Micafungin Reig Iofre

Leaflet accompanying the packaging: information for the user

Micafungin Reig Jofre, 50 mg, powder for concentrate for solution for infusion

Micafungin Reig Jofre, 100 mg, powder for concentrate for solution for infusion

Micafungin

Read the 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 or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Micafungin Reig Jofre and what is it used for
• 2. Important information before using Micafungin Reig Jofre
• 3. How to use Micafungin Reig Jofre
• 4. Possible side effects
• 5. How to store Micafungin Reig Jofre
• 6. Contents of the packaging and other information

1. What is Micafungin Reig Jofre and what is it used for

Micafungin Reig Jofre contains the active substance micafungin. Micafungin Reig Jofre is called an antifungal medicine because it is used to treat infections caused by fungal cells. Micafungin Reig Jofre is used to treat fungal infections caused by fungal cells or yeast called Candida. Micafungin Reig Jofre is effective in treating systemic infections (those that have entered the body). It affects the process of creating a component of the fungal cell wall. An intact cell wall is necessary for the proper development and growth of fungal cells. Micafungin Reig Jofre damages the cell wall, preventing further development and growth of fungi. Your doctor will prescribe Micafungin Reig Jofre 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 infection called invasive candidiasis (generalized body infection);
• Treatment of adults and adolescents over 16 years of age with fungal infection of the esophagus, where it is intended to administer the medicine intravenously (intravenous treatment);
• Prevention of Candidainfections in patients undergoing allogeneic hematopoietic stem cell transplantation or in patients who are expected to develop neutropenia (decrease in the number of neutrophils; a type of white blood cell) lasting 10 or more days.

2. Important information before using Micafungin Reig Jofre

When not to use Micafungin Reig Jofre

Ecaltaor 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, consequently, to liver tumors. The potential risk of developing liver tumors in humans is not known. Before starting treatment, your doctor will assess the benefits and risks of using Micafungin Reig Jofre. You should tell your doctor if you have severe liver disease (e.g., liver failure or hepatitis) or if abnormal liver function test results have been found. During treatment, liver function will be closely monitored. Before starting Micafungin Reig Jofre, discuss this with your doctor or pharmacist.

Micafungin may also cause severe inflammation and (or) skin and mucous membrane rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Micafungin Reig Jofre and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. It is especially important to tell your doctor about the use of amphotericin B deoxycholate or 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 Reig Jofre with food and drink

Since Micafungin Reig Jofre 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 plan to have a child, ask your doctor or pharmacist for advice before taking this medicine. Micafungin Reig Jofre should not be used during pregnancy unless it is absolutely necessary. During treatment with Micafungin Reig Jofre, do not breastfeed.

Driving and using machines

It is unlikely that micafungin will affect your ability to drive or use machines. However, some people may experience dizziness while taking this medicine, and if this happens, do not drive or operate any machinery. Tell your doctor if you experience any symptoms that may cause difficulties in driving or operating machines.

Micafungin Reig Jofre contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to use Micafungin Reig Jofre

Micafungin Reig Jofre must be prepared and administered by a doctor or other medical personnel. Micafungin Reig Jofre should be administered once a day in a slow intravenous infusion (into a vein). The daily dose of the medicine is determined by your doctor.

Use in adults, adolescents over 16 years of age, and the elderly

• In the treatment of invasive Candidainfection, a dose of 100 mg per day is usually used for patients with a body weight over 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 Candidaesophageal infection, the daily dose is 150 mg for patients with a body weight over 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 over 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 over 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 over 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 Reig Jofre

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

Missing a dose of Micafungin Reig Jofre

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

4. Possible side effects

Like all medicines, Micafungin Reig Jofre can cause side effects, although not everybody gets them. If you experience an allergic reaction or a severe skin reaction (e.g., blistering and peeling of the skin), tell your doctor or nurse immediately. Micafungin Reig Jofre may cause other side effects:

Frequently (may occur in less than 1 in 10 people)

• abnormal blood test results (decrease in the number of white blood cells [leukopenia; neutropenia]); decrease in the number of red blood cells (anemia)
• decrease in potassium levels in the blood (hypokalemia); decrease in magnesium levels in the blood (hypomagnesemia); decrease in calcium levels in the blood (hypocalcemia)
• headache
• inflammation of the vein wall (at the injection site)
• nausea (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

Infrequently (may occur in less than 1 in 100 people)

• abnormal blood test results (decrease in the number of blood cells [pancytopenia]); decrease in the number of platelets (thrombocytopenia); increase in the number of a certain type of white blood cells called eosinophils; decrease in albumin levels in the blood (hypoalbuminemia)
• hypersensitivity
• increased sweating
• decrease in sodium levels in the blood (hyponatremia); increase in potassium levels in the blood (hyperkalemia); decrease in phosphate levels in the blood (hypophosphatemia); anorexia (eating disorders)
• insomnia (sleep problems); anxiety; disorientation
• drowsiness (drowsiness); tremors; dizziness; taste disorders
• rapid heartbeat; stronger heartbeat; irregular heartbeat
• high or low blood pressure; flushing
• shortness of breath
• indigestion; constipation
• liver failure; increased activity of liver enzymes (gamma-glutamyltransferase); jaundice (yellowing of the skin or whites of the eyes due to liver or blood disorders); decreased bile secretion into the intestine (cholestasis); liver enlargement; hepatitis
• itchy rash (hives); itching; skin redness (flushing)
• abnormal kidney function test results (increased creatinine levels in the blood; increased urea levels in the blood); worsening of kidney failure
• increased activity of the enzyme called lactate dehydrogenase
• vein thrombosis at the injection site; inflammation at the injection site; pain at the injection site; fluid retention in the body

Rarely (may occur in less than 1 in 1,000 people)

• anemia caused by red blood cell breakdown (hemolytic anemia); red blood cell breakdown (hemolysis)

Unknown frequency (cannot be estimated from the available data)

• coagulation disorders
• anaphylactic shock
• liver cell damage, which can also lead to death
• kidney disease; acute kidney failure

Additional side effects occurring in children and adolescents

The following reactions were observed more frequently in children and adolescents than in adult patients:

Frequently (may occur in less than 1 in 10 patients)

• decrease in the number of platelets (thrombocytopenia)
• rapid heartbeat (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 or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring 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 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 Reig Jofre

Keep the medicine out of the sight and reach of children. Do not use Micafungin Reig Jofre after the expiry date stated on the vial and carton. The expiry date refers to the last day of the month. Closed vials do not require special storage conditions. The prepared concentrate and diluted solution for infusion should be administered immediately, as the medicine does not contain any preservatives to protect against bacterial contamination. This medicine can only be prepared for use by trained, professional medical personnel after carefully reading the entire instructions. Do not use the diluted solution for infusion if it is cloudy or has precipitated. To protect from light, the bottle (bag) containing the diluted solution for infusion should be placed in a closed, non-transparent package. The vial is for single use only. Therefore, any prepared, unused concentrate should be discarded immediately.

6. Contents of the packaging and other information

What Micafungin Reig Jofre contains

• The active substance of the medicine is micafungin (as micafungin sodium). One vial contains 50 mg or 100 mg of micafungin (as micafungin sodium).
• The other ingredients are: lactose monohydrate, citric acid (to adjust pH), and sodium hydroxide (to adjust pH).

What Micafungin Reig Jofre looks like and contents of the packaging

Micafungin Reig Jofre, 50 mg or 100 mg, is a white or off-white powder for concentrate for solution for infusion. Micafungin Reig Jofre is supplied in a carton containing 1 vial.

Marketing authorization holder

Reig Jofre Sp. z o.o. ul. Ostródzka 74N 03-289 Warsaw e-mail: [email protected] Phone: +48 22 487 88 49 (logo of the marketing authorization holder)

Manufacturer

Laboratorio Reig Jofré S.A. C/Gran Capitán 10 Sant Joan Despí 08970 Barcelona Spain

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

France: Micafungine Reig Jofre 50 mg, powder for solution for infusion Micafungine Reig Jofre 100 mg, powder for solution for infusion Spain: Micafungina Sala 50 mg powder for concentrate for solution for infusion EFG Micafungina Sala 100 mg powder for concentrate for solution for infusion EFG Poland: Micafungin Reig Jofre 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 Sweden: Micafungin Bioglan 50 mg powder for concentrate for solution for infusion, solution Micafungin Bioglan 100 mg powder for concentrate for solution for infusion, solution Italy: Micafungin Reig Jofre

Date of last revision of the leaflet:

Detailed information about this medicine can be found on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products https://urpl.gov.pl/pl Information intended for healthcare professionals only: Micafungin Reig Jofre should not be mixed or administered in intravenous infusion simultaneously with other medicinal products, except for those listed below. Under aseptic conditions and at room temperature, Micafungin Reig Jofre 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 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 obtain the correct dose of Micafungin Reig Jofre in mg, prepare the concentrate using the appropriate number of vials (see table below).
• 3. Gently rotate the vial. DO NOT SHAKE! The powder will dissolve completely. The prepared concentrate should be used immediately. The vial is for single use only. Therefore, any prepared, unused concentrate should be discarded immediately.
• 4. Transfer the entire contents of the prepared concentrate from the vials to the infusion solution bottle (bag) from which the solution was initially taken. The diluted solution for infusion should be administered immediately. The prepared solution is chemically and physically stable for 96 hours at 25°C and for 24 hours at a temperature between 2°C and 8°C, if protected from light and diluted according to the instructions above.
• 5. Gently turn the infusion solution bottle (bag) 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 precipitated sediment.
• 6. Place the infusion solution bottle (bag) with the diluted solution in a closed, non-transparent package to protect it from light.

Preparation of the infusion solution