Label: Information for the Patient

Palonosetrón Qilu 250 micrograms injectable solution EFG

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• • If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

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

2. What you need to know before starting to use Palonosetrón Qilu

3. How to use Palonosetrón Qilu

4. Possible adverse effects

5. Storage of Palonosetrón Qilu

6. Contents of the package and additional information

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

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

No usePalonosetrón Qilu:

• If you are allergic to palonosetrón or any of the other components of this medication (listed in section 6).

Advertencias and precautions

Consult your doctor or pharmacist before starting to usepalonosetrón:

• If you have an acute intestinal obstruction or a history of repeated constipation.
• If you are using palonosetrón in addition to other medications that may cause abnormal heart rhythm, such as amiodarona, nicardipina, quinidina, moxifloxacino, eritromicina, haloperidol, clorpromacina, quetiapina, tioridacina or domperidona.
• If you have a personal or family history of heart rhythm abnormalities (prolongation of the QT interval).
• If you have another heart disease.
• If you have an imbalance of certain minerals in the blood, such as potassium and magnesium, that has not been treated.

Palonosetrón is not recommended for use in the days following chemotherapy, unless you are receiving another cycle of chemotherapy.

Use ofPalonosetrónQiluwith other medications

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

SSRIs (selective serotonin reuptake inhibitors), used to treat depression or anxiety, whichinclude: fluoxetina, paroxetina, sertralina, fluvoxamina, citalopram and escitalopram.

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

Pregnancy and lactation

Pregnancy

If you are pregnant or think you may be pregnant, your doctor will not administer palonosetrón unless its use is clearly indicated. It is unknown whether palonosetrón may cause any harmful effects if used during pregnancy.

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor before using this medication.

Lactation

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

Driving and operating machines

Palonosetrón may cause dizziness or fatigue. If you experience either of these effects, do not drive or operate tools or machines.

Palonosetrón Qilucontainssodium

This medication contains less than 1 mmol of sodium (23 mg) per vial; it is essentially «sodium-free».

A healthcare professional, such as a doctor or nurse, will typically inject palonosetrón into a vein about 30 minutes before starting chemotherapy.

Adults

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

Children and adolescents (ages 1 month to 17 years)

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

Palonosetrón will be administered via a slow infusion into a vein.

If you have any other questions about using this medication, consult your doctor.

Like all medications, this medication may cause side effects, although not everyone will experience them.

The following are possible side effects and their frequencies:

Adults

Frequent (may affect up to 1 in 10 people)

• headache, dizziness, constipation, and diarrhea

Infrequent (may affect up to 1 in 100 people)

• high or low blood pressure
• abnormal heart rhythm or reduced blood flow to the heart
• change in vein color or enlarged veins
• abnormally high or low potassium levels in the blood
• high blood sugar or sugar in the urine
• low calcium levels in the blood
• high levels of bilirubin pigment in the blood
• high levels of certain liver enzymes
• elevated mood or feeling anxious
• drowsiness or difficulty sleeping
• decreased or lost appetite
• weakness, fatigue, fever, or flu-like symptoms
• numbness, burning, itching, or tingling sensation in the skin
• pruritic skin rash
• vision changes or eye irritation
• cinetosis
• tinnitus
• hiccups, flatulence, dry mouth, or indigestion
• abdominal pain (stomach)
• difficulty urinating
• joint pain
• electrocardiogram anomalies (prolongation of the QT interval)

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

• Allergic reactions to palonosetron

The signs of an allergic reaction may include swelling of the lips, face, tongue, or throat, difficulty breathing, or collapse; you may also notice itching, pruritic papules (hives), burning, or pain at the injection site

Children and adolescents:

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

• headache

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Usewww.notificaram.es.By reporting side effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the vial and the box after CAD. The expiration date is the last day of the month indicated.

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

For single use only. Dispose of any unused solution.

Medications should not be disposed of through drains or trash. Deposit containers and medications you no longer need at the SIGRE point of your pharmacy or any other medication waste collection system. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofPalonosetrón Qilu

• The active ingredient is palonosetrón (in the form of hydrochloride).

Each milliliter of solution contains 50 micrograms of palonosetrón. Each vial of 5 ml of solution contains 250 micrograms of palonosetrón.

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

Appearance of the product and contents of the package

Palonosetrón Qilu injectable solution is a transparent and colorless solution and is presented in a box containing a type I glass vial of 6 ml volume, with a bromobutyl rubber stopper and a 20 mm thick aluminum and plastic hermetic closure, which contains 5 ml of solution. Each vial contains a dose.

It is presented in packages of 1 vial containing 5 ml of solution.

Marketing Authorization Holder

QILU PHARMA SPAIN S.L.

Paseo de la Castellana 40,

Planta 8, Madrid, 28046,

Spain

Responsible for manufacturing

Netpharmalab Consulting Services

Carretera de Fuencarral, 22

28108 – Alcobendas, Madrid

Spain

and

Kymos , S.L.

Ronda de Can Fatjó,

7B (Parque Tecnológico del Vallès),

Cerdanyola del Vallès, 08290

Barcelona, Spain

Local Representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 – Barcelona

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: 02/2017

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/