MICAFUNGINA SALA 100 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION EFG

2. What you need to know before you use Micafungin Sala

Do not use Micafungin Sala

• if you are allergic to micafungin, to other echinocandins (Ecalta or Cancidas) or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine

• if you are allergic to any medicine
• if you have hemolytic anemia (anemia produced by the rupture of red blood cells) or hemolysis (rupture of red blood cells).
• if you have kidney problems (renal failure or abnormal renal function tests). In this case, your doctor may decide to monitor your renal function more closely.

Micafungin can also cause severe skin and mucous membrane inflammation/eruption (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other medicines and Micafungin Sala

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

It is especially important that you tell your doctor if you are using amphotericin B desoxycholate or itraconazole (antifungal antibiotics), sirolimus (an immunosuppressant), or nifedipine (a calcium channel blocker used to treat high blood pressure).

Your doctor may decide to adjust the dose of these medicines.

Using Micafungin Sala with food and drinks

Since this medicine is administered intravenously (in the vein), there are no restrictions on food or drinks.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine should not be used during pregnancy unless clearly necessary. If you use this medicine, you should not breastfeed.

Driving and using machines

It is unlikely that micafungin will affect your ability to drive or use machines. However, some people may feel dizzy when taking this medicine, and if this happens to you, do not drive or use any machine or tool. Please inform your doctor if you experience any effect that may cause problems when driving or using machinery.

Micafungin Sala contains sodium and lactose

This medicine contains less than 23 mg of sodium (1 mmol) per dose; this is essentially "sodium-free".

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to use Micafungin Sala

This medicine must be prepared and administered by a doctor or other healthcare professional. This medicine must be administered by slow intravenous infusion (in the vein), once a day. Your doctor will determine the dose of micafungin you will receive each day.

Use in adults, adolescents 16 years or older, and elderly patients

• The usual dose for treating 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 for treating an esophageal Candida infection 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 for preventing 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.

Use in children over 4 months of age and adolescents under 16 years

• The usual dose for treating 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 for preventing 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.

Use in children and newborns under 4 months of age

• The usual dose for treating an invasive Candida infection is 4-10 mg/kg per day.
• The usual dose for preventing invasive Candida infections is 2 mg/kg per day.

If you receive more Micafungin Sala than you should

Your doctor will monitor your response and the condition of your disease to determine the necessary dose of this medicine. However, if you are concerned that you have received too much micafungin, consult your doctor or another healthcare professional immediately.

If you miss a dose of Micafungin Sala

Your doctor will monitor your response and the condition of your disease to determine the appropriate treatment with this medicine. However, if you are concerned that you have missed a dose of this medicine, contact your doctor or another healthcare professional immediately.

If you have any other questions about the use of this medicine, 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 suffer an allergic attack or a severe skin reaction (e.g., blistering of the skin and peeling of the skin), you should inform your doctor or nurse immediately.

This medicine can cause these other side effects:

Common(may affect up to 1 in 10 people)

• abnormal blood test results (reduction in the number of white blood cells [leukopenia; neutropenia]); reduction in the number of red blood cells (anemia)
• reduction of potassium in blood (hypokalemia); reduction of magnesium in blood (hypomagnesemia); reduction of calcium in blood (hypocalcemia)
• headache
• inflammation of the vein wall (at the injection site)
• nausea (discomfort); vomiting; diarrhea; abdominal pain
• abnormal liver function tests (increase in alkaline phosphatase; increase in aspartate aminotransferase; increase in alanine aminotransferase)
• increase in bilirubin in the blood (hyperbilirubinemia)
• rash
• fever
• chills

Uncommon(may affect up to 1 in 100 people)

• abnormal blood test results (reduction in the number of blood cells [pancytopenia]); reduction in the number of platelets (thrombocytopenia); increase in the number of a certain type of white blood cells called eosinophils; reduction of albumin in blood (hypoalbuminemia)
• hypersensitivity
• increased sweating
• reduction of sodium in blood (hyponatremia); increase of potassium in blood (hyperkalemia); reduction of phosphates in blood (hypophosphatemia); anorexia (eating disorder)
• insomnia (difficulty sleeping); anxiety; confusion
• drowsiness (somnolence); tremors; dizziness
• increased heart rate; stronger heartbeat; irregular heartbeat
• high or low blood pressure; flushing
• shortness of breath
• indigestion; constipation
• liver failure; increase in liver enzymes (gamma-glutamyltransferase); jaundice (the skin or the white part of the eyes turns yellow due to liver or blood problems); reduction of bile that reaches the intestine (cholestasis); increase in liver size; liver inflammation
• itchy rash (urticaria); itching; flushing (erythema)
• abnormal kidney function tests (increase in creatinine in blood; increase in urea in blood); worsening of kidney failure
• increase in an enzyme called lactate dehydrogenase
• clot formation at the injection site; inflammation at the injection site; pain at the injection site; fluid accumulation in the body

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

• anemia caused by the rupture of red blood cells (hemolytic anemia), rupture of red blood cells (hemolysis)

Frequency not known(frequency cannot be estimated from the available data)

• blood coagulation disorders
• shock (allergic)
• liver cell damage including death
• kidney damage; acute kidney failure

Other side effects in children and adolescents

The following reactions have been described more frequently in pediatric patients than in adults:

Common(may affect up to 1 in 10 people)

• reduction of platelets in blood (thrombocytopenia)
• increase in heart rate (tachycardia)
• high or low blood pressure
• increase in bilirubin in blood (hyperbilirubinemia); increase in liver size
• acute kidney failure; increase in urea in blood

Reporting of side effects

If you experience 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 Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Micafungin Sala

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 after EXP. The expiry date refers to the last day of the month shown.

The intact vial (unopened) does not require special storage conditions.

The reconstituted concentrate and the diluted solution for infusion must be used immediately because it does not contain preservatives to prevent bacterial contamination. Only a healthcare professional who has read the instructions completely and correctly can prepare this medicine for use.

Do not use the diluted solution for infusion if it is cloudy or if a precipitate has formed.

To protect the bottle/bag containing the diluted solution for infusion from light, it should be placed in an opaque bag with a seal.

The vial is for single use only. Therefore, any unused reconstituted concentrate should be discarded immediately.

6. Contents of the pack and other information

Composition of Micafungin Sala

• The active substance is micafungin (as sodium salt).

1 vial contains 50 mg or 100 mg of micafungin (as sodium salt).

• The other ingredients are lactose monohydrate, anhydrous citric acid, and sodium hydroxide.

Appearance and pack contents

Micafungin Sala 50 mg or 100 mg powder for concentrate for solution for infusion is a white to off-white powder.

This medicine is supplied in a box containing 1 vial.

Marketing authorization holder and manufacturer

Laboratorio Reig Jofre, S.A.

Gran Capitán 10

08970 Sant Joan Despí

Barcelona, Spain

This medicine is authorized in the EEA member states with the following names:

Spain: Micafungina Sala 50 mg polvo para concentrado para solución para perfusión EFG

Micafungina Sala 100 mg polvo para concentrado para solución para perfusión EFG

Sweden: Micafungin Bioglan 50 mg pulver till koncentrat till infusionsvätska, lösning

Micafungin Bioglan 100 mg pulver till koncentrat till infusionsvätska, lösning

France: Micafungine Reig Jofre 50 mg, poudre pour solution à diluer pour perfusion

Micafungine Reig Jofre 100 mg, poudre pour solution à diluer pour perfusion

Portugal: Micafungina Reig Jofre 50 mg pó para concentrado para solução para perfusão

Micafungina Reig Jofre 100 mg pó para concentrado para solução para perfusão

Date of last revision of this leaflet:May 2021

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/

---------------------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

This medicine must not be mixed or infused simultaneously with other medicines except those mentioned below. This medicine is reconstituted and diluted using aseptic techniques at room temperature, as follows:

1. The plastic cap must be removed from the vial and the stopper must be disinfected with alcohol.
2. 5 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion (taken from a 100 ml bottle/bag) must be slowly and aseptically injected into each vial along the inner wall. Although the concentrate may foam, care must be taken to minimize the amount of foam generated. A sufficient number of vials of this medicine must be reconstituted to obtain the necessary dose in mg (see the table below).
3. The vial must be gently rotated. IT MUST NOT BE SHAKEN. The powder will dissolve completely. The concentrate must be used immediately. The vial is for single use only. Therefore, any unused reconstituted concentrate must be discarded immediately.
4. All the reconstituted concentrate must be withdrawn from each vial and returned to the infusion bottle/bag from which it was initially taken. The diluted solution for infusion must be used immediately. It has been shown that the chemical and physical stability allows the use of the medicine for 96 hours at 25°C and 24 hours at 2-8°C, provided it is protected from light and the dilution is performed as described above.
5. The infusion bottle/bag must be carefully inverted to disperse the diluted solution but MUST NOT BE SHAKEN to avoid foam formation. The solution must not be used if it is cloudy or if a precipitate has formed.
6. The bottle/bag containing the diluted solution for infusion must be placed in an opaque bag with a seal to protect it from light.

Preparation of the infusion solution