Palonosetron Qilu 250 micrograms solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Palonosetrón Qilu 250 micrograms injectable solution 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Palonosetrón Qilu is and what it is used for
2. What you need to know before using Palonosetrón Qilu
3. How to use Palonosetrón Qilu
4. Possible side effects
5. How to store Palonosetrón Qilu
6. Contents of the pack and other information

1. What Palonosetrón Qilu is and what it is used for

Palonosetrón belongs to a group of medicines known as serotonin (5-HT3) antagonists, which have the ability to block the action of the chemical substance serotonin (which can cause nausea and vomiting).

Palonosetrón is used to prevent nausea and vomiting associated with emetogenic anti-cancer chemotherapy in adults, adolescents, and children over one month of age.

2. What you need to know before using Palonosetrón Qilu

Do not use Palonosetrón Qilu:

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

Warnings and precautions

Consult your doctor or pharmacist before using palonosetron:

• If you have acute intestinal obstruction or a history of recurrent constipation.
• If you are taking palonosetron together with other medicines that may cause abnormal heart rhythm, such as amiodarone, nicardipine, quinidine, moxifloxacin, erythromycin, haloperidol, chlorpromazine, quetiapine, thioridazine, or domperidone.
• If you or a family member has a history of heart rhythm problems (QT interval prolongation).
• If you have any other heart disease.
• If you have an untreated imbalance of certain blood minerals, such as potassium or magnesium.

Use of palonosetron is not recommended in the days following chemotherapy unless you are receiving another cycle of chemotherapy.

Using Palonosetrón Qilu with other medicines

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

SSRIs (selective serotonin reuptake inhibitors), used to treat depression or anxiety, which include: fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, and escitalopram.

SNRIs (serotonin and norepinephrine reuptake inhibitors), used to treat depression or anxiety, which include venlafaxine and duloxetine.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or think you might be pregnant, your doctor will not administer palonosetron unless clearly indicated. It is unknown whether palonosetron may cause harmful effects when used during pregnancy.

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Breastfeeding

It is unknown whether palonosetron is excreted in breast milk. If you are breastfeeding, consult your doctor or pharmacist before taking palonosetron.

Driving and using machines

Palonosetron may cause dizziness or fatigue. If you experience any of these effects, do not drive or operate tools or machinery.

Palonosetrón Qilu contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; essentially, it is "sodium-free".

3. How to use Palonosetrón Qilu

Normally, a doctor or nurse will inject palonosetrón about 30 minutes before starting chemotherapy.

Adults

The recommended dose of palonosetrón is 250 micrograms, administered as a rapid injection into a vein.

Children and adolescents (aged between 1 month and 17 years)

The doctor will decide the dose based on body weight. However, the maximum dose is 1500 micrograms.

Palonosetrón will be given by slow infusion into a vein.

If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The following are possible adverse effects and their frequencies:

Adults

Frequent (may affect up to 1 in 10 people)

• headache, dizziness, constipation, and diarrhoea

Uncommon (may affect up to 1 in 100 people)

• hypertension or hypotension
• abnormal heart beat or reduced blood flow to the heart
• change in vein colour or veins becoming enlarged
• abnormally high or low blood potassium levels
• high blood sugar levels or sugar in urine
• low blood calcium levels
• high levels of the pigment bilirubin in the blood
• elevated levels of certain liver enzymes
• elevated mood or feeling of anxiety
• drowsiness or trouble sleeping
• decreased or loss of appetite
• weakness, fatigue, fever, or flu-like symptoms
• numbness, burning sensation, itching, or tingling sensation in the skin
• itchy skin rash
• visual disturbances or eye irritation
• motion sickness
• ringing in the ears
• hiccups, flatulence, dry mouth, or indigestion
• abdominal (stomach) pain
• difficulty urinating
• joint pain
• abnormalities in the electrocardiogram (ECG) (prolongation of the QT interval)

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

• Allergic reactions to palonosetron

Signs of an allergic reaction may include swelling of the lips, face, tongue, or throat, difficulty breathing, or collapse; you may also notice itching, burning, pain, or itchy raised rash (hives) at the injection site

Children and adolescents:

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

• headache

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

• feeling dizzy
• spasmodic body movements
• abnormal heart rhythm
• cough or breathing difficulty
• nosebleed
• itchy skin rash or hives
• fever
• pain at the infusion site

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Palonosetron Qilu

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

Do not use this medicine after the expiry date stated on the vial and outer carton following EXP. The expiry date refers to the last day of the month indicated.

Store the vial in the outer packaging to protect it from light.

For single use only. Any unused solution should be discarded.

Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the SIGRE collection point at your pharmacy or any other medicine waste collection system. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Palonosetron Qilu

• The active substance is palonosetron (as hydrochloride).

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

• The other components are mannitol, sodium citrate, citric acid monohydrate, and water for injections.

Appearance of the product and contents of the container

Palonosetron Qilu injectable solution is a clear, colourless solution supplied in a box containing one type I glass vial with a volume of 6 ml, fitted with a bromobutyl rubber stopper and a 20 mm aluminium and plastic seal, containing 5 ml of solution. Each vial contains one dose.

It is available in packs of 1 vial containing 5 ml of solution.

Marketing Authorization Holder

QILU PHARMA SPAIN S.L.

Paseo de la Castellana 40,

8th Floor, Madrid, 28046,

Spain

Manufacturer

Netpharmalab Consulting Services

Carretera de Fuencarral, 22

28108 – Alcobendas, Madrid

Spain

and

Kymos, S.L.

Ronda de Can Fatjó,

7B (Parc Tecnològic del Vallès),

Cerdanyola del Vallès, 08290

Barcelona, Spain

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 – Barcelona

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: 02/2017

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/