Fosfomycin Farmalider 3 g granules for oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Fosfomicina Farmalider 3 g granules for oral solution EFG

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

Leaflet contents

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

2. What you need to know before taking Fosfomicina Farmalider

3. How to take Fosfomicina Farmalider

4. Possible side effects

5. How to store Fosfomicina Farmalider

6. Contents of the pack and other information

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

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

Fosfomicina Farmalider is used to treat uncomplicated urinary bladder infections in adult women and adolescents.

2. What you need to know before taking Fosfomicina Farmalider

Do not take Fosfomicina Farmalider:

• If you are allergic to fosfomycin 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 to use Fosfomicina Farmalider if you are in any of the following situations:

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

Symptoms to watch for

Fosfomicina Farmalider 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 reactions” 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 Farmalider

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, even 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 fosfomycin in your body,
• anticoagulants, since fosfomycin and other antibiotics could alter their ability to prevent blood clotting.

Taking Fosfomicina Farmalider 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 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 Farmalider contains sucrose, glucose, sunset yellow FCF (E110), and sodium

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

This medicine may cause allergic reactions because it contains sunset yellow FCF (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

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

3. How to take Fosfomicina Farmalider

Follow exactly the instructions for use of this medicine as given 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 Farmalider (3 g of fosfomycin).

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 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 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 Farmalider 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 everyone experiences them.

Serious adverse effects

If you experience any of the following symptoms while being treated with Fosfomicina Farmalider, 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 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

Frequent (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, or 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 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 through the national reporting system at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fosfomycin Farmalider

No special storage conditions are required.

The medicine should be administered immediately after reconstitution.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the indicated month.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Fosfomicina Farmalider

• The active substance is fosfomycin trometamol. Each sachet contains 3 g of fosfomycin (as fosfomycin trometamol).
• The other components are: sucrose, sodium saccharin, calcium hydroxide and orange flavour [containing glucose in maltodextrin derived from corn and sunset yellow FCF (E-110)].

Appearance of the product and contents of the pack

White granules with a characteristic orange odour.

Fosfomicina Farmalider is available in packs containing 1 or 2 unit-dose sachets made of paper / polyethylene / aluminium / polyethylene.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

FARMALIDER S.A.

C/ Aragoneses 15, 28108

Alcobendas-Madrid

Manufacturer

Esseti Farmaceutici SRL

Via Campobello, 15

00040 Pomezia (Rome)

Italy.

Farmalider, S.A.

C/ Aragoneses,2

1. Alcobendas. Madrid.

Spain

Date of latest revision of this leaflet: March 2021

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