Fosfomycin Level 1 g powder and solvent for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Fosfomycin Level 1 g powder and solvent 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, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if these are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

Fosfomycin Level is used in adults, adolescents, and children to treat bacterial infections of:

• 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, when originating from any of the aforementioned conditions.

2. What you need to know before using Fosfomicina Level

Do not use fosfomycin Level

If you are allergic to fosfomycin or to 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 conditions:

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

Symptoms to watch for

Fosfomycin Level may cause serious adverse 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 in order to reduce the risk of complications. See “Serious adverse effects” in section 4.

Other medicines and Fosfomycin Level

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, even those obtained without a prescription.

This is especially important if you are taking:

• anticoagulants, as fosfomycin and other antibiotics could alter your blood's ability to clot.

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 prescribe this medicine only if strictly necessary.

Driving and using machines

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

Fosfomycin Level contains sodium (supplied by the active ingredient)

This medicine contains 333 mg of sodium (the main component of table/cooking salt) per vial. This corresponds to 17% of the maximum daily sodium intake recommended for an adult.

3. How to use Fosfomicina Level

Follow exactly the instructions given by your doctor or pharmacist for the administration of this medicine. If in doubt, consult your doctor or pharmacist again.

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

Dosage

The dose you will receive and how often it is given will depend on:

• The type and severity of your infection
• Your kidney function

In children, it also depends on:

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

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

Route and method of administration

For intravenous use.

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

The infusion usually lasts between 15 and 60 minutes, depending on the dose administered. In general, this medicine is given 2, 3, or 4 times a day.

Duration of treatment

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

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

If you receive more Fosfomicina Level than you should

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effects

Tell your doctor immediately if you notice any of the following serious adverse 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 may include: difficulty breathing or swallowing, sudden wheezing, dizziness, swelling of the eyelids, face, lips, or tongue, rash, or itching.
• Severe or persistent diarrhoea, which may be accompanied by abdominal pain or fever (frequency not known). This could be a sign of serious intestinal inflammation. Do not take anti-diarrhoeal medicines that inhibit intestinal movements (antiperistaltics).
• Yellowing of the skin or the whites of the eyes (jaundice, frequency not known). This may be an early sign of liver problems.
• Confusion, muscle cramps, or abnormal heart rhythm. These could be caused by high levels of sodium or low levels of potassium 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 adverse effects:

• Pain, burning, redness, or swelling around the vein used for infusion of this medicine (frequent: may affect up to 1 in 10 people).
• You bleed or bruise more easily than usual, or you get more infections than usual. This could be due to low levels of white blood cells or platelets in your blood (frequency not known).

Other adverse effects may include:

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

• Taste disturbance

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

• Dizziness, vomiting, or mild diarrhoea
• Headache
• Increased liver enzyme levels in the blood, possibly associated with liver problems
• Rash
• Weakness

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

• Liver problems (hepatitis)
• Itching, hives   Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse 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.

No special storage conditions are required.

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 must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Fosfomicina Level

• The active substance is fosfomycin. Each vial contains 1 g of fosfomycin in the form of sodium fosfomycin.

• The other components are succinic acid and water for injections.

Appearance of the product and contents of the container

Fosfomicina Level is supplied as a glass vial containing a white or almost white powder and an ampoule of glass containing 10 ml of water for injections. The available pack sizes are:

• Standard pack: 1 vial + 1 solvent ampoule
• Hospital pack: 100 vials + 100 solvent ampoules

Marketing Authorization Holder

LABORATORIOS ERN, S.A.
Perú, 228 - 08020 Barcelona, Spain

Manufacturers

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

Date of the most recent review of this summary: January 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

This information is intended for healthcare professionals only:

Reconstitution of the solution must be performed immediately prior to intravenous administration.

Dissolve the contents of the 1 g vial with the 10 ml of solvent from the ampoule. Withdraw the volume corresponding to the appropriate dose. Dilute with water for injections or glucose solution at a ratio of 4 ml per 1 ml of the previously prepared solution. Administer via a 1-hour infusion.

Dissolving fosfomycin produces an exothermic reaction, resulting in heat release, which may cause the vial to warm slightly.