Fosfomycin Kern Pharma 3 g granules for oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Fosfomicina Kern Pharma 3 g granules for oral solution EFG

Fosfomycin (trometamol)

Read the entire leaflet carefully before you start taking 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Fosfomicina Kern Pharma is and what it is used for
2. What you need to know before taking Fosfomicina Kern Pharma
3. How to take Fosfomicina Kern Pharma
4. Possible adverse effects
5. How to store Fosfomicina Kern Pharma
6. Contents of the pack and other information

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

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

Fosfomicina Kern Pharma is used to treat uncomplicated urinary bladder infection in adult women and adolescents.

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

2. What you need to know before starting Fosfomicina Kern Pharma

Do not take Fosfomicina Kern Pharma

• If you are allergic to fosfomicin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Fosfomicina Kern Pharma if you are in any of the following situations:

• You have persistent bladder infections,
• You have ever had diarrhoea after taking any other antibiotic.

Symptoms to watch for

Fosfomicina Kern Pharma may cause serious adverse effects. For example, allergic reactions and inflammation of the large intestine. 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.

Children and adolescents

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

Other medicines and Fosfomicina Kern Pharma

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

This is especially important if you are taking:

• metoclopramide or other medicines that increase the movement of food through the stomach and intestines, as they may reduce the absorption of fosfomicin into your body,
• anticoagulants, since fosfomicin and other antibiotics could alter your blood's ability to clot.

Taking Fosfomicina Kern Pharma with food

Food may delay the absorption of fosfomicin. 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 might be pregnant, or are planning 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 adverse effects such as dizziness, which could affect your ability to drive or operate machinery.

Fosfomicina Kern Pharma contains sucrose, glucose, sodium, and sunset yellow FCF (E-110)

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

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

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

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

3. How to take Fosfomicina Kern Pharma

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

For the treatment of uncomplicated bladder infection in women and adolescent females, the recommended dose is 1 sachet of Fosfomicina Kern Pharma (3 g of fosfomycin).

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

Use in patients with renal impairment

This medicine must not be used in patients with severe renal impairment (creatinine clearance <10 ml/min).

Use in children and adolescents

This medicine must not be used in individuals 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 going to bed and after having urinated.

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

If you take more Fosfomicina Kern Pharma than you should

If you accidentally take more than the prescribed dose, contact your doctor or pharmacist.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

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

4. Possible adverse effects

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

Serious adverse effects

If you experience any of the following symptoms while being treated with Fosfomicina Kern Pharma, you must stop taking the medicine and contact your doctor immediately:

• anaphylactic shock, a type of potentially life-threatening allergic reaction (frequency not known). Symptoms include sudden onset of rash, itching or hives, and/or shortness of breath, wheezing (whistling sound when breathing), 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 anti-diarrhoeal medicines that inhibit intestinal movements (antiperistaltics).

Other adverse effects

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

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

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

• vomiting
• rash
• urticaria
• itching

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

• allergic reactions

Reporting of 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 leaflet.

You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es

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

5. Storage of Fosfomicin Kern Pharma

No special storage conditions are required.

The medicine should be administered immediately after reconstitution.

Keep out of the sight and reach of children.

Do not use Fosfomicin Kern Pharma after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the package and other information

Composition of Fosfomicina Kern Pharma:

The active substance is fosfomycin. Each tablet contains 3 g of fosfomycin (as trometamol).

The other components are sodium saccharin, sucrose, orange flavour [containing glucose (in maltodextrin derived from maize), gum arabic, butylhydroxyanisole (E-320) and sunset yellow FCF (E-110)] and calcium hydroxide.

Appearance of the medicine and contents of the pack

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

Marketing Authorisation 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 most recent revision of this leaflet: April 2021

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