Prospecto: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 this prospect carefully before starting to take this medicine,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult yourdoctororpharmacist.
• If you experience any adverse effects,consult your doctor or pharmacist,evenifthey are not listed in this prospect. See section 4.

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

2.What you need to knowbeforestarting touse Micafungina Sandoz

3.How to use Micafungina Sandoz

4.Possible adverse effects

5Storage of Micafungina Sandoz

6.Contents of the package and additional information

Micafungina Sandoz contains the active ingredient micafungin. Micafungin is an antifungal medication as it is used to treat infections caused by fungal cells.

This medication is used to treat fungal infections caused by fungal cells or yeasts calledCandida. Micafungin is effective in the treatment of systemic infections (those that have penetrated the body). It interferes with the production of a part of the fungal cell wall.

When there is no other available antifungal treatment, 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 in which it is appropriate to apply the treatment intravenously.

-To preventCandidainfection in patients undergoing a bone marrow transplant or who are expected to have neutropenia (low levels of neutrophils, a type of white blood cell) for 10 days or more.

No use Micafungina Sandoz

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Micafungina Sandoz:

-if you are allergic to any medication

-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 may also cause severe inflammation/eruption of the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Use of Micafungina Sandoz with other medications

Inform your doctor or pharmacist if you areusing, haveusedrecentlyor may have to use any other medication.

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

Use of Micafungina Sandoz with food and drinks

Since this medication is administered intravenously (into the vein), there are no restrictions regarding food or drinks.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Micafungina should not be used during pregnancy unless strictly necessary. If you use micafungina, do not breastfeed.

Driving and operating machinery

It is unlikely that micafungina will have any effect on your ability to drive or operate machinery. However, some people may feel dizzy when taking this medication, and if this happens to you, do not drive or operate any machinery or tools. Please inform your doctor if you experience any effect that may cause you problems driving or operating machinery.

Micafungina Sandoz contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per dose; that is, it is essentially “sodium-free”.

Micafungin Sandoz must be prepared and administered by a doctor or other healthcare professional. Micafungin Sandoz must be administered by slow intravenous infusion (into a vein), once a day. Your doctor will determine the daily dose of micafungin that you will receive.

Use in adults, adolescents ≥ 16 years and elderly patients

-The usual dose for treating an invasive infection byCandidais 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 an esophageal infection byCandidais 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 infections byCandidais 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

-The usual dose for treating an invasive infection byCandidais 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 infections byCandidais 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 newborns <4 months of age

-The usual dose for treating an invasive infection byCandidais 4 to 10 mg/kg per day.

-The usual dose for preventing invasive infections byCandidais 2 mg/kg per day.

If you receive more Micafungin Sandoz than you should

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

If you miss your dose of Micafungin Sandoz

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

If you have any other questions about the use of thismedication, ask your doctororpharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Micafungina may cause these other side effects:

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

-Abnormal results in blood tests (reduction in the number of white blood cells [leucopenia, 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,

-Phlebitis (inflammation in the vein wall) (at the injection site),

-Nausea (discomfort), vomiting, diarrhea, abdominal pain,

-Abnormal results in liver tests (increase in alkaline phosphatase, increase in aspartate aminotransferase, increase in alanine aminotransferase),

-Increased bilirubin in the blood (hyperbilirubinemia),

-Rash,

-Fever,

-Chills.

Less frequent (may affect up to 1 in 100 people):

-Abnormal results in blood tests (reduction in the number of blood cells [pancytopenia]), reduction in the number of platelets (thrombocytopenia), increase in the number of a type of white blood cell called eosinophils, reduction in 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,

-Somnolence (drowsiness), tremors, dizziness, alteration of taste,

-Increased heart rate, stronger heartbeat, irregular heartbeat,

-High or low blood pressure, skin redness,

-Difficulty breathing,

-Indigestion, constipation,

-Liver insufficiency, increase of liver enzymes (gamma-glutamyltransferase), jaundice (the skin or the white part of the eyes turns yellow due to liver or blood problems), reduction of bile that reaches the intestine (cholestasis), enlargement of the liver, liver inflammation,

-Rash with itching (urticaria), pruritus, skin redness (erythema),

-Abnormal results of renal function tests (increase of creatinine in the blood, increase of urea in the blood), worsening of renal insufficiency,

-Increased lactate dehydrogenase enzyme,

-Formation of clots at the injection site, inflammation at the injection site, pain at the injection site, accumulation of fluid 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 (the frequency cannot be estimated from the available data):

-Blood clotting disorders,

-Shock (allergic),

-Liver cell damage including death,

-Renal alterations, acute renal insufficiency.

Other side effects in children and adolescents

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

Frequent (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), enlargement of the liver,

-Acute renal insufficiency, increase of urea in the blood.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the vialand onthe packaging. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it 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 must be used immediately, as they do not contain preservatives to prevent bacterial contamination. Only a properly trained healthcare professional who has read the instructions correctly can prepare this medication for use.

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

To protect the diluted solution for infusion from light, the bottle or bag must be introduced into an opaque bag with a seal.

The vial has a single use. Therefore, the unused reconstituted concentrate must be discarded immediately.

Composition of Micafungin Sandoz

• The active ingredient is micafungin (as sodium salt).Each vialcontains 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 contents of the pack

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 glass vial of 10 ml (type I)with a grey butyl-rubber stopper and an aluminium cap 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 authorisation holder and manufacturer responsible

Marketing authorisation holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer responsible

BAG Health Care GmbH

Amtsgerichtsstrasse 1 - 5

35423 Lich, Hessen

Germany

or

Galenicum Health, S.L.

Avda.Cornellá 144, 7º-1ª, Edificio Lekla

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 authorised in the Member States of the European Economic Area with the following names:

Last update of the summary of product characteristics:June 2020.

Other sources of information

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely 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%) for infusion or glucose 50 mg/ml (5%) for infusion (taken from a 100 ml bottle) must be slowly and aseptically injected into each vial along the inner wall.
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 only. Therefore, the unused reconstituted concentrate must be discarded immediately.
4. The entire reconstituted concentrate must be removed from each vial and returned to the infusion bottle from which it was taken initially. The diluted infusion solution 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 carried out as described above.
5. The infusion bottle 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 infusion bottle containing the diluted infusion solution must be introduced into an opaque bag with a seal to protect it from light.

Preparation of the infusion solution