FOSFOMICINA LEVEL 8 G POWDER FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Fosfomycin Level 8 g Powder for Solution for Infusion

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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

1. What is Fosfomycin Level and what is it used for

Fosfomycin Level contains the active substance fosfomycin. It belongs to a group of medicines called antibiotics. It works by killing certain types of germs (bacteria) that can cause serious infectious diseases. Your doctor has decided to treat you with Fosfomycin Level to help your body fight an infection. It is essential that you receive effective treatment for this condition.

Fosfomycin Level is used in adults, adolescents, and children to treat infections caused by bacteria in:

• the urinary tract
• the heart, sometimes referred to as "endocarditis"
• the bones and joints
• the lungs, known as "pneumonia"
• the skin and tissues under the skin
• the central nervous system
• the abdomen
• the blood, when originating from any of the aforementioned conditions.

2. What you need to know before you use Fosfomycin Level

Do not use Fosfomycin Level

If you are allergic to fosfomycin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Fosfomycin Level if you have any of the following disorders:

• heart problems (heart failure), especially if you are taking digitalis medicines (due to possible hypokalemia)
• high blood pressure (hypertension)
• a specific hormonal disorder (hyperaldosteronism)
• high sodium levels in the blood (hypernatremia)
• fluid accumulation in the lungs (pulmonary edema)
• kidney problems. Your doctor may need to adjust the dose of the medicine (see section 3 of this leaflet)
• previous episodes of diarrhea after taking or being administered any other antibiotic.

Symptoms to which you should pay attention

Fosfomycin Level can cause serious side effects. These include allergic reactions, inflammation of the large intestine, and a decrease in the number of white blood cells. You should pay attention to certain symptoms while taking this medicine to reduce the risk of problems. See "Serious side effects" in section 4.

Other medicines and Fosfomycin Level

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those bought without a prescription.

This is especially important if you are taking:

• anticoagulants, as fosfomycin and other antibiotics may alter their ability to prevent blood clotting.

Pregnancy and breastfeeding

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

Fosfomycin may pass to the baby in the womb or through breast milk. If you are pregnant or breastfeeding, your doctor will only prescribe this medicine when strictly necessary.

Driving and using machines

When Fosfomycin Level is administered, side effects such as confusion and weakness may occur. If these occur, you should not drive or operate machinery.

Fosfomycin Level contains sodium (supplied by the active ingredient)

This medicine contains 2.664 mg of sodium (main component of table salt/cooking salt) in each vial. This is equivalent to 133% of the maximum recommended daily sodium intake for an adult.

3. How to use Fosfomycin Level

Follow exactly the administration instructions of this medicine as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Fosfomycin Level is administered intravenously (drip) by a doctor or nurse.

Dosage

The dose you receive and the frequency of it will depend on:

• The type and severity of the infection you have
• Your kidney function

In children, it also depends on:

• The child's weight
• The child's age

If you have kidney problems or need dialysis, your doctor may need to reduce the dose of this medicine.

Route and method of administration

For intravenous use.

Fosfomycin Level is administered in a vein (drip) by a doctor or nurse.

Normally, the infusion will last between 15 and 60 minutes, depending on the dose administered. In general, this medicine is administered 2, 3, or 4 times a day.

Duration of treatment

Your doctor will decide how long the treatment should last based on how quickly your condition improves. In the treatment of bacterial infections, it is essential to complete the entire treatment cycle. The treatment should continue for a few days after the fever has disappeared and the symptoms have subsided.

Some infections, such as bone infections, may require a longer treatment period once the symptoms have subsided.

If you receive more Fosfomycin Level than you should

It is unlikely that your doctor or nurse will administer too much medicine. If you think you have received too much of this medicine, ask them immediately.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Tell your doctor immediately if you notice any of the following serious side effects: you may need urgent medical treatment:

Signs of a severe allergic reaction (very rare: may affect up to 1 in 10,000 people). These can include: difficulty breathing or swallowing, sudden wheezing, dizziness, swelling of the eyelids, face, lips, or tongue, rash, or itching.

• Severe or persistent diarrhea, which may be accompanied by abdominal pain or fever (frequency not known). This could be indicative of severe intestinal inflammation. Do not take medicines against diarrhea that stop intestinal movement (antiperistaltics).
• Yellowing of the skin or the white part of the eye (jaundice, frequency not known). This could be an initial sign of liver problems.
• Confusion, muscle cramps, or abnormal heart rhythm. These could be caused by high sodium levels in the blood or low potassium levels in the blood (frequent: may affect up to 1 in 10 people).

Tell your doctor or nurse as soon as possible if you notice any of the following side effects:

• Pain, burning, redness, or swelling around the vein used during the infusion of this medicine (frequent: may affect up to 1 in 10 people).
• Bleeding or bruising more easily or getting more infections than usual. This could be due to a low number of white blood cells or platelets in the blood (frequency not known).

Other side effects may include:

Frequent side effects (may affect up to 1 in 10 people)

• Taste disturbance

Uncommon side effects (may affect up to 1 in 100 people)

• Dizziness, vomiting, or mild diarrhea
• Headache
• High levels of liver enzymes in the blood, possibly associated with liver problems
• Rash
• Weakness

Side effects of unknown frequency (cannot be estimated from the available data)

• Liver problems (hepatitis)
• Itching, hives

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fosfomycin Level

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

This medicine does not require special storage conditions.

Keep the vial perfectly closed and store it in the outer packaging.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Fosfomycin Level

• The active ingredient is fosfomycin. Each vial contains 8 g of fosfomycin in the form of fosfomycin sodium.

• The other ingredients are: succinic acid.

Appearance of the product and pack contents

Fosfomycin Level is presented in a glass vial containing a white or almost white powder, inside a box.

Marketing authorization holder

Laboratorios ERN, S.A.

Perú, 228

08020 Barcelona, Spain

Manufacturer

Laboratorios ERN, S.A.

Gorgs Lladó, 188

08210 Barberá del Vallés, Barcelona, Spain

or

Fisiopharma, S.r.l.

Nucleo Industriale

84020 Palomonte, Italy.

Date of the last revision of this leaflet: June 2022.

Detailed and updated 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:

The reconstitution of the solution should be performed at the time of intravenous administration under aseptic conditions, using the following compatible solvents: saline solution for infusion (NaCl 0.9%), glucose solution 5% or 10% for infusion, or Ringer's Lactate solution for infusion.

Dissolve the contents of the 8 g vial with 40 ml of solvent. Transfer to a container with 210 ml of solvent to obtain a total volume of 250 ml and administer as an infusion over 60 minutes.

When dissolving fosfomycin, an exothermic reaction occurs with the consequent release of heat, causing the vial to warm slightly.

The reconstituted solution is clear and has a slightly yellowish color.

The physical-chemical stability of the reconstituted solution in the infusion bottle (low-density polyethylene with a polypropylene cap and an elastomer membrane) has been demonstrated for 24 hours at 25°C/60% RH with light and for 7 days at a temperature of 2°C - 8°C.

From a microbiological point of view, the solution should be used immediately after reconstitution/dilution. If not used immediately, the period and conditions of storage before use are the responsibility of the user and should not exceed 24 hours between 2 and 8°C, unless the method of dilution and reconstitution has been carried out under controlled and validated aseptic conditions.

In case of renal insufficiency, apply a dose reduction and an increase in administration time. For this, the following guideline can be applied:

aThe dose is expressed as a percentage of the dose that would have been considered adequate in the case of normal renal function of the patient, calculated according to the Cockcroft-Gault formula.

The first dose (loading dose) should be increased by 100%, but should not exceed 8 g.

Patients undergoing prolonged intermittent dialysis (every 48 hours) should receive 2 g of fosfomycin at the end of each dialysis session.