Package Insert: Information for the Patient

Fosfocina 500 mg Hard Capsules

Fosfomicina Calcium

Read this package insert carefully before taking this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side 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 fosfomycin 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:

• Suffer from persistent urinary tract infections,
• Have ever had diarrhea after taking any other antibiotic.

Symptoms to be aware of

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 problems. 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, including those purchased without a prescription.

This is especially important if you are taking:

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

Taking Fosfocina with food and drinks

Food may delay the absorption of fosfomycin. 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 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.

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 500 mg–1 g (1 or 2 capsules) every 8 hours.

For the treatment of people with swallowing difficulties (difficulty swallowing food or medication), it is recommended to use Fosfocina 250 mg/5 ml oral powder suspension.

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 children 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 going to bed and after urination.

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 treatment, even if you feel better, unless your doctor tells you to.

If you have any other questions 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 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 anti-diarrheal 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).

Less frequent (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
• phlebitis
• increased white blood cell and platelet count
• appearance of petechiae (small skin vessel hemorrhages)
• liver enzyme alterations

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 leaflet. You can also report them directly through the Spanish System for 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.

Store at room temperature.

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

Composition of Fosfocina

• The active ingredient is fosfomicina calcium. Each capsule contains 500 mg of fosfomicina in the form of calcium salt.
• The other components are: macrogol 6000.

Appearance of the product and content of the packaging

Fosfocina is presented in the form of hard gelatin capsules of red color for oral administration. Each package contains 12, 24 or 500 capsules.

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:September 2021.

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/.