Palonosetron Reig Jofre

Document: Palonosetron Reig Jofre solution for injection ENG PL change

Package leaflet: Information for the user

PalonosetronReig Jofre 250 microgramssolutionforinjection

palonosetron

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.

What is in this leaflet

1. What Palonosetron Reig Jofre is and what it is used for

2. What you need to know before you use Palonosetron Reig Jofre

3. How to use Palonosetron Reig Jofre

4. Possible side effects

5. How to store Palonosetron Reig Jofre

6. Contents of the pack and other information

1. What Palonosetron Reig Jofre is and what it is used for

Palonosetronbelongs to a groupofmedicines known as serotonin (5HT₃)antagonists.

These have theabilityto blockthe action ofthe chemical,serotonin, whichcancause nauseaand vomiting.

Palonosetron is usedfor thepreventionof nausea and vomitingassociated withcancerchemotherapyin adult, adolescents and children over one month of age.

2. What you need to know before you use Palonosetron Reig Jofre

Do not usePalonosetron Reig Jofre:

- If you are allergic to palonosetron or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talkto your doctor,pharmacistor nurse before usingPalonosetron Reig Jofre

If you have acute bowel obstruction or a history of repeated constipation.
If you are using Palonosetron Reig Jofre 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.

Itis not recommended to take Palonosetron Reig Jofre in the days followingchemotherapyunless you are receiving anotherchemotherapycycle.

Other medicines and Palonosetron Reig Jofre

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, breast-feeding and fertility

Pregnancy

Ifyouarepregnantorthinkyoumightbe,yourdoctorwillnotadministerPalonosetron Reig Jofre toyouunlessitis clearlynecessary.

Itis notknown whetherPalonosetron Reig Jofre willcause anyharmfuleffects when usedduringpregnancy.

Askyourdoctororpharmacistforadvicebeforeusinganymedicineifyouarepregnantorthinkyou mightbe.

Breast-feeding

Itis notknown ifPalonosetron Reig Jofre is found inbreastmilk.

Askyourdoctororpharmacistforadvice before usingPalonosetron Reig Jofre ifyou are breast-feeding.

Driving and using machines

Palonosetron Reig Jofre maycause dizzinessortiredness. Ifaffected, donotdrive oruseanytools ormachines.

Palonosetron Reig Jofrecontains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per vial, but if the maximum dose for children are administered (6 vials) the sodium content corresponds to 1.2 mmol sodium (27.90 mg).

3. How to use Palonosetron Reig Jofre

Adoctorornurse willnormallyinjectPalonosetron Reig Jofre about30minutes before the startofchemotherapy.

Adults

Therecommended doseofPalonosetron Reig Jofre is 250 micrograms given as a rapidinjection intoa 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 Reig Jofre will be given as a slow infusion into a vein.

Ifyou have anyfurtherquestions onthe useofthis medicine, askyourdoctor.

4. Possible side effects

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

Possible side effects and their frequencies are listed below:

Adults

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

• headache, dizziness, constipation and 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 Reig Jofre.

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, pharmacist or nurse.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system (see details below) [to be completed nationally]. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Palonosetron Reig Jofre

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 notrequireanyspecialstorage conditions.

Single use only, anyunused solution shouldbe disposed of.

6. Contents of the pack and other information

What Palonosetron Reig Jofre contains

The active substance is palonosetron (as hydrochloride).

Each mlof solutioncontains 50 micrograms of palonosetron. Each vialof5 mlof solution contains 250 micrograms of palonosetron.

The other ingredients are mannitol, disodium edetate (dihydrate), sodium citrate (dihydrate), citric acid monohydrate, and water for injections.

What Palonosetron Reig Jofre looks like and contents of the pack

Palonosetron solution forinjectionis aclear,colourless solution andis suppliedina packofoneType Iglass vialwith chlorobutylsiliconised fluorotecrubberstopperandaluminiumcap, which contains 5 mlofthe solution. Each vialcontainsone dose.

Available inpacks of1 vialcontaining5mlofsolution.

Marketing Authorisation Holder and Manufacturer

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

Local representative

Bioglan AB

P.O. Box 50310

SE-202 13 Malmö

Sweden

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

Denmark: Palonosetron Reig Jofre

Finland: Palonosetron Reig Jofre 250 mikrogrammaa, injektioneste, liuos

Norway: Palonosetron Reig Jofre

Spain: Palonosetron Sala 250 microgramos solución para inyección EFG

Sweden: Palonosetron Reig Jofre

United Kingdom: Palonosetron 250 micrograms solution for injection

This leaflet was last revised in 2016-08-03

Detailed information on this medicine is available on the website of {MS/Agency}.