Active ingredient
- palonosetron hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 41013/0022 .
Palonosetron 250 micrograms solution for injection
Package leaflet: Information for the user
Palonosetron 250 micrograms solution for injection
Palonosetron
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
What is in this leaflet
1. What Palonosetron solution for injection is and what it is used for
2. What you need to know before you are given Palonosetron solution for injection
3. How you are given Palonosetron solution for injection
4. Possible side effects
5. How to store Palonosetron solution for injection
6. Contents of the pack and other information
1. What Palonosetron solution for injection is and what it is used for
Palonosetron solution for injectioncontains the active substance palonosetron. This belongs to a group of medicines called ‘serotonin (5HT3) antagonists’.
Palonosetron solution for injection is used in adults, adolescents and children over one month of age to help stop you feeling or being sick (nausea and vomiting) when having cancer treatments called chemotherapy.
It works by blocking the action of a chemical called serotonin, which can cause you to feel sick or to vomit.
2. What you need to know before you are given Palonosetron solution for injection
Do not take Palonosetron solution for injection if:
You will not be given Palonosetron solution for injection if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you are given this medicine.
Warnings and precautions
Talk to your doctor or nurse before you are given Palonosetron solution for injection if:
If any of the above applies to you (or you are not sure), talk to your doctor or nurse before you are given Palonosetron solution for injection.
Other medicines and Palonosetron solution for injection
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. In particular, tell them if you are taking the following medicines:
Medicines for depression or anxiety
Tell your doctor or nurse if you are taking any medicines for depression or anxiety, including:
Medicines that can affect your heart beat
Tell your doctor or nurse if you are taking any medicines that affect your heart beat – this is because they could cause a heart beat problem when taken with Palonosetron solution for injection. This includes:
If any of the above applies to you (or you are not sure), talk to your doctor or nurse before taking Palonosetron solution for injection – this is because these medicines could cause a heart beat problem when taken with Palonosetron solution for injection.
Pregnancy
If you are pregnant or think you might be pregnant, your doctor will not give you Palonosetron solution for injection unless it is clearly necessary. This is because we do not know if Palonosetron solution for injection may harm the baby.
Ask your doctor or nurse for advice before being given this medicine if you are pregnant or think you might be.
Breast-feeding
It is not known if Palonosetron solution for injection is found in breast milk.
Ask your doctor or nurse for advice before being given this medicine if you are breast-feeding.
Driving and using machines
You may feel dizzy or tired after being given this medicine. If this happens, do not drive or use any tools or machines.
Palonosetron solution for injection contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.
3. How you are given Palonosetron solution for injection
Palonosetron solution for injection is normally given by a doctor or nurse.
Adults
Children and young people (aged 1 month to 17 years)
It is not recommended you are given Palonosetron solution for injection in the days following chemotherapy unless you are going to have another chemotherapy cycle.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
Serious side effects
Tell your doctor straight away if you notice any of the following serious side effects:
Tell your doctor straight away if you notice any of the serious side effects listed above.
Other side effects
Tell your doctor if you notice any of the following side effects:
Adults
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Tell your doctor if you notice any of the side effects listed above.
Uncommon side effects shown in tests: may affect up to 1 in 100 people
Very rare: may affect up to 1 in 10,000 people
Children and young people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Tell your doctor if you notice any of the side effects listed above.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Palonosetron solution for injection
6. Contents of the pack and other information
What Palonosetron solution for injection contains
What Palonosetron solution for injection looks like and contents of the pack
Palonosetron solution for injection is a clear, colourless solution and is supplied in a pack of one Type I clear glass vial with chlorobutyl siliconised grey rubber stopper and aluminium flip-off cap with red polypropylene disk, which contains 5 ml of the solution. Each vial contains one dose.
Available in packs of 1 vial containing 5 ml of solution.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised on 18/01/2021.
uk-pl-v1.3-20210118
Stanmore Place, Honeypot Lane, Stanmore, London, HA7 1BT
+44 (0208 731 5273
+44 (0)208 731 5273
+44 (0)208 731 5273
+44 (0)203 727 0712
+44 (0)203 727 0712