Leaflet: Information for the User

Fosfomicina Kern Pharma 3 g Powder for Oral Solution EFG

Fosfomicina (trometamol)

Read this leaflet carefully before you start taking 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 or pharmacist.

-This medicine has been prescribed for you only, and you must not give it 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 leaflet. See section 4.

Fosfomicina Kern Pharma contains the active ingredient fosfomicina (as fosfomicina trometamol). It is an antibiotic that acts by eliminating the bacteria that can cause infections.

Fosfomicina Kern Pharma is used to treat uncomplicated urinary tract infections in adult and adolescent women.

Fosfomicina Kern Pharma is used as antibiotic prophylaxis for transrectal prostate biopsies in adult men.

Do not takeFosfomicina Kern Pharma

• 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 Fosfomicina Kern Pharma 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 pay attention to

Fosfomicina Kern Pharma 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 Fosfomicina Kern Pharma

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:

• 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.

TakingFosfomicina Kern Pharma with food

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, your doctor will only prescribe this medication when it is strictly necessary.

Mothers who are breastfeeding may take a single oral dose of this medication.

Driving and operating machinery

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

Fosfomicina Kern Pharma contains saccharose, glucose, sodium, and yellow orange S (E-110)

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication contains less than 23 mg of sodium (1mmol), which is essentially “sodium-free”.

This medication contains yellow orange S (E-110). This medication may cause allergic reactions because it contains yellow orange S (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

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 and female adolescents, the recommended dose is 1 packet of Fosfomicina Kern Pharma (3 g of fosfomicina).

When used as antibiotic prophylaxis for transrectal prostate biopsy, the recommended dose is 1 packet of Fosfomicina Kern Pharma (3 g of fosfomicina) 3 hours before the procedure and 1 packet of Fosfomicina Kern Pharma (3 g of fosfomicina) 24 hours after the procedure.

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 patients 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), preferably before going to bed and after urinating.

The contents of a packet should be dissolved in a glass of water and consumed immediately.

If you take more Fosfomicina Kern Pharma than you should

If you accidentally take a higher dose than prescribed, contact your doctor or pharmacist.

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 ingested.

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

Like all medications,this medication mayproduce adverse effects, although not all people will experience them.

Severe Adverse Effects

If you experience any of the following symptoms during treatment with Fosfomicina Kern Pharma, stop taking the medication and contact your doctor immediately:

• anaphylactic shock, a potentially life-threatening 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 medications that prevent intestinal movement (antiperistaltics).

Other Adverse 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).

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

• vomiting
• hives
• urticaria
• itching

Unknown frequency (cannot be estimated from available data):

• allergic reactions

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus.

You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

No requires special conservation conditions.

The medication must be administered immediately after its dissolution.

Keep out of sight and reach of children.

Do not use Fosfomicina Kern Pharma after the date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point of the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and unused medications.By doing so, you will help protect the environment.

Composition of Fosfomicina Kern Pharma:

The active ingredient is fosfomicina. Each tablet contains 3 g of fosfomicina (as trometamol)

The other components are sodium saccharin, sucrose, orange aroma[contains glucose, (in maltodextrin from corn), gum arabic,butilhydroxyanisol (E-320)and yellow-orange S (E-110)]and calcium hydroxide.

Appearance of the product and contents of the packaging

Single-dose blisters in boxes containing 1 or 2 blisters.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for Manufacturing

Special Product’s Line S.p.A.

Via Fratta Rotonda Vado Largo, 1, 240 – 03012

03012 Anagni (FR), Italy.

Last review date of this leaflet:April 2021

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