Prospect: information for the patient

Fosfomicina Farmalider 3 g granulated for oral solution EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2. What you need to know before starting to take Fosfomicina Farmalider

3. How to take Fosfomicina Farmalider

4. Possible adverse effects

5. Storage of Fosfomicina Farmalider

6. Contents of the package and additional information

Fosfomicina Farmalidercontains the active ingredient fosfomicina (as fosfomicina trometamol). It is an antibiotic that acts by eliminating the bacteria that can cause infections.

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

Do not take Fosfomicina Farmalider:

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

•have persistent urinary tract infections,

•have had diarrhea after taking any other antibiotic.

Be aware of these symptoms

Fosfomicina Farmalider may cause severe side effects. For example, allergic reactions and inflammation of the large intestine. Be aware of certain symptoms while you are on treatment with this medication, in order to reduce the risk of complications. See “severe side effects” in section 4.

Children and adolescents

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

Other medications and Fosfomicina Farmalider

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

This is especially important if you are taking:

• metoclopramidaor other medications 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 Farmalider with food

Food may delay the absorption of fosfomicina. 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, or think you may be 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.

Mothers who are breastfeeding may take a single oral dose of this medication.

Driving and operating machinery

You may experience side effects, such as dizziness, that may affect your ability to drive or operate machinery.

Fosfomicina Farmalider contains sacarose, glucose, yellow orange S (E110) and sodium

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

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Use in patients with renal insufficiency

This medication should not be used in patients with severe renal insufficiency (creatinine clearance <10)

Use in children and adolescents

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

Administration Form

For oral use.

This medication should be taken orally, with an empty stomach (approximately 2-3 hours before or 2-3 hours after a meal), preferably before going to bed and after urinating.

The contents of a packet should be dissolved in a glass of water and consumed immediately.

If you take more Fosfomicina Farmalider than you should

If you accidentally take a quantity greater than the prescribed dose, contact your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

Like all medications, this medication may cause adverse effects, although not everyone will experience them.

Severe Adverse Effects

If you experience any of the following symptoms while taking Fosfomicina Farmalider, stop taking the medication and contact your doctor immediately:

• Anaphylactic shock, a potentially life-threatening allergic reaction (unknown frequency). Symptoms include sudden onset of hives, itching or urticaria, and/or shortness of breath, wheezing, or difficulty breathing.
• Swelling of the face, lips, tongue, or throat with difficulty breathing (angioedema) (unknown frequency).
• Moderate to severe diarrhea, abdominal cramps, bloody stools, and/or fever, which may indicate a large intestine infection (antibiotic-associated colitis) (unknown frequency). Do not take medications that prevent intestinal movement (antiperistaltics).

Other Adverse Effects

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

• Headache
• Dizziness
• Diarrhea
• Nausea
• Indigestion
• Abdominal pain
• Female genital organ infection with symptoms such as inflammation, irritation, and itching (vulvovaginitis).

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

• Vomiting
• Hives
• Urticaria
• Itching

Unknown frequency (cannot be estimated from available data):

• Allergic reactions.

Reporting 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 prospectus. You can also report them directly through the national notification system included in www.notificaRAM.es . By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

No special conservation conditions are required.

The medication must be administered immediately after its dissolution.

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

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose of packaging and unused medications if you are unsure. By doing so, you will help protect the environment.

Composition of Fosfomicina Farmalider

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

Appearance of the product and contents of the packaging

White granule, with a characteristic orange odor.

Fosfomicina Farmalider is presented in packaging with 1 and 2 single-dose sachets of paper / polyethylene / aluminum / polyethylene.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

FARMALIDER S.A.

C/ Aragoneses 15, 28108

Alcobendas-Madrid

Responsible for manufacturing

EssetiFarmaceuticiSRL

Via Campobello, 15

00040 Pomezia (Roma)

Italy.

Farmalider, S.A.

C/ Aragoneses,2

28108. Alcobendas. Madrid.

Spain

Last review date of this leaflet: March 2021

“Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”