Micafungin Reig Jofre

Patient Information Leaflet: Information for the User

Micafungin Reig Jofre 50 mg powder for concentrate for solution for infusion, 100 mg powder for concentrate for solution for infusion

micafungin
Generic medicine
Please read all of this leaflet carefully before you start using this medicine as 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 get any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Micafungin Reig Jofre is and what it is used for

Micafungin Reig Jofre contains the active substance micafungin. Micafungin Reig Jofre is classified as an antifungal medicinal product because it is used to treat infections caused by fungal cells.
Micafungin Reig Jofre is used to treat infections caused by fungal or yeast cells called Candida.
Micafungin Reig Jofre is effective in the treatment of systemic infections (infections that have spread within the body). It interferes with the production of a component of the fungal cell wall. An intact cell wall is essential for the survival and growth of fungi. Micafungin Reig Jofre causes defects in the fungal cell wall, rendering the fungus unable to survive and grow.

Your doctor has prescribed Micafungin Reig Jofre under the following circumstances, in the absence of other suitable antifungal treatments available (see section 2):

• To treat adults, adolescents, and children, including newborns, who have a serious fungal infection called invasive candidiasis (an infection that has spread into the body).
• To treat adults and adolescents aged 16 years and older who have a fungal infection of the throat (oesophagus) for which intravenous (IV) treatment is appropriate.
• To prevent Candida infections in patients undergoing bone marrow transplantation or in patients expected to develop neutropenia (low levels of neutrophils, a type of white blood cell) lasting for 10 days or longer.

2. What you need to know before using Micafungin Reig Jofre

Do not use Micafungin Reig Jofre

• 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 leads to liver damage and consequently to liver tumors. The potential risk of tumor development in humans is unknown, and your doctor will evaluate the benefits and risks of treatment with Micafungin Reig Jofre before you start taking this medicine. Inform your doctor if you have severe liver problems (e.g. hepatic impairment or hepatitis) or if you have had abnormal liver function tests. During treatment, liver function tests may be monitored.

Talk to your doctor or pharmacist before using Micafungin Reig Jofre

• if you are allergic to any medicine
• if you suffer from hemolytic anemia (anemia due to breakdown of red blood cells) or hemolysis (breakdown of red blood cells)
• if you have kidney problems (e.g. renal impairment or abnormal kidney function tests). If this occurs, your doctor may decide to monitor your kidney function more closely. Micafungin may also cause a serious inflammation/skin rash and mucous membrane lesions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other medicines and Micafungin Reig Jofre
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important that you inform your doctor if you are being treated with deoxycholate amphotericin B 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.

Micafungin Reig Jofre with food and drink
Since Micafungin Reig Jofre is administered intravenously (into a vein), there are no restrictions on food or drink intake.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Micafungin Reig Jofre should not be used during pregnancy unless strictly necessary. You must not breastfeed during treatment with Micafungin Reig Jofre.

Driving and using machines
Micafungin is unlikely to affect your ability to drive or use machines. However, some people may experience dizziness when taking this medicine, and if this happens to you, you should not drive or operate tools or machinery. Inform your doctor if you experience any effect that could cause problems while driving or using machines.

Micafungin Reig Jofre contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. essentially “sodium-free”.

3. How to use Micafungin Reig Jofre

Micafungin Reig Jofre must be prepared and administered by a doctor or other healthcare professional. Micafungin Reig Jofre must be given once daily as a slow intravenous infusion (into a vein). Your doctor will determine the daily dose of Micafungin Reig Jofre required for you.

Use in adults, adolescents aged 16 years and older, and elderly patients

• The commonly used dose for the treatment of invasive Candida infection is 100 mg daily for patients weighing more than 40 kg and 2 mg/kg daily for patients weighing 40 kg or less.

• The commonly used dose for the treatment of Candida oesophagitis is 150 mg daily for patients weighing more than 40 kg and 3 mg/kg daily for patients weighing 40 kg or less.

• The commonly used dose for the 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 from 4 months of age and adolescents under 16 years of age

• The commonly used dose for the treatment of invasive Candida infection is 100 mg daily for patients weighing more than 40 kg and 2 mg/kg daily for patients weighing 40 kg or less.

• The commonly used dose for the 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 neonates under 4 months of age

• The commonly used dose for the treatment of invasive Candida infection is 4–10 mg/kg daily.

• The commonly used dose for the prevention of invasive Candida infections is 2 mg/kg daily.

If you are given more Micafungin Reig Jofre than you should
To determine the required dose of Micafungin Reig Jofre, your doctor will monitor your response to the medicine and your overall health condition. However, if you are concerned that you have received an excessive dose of Micafungin Reig Jofre, speak to your doctor or another healthcare professional immediately.

If you miss a dose of Micafungin Reig Jofre
To determine the appropriate treatment regimen with Micafungin Reig Jofre, your doctor will monitor your response to the medicine and your overall health condition. However, if you are concerned that you have not received a dose of Micafungin Reig Jofre, speak to your doctor or another healthcare professional immediately.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you have an allergic reaction or a severe skin reaction (e.g. blistering and peeling of the skin), inform your doctor or nurse immediately.
Micafungin Reig Jofre may cause the following additional side effects:

Common (may affect up to 1 in 10 people)

• changes in blood test values (decrease in white blood cells [leucopenia; neutropenia]); decrease in red blood cells (anaemia)
• decrease in potassium in the blood (hypokalaemia); decrease in magnesium in the blood (hypomagnesaemia); decrease in calcium in the blood (hypocalcaemia)
• headache
• inflammation of the vein wall (at the injection site)
• nausea (feeling unwell); vomiting (being sick); diarrhoea; abdominal pain
• abnormal liver function tests (increase in alkaline phosphatase; increase in aspartate aminotransferase; increase in alanine aminotransferase)
• increase in bile pigment in the blood (hyperbilirubinaemia)
• rash
• fever
• chills (shivering)

Uncommon (may affect up to 1 in 100 people)

• changes in blood test values (decrease in number of blood cells [pancytopenia]); decrease in platelets (thrombocytopenia); increase in a certain type of white blood cells called eosinophils; decrease in albumin in the blood (hypoalbuminaemia)
• hypersensitivity
• increased sweating
• decrease in sodium in the blood (hyponatraemia); increase in potassium in the blood (hyperkalaemia); decrease in phosphate in the blood (hypophosphataemia); anorexia (eating disorder)
• insomnia (difficulty sleeping); anxiety; confusion
• drowsiness; tremor; dizziness; taste disturbances
• increased heart rate; increased force of heartbeat; irregular heartbeat
• high or low blood pressure; skin flushing
• shortness of breath
• indigestion; constipation
• liver failure; increase in liver enzymes (gamma-glutamyltransferase); jaundice (yellowing of the skin or whites of the eyes caused by liver or blood problems); reduced bile flow to the intestine (cholestasis); enlarged liver; liver inflammation
• itchy rash (urticaria); itching; skin redness (erythema)
• changes in kidney function tests (increase in blood creatinine; increase in blood urea levels); worsening of kidney failure
• increase in an enzyme called lactate dehydrogenase
• blood clots 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)

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

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

• disorders of the blood clotting system
• shock (allergic)
• liver cell damage, including death
• kidney problems; acute kidney failure

Additional side effects in children and adolescents
The following reactions have been reported more frequently in paediatric patients than in adult patients:

Common (may affect up to 1 in 10 people)

• decrease in blood platelets (thrombocytopenia)
• increased heart rate (tachycardia)
• high or low blood pressure
• increase in bile pigments in the blood (hyperbilirubinaemia); enlarged liver
• acute kidney failure; increased blood urea concentration

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effect not listed in this leaflet. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Micafungin Reig Jofre

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 after “Expiry”. The expiry date refers to the last day of the month.
The unopened vial does not require any special storage conditions.
The reconstituted concentrate and the diluted infusion solution must be used immediately, as they do not contain preservatives to prevent bacterial contamination. Only a healthcare professional who has thoroughly read the instructions should prepare this medicine for use.
Do not use the diluted infusion solution if it appears cloudy or contains precipitate.
The infusion bag containing the diluted infusion solution must be placed inside an opaque, closable bag to protect it from light.
The vial is for single use only. Therefore, any unused reconstituted concentrate should be discarded immediately.

6. Package contents and other information

What Micafungina Reig Jofre contains
The active substance is micafungin (as sodium salt). One vial contains micafungin sodium
equivalent to 50 mg or 100 mg of micafungin (as sodium salt).

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

Description of the appearance of Micafungina Reig Jofre and contents of the pack
Micafungina Reig Jofre 50 mg and 100 mg powder for concentrate for solution for infusion is a
white to off-white powder. Micafungina Reig Jofre is supplied in packs of 1 vial.
Marketing Authorisation Holder
Laboratorio Reig Jofre, S.A.
Gran Capitán, 10
08970 Sant Joan Despí (Barcelona)
Spain
Manufacturer
Laboratorio Reig Jofre, S.A.
Gran Capitan 10
08970 Sant Joan Despí (Barcelona)
Spain
This medicinal product is authorised in the Member States of the European Economic Area under the
following names:
Italy: Micafungina Reig Jofre 50 mg powder for concentrate for solution for infusion
Micafungina Reig Jofre 100 mg powder for concentrate for solution for infusion
Sweden: Micafungin Bioglan 50 mg powder for concentrate for solution for infusion
Micafungin Bioglan 100 mg powder for concentrate for solution for infusion
Spain: Micafungina Sala 50 mg powder for concentrate for solution for perfusion EFG
Micafungina Sala 100 mg powder for concentrate for solution for perfusion EFG
Portugal: Micafungina Reig Jofre 50 mg powder for concentrate for solution for perfusion
Micafungina Reig Jofre 100 mg powder for concentrate for solution for perfusion
France: Micafungine Reig Jofre 50 mg, powder for solution to be diluted for perfusion
Micafungine Reig Jofre 100 mg, powder for solution to be diluted for perfusion
Poland: Micafungin Reig Jofre 50 mg powder for preparation of infusion concentrate solution
Micafungin Reig Jofre 100 mg powder for preparation of infusion concentrate solution
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (https://www.aifa.gov.it/)

The following information is intended exclusively for healthcare professionals:
Micafungina Reig Jofre must not be mixed or infused together with other products except those indicated below. Micafungina Reig Jofre should be reconstituted and diluted at room temperature and under aseptic conditions as follows:

1. Remove the plastic cap from the vial and disinfect the stopper with alcohol.
2. Slowly inject, along the inner wall and under aseptic conditions, 5 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion into each vial (drawn from a 100 ml infusion bottle/bag). Even though foam may form in the concentrate, utmost care must be taken to minimize the amount of foam generated. A sufficient number of Micafungina Reig Jofre vials must be reconstituted 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. Aspirate the entire reconstituted concentrate from each vial and transfer it into the infusion bottle/bag from which the diluent was originally drawn. The diluted infusion solution must be used immediately. Chemical and physical in-use stability of the solution has been demonstrated for 96 hours at 25°C and for 24 hours at 2-8°C, provided it is protected from light and diluted as described above.
5. Gently invert the infusion bottle/bag to facilitate dispersion of the diluted solution, but DO NOT shake to avoid foaming. The solution must not be used if it appears cloudy or if precipitation occurs.
6. Place the infusion bottle/bag containing the diluted infusion solution into an opaque bag with closure capability to protect it from light. Preparation of the infusion solution