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: PLGB 00166/0421.
Mycamine 50mg and 100mg powder for concentrate for solution for infusion
Mycamine 50 mg powder for concentrate for solution for infusion
Mycamine 100 mg powder for concentrate for solution for infusion
1. What Mycamine is and what it is used for
2. What you need to know before you use Mycamine
3. How to use Mycamine
4. Possible side effects
5. How to store Mycamine
6. Contents of the pack and other information
Mycamine contains the active substance micafungin. Mycamine is called an antifungal medicine because it is used to treat infections caused by fungal cells.
Mycamine is used to treat fungal infections caused by fungal or yeast cells called Candida. Mycamine 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. Mycamine causes defects in the fungal cell wall, making the fungus unable to live and grow.
Your doctor has prescribed Mycamine for you in the following circumstances when there are no other suitable antifungal treatments available (see section 2):
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 Mycamine 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 Mycamine
Micafungin may also cause severe inflammation/eruption of the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
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 immunosuppressant) or nifedipine (calcium channel blocker used to treat high blood pressure). Your doctor may decide to adjust the dose of these medicines.
As Mycamine is given intravenously (into a vein), no restrictions on food or drink are required.
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.
Mycamine should not be used during pregnancy unless clearly necessary. If you use Mycamine you should not breast-feed.
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.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
Mycamine must be prepared and given to you by a doctor or another healthcare professional. Mycamine should be administered once daily by slow intravenous (into a vein) infusion. Your doctor will determine how much Mycamine 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
Your doctor monitors your response and condition to determine what dose of Mycamine is needed. However, if you are concerned that you may have been given too much Mycamine, speak to your doctor or another healthcare professional immediately.
Your doctor monitors your response and condition to determine what Mycamine 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.
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.
Mycamine 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)
The following reactions have been reported more often in paediatric patients than in adult patients:
Common (may affect up to 1 in 10 people)
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 at: 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.
Keep this medicine out of the sight and reach of children.
Do not use Mycamine 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.
Mycamine 50 mg or 100 mg powder for concentrate for solution for infusion is a white compact freeze-dried powder. Mycamine is supplied in a box containing 1 vial.
This leaflet was last revised in 01/2023.