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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

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

Leaflet contents

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

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

This medicine contains the active substance micafungin. This medicine is an antifungal medicine because it is 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 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 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 micafungin in 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 using Micafungin Hikma

Do not use Micafungin Hikma

• 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

Talk to your doctor or pharmacist before using Micafungin Hikma

• if you are allergic to any medicine
• if you have haemolytic anaemia (anaemia caused by breakdown of red blood cells) or haemolysis (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 rash and inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other medicines and Micafungin Hikma

Tell 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 tell 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 Hikma with food and drink

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

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 use this medicine, you must not breastfeed.

Driving and using machines

Micafungin is unlikely to 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 may impair your ability to drive or use machinery.

Micafungin Hikma contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; i.e., essentially “sodium-free”.

3. How to use Micafungin Hikma

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

Use in adults, adolescents ≥ 16 years 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 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 preventing 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

• 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 40 kg.
• The usual dose for preventing 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 preventing invasive Candida infections is 2 mg/kg per day.

If you receive more Micafungin Hikma than you should

Your doctor will monitor your response and clinical condition to determine the required dose of this medicine. However, if you are concerned that you have received too much of this medicine, contact your doctor or another healthcare professional immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount received.

If you miss your dose of Micafungin Hikma

Your doctor will monitor your response and clinical 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 experiences 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 the number of white blood cells [leucopenia; neutropenia]); reduction in the number of 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 (increase in alkaline phosphatase; increase in aspartate aminotransferase; increase in alanine aminotransferase)
• increased blood bile pigment (hyperbilirubinaemia)
• 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 (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; tremors, dizziness; altered taste sensation
• 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; flushing (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)

• 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 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)

• reduction in platelets in blood (thrombocytopenia)
• increased heart rate (tachycardia)
• high or low blood pressure
• increased bile pigment in blood (hyperbilirubinaemia); enlarged liver
• acute kidney failure; increased blood urea

Reporting of adverse effects

If you experience any type of adverse effect, talk to 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 Medicinal Products: www.noticaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Micafungin Hikma

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 unopened vial does not require special storage conditions.

Reconstituted concentrate in vial

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

Diluted infusion solution

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

Micafungin Hikma does not contain preservatives. From a microbiological standpoint, reconstituted and diluted solutions should be used immediately. If not used immediately, the storage times and conditions during use are the responsibility of the user and normally would not exceed 24 hours at 2 to 8°C, unless reconstitution and dilution have been carried out under controlled and validated aseptic conditions.

Only a properly trained healthcare professional who has fully read and correctly followed the instructions should prepare this medicine for use.

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

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

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

6. Contents of the pack and other information

Composition of Micafungin Hikma

• The active substance is micafungin (as sodium).

Micafungin Hikma 50 mg: Each vial contains sodium micafunginate equivalent to 50 mg of micafungin.

Micafungin Hikma 100 mg: Each vial contains sodium micafunginate equivalent to 100 mg of micafungin.

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

Nature of the product and contents of the container

Micafungin Hikma powder for concentrate for solution for infusion is a white, compact, lyophilized powder. Micafungin Hikma is supplied in a carton containing 1 vial.

Marketing Authorization Holder and Manufacturer

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó 8, 8A and 8B, Fervença

2705-906 Terrugem SNT

Portugal

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Hikma España, S.L.U.

Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2

28108 - Alcobendas, Madrid

Spain

Date of the most recent review of this summary: October 2025

Detailed and up-to-date 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/

This information is intended for healthcare professionals only:

This medicinal product must not be mixed or co-infused with other medicinal products except those mentioned below. This medicine 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 with the concentrate, care should be taken to minimize the amount of foam generated. Reconstitute a sufficient number of vials of this medicinal product to obtain the required dose in mg (refer to the 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 (the displacement volume is 0.2 ml).
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 should be used immediately. Chemical and physical stability has been demonstrated for up to 96 hours when stored at 25°C, provided it 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. 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, sealed bag to protect it from light.

Preparation of the solution for infusion