FOSFOMICINA KERN PHARMA 3 g ORAL SOLUTION GRANULES

Introduction

Leaflet: Information for the user

Fosfomycin Kern Pharma 3 g granules for oral solution EFG

Fosfomycin (trometamol)

Read the entire leaflet carefully before starting to take this medicine, as 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 to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Fosfomycin Kern Pharma is and what it is used for
2. What you need to know before taking Fosfomycin Kern Pharma
3. How to take Fosfomycin Kern Pharma
4. Possible side effects
5. Storage of Fosfomycin Kern Pharma
6. Package contents and additional information

1. What Fosfomycin Kern Pharma is and what it is used for

Fosfomycin Kern Pharma contains the active ingredient fosfomycin (as fosfomycin trometamol). It is an antibiotic that works by eliminating bacteria that can cause infections.

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

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

2. What you need to know before taking Fosfomycin Kern Pharma

Do not take Fosfomycin Kern Pharma

• If you are allergic to fosfomycin or 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 Fosfomycin 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

Fosfomycin Kern Pharma may cause serious side effects. For example, allergic reactions and inflammation of the large intestine. You should pay attention to certain symptoms while being treated with this medicine to reduce the risk of problems. See "serious side effects" in section 4.

Children and adolescents

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

Other medicines and Fosfomycin Kern Pharma

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

This is especially important if you are taking:

• metoclopramideor other medicines 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 Fosfomycin Kern Pharma with food

Food may delay the absorption of fosfomycin. Therefore, this medicine 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

If you are pregnant, your doctor will only prescribe this medicine when strictly necessary.

Breastfeeding mothers may take a single oral dose of this medicine.

Driving and using machines

You may experience side effects such as dizziness, which could affect your ability to drive or use machines.

Fosfomycin Kern Pharma contains sucrose, glucose, sodium, and orange yellow S (E-110)

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

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

This medicine contains less than 23 mg of sodium (1mmol) per dose; this is essentially "sodium-free".

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

3. How to take Fosfomycin Kern Pharma

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

In the case of treating an uncomplicated urinary tract infection in women and female adolescents, the recommended dose is 1 sachet of Fosfomycin Kern Pharma (3 g of fosfomycin).

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

Use in patients with renal insufficiency

This medicine should not be used in patients with severe renal insufficiency (creatinine clearance <10 ml min).< p>

Use in children and adolescents

This medicine should not be used in children under 12 years of age.

Method of administration

For oral use.

This medicine should be taken orally, on an empty stomach (approximately 2-3 hours before or 2-3 hours after a meal), preferably before bedtime and after urinating.

The contents of one sachet should be dissolved in a glass of water and taken immediately

If you take more Fosfomycin 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

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

• anaphylactic shock, a potentially life-threatening allergic reaction (frequency not known). Symptoms are sudden onset of rash, itching, or hives, and/or shortness of breath, wheezing, or difficulty breathing,
• swelling of the face, lips, tongue, or throat with difficulty breathing (angioedema) (frequency not known),
• moderate to severe diarrhea, abdominal cramps, bloody stools, and/or fever, which may indicate that you have an infection of the large intestine (antibiotic-associated colitis) (frequency not known). Do not take medicines against diarrhea that stop intestinal movement (antiperistaltics).

Other side effects

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

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

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

• vomiting
• rash
• hives
• itching

Frequency not known (cannot be estimated from available data):

• allergic reactions

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet.

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

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fosfomycin Kern Pharma

No special storage conditions are required.

The medicine should be administered immediately after dissolution.

Keep out of sight and reach of children.

Do not use Fosfomycin Kern Pharma after the expiry date stated on the packaging after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Fosfomycin Kern Pharma:

The active ingredient is fosfomycin. Each sachet contains 3 g of fosfomycin (as trometamol)

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

Appearance of the product and package contents

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

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Special Product’s Line S.p.A.

Via Fratta Rotonda Vado Largo, 1, 240 – 03012

03012 Anagni (FR), Italy.

Date of the last revision of this leaflet:April 2021

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/