Palonosetron Dr. Reddy's

PACKAGE LEAFLET: INFORMATION FOR THE USER

Palonosetron Dr. Reddy’s 250 micrograms injectable solution

Generic medicine
Please 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• Contact your doctor if you do not feel better or if you feel worse.

Contents of this leaflet:

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

1. What Palonosetron Dr. Reddy’s is and what it is used for
Palonosetron Dr. Reddy’s belongs to a group of medicines known as serotonin (5HT₃) antagonists.
These medicines are able to block the action of serotonin, a chemical substance that can cause nausea and vomiting.
Palonosetron Dr. Reddy’s is used to prevent nausea and vomiting associated with cancer chemotherapy in adults, adolescents, and children over one month of age.

2. What you need to know before using Palonosetron Dr. Reddy’s
Do not use Palonosetron Dr. Reddy’s:

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Palonosetron Dr. Reddy’s:

• If you have acute intestinal obstruction or a history of repeated constipation.
• If you are using Palonosetron Dr. Reddy’s in combination with other medicines that may cause heart rhythm abnormalities, such as amiodarone, nicardipine, quinidine, moxifloxacin, erythromycin, haloperidol, chlorpromazine, quetiapine, thioridazine, domperidone.
• If you or a family member has a history of heart rhythm disorders (QT prolongation).
• If you have other heart problems.
• If you have untreated imbalances of certain blood minerals such as potassium or magnesium.

Palonosetron Dr. Reddy’s is not recommended for use on days following chemotherapy unless you are scheduled to receive another cycle of chemotherapy.

Other medicines and Palonosetron Dr. Reddy’s
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-norepinephrine reuptake inhibitors) used to treat depression and/or anxiety, including venlafaxine, duloxetine.

Pregnancy
Your doctor will not administer Palonosetron Dr. Reddy’s during pregnancy unless strictly necessary.
It is not known whether Palonosetron Dr. Reddy’s may cause harmful effects when used during pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or think you might be pregnant.

Breast-feeding
It is not known whether Palonosetron Dr. Reddy’s passes into breast milk.
Ask your doctor or pharmacist for advice before using Palonosetron Dr. Reddy’s while breast-feeding.

Driving and using machines
Palonosetron Dr. Reddy’s may cause dizziness or fatigue. If affected, do not drive or operate tools or machinery.

Palonosetron Dr. Reddy’s contains less than 1 mmol of sodium (23 mg) per vial, and is therefore essentially “sodium-free”.

3. How to use Palonosetron Dr. Reddy’s
A doctor or nurse will normally administer Palonosetron Dr. Reddy’s by intravenous injection approximately 30 minutes before the start of chemotherapy.

Adults
Page 2 of 5
The recommended dose of Palonosetron Dr. Reddy’s is 250 micrograms, given as a rapid injection into a vein.

Children and adolescents (from 1 month to 17 years of age)
The doctor will determine the dose based on body weight; however, the maximum dose is 1500 micrograms.
Palonosetron Dr. Reddy’s is administered as a slow intravenous infusion.
If you have any doubts about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The possible side effects and their frequency 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 reduced blood flow to the heart
• change in the colour of the vein and/or swelling of veins
• abnormally high or low levels of potassium in the blood
• high blood sugar levels or presence of sugar in urine
• low levels of calcium in the blood
• high levels of the pigment bilirubin in the blood
• high levels of certain liver enzymes
• euphoric mood or feeling of anxiety
• drowsiness or difficulty sleeping
• decreased or loss of appetite
• weakness, fatigue, fever, or flu-like symptoms
• sensation of numbness, burning, itching, or tingling of the skin
• itchy rash
• changes in vision or eye irritation
• motion sickness
• ringing in the ears
• hiccups, flatulence, dry mouth, or indigestion
• abdominal pain (stomach)
• difficulty urinating
• joint pain
• abnormalities in the electrocardiogram (ECG) (QT prolongation)

Very rare (may affect up to 1 in 10,000 people):
Page 3 of 5

• Allergic reactions to Palonosetron Dr. Reddy’s. Signs may include:
• swelling of the lips, face, tongue, or throat
• difficulty breathing or collapse. You may also notice a rash with raised lumps and itching (urticaria), or burning or pain at the injection site.

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
• irregular heart rate
• cough or shortness of breath
• nosebleeds
• itchy rash or urticaria
• fever
• pain at the infusion site

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Palonosetron Dr. Reddy’s

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial or on the outer carton after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
For single use only; any unused solution must be discarded.

6. Contents of the pack and other information

What Palonosetron Dr. Reddy’s contains
The active substance is palonosetron (as hydrochloride).
Page 4 of 5
Each ml of solution contains 50 micrograms of palonosetron. Each 5 ml vial contains 250 micrograms of palonosetron.
The other components are mannitol, sodium acetate trihydrate, water for injections, and for pH adjustment: sodium hydroxide and hydrochloric acid.

Description of the appearance of Palonosetron Dr. Reddy’s and contents of the pack
Palonosetron Dr. Reddy’s 250 microgrammes solution for injection is a clear, colourless solution.
The product is supplied in a type I glass vial closed with a 20 mm bromobutyl rubber omniflex stopper and sealed with a 20 mm flip-off seal.
Available in packs containing 1 vial with 5 ml of solution.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Dr. Reddy’s S.r.l.
Via F. Wittgens, 3 – 20123 Milano (MI), Italy
Manufacturer:
betapharm Arzneimittel GmbH
Kobelweg 95
D - 86156 Augsburg – Germany

This medicine is authorised in the European Economic Area countries under the
following names:
Germany Palonosetron beta 250 Mikrogramm Injektionslösung
Romania Palonosetron Dr. Reddy's 250 micrograme soluție injectabilă
Italy Palonosetron Dr. Reddy´s 250 microgrammi soluzione iniettabile
Page 5 of 5