- caspofungin acetate
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: PL17780/0769.
Caspofungin 50 mg Powder for Concentrate for Solution for Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
CASPOFUNGIN 50 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What caspofungin is and what it is used for
2.What you need to know before you are given caspofungin
3. How to take caspofungin
4. Possible side effects
5. How to store caspofungin
6. Contents of the pack and other information
1. WHAT CASPOFUNGIN IS AND WHAT IT IS USED FOR
What Caspofungin is
Caspofungin 50mg powder for concentrate for solution for infusion contains a medicine called caspofungin. This belongs to a group of medicines called anti-fungals.
What Caspofungin is used for
Caspofungin is used to treat the following infections in children, adolescents and adults:
How Caspofungin works
Caspofungin makes fungal cells fragile and stops the fungus from growing properly. This stops the infection from spreading and gives the body's natural defenses a chance to completely get rid of the infection.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CASPOFUNGIN
You must not be given caspofungin
If you are not sure, talk to your doctor, nurse or pharmacist before you are given your medicine.
Warnings and precautions
Talk to your doctor, nurse or pharmacist before you are given Caspofungin:
If any of the above applies to you (or you are not sure), talk to your doctor, nurse or pharmacist before you are given caspofungin.
Caspofungin may also cause Serious Cutaneous Adverse Reactions such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).
Other medicines and caspofungin
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because caspofungin can affect the way some other medicines work. Also some other medicines can affect the way caspofungin works.
Tell your doctor, nurse or pharmacist if you are taking any of the following medicines:
If any of the above apply to you (or you are not sure), talk to your doctor, nurse or pharmacist before you are given caspofungin.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before using this medicine.
Driving and using machines
There is no information to suggest that caspofungin affects your ability to drive or operate machinery.
Caspofungin contains sucrose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially 'sodium-free'.
3. HOW CASPOFUNGIN IS GIVEN
Caspofungin will always be prepared and given to you by a healthcare professional.
You will be given caspofungin:
Your doctor will determine the duration of your treatment and how much caspofungin you will be given each day. Your doctor will monitor how well the medicine works for you. If you weigh more than 80 kg, you may need a different dose.
Use in children and adolescents
The dose for children and adolescents may differ from the adult dose.
If you have been given more caspofungin than you should
Your doctor will decide how much caspofungin you need and for how long each day. If you are worried that you may have been given too much caspofungin, tell your doctor or nurse straight away.
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or nurse straight away if you notice any of the following side effects as you may need urgent medical treatment:
As with any prescription medicine, some side effects may be serious. Ask your doctor for more information.
Other side effects in adults include:
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Additional side effects in children and adolescents
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: 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 CASPOFUNGIN
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the vial after EXP. The expiry date refers to the last day of that month.
Unopened vials: Store in a refrigerator at 2°C to 8°C.
Chemical and physical in-use stability has been demonstrated for up to 24 hours at 25°C or less and at 5 ± 3°C when reconstituted with water for injection. From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbiological contamination, the product should be used immediately. This is because it does not contain any ingredients to stop the growth of bacteria. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Chemical and physical in-use stability of the diluted patient infusion solution has been demonstrated for 48 hours at 2 to 8°C and at room temperature (25°C), when diluted with sodium chloride solution 9 mg/ml (0.9%), 4.5 mg/ml (0.45%), or 2.25 mg/ml (0.225%) for infusion, or lactated Ringer's solution. From a microbiological point of view, the product should be used immediately. If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution and dilution have taken place in controlled validated aseptic conditions.
Only a trained healthcare professional who has read the complete directions should prepare the medicine (please see below "Instructions of how to reconstitute and dilute caspofungin").
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Caspofungin 50mg powder for concentrate for solution for infusion contains:
Each 50 mg vial contains 50 mg caspofungin (as acetate).
After reconstitution in 10.5 ml of water for injection, 1 ml of the concentrate contains 5.2 mg caspofungin.
What Caspofungin 50mg powder for concentrate for solution for infusion looks like and contents of the pack:
Caspofungin is a sterile, white to off-white lyophilised powder.
Each pack contains one vial (10 ml) of powder.
Marketing Authorisation Holder
This leaflet was last updated in June 2019