Micafungin polpharma

Patient Information Leaflet

Micafungin Polpharma
50 mg, powder for solution for infusion concentrate
Micafunginum
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet Contents

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

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

Micafungin Polpharma contains the active substance micafungin. Micafungin Polpharma is known as an antifungal medicine because it is used to treat infections caused by fungal cells.
Micafungin Polpharma is used to treat fungal infections caused by fungi or yeast-like organisms called Candida. Micafungin Polpharma is effective in treating systemic infections (those that have spread throughout the body). It acts by interfering with the formation of a component of the fungal cell wall. An intact cell wall is essential for the normal development and growth of fungal cells. Micafungin Polpharma damages the fungal cell wall, thereby preventing further development and growth of the fungi.
Your doctor may prescribe Micafungin Polpharma in the following situations, when no other appropriate antifungal treatment is available (see section 2):

• Treatment of invasive candidiasis (a serious fungal infection that spreads into the body) in adults, adolescents, children, including newborns;
• Treatment of Candida oesophagitis (fungal infection of the oesophagus) in adults and adolescents aged ≥ 16 years, when intravenous (IV) treatment is appropriate;
• Prophylaxis of Candida infections in patients undergoing allogeneic haematopoietic stem cell transplantation or in patients expected to have neutropenia (low levels of neutrophils; a type of white blood cell) lasting for 10 or more days.

2. Information before using Micafungin Polpharma

When not to use Micafungin Polpharma

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

Warnings and precautions
Long-term treatment with micafungin in rats has led to liver damage and subsequently to liver tumours. The potential risk of developing liver tumours in humans is unknown; before starting treatment, the physician will evaluate the benefits and risks of using Micafungin Polpharma. You should tell your doctor if you have severe liver diseases (e.g. liver failure or hepatitis) or if abnormal liver function test results have been observed. Liver function will be closely monitored during treatment.
Before starting treatment with Micafungin Polpharma, discuss this with your doctor or pharmacist.

• if the patient is allergic to any medicine;
• if the patient has haemolytic anaemia (anaemia caused by the breakdown of red blood cells) or haemolysis (breakdown of red blood cells);
• if the patient has kidney diseases (e.g. kidney failure or abnormal kidney function test results). In such cases, the doctor may recommend closer monitoring of kidney function.

Micafungin may cause severe skin reactions or mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome)).
Micafungin Polpharma with other medicines
You should tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
It is especially important to inform your doctor if you are taking amphotericin B deoxycholate or itraconazole (antifungal antibiotics), sirolimus (an immunosuppressive medicine), or nifedipine (a calcium channel blocker used to treat high blood pressure). Your doctor may decide to adjust the dose of these medicinal products.
Micafungin Polpharma with food and drink
Since Micafungin Polpharma is administered intravenously (into a vein), there are no restrictions regarding food and drink.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Micafungin Polpharma must not be used during pregnancy unless considered absolutely necessary by the physician. Breastfeeding must not be undertaken during treatment with Micafungin Polpharma.
Driving and operating machinery
It is unlikely that micafungin will affect the ability to drive or operate machinery. However, dizziness may occur in some patients during treatment, and in such cases, patients should not drive or operate machinery. Inform your doctor if any side effects occur that may cause difficulties in driving or operating machinery.
Micafungin Polpharma contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. this medicine is considered "sodium-free".

3. How to use Micafungin Polpharma

Micafungin Polpharma must be prepared and administered by a doctor or other medical personnel.
Micafungin Polpharma is available in the following doses: 50 mg, 100 mg.
Micafungin Polpharma should be given once daily by slow intravenous infusion (into a vein).
The daily dose of Micafungin Polpharma will be determined by the treating physician.

Use in adults, adolescents aged ≥\ 16 years, and elderly patients

• For treatment of invasive Candida infection, the usual dose is 100 mg once daily for patients weighing more than 40 kg and 2 mg/kg body weight once daily for patients weighing 40 kg or less.
• For treatment of Candida oesophagitis, the daily dose is 150 mg for patients weighing more than 40 kg and 3 mg/kg body weight once daily for patients weighing 40 kg or less.
• For prophylaxis of invasive Candida infections, the usual dose is 50 mg once daily for patients weighing more than 40 kg and 1 mg/kg body weight once daily for patients weighing 40 kg or less.

Use in children aged >\ 4 months and adolescents aged <\ 16 years

• For treatment of invasive Candida infection, the usual dose is 100 mg once daily for patients weighing more than 40 kg and 2 mg/kg body weight once daily for patients weighing 40 kg or less.
• For prophylaxis of invasive Candida infections, the usual dose is 50 mg once daily for patients weighing more than 40 kg and 1 mg/kg body weight once daily for patients weighing 40 kg or less.

Use in children and neonates aged <\ 4 months

• For treatment of invasive Candida infection, the usual dose ranges from 4 mg/kg body weight once daily to 10 mg/kg body weight once daily.
• For prophylaxis of invasive Candida infections, the usual dose is 2 mg/kg body weight once daily.

Use of a higher than recommended dose of Micafungin Polpharma
The doctor will determine the appropriate dose of Micafungin Polpharma based on the patient's response to treatment and clinical condition. If there is any doubt whether too high a dose of Micafungin Polpharma has been administered, contact a doctor or other medical personnel immediately.

Missed dose of Micafungin Polpharma
The need for continued treatment with Micafungin Polpharma will be decided by the doctor based on the patient's response to treatment and clinical condition. If there is any doubt whether a dose of Micafungin Polpharma has been missed, contact a doctor or other medical personnel immediately.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If an allergic reaction or severe skin reaction occurs (e.g. blistering
and peeling of the skin), inform your doctor or nurse immediately.
Micafungin Polpharma may cause the following other adverse reactions:
Common (may occur in up to 1 in 10 patients)

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

Uncommon (may occur in up to 1 in 100 patients)

• abnormal blood test results (reduced number of blood cells (pancytopenia)); reduced platelet count (thrombocytopenia); increased number of a certain type of white blood cells (eosinophils); decreased albumin levels in the blood (hypoalbuminemia)
• hypersensitivity
• increased sweating
• decreased sodium levels in the blood (hyponatremia); increased potassium levels in the blood (hyperkalemia); decreased phosphate levels in the blood (hypophosphatemia); anorexia (loss of appetite)
• insomnia (sleep problems); anxiety; confusion
• drowsiness (somnolence); tremor; dizziness; taste disturbances
• rapid heartbeat; stronger heartbeat; irregular heartbeat
• high or low blood pressure; skin redness
• shortness of breath
• indigestion; constipation
• liver failure; increased liver enzyme activity (gamma-glutamyl transferase); jaundice (yellowing of the skin or whites of the eyes due to liver or blood disorders); bile flow obstruction before reaching the intestine (cholestasis); enlarged liver; liver inflammation
• itchy rash (urticaria); itching; skin redness (erythema)
• abnormal kidney function test results (increased creatinine levels in the blood; increased urea levels in the blood); worsening of kidney failure
• increased activity of an enzyme called lactate dehydrogenase
• venous thrombosis at the injection site; inflammation at the injection site; pain at the injection site; fluid retention in the body

Rare (may occur in up to 1 in 1,000 patients)

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

Not known (frequency cannot be estimated from available data)

• blood coagulation disorder
• shock (allergic)
• liver cell damage, which may also lead to death
• kidney problems; acute kidney failure

Additional adverse reactions observed in children and adolescents
The following reactions have been observed more frequently in pediatric patients than in adult patients:
Common (may occur in up to 1 in 10 patients)

• reduced platelet count (thrombocytopenia)
• increased heart rate (tachycardia)
• high or low blood pressure
• increased bilirubin levels in the blood (hyperbilirubinemia); enlarged liver
• acute kidney failure; increased urea levels in the blood

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49-21-301
Fax: +48 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Micafungin Polpharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Closed vial
Store below 25°C. Store in the original packaging to protect from light.
The prepared concentrate and diluted infusion solution should be used immediately, as they contain no preservatives to protect against bacterial contamination. This medicine may be prepared for use only by a trained healthcare professional who has carefully read the entire instruction.
Do not use the diluted solution if it is cloudy or contains precipitate.
To protect from light, the diluted solution in the infusion bottle (bag) should be placed inside a closed cover.
The vial is intended for single use only. Any unused prepared concentrate should be discarded immediately.

6. Contents of the pack and other information

What Micafungin Polpharma contains

• The active substance is micafungin (in the form of micafungin sodium). One vial contains 50 mg of micafungin (as micafungin sodium).
• Other ingredients are: monohydrate lactose, citric acid (for pH adjustment), sodium hydroxide (for pH adjustment).

What Micafungin Polpharma looks like and contents of the pack
Micafungin Polpharma 50 mg, powder for concentrate for solution for infusion, is a white or almost white powder.
Micafungin Polpharma is supplied in packs containing 1 vial.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Romania, country of export, and manufacturer:
S.C. Rompharm Company S.R.L.
Str. Eroilor, nr. 1A, Otopeni 075100, Jud. Ilfov
Romania

Parallel Importer:
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański

Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o.
ul. Długosza 49
51-162 Wrocław

Marketing Authorisation Number in Romania, country of export: 16162/2025/01
Parallel Import Licence Number: 342/25
[parallel importer logo]

Information intended exclusively for medical personnel or healthcare professionals:

Micafungin Polpharma must not be mixed or administered in the same intravenous infusion with other medicinal products, except those listed below. Under aseptic conditions and at room temperature, Micafungin Polpharma should be prepared as follows:

1. Remove the plastic cap from the vial and disinfect the stopper with alcohol.
2. Under aseptic conditions, slowly inject 5 mL of either sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose 50 mg/mL (5%) solution for infusion (drawn from a 100 mL bottle/bag) down the inner wall of each vial. Although foaming may occur, every effort should be made to minimize foam formation. To achieve the appropriate dose of the drug in mg, prepare the concentrate using the appropriate number of Micafungin Polpharma vials (see table below).
3. Gently rotate the vial. DO NOT SHAKE! The powder should dissolve completely. The prepared concentrate should be clear and colorless. The concentrate must be used immediately. The vial is intended for single use only. Any prepared but unused concentrate must be discarded immediately.
4. Transfer the entire volume of the prepared concentrate from the vials into the infusion bag (bottle) containing the infusion solution from which the original diluent was drawn. The diluted infusion solution should be administered immediately. The solution remains chemically and physically stable for 96 hours at 25°C when protected from light and diluted with sodium chloride 9 mg/mL (0.9%) solution for infusion, and for 48 hours at 25°C when protected from light and diluted with glucose 50 mg/mL (5%) solution for infusion.
5. Gently invert the infusion bag (bottle) to ensure thorough mixing of the diluted solution, and DO NOT SHAKE to avoid foaming. Do not administer the solution if it is cloudy or contains precipitate.
6. The infusion bag (bottle) containing the diluted solution should be placed in a closed light-protective packaging.

Preparation of infusion solution