Leaflet: information for the user

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

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

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

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

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

Micafungina Teva is used to treat fungal infections caused by fungal cells or yeasts called Candida.

Micafungina Teva is effective in the treatment of systemic infections (those that have penetrated inside the body). It interferes with the production of a part of the fungal cell wall. An intact cell wall is necessary for fungi to continue growing and living. Micafungina Teva causes defects in the fungal cell wall, preventing the fungus from growing and living.

Your doctor has prescribed Micafungina Teva when no other antifungal treatment is available in the following circumstances (see section 2):

• For treating adults, adolescents, and children including newborns who have a severe fungal infection called invasive candidiasis (an infection that has penetrated the body).
• For treating adults and adolescents ≥ 16 years with a fungal infection in the throat (esophagus) where intravenous (venous) treatment is appropriate.
• For preventing Candida infections in patients who are receiving 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.

Do not use Micafungina Teva

• if you are allergic to micafungina, other echinocandins (Ecalta or Cancidas) or to some of the other components of this medication (listed in section 6).

Warnings and precautions

In rats, long-term treatment with micafungina produced liver damage and subsequent liver tumors. The potential risk of developing liver tumors in humans is unknown; and your doctor will advise you on the benefits and risks of treatment with Micafungina Teva before starting to use it. You should inform your doctor if you have severe liver problems (e.g., liver failure or hepatitis) or have had abnormal liver function tests. Your liver function will be closely monitored during treatment.

Consult your doctor or pharmacist before starting to use Micafungina Teva

• if you are allergic to any medication
• if you have hemolytic anemia (anemia due to red blood cell rupture) or hemolysis (red blood cell rupture)
• if you have kidney problems (e.g., kidney failure or abnormal kidney function tests). If this occurs, your doctor may decide to closely monitor your kidney function.

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

Other medications and Micafungina Teva

Inform your doctor or pharmacist if you are taking, have recently taken or may need to take 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 high blood pressure). Your doctor may decide to adjust the dose of these medications.

Micafungina Teva with food and drinks

Since Micafungina Teva is administered intravenously (into a vein), there are no restrictions on 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 before using this medication.

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

Driving and operating machines

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

Micafungina Teva contains sodium

Micafungina Teva contains less than 23 mg of sodium (1 mmol) per vial; this is essentially "sodium-free".

Micafungina Teva must be prepared and administered by a doctor or other healthcare professional. This medication should be administered once a day by slow intravenous infusion (into the vein). Your doctor will determine how much micafungina you will receive each day.

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

• The usual dose to treat invasive Candida infection is 100 mg per day for patients weighing more than 40 kg and 2 mg/kg per day for patients weighing 40 kg or less.
• The doseto treat Candida esophagitis 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 to prevent invasive Candida infection 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 and adolescents <16

• The usual dose to treat invasive Candida infection is 100 mg per day for patients weighing more than 40 kg and 2 mg/kg per day for patients weighing 40 kg or less.
• The usual dose to preventinvasive Candida infection 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 newborns <4

• The usual dose to treat invasive Candida infection is 4-10 mg/kg per day.
• The usual dose to prevent invasive Candida infection is 2 mg/kg per day.

If you receive moreMicafunginaTevathan you should

Your doctor will monitor your response and condition to determine what dose of micafungina is necessary. However, if you are concerned that you have received too much medication, consult your doctor or another healthcare professional immediately.

If you think you have experienced an overdose, report it to your doctor immediately. You can also call the Toxicology Information Service, Tel. 91 562 04 20.

If you forget a dose ofMicafungina Teva

Your doctor will monitor your response and condition to determine if treatment with micafungina is necessary. However, if you are concerned that you have missed a dose, consult your doctor or another healthcare professional immediately.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

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

Micafungina Teva may cause the following side effects:

Frequent (may affect up to 1 in 10 people)

• Abnormal results in blood tests (decreased white blood cell count [leucopenia; neutropenia]); decreased red blood cell count (anemia)
• Decreased potassium in the blood (hypokalemia); decreased magnesium in the blood (hypomagnesemia); decreased calcium in the blood (hypocalcemia)
• Headache
• Phlebitis (inflammation of the vein wall) at the injection site
• Nausea (feeling unwell); vomiting (being sick); diarrhea; abdominal pain
• Abnormal liver function test results (increased alkaline phosphatase; increased aspartate aminotransferase; increased 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 (decreased blood cell count [pancytopenia]); decreased platelet count (thrombocytopenia); increased eosinophils; decreased albumin in the blood (hypoalbuminemia)
• Hypersensitivity
• Increased sweating
• Decreased sodium in the blood (hyponatremia); increased potassium in the blood (hyperkalemia); decreased phosphate in the blood (hypophosphatemia); anorexia (eating disorder)
• Insomnia (difficulty sleeping); anxiety, confusion
• Drowsiness; tremors, dizziness, altered taste
• Increased heart rate; stronger heartbeat; irregular heartbeat
• High or low blood pressure; skin redness
• Shortness of breath
• Indigestion; constipation
• Liver failure; increased liver enzymes (gamma-glutamyltransferase); jaundice (yellowing of the skin or eyes caused by liver or blood disorders); decreased bile flow to the intestine (cholestasis); enlarged liver; liver inflammation
• Rash with itching (urticaria); itching; red skin (erythema)
• Abnormal kidney function test results (increased creatinine in the blood; increased urea in the blood); worsening renal failure
• Increased lactate dehydrogenase enzyme
• Formation of blood clots 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 due to red blood cell rupture (hemolytic anemia), white blood cell rupture (hemolysis)

Frequency unknown (frequency cannot be estimated from available data)

• Blood coagulation disorder
• Anaphylactic shock
• Liver cell damage, including death
• Renal problems; acute renal failure

Other side effects in children and adolescents

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

Frequent (may affect up to 1 in 10 people)

• Decreased platelet count (thrombocytopenia)
• Increased heart rate (tachycardia)
• High or low blood pressure
• Increased bilirubin in the blood (hyperbilirubinemia); enlarged liver
• Acute renal failure; increased 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 the Spanish System for Pharmacovigilance of Medicines for Human Use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Maintain this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the vial and on the packaging, after CAD. The expiration date is the last day of the month indicated.

The unopened medication does not require special storage conditions.

Concentrate reconstituted in the vial

Chemical and physical stability has been demonstrated for use up to 48 hours at 25°C when reconstituted with sodium chloride infusion solution 9 mg/ml (0.9%) or a glucose infusion solution 50 mg/ml (5%).

Diluted infusion solution

Chemical and physical stability has been demonstrated for use during 96 hours at 25°C when protected from light when diluted with sodium chloride infusion solution 9 mg/ml (0.9%) or a glucose infusion solution 50 mg/ml (5%).

From a microbiological point of view, reconstituted and diluted solutions should be used immediately. If not used immediately, the storage times in use and the conditions before use are the responsibility of the user and should not normally be greater than 24 hours between 2 and 8°C, unless reconstitution and dilution have taken place in a controlled and validated aseptic environment.

Only a properly trained healthcare professional who has read the instructions correctly can prepare this medication for use.

Do not use the diluted infusion solution if it appears turbid or if a precipitate has formed.

To protect the diluted infusion solution from light, the bottle/bag containing the solution should be introduced into an opaque bag with a seal.

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

Medications should not be thrown away through the drains or in the trash. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

Composition ofMicafungin Teva

• The active ingredient is micafungin (as sodium salt).
• One vial contains micafungin sodium equivalent to 50 mg or 100 mg of micafungin.
• The other components are sucrose, citric acid, and sodium hydroxide.

Appearance ofMicafungin Teva and packaging contents

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

Micafungin Teva is supplied in a container containing a vial.

Marketing Authorization Holder

Teva B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

Responsible Person

s.c. Sindan-Pharma S.R.L.

11, Ion Mihalache Ave.,

The 1st District

Bucarest 011171

Romania

or

Merckle GmbH

Graf-Arco-Str. 3,

89079 Ulm

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta

28108, Alcobendas, Madrid (Spain)

Last review date of this leaflet: August 2020

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

This information is intended only for doctors or healthcare professionals:

Micafungin Teva should not be mixed or infused simultaneously with other medicines except those mentioned below. Micafungin is reconstituted and diluted, using aseptic techniques at room temperature, as indicated below:

1. The plastic cap should be removed from the vial and the stopper should 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/bag) should be slowly and aseptically injected into each vial on one side of the inner wall.
3. The concentrate should be reconstituted with a sufficient number of vials of Micafungin Teva to obtain the required dose in mg (consult the table below).
4. The vial should be gently rotated. DO NOT SHAKE. The powder will dissolve completely. The concentrate should be used immediately. The vial is for single use. Therefore, the unused reconstituted concentrate should be discarded immediately.
5. All the reconstituted concentrate should be removed from each vial and returned to the infusion bottle/bag from which it was initially taken. The diluted infusion solution should be used immediately. Chemical and physical stability has been demonstrated for use over 96 hours, when maintained at 25°C, provided it is protected from light, and the dilution is made as described above.
6. The infusion bottle/bag should be carefully inverted to disperse the diluted solution but NOT shaken, to avoid foam formation. The solution should not be used if it is turbid or a precipitate has formed.
7. The infusion bottle/bag containing the diluted infusion solution should be introduced into an opaque bag with a seal to protect it from light.

Preparation of the infusion solution

After reconstitution and dilution, the solution should be administered by intravenous infusion over approximately 1 hour.