Micafungin Sala 100 mg powder for concentrate for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

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

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

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

Leaflet contents

1. What Micafungina Sala is and what it is used for
2. What you need to know before using Micafungina Sala
3. How to use Micafungina Sala
4. Possible adverse effects
5. How to store Micafungina Sala
6. Contents of the pack and other information

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

This medicine contains the active substance micafungin. Micafungin is an antifungal medicine, as it is used to treat infections caused by fungal cells.

This medicine is used to treat fungal infections caused by fungi or yeasts called Candida. Micafungin is effective in treating systemic infections (those that have spread throughout the body). It interferes with the production of a component of the fungal cell wall. Fungi require an intact cell wall to survive and grow. Micafungin causes defects to form in the fungal cell wall, thereby preventing the fungus from growing and surviving.

When no other antifungal treatment is available, your doctor may prescribe this medicine under the following circumstances (see section 2):

• To treat a serious fungal infection in adults, adolescents and children, including neonates, called invasive candidiasis (an infection that has spread into the body).
• To treat adults and adolescents ≥ 16 years of age with a fungal infection of the oesophagus when intravenous treatment is appropriate.
• To prevent Candida infection in patients undergoing bone marrow transplantation or in patients 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 starting to use Micafungin Sala

Do not use Micafungin Sala

• 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 to use this medicine

• if you are allergic to any medicine
• if you have hemolytic anemia (anemia caused by the breakdown of red blood cells) or hemolysis (breakdown of red blood cells)
• if you have kidney problems (renal failure or abnormal kidney function tests). In this case, your doctor may decide to monitor your kidney function more closely.

Micafungin may also cause severe skin inflammation/rash and mucosal membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other medicines and Micafungin Sala

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

It is especially important that you inform your doctor if you are taking amphotericin B deoxycholate 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.

Use of Micafungin Sala with food and drinks

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

Pregnancy and breastfeeding

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

This medicine should not be used during pregnancy unless clearly necessary. If you take this medicine, you must not breastfeed.

Driving and using machines

It is unlikely that micafungin will affect your ability to drive or operate machinery. However, some people may feel dizzy when taking this medicine, and if this happens to you, you should not drive or operate any machinery or tools. Please inform your doctor if you experience any effect that could impair your ability to drive or use machinery.

Micafungin Sala contains sodium and lactose

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

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to use Micafungin Sala

This medicine must be prepared and administered by a doctor or other healthcare professional. This medicine should be given by slow intravenous infusion (into a vein) once daily. Your doctor will determine the daily dose of micafungin you will receive.

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

• The usual dose for the treatment of invasive Candida infection is 100 mg once daily for patients weighing more than 40 kg, and 2 mg/kg once daily for patients weighing 40 kg or less.
• The dose for the treatment of esophageal Candida infection is 150 mg once daily for patients weighing more than 40 kg, and 3 mg/kg once daily for patients weighing 40 kg or less.
• The usual dose for the prevention of invasive Candida infections is 50 mg once daily for patients weighing more than 40 kg, and 1 mg/kg once daily for patients weighing 40 kg or less.

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

• The usual dose for the treatment of invasive Candida infection is 100 mg once daily for patients weighing more than 40 kg, and 2 mg/kg once daily for patients weighing 40 kg or less.
• The usual dose for the prevention of invasive Candida infections is 50 mg once daily for patients weighing more than 40 kg, and 1 mg/kg once daily for patients weighing 40 kg or less.

Use in children and newborns under 4 months of age

• The usual dose for the treatment of invasive Candida infection is 4–10 mg/kg per day.
• The usual dose for the prevention of invasive Candida infections is 2 mg/kg per day.

If you receive more Micafungin Sala than you should

Your doctor will monitor your response and the status of your condition to determine the appropriate dose of this medicine. However, if you are concerned that you have received too much micafungin, contact your doctor or another healthcare professional immediately.

If you miss your dose of Micafungin Sala

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

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

4. Possible adverse effects

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

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

This medicine may cause the following adverse effects:

Frequent (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)
• low potassium levels in blood (hypokalemia); low magnesium levels in blood (hypomagnesemia); low calcium levels in blood (hypocalcemia)
• headache
• inflammation of the vein wall (at the injection site)
• nausea (feeling unwell); vomiting; diarrhoea; abdominal pain
• abnormal liver function tests (increase in alkaline phosphatase; increase in aspartate aminotransferase; increase in alanine aminotransferase)
• increased blood bile pigment (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 specific type of white blood cells called eosinophils; reduction in albumin levels in blood (hypoalbuminemia)
• hypersensitivity
• increased sweating
• low sodium levels in blood (hyponatremia); high potassium levels in blood (hyperkalemia); low phosphate levels in blood (hypophosphatemia); anorexia (eating disorder)
• insomnia (difficulty sleeping); anxiety; confusion
• drowsiness; tremors; dizziness; altered sense of taste
• increased heart rate; stronger heartbeat; irregular heartbeat
• high or low blood pressure; flushing
• shortness of breath
• indigestion; constipation
• liver failure; increased liver enzymes (gamma-glutamyl transferase); jaundice (yellowing of the skin or whites of the eyes due to liver or blood problems); reduced amount of bile reaching the intestine (cholestasis); enlarged liver; liver inflammation
• itchy rash (urticaria); pruritus; redness (erythema)
• abnormal kidney function tests (increased blood creatinine; increased blood urea); worsening of kidney failure
• increased levels of an enzyme called lactate dehydrogenase
• blood clot formation at injection site; inflammation at injection site; pain at injection site; fluid accumulation in the body

Rare (may affect up to 1 in 1,000 people)

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

Frequency not known (frequency cannot be estimated from available data)

• disorders related to blood coagulation
• shock (allergic)
• liver cell injury including death
• kidney disorders; acute kidney failure

Other adverse effects in children and adolescents

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

Frequent (may affect up to 1 in 10 people)

• reduced platelet count in blood (thrombocytopenia)
• increased heart rate (tachycardia)
• high or low blood pressure
• increased blood bile pigment (hyperbilirubinemia); enlarged liver
• acute kidney failure; increased blood urea

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Micafungin Sandoz

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

Do not use this medicine after the expiry date stated on the vial and outer packaging EXP. The expiry date refers to the last day of the month indicated.

The unopened vial does not require any special storage conditions.

The reconstituted concentrate and the diluted solution for infusion must be used immediately, as they contain no preservatives to prevent bacterial contamination. Only a properly trained healthcare professional who has fully read and correctly understood the instructions should prepare this medicine for use.

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

To protect from light, the bottle/bag containing the diluted solution for infusion must be placed in an opaque, sealed bag.

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

6. Contents of the container and additional information

Composition of Micafungina Sala

• The active substance is micafungin (as sodium salt).

1 vial contains 50 mg or 100 mg of micafungin (as sodium salt).

• The other components are monohydrate lactose, anhydrous citric acid and sodium hydroxide.

Appearance of the product and contents of the pack

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

This medicine is supplied in a box containing 1 vial.

Marketing Authorization Holder and Manufacturer

Laboratorio Reig Jofre, S.A.

Gran Capitán 10

08970 Sant Joan Despí

Barcelona, Spain

This medicine is authorized in the EEA Member States under the following names:

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

Sweden: Micafungin Bioglan 50 mg powder for concentrate for infusion solution

Micafungin Bioglan 100 mg powder for concentrate for infusion solution

France: Micafungine Reig Jofre 50 mg, powder for solution for dilution for infusion

Micafungine Reig Jofre 100 mg, powder for solution for dilution for infusion

Portugal: Micafungina Reig Jofre 50 mg powder for concentrate for infusion solution

Micafungina Reig Jofre 100 mg powder for concentrate for infusion solution

Date of the most recent review of this leaflet: May 2021

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/

This information is intended for healthcare professionals only:

This medicinal product must not be mixed or co-administered simultaneously with other medicinal products except those mentioned below. This medicinal product should be reconstituted and diluted using aseptic techniques at room temperature as follows:

1. Remove the plastic cap from the vial and disinfect the stopper with alcohol.
2. Slowly and aseptically 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, directing the stream against the inner wall of the vial. Although foaming may occur with the concentrate, care should be taken to minimize the amount of foam generated. A sufficient number of vials of this medicinal product should be reconstituted to obtain the required dose in mg (see table below).
3. Gently rotate the vial. DO NOT SHAKE. The powder will dissolve completely. The concentrate should be used immediately. The vial is for single use only. Therefore, any unused reconstituted concentrate must be discarded immediately.
4. All of the reconstituted concentrate should be withdrawn from each vial and returned to the infusion bottle/bag from which it was initially taken. The diluted solution for infusion should be used immediately. Chemical and physical stability has been demonstrated for up to 96 hours at 25°C and 24 hours at 2–8°C, provided the solution is protected from light and the dilution has been performed as described above.
5. Carefully invert the infusion bottle/bag to disperse the diluted solution, but DO NOT SHAKE, to avoid foam formation. The solution must not be used if it is cloudy or if a precipitate has formed.
6. The bottle/bag containing the diluted solution for infusion should be placed in a sealed opaque bag to protect it from light.

Preparation of the solution for infusion