FOSFOMICINA QUALIGEN 3 g ORAL SOLUTION GRANULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

FOSFOMICINA QUALIGEN3 ggranulate for oral solution EFG

Fosfomicina trometamol

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the package leaflet

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

1. What is Fosfomicina Qualigen and what is it used for

Fosfomicina Qualigen contains the active substance fosfomicina (as fosfomicina trometamol). It is an antibiotic that works by eliminating the bacteria that can cause infections.

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

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

2. What you need to know before taking Fosfomicina Qualigen

Do not take Fosfomicina Qualigen:

• if you are allergic to fosfomicina 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 Fosfomicina Qualigen 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:

Fosfomicina Qualigen 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 in order 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 the safety and efficacy in this age group have not been established.

Other medicines and Fosfomicina Qualigen

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 fosfomicina in your body,

• anticoagulants, as fosfomicina and other antibiotics may alter your ability to prevent blood clotting.

Taking Fosfomicina Qualigen with food:

Food may delay the absorption of fosfomicina. 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant, your doctor will only prescribe this medicine when it is 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 that could affect your ability to drive or use machines.

Fosfomicina Qualigen contains saccharose, glucose, orange yellow S, and sodium:

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

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

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.

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

3. How to take Fosfomicina Qualigen

Follow exactly the administration instructions indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

In the case of treatment of an uncomplicated urinary tract infection in women and female adolescents, the recommended dose is 1 sachet of Fosfomicina Qualigen (3 g of fosfomicina).

When used as antibiotic prophylaxis for transrectal prostate biopsy, the recommended dose is 1 sachet of Fosfomicina Qualigen (3 g of fosfomicina) 3 hours before the procedure and 1 sachet of Fosfomicina Qualigen (3 g of fosfomicina) 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 moreFosfomicina Qualigenthan 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 Fosfomicina Qualigen 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 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 the available data):

• allergic reactions.

Reporting of side effects

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

You can also report side effects directly to 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 Fosfomicina Qualigen

Keep out of the reach and sight of children.

Do not use Fosfomicina Qualigen after the expiry date stated on the packaging, after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Take the packaging and any unused medicines to a pharmacy for proper disposal. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and further information

Composition ofFosfomicina Qualigen

• The active substance is Fosfomicina trometamol 5,631 g (equivalent to 3 g of fosfomicina).

• The other ingredients are: saccharin sodium, calcium hydroxide, saccharose, orange flavor [contains glucose (in maltodextrin from corn) and orange yellow S (E-110)].

Appearance of the product and package contents

Fosfomicina Qualigen 3 g is presented in the form of sachets containing a granulate to be dissolved in water.

There are packs of 1 and 2 sachets of granulate.

Marketing authorization holder and manufacturer

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 – Sant Joan Despí

(Barcelona) Spain

Manufacturer

SPECIAL PRODUCT’S LINE S.p.A.

Via Fratta Rotonda Vado Largo, 1

03012 – Anagni (FR)

Italy

Date of the last revision of this leaflet: May 2021

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