Package Insert: Information for the Patient

Fosfocina 250 mg/5 ml Powder for Oral Suspension

Fosfomicinacalcica

Read this package insert carefully before starting to take 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.
• This medication has been prescribed only for you and should not be given to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Fosfocina contains the active ingredient fosfomicin (as fosfomicin calcium). It is an antibiotic that acts by eliminating bacteria that can cause infections.

Fosfocina is used for the treatment of uncomplicated urinary tract infections in women.

Do not take Fosfocina

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 Fosfocina if you are in any of the following situations:

• You have persistent urinary tract infections,
• You have ever had diarrhea after taking any other antibiotic.

Symptoms to which you should pay attention

Fosfocina may cause severe side effects. For example, allergic reactions and inflammation of the large intestine. You should pay attention to certain symptoms while you are being treated with this medication, in order to reduce the risk of complications. See "severe side effects" in section 4.

Children and adolescents

This medication should not be administered to children under 12 years of age, as its safety and efficacy have not been established in this age group.

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:

• metoclopramidaor other medications that increase the movement of food through the stomach and intestines, as they may reduce the absorption of fosfomicina in your body,
• anticoagulants, as fosfomicina and other antibiotics may alter your ability to prevent blood clotting.

Taking Fosfocina with food and drinks

Food may delay the absorption of fosfomicina. Therefore, this medication should be taken on an empty stomach (2-3 hours before or 2-3 hours after a meal).

Pregnancy, breastfeeding, and fertility

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

If you are pregnant or breastfeeding, your doctor will only prescribe this medication when it is strictly necessary.

Driving and operating machinery

You may experience side effects, such as dizziness, that may affect your ability to drive or operate machinery.

Fosfocina contains fructose and sucrose

This medication contains 2,000 mg of fructose per 5 ml. If your doctor has told you that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication.

It also contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

For the treatment of uncomplicated urinary tract infections in women, the recommended dose is 2 teaspoons of 5 ml (500 mg of fosfomycin) or 4 teaspoons of 5 ml (1 g of fosfomycin) every 8 hours.

Fosfocina suspension is suitable for individuals with swallowing difficulties who cannot take Fosfocina 500 mg hard capsules.

Use in patients with renal insufficiency

This medication should not be used in patients with severe renal insufficiency (creatinine clearance <10

Use in children and adolescents

This medication should not be used in individuals under 12 years of age.

Administration form

For oral use.

This medication should be taken orally, with an empty stomach (approximately 2-3 hours before or 2-3 hours after a meal), the last dose preferably before bedtime and after urination.

To prepare the extemporaneous suspension, invert the bottle to release the powder adhering to the bottom. Add a little water and shake. Complete with water up to the line marked by the arrow on the label.

Record the preparation date in the corresponding box. Keep in mind the days of validity of the suspension once reconstituted (15 days). Shake always before using it.

For correct dosing, use the spoon included in the package.

If you take more Fosfocina than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Fosfocina

Do not take a double dose to compensate for the missed doses.

If you forget to take a dose, take the next one as soon as possible and continue as before.

If you interrupt the treatment with Fosfocina

Remember to take your medication. Your doctor will indicate the duration of your treatment with Fosfocina.

Do not interrupt the treatment, even if you feel better, unless your doctor tells you to.

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

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

Severe side effects

If during treatment with Fosfocina you experience any of the following symptoms, stop taking the medicine and contact your doctor immediately:

• anaphylactic shock, a potentially fatal allergic reaction (unknown frequency). Symptoms include sudden onset of hives, itching or urticaria, and/or shortness of breath, wheezing (emission of whistling sounds while breathing) or difficulty breathing,
• swelling of the face, lips, tongue, or throat with difficulty breathing (angioedema) (unknown frequency),
• moderate to severe diarrhea, abdominal cramps, bloody stools, and/or fever, which may indicate a large intestine infection (antibiotic-associated colitis) (unknown frequency). Do not take medications that prevent intestinal movement (antiperistaltics).

Other side effects

Frequent (may affect up to 1 in 10 people):

• headache
• dizziness
• diarrhea
• nausea
• indigestion
• abdominal pain
• female genital organ infection with symptoms such as inflammation, irritation, and itching (vulvovaginitis).

Infrequent (may affect up to 1 in 100 people):

• vomiting
• hives
• urticaria
• itching

Rare (may affect up to 1 in 1,000 people):

• anemia
• superinfections with bacteria resistant to the antibiotic

Unknown frequency (cannot be estimated from available data):

• allergic reactions
• visual disturbances
• loss of appetite
• inflammation of the veins
• increase in white blood cells and platelets
• appearance of petechiae (small skin vessel hemorrhages)
• alteration of liver enzymes

If during treatment you experience any of these reactions or other discomforts that you believe are related to the treatment, inform your doctor as soon as possible.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the 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.

This medication does not require special storage conditions. Once reconstituted, the suspension can be used for 15 days, keeping it below 25°C.

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 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 fosfomicina calcium. Each 5 ml of reconstituted suspension contains 250 mg of fosfomicina in the form of calcium salt.
• The other components are: saccharose palmitate (E-473), guar gum (E-412), banana essence, colloidal silica and fructose.

Appearance of the product and contents of the packaging

Fosfocina is presented in the form of a white powder for oral extemporaneous suspension, in amber glass bottles to prepare 60 ml or 120 ml of suspension, with an aluminum cap, along with a graduated spoon.

Holder of the marketing authorization

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.

Date of the last review of this leaflet: February 2022.

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/.