Palonosetron Hospira - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Palonosetron Hospira 250 micrograms solution for injection

palonosetron

Read all of this leaflet carefully before you are given 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 or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Palonosetron Hospira is and what it is used for

• 2. What you need to know before you are given Palonosetron Hospira

• 3. How Palonosetron Hospira is given

• 4. Possible side effects

• 5. How to store Palonosetron Hospira

• 6. Contents of the pack and other information

1. What Palonosetron Hospira is and what it is used for

Palonosetron Hospira belongs to a group of medicines known as serotonin (5HT3) antagonists.

These have the ability to block the action of the chemical, serotonin, which can cause nausea and vomiting.

Palonosetron Hospira is used for the prevention of nausea and vomiting associated with cancer chemotherapy in adults, adolescents and children over one month of age.

2. What you need to know before you are given Palonosetron Hospira

You must not be given Palonosetron Hospira:

• if you are allergic to palonosetron or any of the other ingredients of this medicine (listed in

• section 6).

Warnings and precautions

Talk to your doctor or pharmacist before you are given Palonosetron Hospira:

• if you have acute bowel obstruction or a history of repeated constipation;
• if you are using Palonosetron Hospira in addition to other medicines that may induce an

abnormal heart rhythm such as amiodarone, nicardipine, quinidine, moxifloxacin, erythromycin, haloperidol, chlorpromazine, quetiapine, thioridazine, domperidone;

• if you have a personal or family history of alterations in heart rhythm (QT prolongation);
• if you have other heart problems;
• if you have an imbalance of certain minerals in your blood such as potassium and magnesium

which has not been treated.

It is not recommended to receive Palonosetron Hospira in the days following chemotherapy unless you are receiving another chemotherapy cycle.

Other medicines and Palonosetron Hospira

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including:

• SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including

• fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram;

• SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety

including venlafaxine, duloxetine.

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 you are given this medicine.

If you are pregnant or think you might be, your doctor will not administer Palonosetron Hospira to you unless it is clearly necessary.

It is not known whether Palonosetron Hospira will cause any harmful effects when used during pregnancy.

It is not known if Palonosetron Hospira is found in breast milk.

Driving and using machines

Palonosetron Hospira may cause dizziness or tiredness. If affected, do not drive or use any tools or machines.

Important information about some of the ingredients of Palonosetron Hospira

This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium- free’.

• 3. How Palonosetron Hospira is given

A doctor or nurse will normally inject Palonosetron Hospira about 30 minutes before the start of chemotherapy.

Adults

The recommended dose of Palonosetron Hospira is 250 micrograms given as a rapid injection into a vein.

Children and Adolescents (aged 1 month to 17 years)

The doctor will decide the dose, depending on bodyweight, however the maximum dose is

1500 micrograms. Palonosetron Hospira will be given as a slow infusion into a vein.

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Adults:

Common (may affect up to 1 in 10 people):

• headache
• dizziness
• constipation
• diarrhoea

Uncommon (may affect up to 1 in 100 people):

• high or low blood pressure
• abnormal heart rate or lack of blood flow to the heart
• change in the colour of the vein and/or veins becoming larger
• abnormally high or low levels of potassium in the blood
• high levels of sugar in the blood or sugar in the urine
• low levels of calcium in the blood
• high levels of the pigment bilirubin in the blood
• high levels of certain liver enzymes
• elevated moods or feelings of anxiousness
• sleepiness or trouble sleeping
• decrease or loss of appetite
• weakness, tiredness, fever or flu like symptoms
• numbness, burning, prickling or tingling sensations on the skin
• itchy skin rash
• impaired vision or eye irritation
• motion sickness
• ringing in the ear
• hiccups, flatulence, dry mouth or indigestion
• abdominal (stomach) pain
• difficulty urinating
• joint pain
• electrocardiogram abnormalities (QT prolongation)

Very rare (may affect up to 1 in 10,000 people):

Allergic reactions to Palonosetron Hospira. The signs may include swelling of the lips, face, tongue or throat, having difficulty breathing or collapsing, you could also notice an itchy, lumpy rash (hives), burning or pain at the site of injection.

Children and Adolescents:

Common (may affect up to 1 in 10 people):

• headache

Uncommon (may affect up to 1 in 100 people):

• dizziness
• jerky body movements
• abnormal heart rate
• coughing or shortness of breath
• nosebleed
• itchy skin rash or hives
• fever
• pain at the site of infusion

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Palonosetron Hospira

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

Do not use this medicine after the expiry date which is stated on the vial and carton after ‘EXP’. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Single use only, any unused solution should be disposed of.

6. Contents of the pack and other information

What Palonosetron Hospira contains

• The active substance is palonosetron (as hydrochloride). Each ml of solution contains

50 micrograms palonosetron. Each vial of 5 ml of solution contains 250 micrograms of palonosetron.

• The other ingredients are mannitol, disodium edetate, sodium citrate, citric acid monohydrate,

water for injections, sodium hydroxide and hydrochloric acid (for pH adjustment).

What Palonosetron Hospira looks like and contents of the pack

Palonosetron Hospira solution for injection is a clear, colourless solution and is supplied in a pack of one Type I glass vial with a chlorobutyl rubber stopper and aluminium cap, which contains 5 ml of the solution. Each vial contains one dose.

Available in packs of 1 vial containing 5 ml of solution.

Marketing Authorisation Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Manufacturer

Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom

HOSPIRA Enterprises B.V., Randstad 22–11, 1316 BN Almere, The Netherlands

Avara Liscate Pharmaceutical Services S.p.A., Via Fosse Ardeatine, 2, 20060, Liscate (MI), Italy

Pfizer Service Company BVBA, Hoge Wei 10, 1930 Zaventem, Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

DE Pfizer Pharma PFE GmbH Tel: + 49 (0)800 8535555	NL Pfizer bv Tel: +31 (0)10 406 43 01
EE Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7500	NO Pfizer AS Tlf: +47 67 52 61 00
EL Pfizer EAAAZ A.E. Tq!.: +30 210 6785 800	AT Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 521 15–0
ES Pfizer, S.L. Tel: +34 91 490 99 00	PL Pfizer Polska Sp. z o.o. Tel: +48 22 335 61 00
FR Pfizer PFE France Tél: + 33 (0)1 58 07 34 40	PT Laboratórios Pfizer, Lda. Tel: + 351 21 423 55 00
HR Pfizer Croatia d.o.o. Tel: +385 1 3908 777	RO Pfizer România S.R.L. Tel: +40 (0)21 207 28 00
IE Pfizer Healthcare Ireland Tel: 1800 633 363 (toll free) +44 (0) 1304 616161	SI Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: +386 (0)1 52 11 400
IS Icepharma hf. Sími: +354 540 8000	SK Pfizer Luxembourg SARL, organizačná zložka Tel: +421–2–3355 5500
IT Pfizer Italia Srl Tel: +39 06 33 18 21	FI Pfizer PFE Finland Oy Puh/Tel: +358 (0)9 430 040
CY Pharmaceutical Trading Co Ltd Tn!: 24656165	SE Pfizer AB Tel: +46 (0)8 550 520 00
LV Pfizer Luxembourg SARL filiäle Latvijä Tel.: + 371 670 35 775	UK Hospira UK Limited Tel: + 44 (0) 1628 515500

This leaflet was last revised in month YYYY.

Detailed information on this medicine is available on the European Medicines Agency web site:

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