Fosfocin 8 g powder for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Fosfocina 8 g powder for solution for infusion

Fosfomycin

Read the entire 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, consult 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 they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Fosfocina is and what it is used for

Fosfocina contains the active substance fosfomycin. 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 important that you receive effective treatment for this condition.

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

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

2. What you need to know before using Fosfocina

Do not use Fosfocina

If you are allergic to fosfomycin or to any of the other components of this medicine (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 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

Fosfocina may cause serious adverse effects. These include allergic reactions, inflammation of the large intestine, and decreased white blood cell count. 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 Fosfocina

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

This is especially important if you are taking:

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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

Fosfocina may cause adverse effects such as confusion and weakness. If these occur, you must not drive or operate machinery.

Fosfocina contains sodium (supplied by the active substance)

This medicine contains 2,664 mg of sodium (main component of table/cooking salt) per vial. This corresponds to 133% of the maximum daily intake of sodium recommended for an adult.

3. How to use Fosfocina

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

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

Dosage

The dose you will receive and how often it is given 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.

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

Normally, the infusion will last 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 your treatment should last, depending on how quickly you improve. In treating bacterial infections, it is important to complete the entire course of treatment. Treatment should continue for a few more days after fever has disappeared and symptoms have subsided.

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

If you receive more Foscavir than you should

It is unlikely that a doctor or nurse would administer too much of this medicine. If you think you have been given an excessive amount of this medicine, ask them 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 will experience 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 may indicate that you have a serious intestinal inflammation. Do not take anti-diarrhoeal medicines that inhibit intestinal movements (antiperistaltics).
• Yellowing of the skin or the white part of the eye (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 (common: 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 (common: may affect up to 1 in 10 people).
• You bleed or bruise more easily than usual, or suffer more infections than usual. This could be due to a low number of white blood cells or platelets in your blood (frequency not known).

Other adverse effects may include:

Common 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, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fosfocina

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

This medicine does not require special storage conditions.

Keep the vial tightly 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 must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Fosfocina

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

• The other components are: succinic acid.

Appearance of the product and contents of the container

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

Marketing Authorization Holder

Laboratorios ERN, S.A.

Perú, 228

08020 Barcelona, Spain.

Manufacturer

Laboratorios ERN, S.A.

Gorgs Lladó, 188

08210 Barberà del Vallès, Barcelona, Spain.

or

Fisiopharma, S.r.l.

Nucleo Industriale

84020 Palomonte, Italy.

Date of the most recent revision of this summary: November 2022

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 under aseptic conditions, using the following compatible solvents: sodium chloride 0.9% for infusion, 5% or 10% glucose solution for infusion, or Ringer's lactate solution for infusion.

Dissolve the contents of the 8 g vial with 40 ml of solvent. Transfer into a container with 210 ml of solvent to obtain a total volume of 250 ml, and administer as a 60-minute infusion.

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

The reconstituted solution is clear with a slightly yellowish tint.

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

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

In cases of renal impairment, a dose reduction and prolonged administration time should be applied. The following dosage regimen may be used:

The dose is expressed as a percentage of the dose that would have been considered appropriate 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 must not exceed 8 g.

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