Micafungin Zentiva

Package Leaflet: Information for the Patient

Micafungin Zentiva, 50 mg, Powder for Concentrate for Solution for Infusion

Micafungin Zentiva, 100 mg, Powder for Concentrate for Solution for Infusion

Micafungin

Read the package leaflet carefully before using the medicine, as it contains

important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Micafungin Zentiva and what is it used for
• 2. Important information before taking Micafungin Zentiva
• 3. How to take Micafungin Zentiva
• 4. Possible side effects
• 5. How to store Micafungin Zentiva
• 6. Contents of the pack and other information

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

Micafungin Zentiva contains the active substance micafungin. It is an antifungal medicine, used to treat infections caused by fungal cells. Micafungin Zentiva is used to treat fungal infections caused by yeast or fungi called Candida. Micafungin Zentiva is effective in treating systemic infections (those that have spread throughout the body). It works by interfering with the production of a component of the fungal cell wall. An intact cell wall is necessary for the normal development and growth of fungal cells. Micafungin Zentiva damages the cell wall, preventing further growth and development of the fungus. Your doctor will prescribe Micafungin Zentiva in the following cases, if no other suitable antifungal treatment is available (see section 2): treatment of adults, adolescents, and children, including newborns, with severe fungal infections called invasive candidiasis (an infection that penetrates the body); treatment of adults and adolescents aged 16 years and older with fungal infection of the esophagus, where intravenous administration is intended; prevention of Candidainfections in patients undergoing allogeneic hematopoietic stem cell transplantation or in patients who are expected to have neutropenia (reduced number of neutrophils, a type of white blood cell) lasting 10 days or more.

2. Important information before taking Micafungin Zentiva

When not to use Micafungin Zentiva

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

Warnings and precautions

Long-term treatment with micafungin in rats led to liver damage and subsequent liver tumors. The potential risk of liver tumor development in humans is unknown; your doctor will assess the benefits and risks of using Micafungin Zentiva before starting treatment. Tell your doctor if you have severe liver disease (e.g., liver failure or hepatitis) or if you have abnormal liver function test results. During treatment, liver function will be closely monitored. Before starting Micafungin Zentiva, discuss with your doctor or pharmacist if you have an allergy to any medicine; if you have hemolytic anemia (anemia caused by red blood cell destruction) or hemolysis (red blood cell destruction); if you have kidney disease (e.g., kidney failure or abnormal kidney function test results). In such cases, your doctor may order closer monitoring of kidney function. Micafungin Zentiva may cause severe skin and mucous membrane inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Micafungin Zentiva and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. It is especially important to tell your doctor about the use of amphotericin B, itraconazole (antifungal antibiotics), sirolimus (an immunosuppressive medicine), or nifedipine (a calcium antagonist used to treat high blood pressure). Your doctor may decide to adjust the dose of these medicines.

Micafungin Zentiva with food and drink

Since Micafungin Zentiva is administered intravenously (into a vein), there are no restrictions on taking the medicine with food and drink.

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 taking this medicine. Micafungin Zentiva should not be used during pregnancy unless your doctor considers it essential. During treatment with Micafungin Zentiva, do not breastfeed.

Driving and using machines

It is unlikely that Micafungin Zentiva will affect your ability to drive or use machines. However, some patients may experience dizziness while taking this medicine, and in such cases, you should not drive or use machines. Inform your doctor if you experience any effects that may interfere with driving or using machines.

Micafungin Zentiva contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per 1 ml, i.e., the medicine is considered "sodium-free".

3. How to take Micafungin Zentiva

Micafungin Zentiva must be prepared and administered by a doctor or other healthcare professional. Micafungin Zentiva should be administered once daily by slow intravenous infusion (into a vein). The daily dose of the medicine is determined by your doctor.

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

In the treatment of invasive Candidainfection, a dose of 100 mg per day is usually used for patients with a body weight greater than 40 kg, and 2 mg/kg body weight per day for patients with a body weight of 40 kg or less. In the treatment of Candidaesophagitis, the daily dose is 150 mg for patients with a body weight greater than 40 kg, and 3 mg/kg body weight per day for patients with a body weight of 40 kg or less. In the prevention of invasive Candidainfections, a dose of 50 mg per day is usually used for patients with a body weight greater than 40 kg, and 1 mg/kg body weight per day for patients with a body weight of 40 kg or less.

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

In the treatment of invasive Candidainfection, a dose of 100 mg per day is usually used for patients with a body weight greater than 40 kg, and 2 mg/kg body weight per day for patients with a body weight of 40 kg or less. In the prevention of invasive Candidainfections, a dose of 50 mg per day is usually used for patients with a body weight greater than 40 kg, and 1 mg/kg body weight per day for patients with a body weight of 40 kg or less.

Use in children and newborns under 4 months of age

In the treatment of invasive Candidainfection, a dose of 4 mg/kg body weight per day to 10 mg/kg body weight per day is usually used. In the prevention of invasive Candidainfections, a dose of 2 mg/kg body weight per day is usually used.

Use of a higher than recommended dose of Micafungin Zentiva

Your doctor will determine the correct dose of Micafungin Zentiva based on your response to treatment and your health condition. If you are unsure whether you have taken too much Micafungin Zentiva, contact your doctor or other healthcare professional immediately.

Missing a dose of Micafungin Zentiva

Your doctor will decide whether you need treatment with Micafungin Zentiva based on your response to treatment and your health condition. If you are unsure whether you have missed a dose of Micafungin Zentiva, contact your doctor or other healthcare professional immediately. If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Micafungin Zentiva can cause side effects, although not everybody gets them.

If you experience an allergic reaction or severe skin reaction (e.g., blistering and peeling of the skin)

Tell your doctor or nurse immediately. Micafungin Zentiva may cause the following other side effects: Common (may affect up to 1 in 10 people) abnormal blood test results (reduced white blood cell count [leukopenia; neutropenia]); reduced red blood cell count (anemia) reduced potassium levels in the blood (hypokalemia); reduced magnesium levels in the blood (hypomagnesemia); reduced calcium levels in the blood (hypocalcemia) headache inflammation of the vein wall (at the injection site) nausea (feeling sick); vomiting; diarrhea; abdominal pain abnormal liver function test results (increased alkaline phosphatase, increased aspartate aminotransferase, increased alanine aminotransferase) increased bilirubin levels in the blood (hyperbilirubinemia) rash fever chills Uncommon (may affect up to 1 in 100 people) abnormal blood test results (reduced blood cell count [pancytopenia]); reduced platelet count (thrombocytopenia); increased eosinophil count; reduced albumin levels in the blood (hypoalbuminemia) hypersensitivity increased sweating reduced sodium levels in the blood (hyponatremia); increased potassium levels in the blood (hyperkalemia); reduced phosphate levels in the blood (hypophosphatemia); anorexia (loss of appetite) insomnia (sleeping problems); anxiety; confusion drowsiness (drowsiness); tremors; dizziness increased heart rate; stronger heartbeat; irregular heartbeat high or low blood pressure flushing shortness of breath constipation liver failure; increased liver enzyme activity (gamma-glutamyltransferase); jaundice (yellowing of the skin or whites of the eyes due to liver or blood disorders); bile duct obstruction; liver enlargement; hepatitis itching rash (hives); itching; skin redness (erythema) abnormal kidney function test results (increased creatinine levels in the blood; increased urea levels in the blood); worsening kidney failure increased activity of an enzyme called lactate dehydrogenase vein thrombosis at the injection site; inflammation at the injection site; pain at the injection site; fluid retention Rare (may affect up to 1 in 1,000 people) hemolytic anemia (anemia caused by red blood cell destruction); red blood cell destruction (hemolysis) Unknown (frequency cannot be estimated from the available data) blood clotting disorder anaphylactic shock (allergic shock) liver cell damage, including fatal cases kidney problems; acute kidney failure.

Additional side effects in children and adolescents

The following reactions were observed more frequently in pediatric patients than in adult patients: Common (may affect up to 1 in 10 people) reduced platelet count (thrombocytopenia) increased heart rate (tachycardia) high or low blood pressure increased bilirubin levels in the blood (hyperbilirubinemia); liver enlargement acute kidney failure; increased urea levels in the blood

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Micafungin Zentiva

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the vial and carton after EXP. The expiry date refers to the last day of that month. Closed vials do not require special storage conditions. The reconstituted concentrate and diluted infusion solution should be used immediately, as they do not contain any preservatives to prevent bacterial contamination. This medicine can only be prepared for use by a trained healthcare professional after carefully reading the instructions. Do not use the diluted solution if it is cloudy or contains precipitate. To protect from light, the infusion bag (container) should be placed in a closed, non-transparent cover. The vial is for single use only. Any unused reconstituted concentrate should be discarded immediately.

6. Contents of the pack and other information

What Micafungin Zentiva contains

• The active substance is micafungin (as sodium salt). Each vial contains 50 mg or 100 mg of micafungin (as sodium salt).
• The other ingredients are lactose monohydrate, citric acid, and sodium hydroxide.

What Micafungin Zentiva looks like and contents of the pack

Micafungin Zentiva 50 mg or 100 mg, powder for concentrate for solution for infusion, is a white or off-white, lyophilized powder. Micafungin Zentiva is available in packs containing 1 vial.

Marketing authorization holder

Zentiva k.s. U Kabelovny 130 Dolni Měcholupy 102 37 Prague 10 Czech Republic

Manufacturer

LABORATORI FUNDACIÓ DAU C/C, 12-14 Pol. Ind. Zona Franca 08040 Barcelona Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Iceland, Poland Micafungin Zentiva

For further information about this medicine, contact the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o. ul. Bonifraterska 17 00-203 Warsaw tel: +48 22 375 92 00

Date of last revision of the package leaflet:

Information intended for healthcare professionals only:

Micafungin Zentiva should not be mixed or infused with other medicinal products, except for those listed below. In aseptic conditions and at room temperature, Micafungin Zentiva should be prepared as follows: 1. Remove the plastic cap from the vial and disinfect the rubber stopper with alcohol. 2. In 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) into each vial. Although the concentrate will foam, make every effort to minimize the amount of foam formed. To achieve the correct dose of the medicine in mg, prepare the concentrate using the appropriate number of Micafungin Zentiva vials (see the table below). 3. Gently rotate the vial along its longer axis. DO NOT SHAKE! The powder will dissolve completely. The reconstituted concentrate should be used immediately. The vial is for single use only. Any unused reconstituted concentrate should be discarded immediately. 4. Transfer the entire contents of the reconstituted concentrate from each vial to an infusion bag (container) from which the infusion solution was initially taken. The diluted infusion solution should be administered immediately. The reconstituted solution remains chemically and physically stable for 96 hours at 25°C, provided it is protected from light and diluted according to the instructions above. 5. Gently turn the infusion bag (container) to ensure thorough mixing of the diluted solution and DO NOT SHAKE, to avoid foaming. The solution should not be administered if it is cloudy or contains precipitate. 6. Place the infusion bag (container) in a closed, non-transparent cover to protect it from light. 7. Only use a clear and colorless solution without particles.

Preparation of the infusion solution

Standard infusion solution (after dilution to

100 ml)

Final concentration

50 1 x 50 5 ml approximately 5 ml (10 mg/ml) 0.5 mg/ml 100 1 x 100 5 ml approximately 5 ml (20 mg/ml) 1.0 mg/ml 150 1 x 100 + 1 x 50 5 ml approximately 10 ml 1.5 mg/ml 200 2 x 100 5 ml approximately 10 ml 2.0 mg/ml After reconstitution and dilution, the solution should be administered by intravenous infusion over approximately 1 hour.

Dose (mg)

Number of Micafungin Zentiva vials to use

Micafungin Zentiva (mg/vial)

Volume of sodium chloride (0.9%) or glucose (5%) solution to add to the vial

to be added to the vial

Volume (concentration) of the reconstituted powder