Active ingredient
- caspofungin acetate
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: PL08553/0574.
Caspofungin 70 mg Powder For Concentrate For Solution For Infusion
Package Leaflet: Information for the user
Caspofungin 70 mg Powder For Concentrate For Solution For Infusion
Caspofungin
Read all of this leaflet carefully before you or your child are given 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 use 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 contains a medicine called caspofungin. This belongs to a group of medicines called antifungals.
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 defences a chance to completely get rid of the infection.
2. What you need to know before you are given Caspofungin
Do not use 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:
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
Please 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
Ask your doctor for advice before taking any medicine, if you are pregnant or breast-feeding or think you are pregnant.
Driving and using machines
There is no information to suggest that Caspofungin affects your ability to drive or operate machinery.
3. How to use Caspofungin
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.
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 – 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:
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, nurse 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. 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.
Store in a refrigerator (2°C to 8°C).
Once Caspofungin has been prepared, it should be used straight away. This is because it does not contain any ingredients to stop the growth of bacteria. 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”).
Reconstituted concentrate: should be used immediately. Stability data have shown that the concentrate for solution for infusion can be stored for up to 24 hours when the vial is stored at 25°C or less and reconstituted with water for injection. Chemical and physical stability has been demonstrated up to 24 hours when the vial is stored at 25°C or less and reconstituted with water.
Diluted patient infusion solution: should be used immediately. Stability data have shown that the product can be used within 24 hours when stored at 25°C or less, or within 48 hours when the intravenous infusion bag (bottle) is stored refrigerated (2 to 8°C) and 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.
Caspofungin contains no preservatives. Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C before its use. 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.
Do not use this medicine if you notice any signs of deterioration such as cracks in the vial.
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 to protect the environment.
6. Contents of the pack and other information
What Caspofungin contains
What Caspofungin looks like and contents of the pack
Caspofungin is a sterile, white to off-white compact powder in a glass vial with a rubber stopper and a yellow aluminium cap.
Each pack contains one vial of powder.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in 08/2017
11505218-00
6 Riverview Road, Beverley, Hull, HU17 0LD
+44 (0)1482 860228
+44 (0)1748 828873
+44 (0)1482 389858
+44 (0)1482 860204
+44 (0)1748 828801