Product Information for the User

Micafungin Sodium 50 mg Powder for Concentrate for Solution for Infusion EFG

Micafungin Sodium 100 mg Powder for Concentrate for Solution for Infusion EFG

Read this entire product information carefully before starting to use this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

1. What Micafungin Sodium is and for what it is used

2. What you need to know before starting to use Micafungin Sodium

3. How to use Micafungin Sodium

4. Possible adverse effects

5. Storage of Micafungin Sodium

6. Contents of the pack and additional information

This medication contains the active ingredient micafungina. Micafungina is an antifungal medication as it is used to treat infections caused by fungal cells.

This medication is used to treat fungal infections caused by fungal cells or yeasts called Candida. Micafungina is effective in the treatment of systemic infections (those that have penetrated the body). It interferes with the production of a part of the fungal cell wall.

When there is no other available antifungal treatment, your doctor prescribes this medication 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 esophagus in which it is appropriate to apply the treatment by intravenous administration.
• To prevent Candida infection in patients undergoing a bone marrow transplant or who are expected to have neutropenia (low levels of neutrophils, a type of white blood cell) for 10 days or more.

No use Micafungina Sala

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to use this medication

-if you are allergic to any medication

-if you have hemolytic anemia (anemia caused 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.

Micafungina may also cause severe inflammation/eruption of the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other Medications and Micafungina Sala

Inform your doctor or pharmacist if you are using, have used recently or may have to use any other medication.

It is especially important to inform your doctor if you are using amphotericin B desoxicolate or itraconazole (antifungal antibiotics), sirolimus (an immunosuppressant) or nifedipine (a calcium channel blocker used to treat hypertension).

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

Use of Micafungina Sala with Food and Drinks

Since this medication is administered intravenously (into a vein), there are no restrictions related to food or drinks.

Pregnancy and Breastfeeding

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

This medication should not be used during pregnancy unless it is clearly necessary. If you use this medication, do not breastfeed.

Driving and Operating Machines

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

Micafungina Sala contains sodium and lactose

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

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

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

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

-The usual dose for treating 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 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 older than 4 months of age and adolescents younger than 16 years

-The usual dose for treating 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 younger than 4 months of age

-The usual dose for treating 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 state of your disease to determine the necessary dose of this medication. However, if you are concerned that you have received too much micafungin, consult your doctor or another healthcare professional immediately.

If you miss your dose of Micafungin

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience an allergic attack, or a severe skin reaction (e.g. blistering of the skin and peeling of the skin), you must inform your doctor or nurse immediately.

This medicine may cause these other side effects:

Frequent(may affect up to 1 in 10 people)

-abnormal results in blood tests (reduction in the number of white blood cells [leucopenia; 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 in the vein wall (at the injection site)

-nausea (dizziness); vomiting; diarrhea, abdominal pain

-abnormal results in liver tests (increase in alkaline phosphatase; increase in aspartate aminotransferase; increase in alanine aminotransferase)

-increase in bilirubin in the blood (hyperbilirubinemia)

-eruption

-fever

-chills

Infrequent(may affect up to 1 in 100 people)

-abnormal results in blood tests (reduction in the number of blood cells [pancytopenia]); reduction in the number of platelets (thrombocytopenia); increase in the number of a type of white blood cell called eosinophils; reduction in albumin in the blood (hypoalbuminemia)

-hypersensitivity

-increased sweating

-reduction of sodium in the blood (hyponatremia); increase of potassium in the blood (hyperkalemia); reduction of phosphate in the blood (hypophosphatemia); anorexia (eating disorder)

-insomnia (difficulty sleeping); anxiety; confusion

-feeling of sleepiness (somnolence); tremors, dizziness; alteration of taste

-increase in heart rate; stronger heartbeat; irregular heartbeat

-high or low blood pressure; redness

-shortness of breath

-indigestion; constipation

-hepatic 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 the amount of bile that reaches the intestine (cholestasis); enlargement of the liver; inflammation of the liver

-eruption with itching (urticaria); pruritus; redness (erythema)

-abnormal results in renal function tests (increase in creatinine in the blood; increase in urea in the blood); worsening of renal failure

-increase in an enzyme called lactate dehydrogenase

-formation of blood clots at the injection site; inflammation at the injection site; pain at the injection site; accumulation of fluid 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)

Unknown frequency(the frequency cannot be estimated from the available data)

-blood clotting disorders

-anaphylactic shock

-liver cell damage including death

-renal alterations; acute renal failure

Other side effects in children and adolescents

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

Frequent(may affect up to 1 in 10 people)

-reduction of platelets in the blood (thrombocytopenia)

-increase in heart rate (tachycardia)

-high or low blood pressure

-increase in bilirubin in the blood (hyperbilirubinemia); enlargement of the liver

-acute renal failure; increase in urea in the blood

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly throughthe Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the vial and on the CAD packaging. The expiration date is the last day of the month indicated.

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

The reconstituted concentrate and the diluted solution for infusion must be used immediately, as they do not contain preservatives to prevent bacterial contamination. Only a properly trained healthcare professional who has read the instructions correctly can prepare this medication for use.

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

To protect the diluted solution for infusion from light, the bottle/bag containing it must be introduced into an opaque bag with a seal.

The vial has a single use. Therefore, unused reconstituted concentrate must be discarded immediately.

Composition of Micafungin Sod

-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, anhydrous citric acid, and sodium hydroxide.

Appearance of the product and contents of the package

Micafungin Sod 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.

Holder of the marketing authorization and manufacturer responsible

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:Micafungin Sod 50 mg powder for concentrate for solution for infusion EFG

Micafungin Sod 100 mg powder for concentrate for solution for infusion EFG

Sweden:Micafungin Bioglan 50 mg powder for concentrate for infusion solution

Micafungin Bioglan 100 mg powder for concentrate for infusion solution

France: Micafungine Reig Jofre 50 mg, powder for solution to be diluted for infusion

Micafungine Reig Jofre 100 mg, powder for solution to be diluted for infusion

Portugal: Micafungina Reig Jofre 50 mg powder for concentrate for solution for infusion

Micafungina Reig Jofre 100 mg powder for concentrate for solution for infusion

Last review date of this leaflet:May 2021

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/

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This information is intended solely for medical professionals or healthcare professionals:

This medicine should 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 indicated below:

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%) for infusion or glucose 50 mg/ml (5%) for infusion (taken from a 100 ml bottle/bag) must be slowly and aseptically injected into each vial along the inner wall.

3.The vial must be gently rotated. DO NOT SHAKE. The powder will dissolve completely. The concentrate must be used immediately. The vial is for single use. Therefore, the unused reconstituted concentrate must be discarded immediately.

4.All the reconstituted concentrate must be removed from each vial and returned to the infusion bag from which it was initially taken. The diluted solution for infusion must be used immediately. It has been proven 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, as long as it is protected from light, and the dilution is carried out as described above.

5.The infusion bag must be carefully inverted to disperse the diluted solution but NOT shaken, to avoid foam formation. The solution should not be used if it is turbid or if a precipitate has formed.

6.The infusion bag containing the diluted solution for infusion must be introduced into an opaque bag with a seal to protect it from light.

Preparation of the infusion solution