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 this 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, consult your doctor or pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start using Micafungina Hikma

3. How to use Micafungina Hikma

4. Possible side effects

5. Storage of Micafungina Hikma

6. Contents of the pack and additional information

This medication contains the active ingredient micafungin. This medication is an antifungal medication as it is used to treat infections caused by fungal cells.

This medication 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 penetrated the body). It interferes with the production of a part of the fungal cell wall.

When no other antifungal treatment is available, your doctor prescribes 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 in which it is appropriate to apply the treatment by intravenous administration.
• To prevent Candida infection in patients undergoing a bone marrow transplant or who are expected to have neutropenia (low levels of neutrophils, a type of white blood cell) for 10 days or more.

No use Micafungina Hikma

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Micafungina Hikma

• if you are allergic to any medication
• if you have hemolytic anemia (anemia caused 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 may also cause severe inflammation/eruption of the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other medications and Micafungina Hikma

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

It is especially important to inform your doctor if you are using amphotericin B desoxicolate or itraconazole (antifungal antibiotics), sirolimus (an immunosuppressant) or nifedipine (a calcium channel blocker used to treat hypertension). Your doctor may decide to adjust the dose of these medications.

Use of Micafungina Hikma with food and drinks

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

Pregnancy and breastfeeding

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

This medication should not be used during pregnancy except when clearly necessary. If you use this medication, do not breastfeed.

Driving and operating machinery

It is unlikely that micafungin will affect your ability to drive or operate machinery. However, some people may feel dizzy when taking this medication, and if this happens to you, do not drive or operate any machinery or equipment. Please inform your doctor if you experience any effects that may cause you problems driving or operating machinery.

Micafungina Hikma contains sodium

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

This medication must be prepared and administered by a doctor or other healthcare professional. This medication must be administered by slow intravenous infusion (into a vein), once a day. Your doctor will determine the dose of micafungina that you will receive each day.

Use in adults, adolescents ≥ 16 years and elderly patients

• The usual dose to treat 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 to treat 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 to prevent 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

• The usual dose to treat 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 to prevent 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 newborns

• The usual dose to treat invasive Candida infection is 4-10 mg/kg per day.
• The usual dose to prevent 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 state of your disease to determine the necessary dose of this medication. However, if you are concerned that you have received too much of this medication, consult immediately with your doctor or other healthcare professional or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount received.

If you do not receive your dose of Micafungina Hikma

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

Micafungin may cause these other side effects:

Frequent (may affect up to 1 in 10 people)

• Abnormal results in blood tests (reduction in the number of white blood cells [leucopenia; neutropenia]); reduction in the number of red blood cells (anemia)
• Reduction of potassium in the blood (hypokalemia); reduction of magnesium in the blood (hypomagnesemia); reduction of calcium in the blood (hypocalcemia)
• Headache
• Inflammation in the venous wall (at the injection site)
• Nausea (discomfort); vomiting; diarrhea, abdominal pain
• Abnormal results in liver tests (increase in alkaline phosphatase; increase in aspartate aminotransferase; increase in alanine aminotransferase)
• Increased bilirubin in the blood (hyperbilirubinemia)
• Rash
• Fever
• Chills

Rare (may affect up to 1 in 100 people)

• Abnormal results in blood tests (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 cell; called eosinophils; reduction of albumin in the blood (hypoalbuminemia)
• Hypersensitivity
• Increased sweating
• Reduction of sodium in the blood (hyponatremia); increase of potassium in the blood (hyperkalemia); reduction of phosphates in the blood (hypophosphatemia); anorexia (eating disorder)
• Insomnia (difficulty sleeping); anxiety; confusion
• Sensation of sleep (somnolence); tremors, dizziness; alteration of the sense of taste
• Increased heart rate; stronger heartbeat; irregular heartbeat
• High or low blood pressure; redness
• Lack of breath
• Indigestion; constipation
• Liver failure; increase of liver enzymes (gamma-glutamyltransferase); jaundice (the skin or the white part of the eyes turn yellow due to liver or blood problems); reduction of the amount of bile that reaches the intestine (cholestasis); enlargement of the liver; inflammation of the liver
• Rash with itching (urticaria); pruritus; redness (erythema)
• Abnormal tests of renal function (increase of creatinine in the blood; increase of urea in the blood); worsening of renal failure
• Increased activity of an enzyme called lactate dehydrogenase
• Formation of blood clots at the injection site; inflammation at the injection site; pain at the injection site; accumulation of fluid 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)

Unknown (the frequency cannot be estimated from the available data)

• Blood clotting disorders
• Shock (allergic)
• Damage to liver cells including death
• Renal alterations; acute renal failure

Other side effects in children and adolescents

The following reactions have been described more frequently in pediatric patients than in adults:

Frequent (may affect up to 1 in 10 people)

• Reduction of platelets in the blood (thrombocytopenia)
• Increased heart rate (tachycardia)
• High or low blood pressure
• Increased bilirubin in the blood (hyperbilirubinemia); enlargement of the liver
• Acute renal failure; increase of urea in the blood

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Usewww.noticaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the vial and on the packaging. The expiration date is the last day of the month indicated.

The unopened vial does not require special storage conditions.

Concentrate in vial after reconstitution

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

Diluted infusion solution

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

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

Only a properly trained healthcare professional who has read the instructions correctly can prepare this medication for use.

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

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

The vial has a single use. Therefore, unused reconstituted concentrate should be discarded immediately.

Composition of Micafungin Hikma

• The active ingredient is micafungin (as sodium).

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

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

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

Appearance of the product and contents of the package

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

Marketing authorization holder and responsible manufacturer

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó 8, 8A e 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

Last review date of this leaflet: November 2020

The detailed and updated information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

-----------------------------------------------------------------------------------------------------------------------------

This information is intended only for medical professionals or healthcare professionals:

This medicinal product must not be mixed or infused simultaneously with other medicinal products except those mentioned below. This medicinal product is reconstituted and diluted using aseptic techniques at room temperature, as indicated below:

Preparation of the infusion solution