Micafungin polpharma

Package leaflet: Information for the patient

Warning! Keep the leaflet; the information on the immediate packaging is in a foreign language.
Micafungin Polpharma (Micafungin Rompharm)
100 mg, powder for solution for infusion concentrate
Micafunginum
Micafungin Polpharma and Micafungin Rompharm are different trade names of the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Micafungin Polpharma is and what it is used for
2. Important information 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 called 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 into 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 cell wall, thereby preventing further development and growth of fungi.

Your doctor may prescribe Micafungin Polpharma in the following situations, when no other appropriate antifungal treatment is available (see section 2):

• Treatment of adults, adolescents, and children, including newborns, with a serious fungal infection called invasive candidiasis (an infection that invades the body);
• Treatment of adults and adolescents aged ≥ 16 years with fungal infection of the oesophagus (oesophageal candidiasis) requiring intravenous administration (intravenous therapy);
• Prevention of Candida-induced infections in patients undergoing allogeneic haematopoietic stem cell transplantation or in patients expected to develop neutropenia (reduction in neutrophil count; 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 doctor will assess 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 monitored more closely during treatment.
Before starting treatment with Micafungin Polpharma, please 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 a severe inflammatory reaction/skin rash and mucosal lesions (Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome)).

Micafungin Polpharma with other medicines
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 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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Micafungin Polpharma must not be used during pregnancy unless considered absolutely necessary by the doctor. Breastfeeding must not be undertaken during treatment with Micafungin Polpharma.

Driving and using machines
It is unlikely that micafungin will affect the ability to drive or operate machinery. However, dizziness may occur in some patients while receiving the medicine, and in such cases, the patient should not drive or operate machinery. Inform your doctor if any side effects occur that may impair the ability to drive or operate machinery.

Micafungin Polpharma contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. the 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 as a slow intravenous infusion (into a vein).
The daily dose of Micafungin Polpharma is determined by the treating physician.

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

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

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

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

Use in children and neonates aged <\ 4\ months

• For treatment of invasive Candida infections, the usual dose ranges from 4 mg/kg 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 doctor will decide on the need for continued treatment with Micafungin Polpharma 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 (decreased white blood cell count (leukopenia; neutropenia)); decreased red blood cell count (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 tests (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 (decreased blood cell count (pancytopenia)); decreased 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 tests (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 destruction of red blood cells (hemolytic anemia), breakdown of red blood cells (hemolysis)

Unknown (frequency cannot be estimated from available data)

• blood clotting disorders
• 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)

• decreased 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 sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Closed vial
Store below 25°C.
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 trained healthcare personnel after carefully reading the entire instruction.
Do not use the diluted solution if it is cloudy or contains precipitate.
To protect from light, the bottle (bag) containing the diluted solution should be placed inside a closed cover.
The vial is intended for single use only. Any unused, prepared concentrate should be immediately discarded.

6. Contents of the pack and other information

What Micafungin Polpharma contains

• The active substance is micafungin (as micafungin sodium). One vial contains 100 mg of micafungin (as micafungin sodium).
• The other components 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 100 mg, powder for concentrate for solution for infusion, is a lyophilized solid or a white or almost white powder.
Micafungin Polpharma is supplied in packs containing 1 vial.
For more detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing authorization holder in Romania, country of export, and manufacturer:
S.C. Rompharm Company S.R.L.
Str. Eroilor, No. 1A, Otopeni 075100, Jud. Ilfov
Romania
Parallel importer:
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska 19
83-200 Starogard Gdański
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warsaw
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o.
Długosza 49
51-162 Wrocław
Marketing authorization number in Romania, country of export: 16163/2025/01
Parallel import authorization number: 336/25
[parallel importer's logo]

Information intended exclusively for medical or healthcare personnel:

Micafungin Polpharma must not be mixed or administered simultaneously in the same 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 rubber stopper with alcohol.
2. Under aseptic conditions, slowly inject 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) down the inner wall of each vial. Although foaming may occur, every effort should be made to minimize foam formation. To achieve the correct dose 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 resulting concentrate should be clear and colorless. The concentrate must be used immediately. The vial is 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 initial 5 mL was withdrawn. 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 a precipitate.
6. Place the bag (bottle) containing the diluted solution into a closed, light-protective packaging.

Preparation of infusion solution