Fosfomycin Qualigen 3 g granules for oral solution EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

FOSFOMICIN QUALIGEN 3 g granules for oral solution EFG

Fosfomycin trometamol

Read the entire leaflet carefully before you start taking this medicine.

• 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 and should not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

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

Fosfomicina Qualigen is an antibiotic. The active substance is fosfomycin, which belongs to the group of antibiotics known as phosphonic acid derivatives. It works by stopping the growth of bacteria that cause infections.

Fosfomicina Qualigen is used for the treatment of certain bacterial infections, such as urinary tract infections (infections of the bladder and urethra). It is effective against a variety of bacteria that commonly cause these types of infections.

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

Fosfomicina Qualigen is used to treat uncomplicated urinary bladder 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 starting to take Fosfomicina Qualigen

Do not take Fosfomicina Qualigen:

• if you are allergic to fosfomycin or to any of the other ingredients 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 suffer from persistent bladder infections,
• you have ever had diarrhea after taking any other antibiotic.

Symptoms to watch for:

Fosfomicina Qualigen 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 must 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 Qualigen

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, even if they are medicines 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 fosfomycin in your body,

• anticoagulants, since fosfomycin and other antibiotics could alter their ability to prevent blood clotting.

Taking Fosfomicina Qualigen 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, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may 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.

Breast-feeding 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 Qualigen contains sucrose, glucose, sunset yellow FCF, and sodium:

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

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

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

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

3. How to take Fosfomicina Qualigen

Follow exactly the administration instructions 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 Qualigen (3 g of fosfomycin).

When used as antibiotic prophylaxis for transrectal prostate biopsy, the recommended dose is 1 sachet of Fosfomicina Qualigen (3 g of fosfomycin) 3 hours before the procedure and 1 sachet of Fosfomicina Qualigen (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 bedtime 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 Qualigen 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 may cause adverse effects, although not everybody will experience them.

Serious adverse effects

If you experience any of the following symptoms during treatment with Fosfomicina Qualigen, 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 sounds 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-diarrheal 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 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 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 refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the package and other information

Composition of Fosfomicina Qualigen

• The active substance is Fosfomicin trometamol 5.631 g (equivalent to 3 g of fosfomicin).

• The other components are: sodium saccharin, calcium hydroxide, sucrose, orange flavour [contains glucose (in maltodextrin derived from maize) and sunset yellow FCF (E-110)].

Nature of the product and pack contents

Fosfomicina Qualigen 3 g is presented in sachets containing a granulate for dissolution in water.

Pack sizes of 1 and 2 sachets of granulate are available.

Marketing Authorization Holder and Manufacturer

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 most recent revision of this leaflet: May 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/