Micafungin 100 mg powder for concentrate for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to micafungin, other echinocandins (anidulafungin or caspofungin) or any of the other ingredients of this medicine (listed in section 6).

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

• if you are allergic to any medicine.
• if you have haemolytic anaemia (anaemia due to breakdown of red blood cells) or haemolysis (breakdown of red blood cells).
• if you have kidney problems (e.g. kidney failure and abnormal kidney function test). If this happens, your doctor may decide to monitor your kidney function more closely.

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 immuno-suppressant) or nifedipine (calcium channel blocker used to treat high blood pressure). Your doctor may decide to adjust the dose of these medicines.

As Micafungin 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.

Micafungin should not be used during pregnancy unless clearly necessary. If you use Micafungin 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 vial, that is to say essentially ‘sodium-free’.

• The usual dose to treat an invasive Candida infection is 100 mg per day for patients weighing more than 40 kg and 2 mg/kg per day for patients weighing 40 kg or less.
• The dose to treat a Candida infection of the oesophagus is 150 mg for patients weighing more than 40 kg and 3 mg/kg per day for patients weighing 40 kg or less.
• The usual dose to prevent invasive Candida infections is 50 mg per day for patients weighing more than 40 kg and 1 mg/kg per day for patients weighing 40 kg or less.

• The usual dose to treat an invasive Candida infection is 100 mg per day for patients weighing more than 40 kg and 2 mg/kg per day for patients weighing 40 kg or less.
• The usual dose to prevent invasive Candida infections is 50 mg per day for patients weighing more than 40 kg and 1 mg/kg per day for patients weighing 40 kg or less.

• The usual dose to treat an invasive Candida infection is 4-10 mg/kg per day.
• The usual dose to prevent invasive Candida infections is 2 mg/kg per day.

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.

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.

Micafungin may cause the following other side effects:

Common (may affect up to 1 in 10 people)

• abnormal blood tests (decreased white blood cells [leukopenia; neutropenia]); decreased red blood cells (anaemia)
• decreased potassium in the blood (hypokalaemia); decreased magnesium in the blood (hypomagnesaemia); decreased calcium in the blood (hypocalcaemia)
• headache
• inflammation of the vein wall (at injection-site)
• nausea (feeling sick); vomiting (being sick); diarrhoea; abdominal pain
• abnormal liver function tests (increased alkaline phosphatase; increased aspartate aminotransferase, increased alanine aminotransferase)
• increased bile pigment in the blood (hyperbilirubinaemia)
• rash
• fever
• rigors (shivering)

Uncommon (may affect up to 1 in 100 people)

• abnormal blood tests (decreased blood cells [pancytopenia]); decreased blood platelets (thrombocytopenia); increases in a certain type of white blood cells called eosinophils; decreased albumin in the blood (hypoalbuminaemia)
• hypersensitivity
• increased sweating
• decreased sodium in the blood (hyponatraemia); increased potassium in the blood (hyperkalaemia); decreased phosphates in the blood (hypophosphataemia); anorexia (eating disorder)
• insomnia (difficulty in sleeping); anxiety; confusion
• feeling lethargic (somnolence); trembling; dizziness; disturbed taste
• increased heart rate; stronger heartbeat; irregular heartbeat
• high or low blood pressure; skin flushing
• shortness of breath
• indigestion; constipation
• liver failure; increased liver enzymes (gamma-glutamyltransferase); jaundice (yellowing of the skin or whites of the eyes caused by liver or blood problems); reduced bile reaching the intestine (cholestasis); enlarged liver; liver inflammation
• itchy rash (urticaria); itching; skin flushing (erythema)
• abnormal kidney function tests (increased blood creatinine; increased urea in the blood); aggravated kidney failure
• increase in an enzyme called lactate dehydrogenase
• clotting in vein at injection-site; inflammation at injection-site; pain at injection-site; collection of fluid in your body

Rare (may affect up to 1 in 1,000 people)

• anaemia due to breakdown of red blood cells (haemolytic anaemia), breakdown of red blood cells (haemolysis)

Not known (frequency cannot be estimated from the available data)

• disorder of blood clotting system
• (allergic) shock
• damage to liver cells including death
• kidney problems; acute kidney failure

The following reactions have been reported more often in paediatric patients than in adult patients:

Common (may affect up to 1 in 10 people)

• decreased blood platelets (thrombocytopenia)
• increased heart rate (tachycardia)
• high or low blood pressure
• increased bile pigment in the blood (hyperbilirubinaemia); enlarged liver
• acute kidney failure; increased urea in the blood

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.

• The active substance is micafungin.
  Micafungin 50 mg: Each vial contains 50 mg micafungin (as sodium). After reconstitution each ml concentrate for solution for infusion contains 10 mg micafungin (as sodium).
  Micafungin 100 mg: Each vial contains 100 mg micafungin (as sodium). After reconstitution each ml concentrate for solution for infusion contains 20 mg micafungin (as sodium).
• The other ingredients are lactose monohydrate, citric acid anhydrous (for pH adjustment) and sodium hydroxide (1 M) (for pH adjustment).

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.

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany Micafungin Inresa

United Kingdom Micafungin