Prospecto: information for the user

Caspofungina Normon 50 mg powder for concentrate for solution forinfusion EFG

Caspofungina

Read this prospectus carefully before you or your child start using this medicine, because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus. See section4.

1.What isCaspofungina Normonand for what it is used

2.What you need to know before starting to useCaspofungina Normon

3.How to useCaspofungina Normon

4.Possible adverse effects

5.Storage ofCaspofungina Normon

6.Contents of the package and additional information

What isCaspofungina Normon

Caspofungina Normoncontains a medicine called caspofungin. This belongs to a group of medicines called antifungals.

What is Caspofungina Normon used for

Caspofungina Normonis used to treat the following fungal infections in children, adolescents, and adults:

• Fungal infections that are severe in tissues or organs (designated as “invasive candidiasis”). This infection is caused by fungal cells (yeast) called Candida.

People who may be at risk of this type of infection include those who have recently undergone surgery or those whose immune system is weakened. Fever and chills that do not respond to antibiotic treatment are the most common symptoms of this type of infection.

• Fungal infections in the nose, nasal sinuses, or lungs (designated as “invasive aspergillosis”) if other antifungal treatments have not worked or have caused side effects. This infection is caused by molds called Aspergillus.

People who may be at risk of this type of infection include those who are receiving chemotherapy, those who have undergone a transplant, and those whose immune system is weakened.

• Presumed fungal infections if you have fever and a low white blood cell count, which have not improved with antibiotic treatment. People who are at risk of developing a fungal infection include those who have recently undergone surgery or those whose immune system is weakened.

How it worksCaspofungina Normon

Caspofungina Normonmakes fungal cells fragile and prevents the fungus from growing properly. This prevents the infection from spreading and gives the body's natural defenses the opportunity to completely get rid of the infection.

No use Caspofungina Normon

• If you are allergic to caspofungin or any of the other components of this medication (listed in section6).

If you are unsure, consult your doctor, pharmacist, or nurse before starting to use your medication.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use caspofungin if:

• You are allergic to any other medication.
• You have ever had liver problems; you may need a different dose of this medication.
• You are already taking ciclosporin (used toprevent organ transplant rejectionor to cause a suppression of your immune system), as your doctor may need to perform additional blood tests during treatment.

• You have ever had any other medical condition.

If any of the above points apply to you (or you are unsure), consult your doctor, pharmacist, or nurse before starting to use caspofungin.

Caspofungin may also cause severe skin reactions, such as Stevens-Johnson syndrome (SSJ) and toxic epidermal necrolysis (NET).

Use of Caspofungina Normon with other medications

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication. This includes medications obtained without a prescription, including herbal remedies.This is because caspofungin may affect how other medications work. Other medications may also affect how caspofungin works.

Inform your doctor, pharmacist, or nurse if you are taking any of the following medications:

• Ciclosporin or tacrolimus (used toprevent organ transplant rejectionor to cause a suppression of your immune system), as your doctor may need to perform additional blood tests during your treatment.
• Some HIV medications such as efavirenz or nevirapina.
• Phenobarbital or carbamazepine(used to treat seizures).
• Dexamethasone (a steroid).
• Rifampicin (an antibiotic).

If any of the above points apply to you (or you are unsure), consult your doctor, pharmacist, or nurse before starting to use caspofungin.

Pregnancy and breastfeeding

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

• Caspofungin has not been studied in pregnant women. It should only be used during pregnancy if the potential benefits outweigh the possible risks to the developing fetus.
• Women using caspofungin should not breastfeed.

Driving and operating machinery

There is no information to suggest that caspofungin affects your ability to drive or operate machinery.

Caspofungina Normon contains sodium

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

Caspofungina will always be prepared and administered by a healthcare professional.

Caspofungina will be administered to you:

• Once a day.
• Through slow injection into a vein (intravenous infusion).
• For approximately 1 hour.

Your doctor will determine the duration of treatment and the amount of caspofungina to be administered each day. Your doctor will monitor if the medication's effect is adequate. If you weigh more than 80 kg, you may need a different dose.

Use in children and adolescents

The dosage for children and adolescents may be different from the adult dosage.

If you use more Caspofungina Normon than you should

Your doctor will decide how much caspofungina you need and for how long each day. If you are concerned that you may have been given too much caspofungina, inform your doctor or nurse immediately.

In case ofoverdose, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested

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

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

Consult your doctor or nurse immediately if you notice any of the following side effects – you may need urgent medical treatment:

• Rash, itching, feeling of heat, swelling of your face, lips or throat, or difficulty breathing: you may be having a histamine reaction to the medicine.
• Difficulty breathing with wheezing or worsening of an existing rash: you may be having an allergic reaction to the medicine.
• Cough, severe breathing difficulties: if you are an adult and have invasive aspergillosis, you may experience a severe respiratory problem that could lead to respiratory failure.
• Rash, skin peeling, mouth membrane sores, hives, large areas of skin peeling.

As with any prescription medication, some side effects can be serious. Ask your doctor for more information.

Other side effects in adults include

Common: can affect up to 1in every10people:

• Decreased hemoglobin (decrease in the substance that carries oxygen in the blood), decreased white blood cells.
• Decreased albumin (a type of protein) in your blood, decreased potassium or low potassium levels in the blood.
• Headache.
• Vein inflammation.
• Lack of breath.
• Diarrhea, nausea, or vomiting.
• Changes in some laboratory blood tests (such as increased values in some liver function tests).
• Itching, rash, redness of the skin, or excessive sweating.
• Joint pain.
• Chills, fever.
• Itching at the injection site.

Uncommon: can affect up to 1in every100people:

• Changes in some laboratory blood tests (including blood clotting disorders, platelets, red blood cells, and white blood cells).
• Loss of appetite, increased body fluid, electrolyte imbalance, high blood sugar, low calcium levels in the blood, high calcium levels in the blood, low magnesium levels in the blood, increased blood acidity.
• Disorientation, feeling of nerves, unable to sleep.
• Feeling of dizziness, decreased sensations or sensitivity (especially in the skin), restlessness, feeling of sleepiness, change in the way things taste, tingling or numbness.
• Blurred vision, increased tearing, swollen eyelid, yellow discoloration of the white part of the eyes.
• Feeling of rapid or irregular heartbeats, rapid heartbeat, irregular heartbeat, abnormal heart rhythm, heart failure.
• Rubor, hot flashes, high blood pressure, low blood pressure, redness along a vein that is very sensitive to the touch.
• Tension in the muscle bands around the airways, leading to wheezing or coughing, rapid breathing, shortness of breath that wakes you up, low oxygen levels in the blood, abnormal respiratory sounds, crepitant sounds in the lungs, wheezing, nasal congestion, cough, sore throat.
• Abdominal pain, upper abdominal pain, abdominal swelling, constipation, difficulty swallowing, dry mouth, indigestion, gas passing, stomach discomfort, swelling due to fluid accumulation around the abdomen.
• Decreased bile flow, enlarged liver, yellow discoloration of the skin and/or white part of the eyes, liver damage caused by a medication or chemical compound, liver disorder.
• Abnormal skin tissue, generalized itching, hives, rash of varying appearance, abnormal skin, red patches, often with itching, on arms and legs and sometimes on the face and rest of the body.
• Back pain, pain in an arm or leg, bone pain, muscle pain, muscle weakness.
• Renal function loss, sudden loss of renal function.
• Pain at the catheter site, symptoms at the injection site (redness, hard lump, pain, swelling, irritation, rash, hives, fluid leakage from the catheter into the tissue), vein inflammation at the injection site.
• Increased blood pressure and alterations in some laboratory blood tests (such as kidney function tests and coagulation tests), increased levels of medications you are taking that weaken the immune system.
• Chest discomfort, chest pain, feeling of change in body temperature, feeling generally unwell, general pain, facial swelling, ankle, hand, or foot swelling, swelling, pain on palpation, feeling of fatigue.

Other side effects in children and adolescents

Very common:can affect more than1in every10people:

• Fever.

Common:can affect up to1in every10people:

• Headache.
• Rapid heartbeat.
• Rubor, low blood pressure.
• Changes in some laboratory blood tests (increased values in some liver function tests).
• Itching, rash.
• Pain at the catheter site.
• Chills.
• Changes in some laboratory blood tests.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.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 packaging and vial (after “CAD”). The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°C).

Caspofungin Normon does not contain preservatives. From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times in use and conditions before use are the responsibility of the user and should not be greater than 24 hours between 2 and 8 °C, unless reconstitution and dilution have taken place in controlled and validated aseptic conditions.

Only a trained healthcare professional who has read the complete instructions should prepare the medication (see later “Instructions for reconstituting and diluting Caspofungin Normon”).

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition ofCaspofungin Normon

• The active ingredient is caspofungin. Each vial of Caspofungin Normon contains 50 mg of caspofungin.
• The other components are sucrose, mannitol, glacial acetic acid and sodium hydroxide (see section 2. What you need to know before starting to use Caspofungin Normon).

Appearance of the product and contents of the pack

Caspofungin Normon is a compact, sterile, white to off-white powder.

Each pack contains a vial of powder.

Holder of the marketing authorisation and manufacturer responsible

This information is intended solely for healthcare professionals:

Instructions for reconstituting and diluting Caspofungin Normon:

Reconstitution of Caspofungin Normon

DO NOT USE DILUENTS CONTAINING GLUCOSE, as Caspofungin Normon is not stable in diluents containing glucose. DO NOT MIX OR INFUSE CASPOFUNGIN NORMON CONCURRENTLY WITH ANY OTHER MEDICINE, as there are no data on the compatibility of Caspofungin Normon with other substances, additives or intravenous pharmaceutical specialties. The infusion solution must be visually inspected for solid particles or a change in color.

INSTRUCTIONS FOR USE IN ADULT PATIENTS

Step 1 Reconstitution of vials

To reconstitute the powder, bring the vial to room temperature and add asetically 10.5 ml of water for injection. The concentration of the reconstituted vial will be 5.2 mg/ml.

The compact, lyophilized powder of white to off-white color will dissolve completely. Gently mix until a transparent solution is obtained. The reconstituted solutions must be visually inspected for solid particles or a change in color. The reconstituted solution can be stored for a maximum of 24 hours at a temperature equal to or less than 25 °C.

Step 2 Addition of reconstituted Caspofungin Normon to the patient's infusion solution

The diluents for the final infusion solution are: sodium chloride solution for injection or Ringer lactate solution. The infusion solution is prepared by adding asetically the appropriate amount of the reconstituted concentrate (as shown in the table below) to a 250 ml infusion bag or bottle. Reduced volume infusions of 100 ml may be used if medically necessary for doses of 50 mg or 35 mg. Do not use if the solution is turbid or has precipitated.

PREPARATION OF THE INFUSION SOLUTION FOR ADULTS

*10.5ml must be used for the reconstitution of all vials

INSTRUCTIONS FOR USE IN PEDIATRIC PATIENTS

CALCULATION OF BODY SURFACE AREA (SC) FOR PEDIATRIC DOSING

Before preparing the infusion, calculate the body surface area (SC) of the patient using the following formula: (Mosteller formula[1])

PREPARATION OF THE INFUSION OF 70mg/m2FOR PATIENTS >3MONTHS (USING A 50MG VIAL)

1.Determine the actual loading dose to be used in the pediatric patient using the patient's SC (as calculated above) and the following equation:

SC(m2)X70mg/m2=loading dose

The maximum loading dose on day 1 should not exceed 70 mg regardless of the dose calculated for the patient.

2.Wait for the refrigerated vial of Caspofungin Normon to reach room temperature.

3.Add asetically 10.5ml of water for injection.aThis reconstituted solution can be stored for up to 24 hours at a temperature equal to or less than 25 °C.bThis will result in a final concentration of caspofungin in the vial of 5.2mg/ml.

4.Extract from the vial a volume of the medicine equal to the loading dose calculated (Step1). Transfer asetically this volume (ml)cof reconstituted Caspofungin Normon to an IV bag (or bottle) that contains 250ml of sodium chloride solution for injection or Ringer lactate solution. Alternatively, the volume (ml)cof reconstituted Caspofungin Normon can be added to a reduced volume of sodium chloride solution for injection or Ringer lactate solution, without exceeding a final concentration of 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at a temperature equal to or less than 25 °C or within 48 hours if stored refrigerated between 2 and 8 °C.

PREPARATION OF THE INFUSION OF 50MG/M2FOR PATIENTS >3MONTHS (USING A 50MG VIAL)

1.Determine the actual daily maintenance dose to be used in the pediatric patient using the patient's SC (as calculated above) and the following equation:

SC(m2)X50mg/m2=daily maintenance dose

The daily maintenance dose should not exceed 70 mg regardless of the dose calculated for the patient.

2.Wait for the refrigerated vial of Caspofungin Normon to reach room temperature.

3.Add asetically 10.5ml of water for injection.aThis reconstituted solution can be stored for up to 24 hours at a temperature equal to or less than 25 °C.bThis will result in a final concentration of caspofungin in the vial of 5.2mg/ml.

4.Extract from the vial a volume of the medicine equal to the daily maintenance dose calculated (Step1). Transfer asetically this volume (ml)cof reconstituted Caspofungin Normon to an IV bag (or bottle) that contains 250ml of sodium chloride solution for injection or Ringer lactate solution. Alternatively, the volume (ml)cof reconstituted Caspofungin Normon can be added to a reduced volume of sodium chloride solution for injection or Ringer lactate solution, without exceeding a final concentration of 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at a temperature equal to or less than 25 °C or within 48 hours if stored refrigerated between 2 and 8 °C.