Micafungin Macleods 50 mg powder for concentrate for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

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

Read the entire 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, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What is Micafungin Macleods and what is it used for?

Micafungin Macleods 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 fungi or yeasts called Candida. Micafungin is effective in the treatment of 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 in the fungal cell wall to form, thereby preventing the fungus from growing and surviving.

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

• To treat a serious fungal infection in adults, adolescents, and children, including neonates, known as invasive candidiasis (an infection that has spread into the body).
• To treat adults and adolescents ≥ 16 years of age with fungal infection of the esophagus when intravenous treatment is appropriate.

To prevent Candida infection in patients undergoing bone marrow transplantation or in those expected to have neutropenia (low levels of neutrophils, a type of white blood cell) for 10 days or longer.

2. What you need to know before using Micafungin Macleods

Do not use Micafungin Macleods

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

Warnings and precautions

In rats, long-term treatment with micafungin caused liver injury and subsequent liver tumors. The potential risk of developing liver tumors in humans is unknown; your doctor will advise you on the benefits and risks of treatment with micafungin before you start using it. You must inform your doctor if you have severe liver problems (e.g., liver failure or hepatitis) or if you have abnormal liver function tests. During treatment, your liver function will be monitored more closely.

Consult your doctor or pharmacist before starting to use Micafungin Macleods

• 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 Macleods

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 Macleods with food and drinks

As 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Micafungin must not be used during pregnancy unless clearly necessary. If you are using micafungin, you must not breastfeed.

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, you should not drive or operate any machinery or tools. Please inform your doctor if you experience any side effect that could impair your ability to drive or use machinery.

Micafungin Macleods contains sodium

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

3. How to use Micafungin Macleods

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

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

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

Use in children > 4 months of age and adolescents < 16 years of age

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

Use in children and newborns < 4 months of age

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

If you receive more Micafungin Macleods than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medication and the amount ingested.

If you miss your dose of Micafungin Macleods

Your doctor will monitor your response and your medical condition to determine the appropriate treatment with Micafungin Macleods. 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.

Micafungin may cause the following adverse effects:

Frequent (may affect up to 1 in 10 people)

• abnormal blood test results (reduction in white blood cells [leucopenia; neutropenia]); reduction in red blood cells (anaemia)
• low potassium levels in blood (hypokalaemia); low magnesium levels in blood (hypomagnesaemia); low calcium levels in blood (hypocalcaemia)
• headache
• inflammation of the vein wall (at the injection site)
• nausea (feeling unwell); vomiting; diarrhoea; abdominal pain
• abnormal liver function tests (increased alkaline phosphatase; increased aspartate aminotransferase; increased alanine aminotransferase)
• increased bilirubin pigment in blood (hyperbilirubinaemia)
• rash
• fever
• chills

Uncommon (may affect up to 1 in 100 people)

• abnormal blood test results (reduction in blood cells [pancytopenia]); reduction in platelets (thrombocytopenia); increase in a specific type of white blood cells called eosinophils; low albumin levels in blood (hypoalbuminaemia)
• hypersensitivity
• increased sweating
• low sodium levels in blood (hyponatraemia); high potassium levels in blood (hyperkalaemia); low phosphate levels in blood (hypophosphataemia); anorexia (eating disorder)
• insomnia (difficulty sleeping); anxiety; confusion
• drowsiness; tremor; 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 bile flow to the intestine (cholestasis); enlarged liver; liver inflammation
• itchy rash (urticaria); pruritus; redness (erythema)
• abnormal kidney function tests (increased creatinine in blood; increased urea in blood); worsening of renal 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)

• anaemia caused by breakdown of red blood cells (haemolytic anaemia); breakdown of red blood cells (haemolysis)

Not known (frequency cannot be estimated from available data)

• disorders related to blood coagulation
• shock (allergic)
• liver cell injury including death
• kidney abnormalities; acute renal 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 bilirubin pigment in blood (hyperbilirubinaemia); enlarged liver
• acute kidney failure; increased urea in blood

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Macleods

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. The expiry date refers to the last day of the month indicated.

The intact vial (unopened) requires no special storage conditions.

The reconstituted concentrate and the diluted solution for infusion must be used immediately, as it contains no preservatives to prevent bacterial contamination. Only a 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 pack and other information

Composition of Micafungin Macleods

• 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 lactose monohydrate, citric acid (E330), and sodium hydroxide.

Presentation of the product and contents of the pack

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

Micafungin Macleods 50 mg or 100 mg powder for concentrate for solution for infusion EFG is supplied in a Type I amber glass vial 10R with a 20 mm bromobutyl rubber stopper and an aluminum cap with a blue or red plastic flip-off seal.

Micafungin Macleods is supplied in a carton containing 1 vial.

Marketing Authorization Holder

Macleods Pharma España S.L.U.

World Trade Center Barcelona

Moll de Barcelona, s/n,

08039 Barcelona, Spain

Manufacturer

ROMPHARM COMPANY S.R.L.

1A Eroilor Street, 075100 Otopeni, Ilfov county

Romania

or

Synoptis Industrial Sp. z o.o.

ul. Rabowicka 15, 62-020 Swarzedz, Poland

Date of the most recent revision of this summary: 08/2024.

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

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This information is intended for healthcare professionals only:

Micafungin Macleods must not be mixed or co-infused with other medicinal products except those mentioned below. Micafungin Macleods must be reconstituted and diluted using aseptic techniques at room temperature as described below:

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 along the inner wall. Although foaming may occur, care should be taken to minimize the amount of foam generated. Reconstitute a sufficient number of Micafungin Macleods vials 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 must be used immediately. The vial is for single use only. Therefore, any unused reconstituted concentrate must be discarded immediately.
4. Withdraw all of the reconstituted concentrate from each vial and return it to the infusion bottle/bag from which the diluent was originally taken. The diluted solution for infusion must be used immediately. Chemical and physical stability has been demonstrated for up to 96 hours at 25°C, provided the solution is protected from light and the dilution is performed as described above.
5. Carefully invert the infusion bottle/bag to disperse the diluted solution, but DO NOT SHAKE to avoid foaming. Do not use the solution if it is cloudy 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