers (drugs that slow heart rate such as atenolol or timolol): use of ondansetron with other QT prolonging drugs may result in an additional QT prolongation, i.e. increase the risk of arrhythmias.

If you are taking other serotonergic drugs such as selective serotonin reuptake inhibitors (SSRIs) or serotonin noradrenaline reuptake inhibitors (SNRIs) like sertraline or duloxetine (both are antidepressants): there are case reports describing patients with the so-called serotonin syndrome (e.g. hypervigilance and agitation, increased heart rate and blood pressure, tremor and overresponsive reflexes) following the concomitant use of ondansetron with other serotonergic drugs.

If you are taking apomorphine (drug to treat Parkonson's disease): apomorphine must not be used together with ondansetron, as there are case reports of profound hypotension (low blood pressure) and loss

of consciousness when both drugs are concomitantly administered.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Because of insufficient experience the use of ondansetron during pregnancy is not recommended. Ondansetron passes into mother's milk. Therefore mothers receiving ondansetron should NOT breast-feed.

Ask your doctor for advice before taking any medicine.

Driving and using machines

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

Important information about some of the ingredients of Ondansetron Kabi

This medicinal product contains 2.3 mmol (53.5 mg) sodium per maximum daily dose. To be taken into consideration by patients on a controlled sodium diet.

3. HOW TO USE ONDANSETRON KABI

Method of administration

Ondansetron Kabi is administered by intravenous injection (into a vein) or, after dilution, by intravenous infusion (for a longer time). It will usually be given by a doctor or a nurse.

Dosage

Adults (less than 75 years of age)

Your doctor will decide on the correct dose of ondansetron therapy for you.

The dose varies depending on your medicinal treatment (chemotherapy or surgery), on your liver function and on whether it is given by injection or infusion.

In case of chemotherapy or radiotherapy the usual dose in adults is 8 - 32 mg ondansetron a day. A single dose greater than 16mg must not be given.

For treatment of post-operative nausea and vomiting usually a single dose of 4 mg ondansetron is administered. For prevention of post-operative nausea and vomiting usually a single dose of 4 mg ondansetron is administered.

Children aged >    6 months and

adolescents

In case of chemotherapy the usual dose is a single intravenous dose of 5 mg/m² (body area) immediately before chemotherapy. The intravenous dose must not exceed 8 mg.

Children aged >1 month and adolescents

For treatment of post-operative nausea and vomiting the usual dose is of 0.1 mg/kg (body weight). The maximum dose is 4 mg as an injection into a vein.

For prevention of post-operative nausea and vomiting the usual dose is of 0.1 mg/kg (body weight). The maximum dose is 4 mg as an injection into a vein. This will be given just before the operation.

Dosage adjustment

Older people:

In case of chemotherapy the initial dosage should not exceed 8 mg for patients 75 years of age or older.

Patients with hepatic impairment:

In patients having hepatic problems the dose has to be adjusted to a maximum daily dose of 8 mg ondansetron.

Patients with renal impairment or poor sparteine/debrisoquine metabolism:

No alteration of daily dosage or frequency of dosing or route of administration is required.

Duration of treatment

Your doctor will decide on the duration of ondansetron therapy for you.

After intravenous administration of Ondansetron Kabi the therapy may be continued with ondansetron tablets or suppositories for up to 5 days.

If you received more Ondansetron Kabi than you should

Little is known at present about overdosage with ondansetron. Overdose increases the probability of side effects described in section 4. In a few patients, the following effects were observed after overdose: visual disturbances, severe constipation, low blood pressure, disturbance in heart rhythm and unconsciousness. In all cases, the symptoms disappeared completely.

Your doctor or nurse will give you or your child Ondasetron Kabi so it is unlikely that you or your child will receive too much. If you think you or your child have been given too much or have missed a dose, tell your doctor or nurse.

There is no specific antidote to ondansetron; for that reason, if overdose is suspected, only the symptoms should be treated.

Tell your doctor if any of these symptoms occur.

4. POSSIBLE SIDE EFFECTS

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

Very common

-    headache

Common

-    constipation

-    sensation of warmth or flushing

-    irritation and redness at the site of injection

Uncommon

-    low blood pressure, which can make you feel faint or dizzy

-    slow or uneven heart beat

-    chest pain fits

-    unusual body movements or shaking

-    hiccups

-    interference with liver function tests Rare

-    feeling dizzy or light headed

-    blurred vision

-    hypersensitivity reactions

-    disturbance in heart rhythm (sometimes causing a sudden loss of consciousness)

Very rare

-    temporary blindness (most resolved 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

For UK: via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

For Ireland via:

HPRA Pharmacovigilance,

Earlsfort Terrace,

IRL - Dublin 2;

Tel: +353 1 6764971;

Fax: +353 1 6762517. Website:www.hpra.ie;

E-mail: medsafety@hpra.ie

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE ONDANSETRON KABI

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

Ondansetron Kabi must not be administered after the expiry date, which is stated on the ampoule label and carton. The expiry date refers to the last day of that month.

Keep the ampoules in the outer carton, in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Ondansetron Kabi contains

The active substance is ondansetron.

Each ampoule with 2 ml contains 4 mg ondansetron.

Each ampoule with 4 ml contains 8 mg ondansetron.

Each millilitre contains 2 mg ondansetron as ondansetron hydrochloride dihydrate.

The other ingredients are sodium chloride, sodium citrate dihydrate, citric acid monohydrate and water for injections.

What Ondansetron Kabi looks like and contents of the pack

Ondansetron Kabi is a clear and colourless solution in colourless glass ampoules containing 2 ml or 4 ml of solution for injection.

Pack sizes: 1, 5 and 10 ampoules Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder:

Fresenius Kabi Limited Cestrian Court, Eastgate Way Manor Park, Runcorn Cheshire WA7 1NT United Kingdom

Manufacturer:

Labesfal - Laboratorios Almiro S.A.

Lagedo, 3465-157 Santiago de Besteiros, Portugal.

This medicinal product is authorised in the Member States of the EEA under the following names:

BE: Ondansetron Fresenius Kabi 2 mg/ml, solution injectable/ Injektionslosung/ oplossing voor injectie CZ: Ondansetron Kabi 2 mg/ml, injekcm roztok

DK: Ondansetron Fresenius Kabi injektionsv^ske, oplosning EL: Ondansetron Kabi 2 mg/ml svsaipo SidAupa

ES: Ondansetron Fresenius Kabi 2 mg/ml, inyectable

FI: Ondansetron Fresenius Kabi 2 mg/ml, injektioneste, liuos

HU: Ondansetron Kabi 2 mg/ml injekcio IE: Ondansetron Kabi 2 mg/ml, solution for injection

IT:    Ondansetron Kabi 2 mg/ml, soluzione

iniettabile

NL: Ondansetron Kabi 2 mg/ml, oplossing voor injectie

NO: Ondansetron Fresenius Kabi 2 mg/ml, injeksjonsv^ske, opplosning PL: Ondansetron Kabi 2 mg/ml roztwor do wstrzykiwa n

SE: Ondansetron Fresenius Kabi 2 mg/ml, injektionsvatska, losning SK: Ondansetron Kabi 2 mg/ml injekcny roztok

UK: Ondansetron Kabi 2 mg/ml, solution for injection

This leaflet was last revised in February 2016

The following information is intended for medical or healthcare professionals only.

A single dose greater than 16mg must not be given due to the risk of dose dependent increase in QT prolongation (see sections 4.2, 4.4, 4.8 and 5.1 of the SmPC).

Use only clear and colourless solutions.

For single use only. Any unused solution and the ampoule should be adequately disposed of, in accordance with local requirements.

To be used immediately after the ampoule is opened.

Ondansetron Kabi may be diluted with solutions for infusion containing:

Sodium chloride 9 mg/ml (0.9 % w/v) solution

Glucose 50 mg/ml (5 % w/v) solution Mannitol 100 mg/ml (10 % w/v) solution Ringer's lactate solution Chemical and physical in-use stability has been demonstrated for 48 hours at 25°C with these solutions. Unless compatibility is proven, the solution for infusion should always be administered separately.

The diluted solutions should be stored protected from light.

L J