Prospect: information for the patient

Fosfomicin Level 4 g powder for solution for infusion

Read this prospect carefully before starting to use this medication, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist or nurse.

-This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience adverse effects, consult your doctor or pharmacist or nurse, even if they are not listed in this prospect. See section 4.

Fosfomicina Level contains the active ingredient fosfomicina. It belongs to a group of medicines called antibiotics. It acts by eliminating certain types of germs (bacteria) that can cause severe infectious diseases. Your doctor has decided to treat you with Fosfomicina Level to help your body fight an infection. It is essential that you receive an effective treatment for this condition.

Fosfomicina 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 underlying tissues

the central nervous system

the abdomen

the blood, originating from any of the previously mentioned conditions.

No use Fosfomicina Level

If you are allergic to fosfomicina or any of the other components of this medication (listed in section 6).

Warnings and Precautions

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

• Heart problems (heart failure), especially if you are taking digitalis medications (due to possible hypopotasemia)

• High blood pressure (hypertension)

• A certain hormonal system disorder (hyperaldosteronism)

• High levels of sodium in the blood (hypernatremia)

• Fluid accumulation in the lungs (pulmonary edema)

• Kidney problems. Your doctor may need to adjust the medication dosage (see section 3 of this leaflet)

• Previous episodes of diarrhea after taking or being given any other antibiotic.

Symptoms to Watch Out For

Fosfomicina Level may cause severe 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 medication, in order to reduce the risk of complications. See "Severe Side Effects" in section 4.

Other Medications and Fosfomicina Level

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

This is especially important if you are taking:

•Anticoagulants, as fosfomicina and other antibiotics may alter your ability to prevent blood clotting.

Pregnancy and Breastfeeding

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

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

Driving and Operating Machines

When fosfomicina level is administered, side effects such as confusion and weakness may occur. If these occur, do not drive or operate machines.

Fosfomicina Level Contains Sodium

This medication contains 1.333 mg of sodium (provided by the active ingredient) in each vial.This is equivalent to 67% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Fosfomicina Level is administered intravenously (infusion) by a doctor or nurse.

Dosage

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

− The type and severity of the infection you have

− Your renal 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 medication.

Route andform of administration

For intravenous use.

Fosfomicina Level is administered through a vein (infusion) by a doctor or nurse.

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

Treatment duration

Your doctor will decide how long the treatment should last based on how quickly you improve. In the treatment of infections caused by bacteria, it is essential to complete the entire treatment cycle. Treatment should continue for a few more days, even if the fever has disappeared and symptoms have subsided.

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

If you receive more Fosfomicina Level than you should

It is unlikely that a doctor or nurse will administer too much medication. If you think you have received an excessive amount of this medication, ask immediately.

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

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

Severe side effects

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

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

− Severe or persistent diarrhea, which may be accompanied by abdominal pain or fever (frequency not known). It may be indicative of severe intestinal inflammation. Do not take medications against diarrhea that prevent intestinal movement (antiperistaltics).

− Yellowing of the skin or the white part of the eye (jaundice, frequency not known). It may be an initial sign of liver problems.

− Confusion, muscle cramps, or abnormal heart rhythm. They could be caused by high levels of sodium in the blood or low levels of potassium in the blood (frequent: may affect up to 1 in 10 people).

Inform 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 experiencing more frequent infections than usual. This could be due to having a low number of white blood cells or platelets in the blood (frequency not known).

Other side effects may include:

Side effects that are frequent (may affect up to 1 in 10 people)

−Alteration of taste

Side effects that are infrequent (may affect up to 1 in 100 people)

−Mild dizziness, vomiting, or diarrhea

−Headache

−Elevated liver enzyme levels in the blood, possibly associated with liver problems

−Eruption

−Dizziness

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

−Liver problems (hepatitis)

−Itching, hives

Reporting 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: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.

No special storage conditions are required.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

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Composition of Fosfomicina Level

• The active ingredient is fosfomicina.Each vial contains 4 g of fosfomicina in the form of fosfomicina sodium.
• The other components are succinic acid.

Appearance of the product and contents of the packaging

Fosfomicina Level is presented in a glass vial containing a white or almost white powder. The available formats are:

• Standard packaging: 1 vial
• Clinical packaging: 50 vials

Marketing Authorization Holder

LABORATORIOS ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain

Manufacturing Responsible Parties

FISIOPHARMA, S.r.l.

Nucleo industriale. 84020

Palomonte (SA)

Codice Fiscale: 02580140651

LABORATORIOS ERN, S.A.

Gorgs Lladó, 188 – 08210 Barberá del Vallés, Barcelona. Spain

Last review date of this leaflet: January 2023.

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

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This information is intended solely for healthcare professionals:

The reconstitution of the solution must be performed at the time of intravenous administration.

Dissolve the contents of the 4 g vial with 20 ml of water for injectable preparations or glucose solution. Transfer to a container with 200 ml of water for injectable preparations or glucose solution and administer by infusion over a 1-hour period.

When dissolving fosfomicina, an exothermic reaction occurs, resulting in the release of heat, which causes the vial to warm slightly.