MICAFUNGINA MACLEODS 50 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Micafungina Macleods50 mg powder for concentrate for solution for infusion EFG

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

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Micafungina 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 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 Micafungina Macleods 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 it is appropriate to apply intravenous treatment.

To prevent Candida infection 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 Macleods

Do not use Micafungina Macleods

• 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

In rats, long-term treatment with micafungin produced liver damage 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 starting to use it. You should tell 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 Micafungina Macleods

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

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

Other medicines and Micafungina Macleods

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

It is especially important that you tell 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 Macleods with food and drinks

Since this medicine is given by intravenous infusion (in a vein), there are no restrictions on food or drinks.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 clearly necessary. If you use micafungin, you should 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, do not drive or use any machine or tool. Please inform your doctor if you experience any effect that may cause problems when driving or using machinery.

Micafungina Macleods contains sodium

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

3. How to use Micafungina Macleods

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

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

• The usual dose for treating an invasive Candida infection 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 a Candida esophagus infection 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 Candida infections 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 an invasive Candida infection 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 Candida infections 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 an invasive Candida infection is 4-10 mg/kg per day.
• The usual dose for preventing invasive Candida infections is 2 mg/kg per day.

If you receive more Micafungina Macleods than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you miss a dose of Micafungina Macleods

Your doctor will monitor your response and the condition of your disease to determine the appropriate treatment with Micafungina 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 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), 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 blood (hypokalemia); reduction of magnesium in blood (hypomagnesemia); reduction of calcium in blood (hypocalcemia)
• headache
• inflammation of the vein wall (at the injection site)
• nausea (discomfort); vomiting; diarrhea; abdominal pain
• abnormal liver function tests (increase in alkaline phosphatase; increase in aspartate aminotransferase; increase in alanine aminotransferase)
• increase in 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 blood (hypoalbuminemia)
• hypersensitivity
• increased sweating
• reduction of sodium in blood (hyponatremia); increase of potassium in blood (hyperkalemia); reduction of phosphates in 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
• shortness of breath
• indigestion; constipation
• liver failure; increase in liver enzymes (gamma-glutamyltransferase); jaundice (the skin or the white of the eyes turns yellow due to liver or blood problems); reduction of bile reaching the intestine (cholestasis); increase in liver size; liver inflammation
• rash with itching (urticaria); itching; flushing (erythema)
• abnormal kidney function tests (increase in creatinine in blood; increase in urea in blood); worsening of kidney failure
• increase in 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 produced by the breakdown of red blood cells (hemolytic anemia), breakdown of red blood cells (hemolysis)

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

• blood coagulation disorders
• shock (allergic)
• liver cell damage including death
• kidney problems; 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 blood (thrombocytopenia)
• increase in heart rate (tachycardia)
• high or low blood pressure
• increase in bilirubin in blood (hyperbilirubinemia); increase in liver size
• acute kidney failure; increase in urea in blood

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Micafungina Macleods

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 carton. The expiry date is the last day of the month stated.

The intact vial (unopened) does not require special storage conditions.

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 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 bottle/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. Contents of the pack and other information

Composition of Micafungina Macleods

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

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

• The other ingredients are lactose monohydrate, citric acid (E330), and sodium hydroxide.

Appearance and pack of the product

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

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

Micafungina Macleods is supplied in a carton containing 1 vial.

Marketing Authorisation 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

Date of last revision of this leaflet:08/2024.

Detailed information on this medicine 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:

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

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%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion (taken from a 100 ml bottle/bag) should be slowly and aseptically injected into each vial along the inner wall. Although the concentrate will foam, care should be taken to minimize the amount of foam generated. A sufficient number of Micafungina Macleods vials should be reconstituted to obtain the necessary dose in mg (see the table below).
3. The vial should be gently rotated. IT SHOULD NOT BE SHAKEN. The powder will dissolve completely. The concentrate should be used immediately. The vial is for single use only. Therefore, any unused reconstituted concentrate should be discarded immediately.
4. All 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. It has been shown that the chemical and physical stability allows the use of the medicine for 96 hours at 25°C, provided it is protected from light and the dilution is performed as described above.
5. The infusion bottle/bag should be carefully inverted to disperse the diluted solution but SHOULD NOT BE SHAKEN to avoid foam formation. The solution should not be used if it is cloudy or a precipitate has formed.
6. The bottle/bag containing the diluted solution for infusion should be placed in an opaque bag with a seal to protect it from light.

Preparation of the infusion solution