Patient Leaflet Updated 21-Sep-2022 | Flynn Pharma Ltd
Micafungin 50 mg or 100 mg powder for concentrate for solution for infusion
Package Leaflet: Information for the user
Micafungin 50 mg
Micafungin 100 mg
powder for concentrate for solution for infusion
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Micafungin is and what it is used for
2. What you need to know before you use Micafungin
3. How to use Micafungin
4. Possible side effects
5. How to store Micafungin
6. Contents of the pack and other information
1 What Micafungin is and what it is used for
Micafungin contains the active substance micafungin. Micafungin is called an antifungal medicine because it is used to treat infections caused by fungal cells.
Micafungin is used to treat fungal infections caused by fungal or yeast cells called Candida. Micafungin is effective in treating systemic infections (those that have penetrated within the body). It interferes with the production of a part of the fungal cell wall. An intact cell wall is necessary for the fungus to continue living and growing.
Micafungin causes defects in the fungal cell wall, making the fungus unable to live and grow.
Your doctor has prescribed Micafungin for you in the following circumstances when there are no other suitable antifungal treatments available (see section 2):
2 What you need to know before you use Micafungin
Do not use Micafungin
Warnings and precautions
In rats, long-term treatment with micafungin led to liver damage and subsequent liver tumours. The potential risk of developing liver tumours in humans is not known, and your doctor will assess the benefits and risks of Micafungin treatment before starting your medicine. Please tell your doctor if you have severe liver problems (e.g. liver failure or hepatitis) or have had abnormal liver function tests. During treatment your liver functions will be monitored more closely.
Talk to your doctor or pharmacist before using Micafungin
Micafungin may also cause severe inflammation/eruption of the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Other medicines and Micafungin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is especially important to inform your doctor if you are using amphotericin B desoxycholate or itraconazole (antifungal antibiotics), sirolimus (an immuno-suppressant) or nifedipine (calcium channel blocker used to treat high blood pressure). Your doctor may decide to adjust the dose of these medicines.
Micafungin with food and drink
As Micafungin is given intravenously (into a vein), no restrictions on food or drink are required.
Pregnancy and breast-feeding
If you are pregnant of breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Micafungin should not be used during pregnancy unless clearly necessary. If you use Micafungin you should not breast-feed.
Driving and using machines
Micafungin is unlikely to have an effect on driving or using machines. However, some people may feel dizzy when taking this medicine and if this happens to you, do not drive or use any tools or machines. Please inform your doctor if you experience any effects that may cause you to have problems with driving or using other machinery.
Micafungin contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.
3 How to use Micafungin
Micafungin must be prepared and given to you by a doctor or another healthcare professional.
Micafungin should be administered once daily by slow intravenous (into a vein) infusion. Your doctor will determine how much Micafungin you will receive each day.
Use in adults, adolescents ≥ 16 years of age and elderly
Use in children ≥ 4 months of age and adolescents < 16 years of age
Use in children and newborns < 4 months of age
If you receive more Micafungin than you should
Your doctor monitors your response and condition to determine what dose of Micafungin is needed. However, if you are concerned that you may have been given too much Micafungin, speak to your doctor or another healthcare professional immediately.
If you miss a dose of Micafungin
Your doctor monitors your response and condition to determine what Micafungin treatment is needed. However, if you are concerned that you may have missed a dose, speak to your doctor or another healthcare professional immediately.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience an allergic attack, or a severe skin reaction (e.g. blistering and peeling of the skin), you must inform your doctor or nurse immediately.
Possible side effects continued
Micafungin may cause the following other side effects:
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Not known (frequency cannot be estimated from the available data)
Additional side effects in children and adolescents
The following reactions have been reported more often in paediatric patients than in adult patients:
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 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 Micafungin
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 vial and on the carton. The expiry date refers to the last day of that month.
The unopened vial does not require any special storage conditions.
The reconstituted concentrate and the diluted infusion solution should be used immediately, because it does not contain any preservatives to prevent bacterial contamination. Only a trained healthcare professional who has read the complete directions properly can prepare this medicine for use.
Do not use the diluted infusion solution if it is cloudy or precipitated.
In order to protect the infusion bottle/bag containing the diluted infusion solution from light it should be inserted into a closable opaque bag.
The vial is for single use only. Therefore, please discard unused reconstituted concentrate immediately.
6 Contents of the pack and other information
What Micafungin contains
What Micafungin looks like and contents of the pack
Micafungin 50 mg or 100 mg powder for concentrate for solution for infusion is a white to off white cake or powder.
Micafungin is supplied in a box containing 1 vial.
Marketing Authorisation Holder
This medicinal product is authorised in the Member States of the EEA under the following names:
Germany Micafungin Inresa
United Kingdom Micafungin
This leaflet was last revised in May 2022
Hertlands House, Primett Road, Stevenage, Hertfordshire, SG1 3EE, UK
+44 (0)1438 727822
+44 (0)1438 727822