MICAFUNGINA HIKMA 50 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

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

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

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

This medicine contains the active substance micafungin. This medicine 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 defects in the fungal cell wall, preventing the fungus from growing and living.

When no other antifungal treatment is available, your doctor will prescribe micafungin 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 Hikma

Do not use Micafungina 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

Consult your doctor or pharmacist before starting to use Micafungina Hikma

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

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

Other medicines and Micafungina Hikma

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 Hikma 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.

This medicine should not be used during pregnancy unless clearly necessary. If you use this medicine, 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 Hikma 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 Hikma

This medicine must be prepared and administered by a doctor or other healthcare professional. This medicine must be given by slow intravenous infusion (in a vein), once a day. 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 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 an esophageal Candida 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 neonates <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 Hikma than you should

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

If you miss a dose of Micafungina Hikma

Your doctor will monitor your response and the condition of your disease 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 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 of the skin), you must inform your doctor or nurse immediately.

Micafungina may 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 the sense 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 part of the eyes turns yellow due to liver or blood problems); reduction of the amount of bile that reaches 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 caused by the rupture of red blood cells (hemolytic anemia), rupture of red blood cells (hemolysis)

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

• blood clotting 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)
• increased 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 Pharmacovigilance System of Medicines for Human Use www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Micafungina Hikma

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 unopened vial does not require any special storage conditions.

Reconstituted concentrate in vial

Chemical and physical 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.

Infusion solution

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

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

Only a healthcare professional who has read the instructions completely and correctly can prepare this medicine for use.

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

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

The vial is for single use only. Therefore, the reconstituted concentrate that is not used should be discarded immediately.

6. Contents of the pack and other information

Composition of Micafungina Hikma

• The active substance is micafungin (as sodium).

Micafungina Hikma 50 mg: Each vial contains 50.86 mg of micafungin sodium (equivalent to 50 mg of micafungin).

Micafungina Hikma 100 mg: Each vial contains 101.73 mg of micafungin sodium (equivalent to 100 mg of micafungin)

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

Appearance and pack contents

Micafungina Hikma powder for concentrate for solution for infusion is a compact white lyophilized powder. Micafungina 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 e 8B, Fervença

2705-906 Terrugem SNT

Portugal

You can obtain further information on this medicine from the 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 last revision of this leaflet:November 2020

Detailed and up-to-date 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:

This medicine should not be mixed or infused simultaneously with other medicines except those mentioned below. This medicine 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 vials of this medicine 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, the reconstituted concentrate that is not used should be discarded immediately (the displacement volume is 0.2 ml).
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 infusion solution should be used immediately. Chemical and physical stability has been demonstrated for up to 96 hours at 25°C, provided it is protected from light, and the dilution is carried out as described above.
5. The infusion bottle/bag should be carefully inverted to disperse the infusion solution but SHOULD NOT BE SHAKEN, to avoid foam formation. The solution should not be used if it is cloudy or if a precipitate has formed.
6. The bottle/bag containing the infusion solution should be placed in an opaque bag with a seal to protect it from light.

Preparation of the infusion solution