MICAFUNGINA SANDOZ 100 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet:information for the user

Micafungina Sandoz 50 mg powder for concentrate for solution for infusion EFG

Micafungina Sandoz 100 mg powder for concentrate for solution for infusion EFG

Read all of this leaflet carefully before you start taking this medicine,because it contains important information for you.

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

Contents of the pack

1. What Micafungina Sandoz is and what it is used for
2. What you need to know before you use Micafungina Sandoz
3. How to use Micafungina Sandoz
4. Possible side effects

5 Storage of Micafungina Sandoz

1. Contents of the pack and other information

1. What Micafungina Sandoz is and what it is used for

Micafungina Sandoz contains the active substance micafungin. Micafungin is an antifungal medicine used to treat infections caused by fungal cells.

This medicine is used to treat fungal infections caused by fungal cells or yeasts called Candida. Micafungin is effective in treating systemic infections (those that have penetrated the body). It interferes with the production of a part of the fungal cell wall. The fungus needs an intact cell wall to live and grow. Micafungin causes the formation of defects in the fungal cell wall, preventing the fungus from growing and living.

When no other antifungal treatment is available, your doctor will prescribe micafungin 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 where intravenous treatment is appropriate.
• To prevent Candidainfection in patients undergoing bone marrow transplantation or who are expected to have neutropenia (low levels of neutrophils, a type of white blood cell) for 10 days or more.

2. What you need to know before you use Micafungina Sandoz

Do not use Micafungina Sandoz

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

Warnings and precautions

Consult your doctor or pharmacist before starting Micafungina Sandoz:

• if you are allergic to any medicine
• 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 can also cause severe skin and mucous membrane inflammation/eruption (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Using Micafungina Sandoz with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

It is especially important to inform your doctor if you are using amphotericin B desoxycholate or itraconazole (antifungal antibiotics), sirolimus (an immunosuppressant), or nifedipine (a calcium channel blocker used to treat high blood pressure). Your doctor may decide to adjust the dose of these medicines.

Using Micafungina Sandoz with food and drinks

Since this medicine is administered intravenously (in the vein), there are no restrictions on food or drinks.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Micafungin should not be used during pregnancy unless strictly necessary. If you use micafungin, you should not breast-feed.

Driving and using machines

It is unlikely that micafungin will affect your ability to drive or use machines. However, some people may feel dizzy when taking this medicine, and if this happens to you, do not drive or use any machine or tool. Please inform your doctor if you experience any effect that may cause problems with driving or using machinery.

Micafungina Sandoz contains sodium

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

3. How to use Micafungina Sandoz

Micafungina Sandoz should be prepared and administered by a doctor or other healthcare professional. Micafungina Sandoz should be administered by slow intravenous infusion (in the vein), once a day. Your doctor will determine the dose of micafungin you will receive each day.

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

• The usual dose for treating invasive Candidainfection is 100 mg per day for patients weighing 40 kg or more and 2 mg/kg per day for patients weighing 40 kg or less.
• The dose for treating esophageal Candidainfection 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 Candidainfections 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 > 4 months of age and adolescents <16 years< strong>

• The usual dose for treating invasive Candidainfection is 100 mg per day for patients weighing 40 kg or more and 2 mg/kg per day for patients weighing 40 kg or less.
• The usual dose for preventing invasive Candidainfections 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 infants <4 months of age< strong>

• The usual dose for treating invasive Candidainfection is 4 to 10 mg/kg per day.
• The usual dose for preventing invasive Candidainfections is 2 mg/kg per day.

If you receive more Micafungina Sandoz than you should

Your doctor will monitor your response and the condition of your disease to determine the necessary dose of Micafungina Sandoz. However, if you are concerned that you have received too much of this medicine, consult your doctor, another healthcare professional, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount received.

If you miss a dose of Micafungina Sandoz

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Micafungina can cause these other side effects:

Common (may affect up to 1 in 10 people):

• abnormal blood test results (reduction in the number of white blood cells [leukopenia, 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 of the vein wall (at the injection site),
• nausea (discomfort), vomiting, diarrhea, abdominal pain,
• abnormal liver function tests (increased alkaline phosphatase, increased aspartate aminotransferase, increased alanine aminotransferase),
• increased bilirubin in the blood (hyperbilirubinemia),
• rash,
• fever,
• chills.

Uncommon (may affect up to 1 in 100 people):

• abnormal blood test results (reduction in the number of blood cells [pancytopenia]), reduction in the number of platelets (thrombocytopenia), increase in the number of a certain type of white blood cells called eosinophils, reduction of albumin in the blood (hypoalbuminemia),
• hypersensitivity,
• increased sweating,
• reduction of sodium in the blood (hyponatremia), increase of potassium in the blood (hyperkalemia), reduction of phosphates in the blood (hypophosphatemia), anorexia (eating disorder),
• insomnia (difficulty sleeping), anxiety, confusion,
• drowsiness (somnolence), tremors, dizziness, alteration of taste,
• increased heart rate, stronger heartbeat, irregular heartbeat,
• high or low blood pressure, flushing of the skin,
• difficulty breathing,
• indigestion, constipation,
• liver failure, increased liver enzymes (gamma-glutamyltransferase), jaundice (the skin or the white part of the eyes turn yellow due to liver or blood problems), reduction of bile that reaches the intestine (cholestasis), increased liver size, liver inflammation,
• urticaria (hives), pruritus, skin redness (erythema),
• abnormal kidney function tests (increased creatinine in the blood, increased urea in the blood), worsening of kidney failure,
• increase of an enzyme called lactate dehydrogenase,
• clot formation at the injection site, inflammation at the injection site, pain at the injection site, fluid accumulation 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).

Not known (frequency cannot be estimated from the available data):

• blood coagulation disorders,
• allergic shock,
• liver cell damage including death,
• kidney damage, acute kidney failure.

Other side effects in children and adolescents

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

Common (may affect up to 1 in 10 people):

• reduction of platelets in the blood (thrombocytopenia),
• increased heart rate (tachycardia),
• high or low blood pressure,
• increased bilirubin in the blood (hyperbilirubinemia), increased liver size,
• acute kidney failure, increased urea in the blood.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Micafungina Sandoz

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

Do not use this medicine after the expiry date which is stated on the vial and the carton. The expiry date is the last day of the month stated.

Store in the original package to protect from light. The product can withstand direct exposure to light for up to 60 days (2 months).

The reconstituted concentrate and the diluted solution for infusion should be used immediately, as it does not contain preservatives to prevent bacterial contamination. Only a healthcare professional who has read the instructions completely and correctly can prepare this medicine for use.

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

To protect the vial or bag containing the diluted solution for infusion from light, it should be placed in an opaque bag with a seal.

The vial is for single use only. Therefore, any unused reconstituted concentrate should be discarded immediately.

6. Container Contents and Additional Information

Composition of Micafungin Sandoz

• The active ingredient is micafungin (as sodium salt). Each vial contains 50 mg or 100 mg of micafungin (as sodium salt).
• The other components are lactose monohydrate, anhydrous citric acid (for pH adjustment), and sodium hydroxide (for pH adjustment) (see section 2).

Appearance of the Product and Container Contents

Micafungin Sandoz 50 mg or 100 mg powder for concentrate for solution for infusion is a white to off-white lyophilized powder.

Micafungin Sandoz is supplied in a box containing 1 transparent glass vial of 10 ml (type I) with a gray isobutylene-isoprene rubber stopper and an aluminum seal with a blue plastic flip-off cap for Micafungin Sandoz 50 mg and a red plastic flip-off cap for Micafungin Sandoz 100 mg. The vial is sealed with a UV protective film.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

BAG Health Care GmbH

Amtsgerichtsstrasse 1 - 5

35423 Lich, Hessen

Germany

or

Galenicum Health, S.L.U

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

Spain

or

SAG MANUFACTURING, S.L.U.

Ctra. N-I, km 36

28750 San Agustín del Guadalix

Madrid – Spain

or

Lek Pharmaceuticals d.d.

Verovskova ulica 57

1526 Ljubljana

Slovenia

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

Date of the Last Revision of this Leaflet:June 2020.

Other Sources of Information

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

Instructions for Use and Handling (see also section 3. How to Use Micafungin Sandoz)

Micafungin Sandoz is reconstituted and diluted as follows:

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%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion (taken from a 100 ml bottle/bag) must be slowly and aseptically injected into each vial along the inner wall. Although the concentrate will foam, special care must be taken to minimize the amount of foam generated. A sufficient number of micafungin vials must be reconstituted to obtain the required dose in mg (see the table below).
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, any unused reconstituted concentrate must be discarded immediately.
4. All the reconstituted concentrate must be withdrawn from each vial and returned to the infusion bottle/bag from which it was initially taken. The diluted solution for infusion must be used immediately. Chemical and physical stability has been demonstrated for 24 hours when stored at 25 °C, provided it is protected from light and the dilution is performed as described above.
5. The infusion bottle/bag must be carefully inverted to disperse the diluted solution but MUST NOT be shaken to avoid foam formation. The solution must not be used if it is turbid or if a precipitate has formed.
6. The bottle/bag containing the diluted solution for infusion must be placed in an opaque bag with a seal to protect it from light.

Preparation of the Solution for Infusion