Package Insert: Information for the Patient

Fosfocina 8 g Powder for Solution for Infusion

Fosfomicina

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist or nurse.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Fosfocina contains the active ingredient fosfomicina. 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 Fosfocina to help your body fight an infection. It is essential that you receive effective treatment for this condition.

Fosfocina 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, referred to 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 Fosfocina

If you are allergic to fosfomicin 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 Fosfocina 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 for

Fosfocina 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 problems. See "Severe side effects" in section 4.

Other medications and Fosfocina

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication, even if it is an over-the-counter medication.

This is especially important if you are taking:

•anticoagulants, as fosfomicin 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.

Fosfomicin may pass into the fetus or through breast milk. If you are pregnant or breastfeeding, your doctor will only prescribe this medication when it is strictly necessary.

Driving and operating machinery

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

Fosfocina contains sodium (provided by the active ingredient)

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

Fosfocina 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.

Fosfocina is administered intravenously (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 Fosfocina 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 when 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:

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

− Alteration of taste

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

− Mild dizziness, vomiting, or 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 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 the 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.

This medication does not require special storage conditions.

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

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. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Fosfocina

• The active principle is fosfomicin. Each vial contains 8 g of fosfomicin in the form of fosfomicin sodium.

• The other components are: succinic acid.

Appearance of the product and contents of the package

Fosfocina is presented in a glass vial containing a white or almost white powder. Each box contains 10 vials.

Marketing Authorization Holder

Laboratorios ERN, S.A.

Perú, 228

08020 Barcelona, Spain.

Responsible for manufacturing

Laboratorios ERN, S.A.

Gorgs Lladó, 188

08210 Barberá del Vallés, Barcelona. Spain.

or

Fisiopharma, S.r.l.

Nucleo Industriale

84020 Palomonte, Italy.

Last review date of this leaflet: November 2022

The detailed and updated information of this medicine 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 in aseptic conditions, using the following compatible solvents: saline solution for infusion (NaCl 0.9%), glucose solution for infusion at 5 or 10%, or Ringer Lactate solution for infusion.

Dissolve the contents of the 8 g vial with 40 ml of solvent. Pass to a container with 210 ml of solvent, to obtain a total volume of 250 ml, and put on a 60-minute infusion.

When dissolving fosfomicin, 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 (of low-density polyethylene to which a polypropylene capsule with an elastomer membrane is added) has been demonstrated for 24 hours at 25°C/60% HR with light and for 7 days at a temperature of 2°C – 8°C.

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

In the case of renal insufficiency, apply a dose reduction and an increase in administration time. To do this, the following dosage regimen 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 Cockgroft-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 fosfomicin at the end of each dialysis session.