Fosfocin 1 g powder and solvent for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Fosfocina 1 g powder and solvent 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 must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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 adverse 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 bacterial infections of the:

• urinary tract
• heart, sometimes referred to as “endocarditis”
• bones and joints
• lungs, known as “pneumonia”
• skin and underlying tissues
• central nervous system
• abdomen
• blood, 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

Talk to your doctor, pharmacist, or nurse before using Fosfocina if you have any of the following conditions:

• heart problems (heart failure), especially if you are taking digitalis medications (due to possible hypokalemia)
• high blood pressure (hypertension)
• a specific 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 dose of the medicine (see section 3 of this leaflet)
• previous episodes of diarrhea 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 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 Fosfocina

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 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

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

Fosfocina contains sodium (supplied by the active substance)

This medicine contains 333 mg of sodium (main component of table/cooking salt) per vial. This corresponds to 17% of the maximum daily recommended sodium intake 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. Fosfocina 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 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 require dialysis, your doctor may need to reduce the dose of this medicine.

Route and method of administration

For intravenous use.

Fosfocina is administered into a vein (by infusion) 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 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 treating bacterial infections, it is important to complete the entire course of treatment. Treatment should continue for a few more days after fever has subsided and symptoms have resolved.

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

If you receive more Fosfocina than you should

It is unlikely that the doctor or nurse will administer too much medicine. If you think you have received 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 could be a sign of a serious intestinal inflammation. Do not take anti-diarrhoeal medicines that stop intestinal movement (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 (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 normal. 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
• High levels of liver enzymes in the blood, possibly associated with liver problems
• Rash
• Weakness

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

• Liver problems (hepatitis)
• Itching, hives

Reporting of adverse effects

If you experience any type of 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 Fosfocina

Keep this medicine out of sight and reach of children.

Store in a dry place.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to 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 collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fosfocina

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

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

Appearance of the medicine and contents of the pack

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

• Standard pack: 1 vial + 1 solvent ampoule
• Clinical pack: 50 vials + 50 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 Barberà del Vallès, Barcelona, Spain

Date of the most recent review of this leaflet: February 2023.

Detailed and up-to-date information on this medicine 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:

The solution must be reconstituted immediately before intravenous administration.

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

When dissolving fosfomycin, an exothermic reaction occurs, releasing heat and causing the vial to warm up slightly.