Palonosetron 5 ml Solution

PALONOSETRON 250μg /5 ml CIPLA contains the active substance called palonosetron. This belongs to a group of medicines called serotonin (5-HT3) antagonists. PALONOSETRON 250μg /5 ml CIPLA is used for the prevention of nausea and vomiting associated with cancer treatment (chemotherapy). PALONOSETRON 250μg /5 ml CIPLA can be used by patients 18 years and older.

Do not take PALONOSETRON 250μg /5 ml CIPLA if:

• You are hypersensitive (allergic) to palonosetron or any other ingredient of PALONOSETRON 250μg /5 ml CIPLA.

Tell your doctor or healthcare professional before being given PALONOSETRON 250μg /5 ml CIPLA injections if:

• You have a history of constipation or signs of bowel obstruction.
• If you have a personal or family history of abnormal heart rhythms or other heart problems including a problem called “congenital QT syndrome”.
• If you have heart problems or are taking medicines that are known to alter heart rhythms, ask your doctor if you are unsure.
• If you have an imbalance of certain minerals in your blood such as low potassium and low magnesium which has not been treated.
• If you are using PALONOSETRON 250μg /5 ml CIPLA in addition to other medicines that may induce an abnormal heart rhythm such as amiodarone, nicardipine, quinidine, moxifloxacin, erythromycin, haloperidol, chlorpromazine, quetiapine, thioridazine, domperidone.

Warnings and precautions

Take special care with PALONOSETRON 250μg /5 ml CIPLA:

• If you are taking medicines for depression or anxiety, including medicines called selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram and medicines called SNRIs (serotonin noradrenaline reuptake inhibitors) such as venlafaxine, duloxetine. These medicines used in combination with 5-HT3 antagonists can cause a condition called serotonin syndrome and should be used with caution.

Children and adolescents

PALONOSETRON 250μg /5 ml CIPLA should not be used in children under 18 years of age.

Other medicines and PALONOSETRON 250μg /5 ml CIPLA

Always tell your healthcare professional if you are taking any other medicine. This includes complementary or traditional medicines. There is a potential risk of worsening of your heart condition when PALONOSETRON 250μg /5 ml CIPLA is used together with medicines used to treat heart rhythm disorders or those with an impact on heart rate. Tell your doctor if you are taking medicines used to treat heart rhythms or those that have an effect on heart rhythms.

PALONOSETRON 250μg /5 ml CIPLA will be injected into one of your veins, usually 30 minutes before you receive your cancer chemotherapy. The usual dose is 250 micrograms. You will not be expected to give yourself PALONOSETRON 250μg /5 ml CIPLA. It will be given to you by a person who is qualified to do so (such as your doctor or other healthcare professional). Your doctor will tell you how long your treatment with PALONOSETRON 250μg /5 ml CIPLA will last.

PALONOSETRON 250μg /5 ml CIPLA can have side effects. Not all side effects reported for PALONOSETRON 250μg /5 ml CIPLA are included in this leaflet. Should your general health worsen or if you experience any untoward effect while receiving PALONOSETRON 250μg /5 ml CIPLA, please consult your doctor, pharmacist or healthcare professional for advice. If any of the following happens, stop taking / using PALONOSETRON 250μg /5 ml CIPLA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting

These are all very serious side effects. If you have them, you may have had a serious reaction to PALONOSETRON 250μg /5 ml CIPLA. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Frequent side effects:

• Constipation
• Diarrhoea

Less frequent side effects:

• Swelling of the face, lips, or tongue, tightness of the chest, wheezing, or shortness of breath, hives or itching, fever or nausea, since these symptoms may be due to a serious allergic reaction.
• Severe itching of the skin, hives
• Fast, slow or irregular heart beats
• Lack of blood flow to heart muscles (signs include chest pain, chest tightness and shortness of breath)
• Seizures or fits
• Low blood pressure (signs include fainting, light-headedness and dizziness)
• High blood pressure (signs may include shortness of breath and headaches)
• Urinary retention / infrequent urination
• Flu-like illness

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

Frequent side effects:

• Dizziness
• Headache

Less frequent side effects:

• Flu-like illness
• Anorexia / loss of appetite
• Decreased appetite
• Anxiety
• Euphoria / feeling of elation
• Drowsiness / sleepiness
• Sleeplessness
• Excessive sleeping
• A feeling of pins and needles
• Numbness
• Eye irritation
• Motion sickness
• Ringing in ears
• Vein discolouration
• Vein distended/ enlarged
• Hiccups
• Dry mouth
• Abdominal or stomach pain
• Indigestion
• Flatulence / gas
• Skin rashes
• Itching
• Feeling weak and feverish
• Joint pain
• Feeling hot
• Fatigue
• Burning pain and discomfort at site of injection

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your healthcare professional. This includes any possible side effects not listed in this leaflet. You can also report side effects via this link. You can further report side effects directly to the marketing authorisation holder via: Customer Care: 080 222 6662. By reporting side effects, you can help provide more information on the safety of this medicine.

Store at or below 30 °C. Do not refrigerate. Any unused solution should be discarded after opening the vial. KEEP OUT OF REACH OF CHILDREN.