MICAFUNGINA ACCORDPHARMA 50 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Micafungina Accordpharma 50 mg powder for concentrate for solution for infusion EFG

Micafungina Accordpharma 100 mg powder for concentrate for solution for infusion EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What is Micafungina Accordpharma and what is it used for
2. What you need to know before you use Micafungina Accordpharma
3. How to use Micafungina Accordpharma
4. Possible side effects
5. Storage of Micafungina Accordpharma
6. Contents of the pack and other information

1. What is Micafungina Accordpharma and what is it used for

Micafungina Accordpharma contains the active substance micafungin. Micafungin is an antifungal medicine used to treat infections caused by fungal cells.

Micafungin is used to treat fungal infections caused by fungal cells or yeasts called Candida. Micafungin is effective in treating systemic infections (those that have penetrated the body). It interferes with the production of a part of the fungal cell wall. The fungus needs an intact cell wall to live and grow. Micafungin causes defects in the fungal cell wall, preventing the fungus from growing and living.

When no other antifungal treatment is available, your doctor will prescribe micafungin in the following circumstances (see section 2):

• To treat a severe fungal infection in adults, adolescents, and children, including newborns, called invasive candidiasis (infection that has penetrated the body).
• To treat adults and adolescents ≥ 16 years with a fungal infection in the throat (esophagus) where intravenous treatment is appropriate.
• To prevent Candida infection in patients undergoing bone marrow transplantation or who are expected to have neutropenia (low levels of neutrophils, a type of white blood cell) for 10 days or more.

2. What you need to know before you use Micafungina Accordpharma

Do not use Micafungina Accordpharma

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to use micafungin

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

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

Other medicines and micafungin

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

It is especially important to 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 with food and drinks

Since micafungin is given by intravenous infusion (in a vein), there are no restrictions on food or drinks.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Micafungin should not be used during pregnancy unless clearly necessary. If you use micafungin, 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 tell your doctor if you experience any effect that may cause problems when driving or using machinery.

Micafungina Accordpharma contains sodium

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

3. How to use Micafungina Accordpharma

Micafungina should be prepared and administered by a doctor or other healthcare professional. Micafungina should be given by slow intravenous infusion (in a vein) once a day. Your doctor will decide the dose of micafungina you will receive each day.

Use in adults, adolescents ≥ 16 years, 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 ≥ 4 months of age and adolescents <16 years of age< strong>

• 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 infants <4 months of age< strong>

• 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 than you should

Your doctor will monitor your response and the condition of your disease to determine the necessary dose of micafungin. However, if you are concerned that you have received too much micafungin, contact your doctor or other healthcare professional immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount received.

If you miss a dose of micafungin

Your doctor will monitor your response and the condition of your disease to determine the appropriate treatment with micafungin. However, if you are concerned that you have missed a dose of micafungin, contact your doctor or other 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 reaction or a severe skin reaction (e.g., blistering of the skin and peeling of the skin), you should inform your doctor or nurse immediately.

Micafungin 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 the blood (hypokalemia); reduction of magnesium in the blood (hypomagnesemia); reduction of calcium in the blood (hypocalcemia)
• headache
• inflammation of the vein wall (at the injection site)
• nausea (feeling sick); 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 the blood (hypoalbuminemia)
• hypersensitivity
• increased sweating
• reduction of sodium in the blood (hyponatremia); increase of potassium in the blood (hyperkalemia); reduction of phosphates in the blood (hypophosphatemia); anorexia (eating disorder)
• insomnia (difficulty sleeping); anxiety; confusion
• drowsiness (somnolence); tremors; dizziness; alteration of taste
• 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 (yellowing of the skin or the white part of the eyes due to liver or blood problems); reduction of bile reaching the intestine (cholestasis); increase in liver size; liver inflammation
• itching rash (urticaria); itching; flushing (erythema)
• abnormal kidney function tests (increase in creatinine in the blood; increase in urea in the 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 breakdown of red blood cells (hemolytic anemia), breakdown of red blood cells (hemolysis)

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

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

Other side effects in children and adolescents

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

Common (may affect up to 1 in 10 people)

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Micafungina Accordpharma

Keep this medicine out of the sight and reach of children.

Do not use micafungin after the expiry date which is stated on the vial and on the carton (EXP). The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Keep the vial in the outer packaging to protect it from light.

Reconstituted concentrate in the vial

The chemical and physical stability of the product has been demonstrated for 48 hours at 2-8°C and at 20-25°C, when reconstituted with sodium chloride 9 mg/ml (0.9%) solution for infusion or with glucose 50 mg/ml (5%) solution for infusion.

Diluted solution for infusion

The chemical and physical stability that allows its use has been demonstrated for 96 hours at 2-8°C and at 20-25°C, protected from light, when diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion or with glucose 50 mg/ml (5%) solution for infusion.

Micafungin does not contain preservatives. From a microbiological point of view, the diluted and reconstituted solutions should be used immediately. If not used immediately, the times and conditions of storage prior to use are the responsibility of the user and should not exceed 24 hours at a temperature between 2 and 8°C, unless the reconstitution and dilution have been produced under controlled and validated aseptic conditions.

Do not use the diluted solution for infusion if you notice 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Micafungina Accordpharma Composition

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

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

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

Product Appearance and Package Contents

Micafungina Accordpharma is supplied as a white lyophilized powder in a glass vial with a rubber stopper and an aluminum seal. Each vial contains 50 mg or 100 mg of micafungin (as sodium salt).

Each package contains 1 vial.

Marketing Authorization Holder

Accord Healthcare, S.L.U.

World Trade Center

Moll de Barcelona, s/n.

Edifici Est 6ª planta 08039 - Barcelona

Spain

Manufacturer

Accord Healthcare Polska Sp.z o.o.

ul. Lutomierska 50,

95-200 Pabianice, Poland

or

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind.

Zona Franca, Barcelona, 08040,

Spain

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

Date of the Last Revision of this Leaflet:May 2025

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

This information is intended solely for healthcare professionals:

Micafungin should not be mixed or infused simultaneously with other medicinal products except those mentioned below. Micafungin is reconstituted and diluted using aseptic techniques at room temperature, as follows:

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

Preparation of the Solution for Perfusion