FOSFOMICINA FARMALIDER 3 G ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the Patient

Fosfomycin Farmalider 3 g Granules for Oral Solution EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication 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 package leaflet. See section 4.

Contents of the Package Leaflet

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

2. What you need to know before taking Fosfomycin Farmalider

3. How to take Fosfomycin Farmalider

4. Possible side effects

5. Storage of Fosfomycin Farmalider

6. Contents of the pack and further information

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

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

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

2. What you need to know before taking Fosfomycin Farmalider

Do not take Fosfomycin Farmalider:

• If you are allergic to fosfomycin or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Fosfomycin Farmalider 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

Fosfomycin Farmalider 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 medication to reduce the risk of problems. See "serious side effects" in section 4.

Children and adolescents

This medication 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 medications and Fosfomycin Farmalider

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

This is especially important if you are taking:

• metoclopramideor other medications 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 Farmalider with food

Food may delay the absorption of fosfomycin. Therefore, this medication 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 medication.

If you are pregnant, your doctor will only prescribe this medication when it is strictly necessary.

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

Driving and using machines

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

Fosfomycin Farmalider contains saccharose, glucose, orange yellow S (E110), and sodium

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

This medication may cause allergic reactions because it contains orange yellow S (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

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

3. How to take Fosfomycin Farmalider

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

In the case of treating an uncomplicated urinary tract infection in women and adolescent females, the recommended dose is 1 sachet of Fosfomycin Farmalider (3 g of fosfomycin).

Use in patients with renal impairment

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

Use in children and adolescents

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

Method of administration

For oral use.

This medication 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 Farmalider 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 medication and the amount ingested.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Serious side effects

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

• anaphylactic shock, a potentially life-threatening allergic reaction (frequency not known). Symptoms are sudden onset of a 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 a large intestine infection (antibiotic-associated colitis) (frequency not known). Do not take medications against diarrhea that stop intestinal movement (antiperistaltics).

Other side effects

Frequent (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 package leaflet. You can also report them directly through the national reporting system included in www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fosfomycin Farmalider

No special storage conditions are required.

The medication should be administered immediately after dissolution.

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

Do not use this medication after the expiration date stated on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Contents of the pack and further information

Composition of Fosfomycin Farmalider

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

Appearance of the product and contents of the pack

White granules with a characteristic orange odor.

Fosfomycin Farmalider is available in packs containing 1 and 2 single-dose sachets of paper/polyethylene/aluminum/polyethylene.

Marketing authorization holder and manufacturer

Marketing authorization holder

FARMALIDER S.A.

C/ Aragoneses 15, 28108

Alcobendas-Madrid

Manufacturer

Esseti Farmaceutici SRL

Via Campobello, 15

00040 Pomezia (Roma)

Italy.

Farmalider, S.A.

C/ Aragoneses, 2

1. Alcobendas. Madrid.

Spain

Date of the last revision of this package leaflet: March 2021

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