FOSFOMICINA STADA 3 g ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the Patient

Fosfomicina Stada 3 g Granules for Oral Solution EFG

Fosfomicina (Trometamol)

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 Fosfomicina Stada and what is it used for

1. What you need to know before taking Fosfomicina Stada
2. How to take Fosfomicina Stada

1. Possible side effects
2. Storage of Fosfomicina Stada
3. Package Contents and Additional Information

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

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

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

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

2. What you need to know before taking Fosfomicina Stada

Do not take Fosfomicina Stada

• 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 take Fosfomicina Stada 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 pay attention to

Fosfomicina 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 Fosfomicina Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication, 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 fosfomicina in your body,
• anticoagulants, as fosfomicina and other antibiotics may alter your ability to prevent blood clotting.

Taking Fosfomicina Stada 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, 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.

Fosfomicina Stada contains saccharose, glucose, yellow-orange S (E110), and sodium

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

This medication contains 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 can cause asthma, especially in patients allergic to acetylsalicylic acid.

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

3. How to take Fosfomicina Stada

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

When used as antibiotic prophylaxis for transrectal prostate biopsy, the recommended dose is 1 sachet of Fosfomicina Stada (3 g of fosfomicina) 3 hours before the procedure and 1 sachet of Fosfomicina Stada (3 g of fosfomicina) 24 hours after the procedure.

Use in patients with renal insufficiency

This medication should not be used in patients with severe renal insufficiency (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 Fosfomicina Stada than you should

If you accidentally take a higher dose than prescribed, contact your doctor or pharmacist or consult the Toxicology Information Service, phone 91.562 04 20, indicating the medication and the amount taken.

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 fosfomicina, 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 rash, itching or hives, and/or shortness of breath, wheezing (emission of 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 antibiotic-associated intestinal infection (colitis). Do not take medications 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 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 Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fosfomicina Stada

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

No special storage conditions are required.

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

Medications should not be thrown away in drains or trash. Deposit the packaging and any unused medications in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Fosfomicina Stada

• The active ingredient is fosfomicina (as fosfomicina trometamol). Each sachet contains 3 grams of fosfomicina (as fosfomicina trometamol).

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

Appearance of the Product and Package Contents

Granules for oral solution in sachets, white or almost white in color with a characteristic orange odor.

It is presented in cardboard boxes containing 1 or 2 sachets of 8 g of granules for oral solution.

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

SPECIAL PRODUCT'S LINE S.P.A.

Via Fratta Rotonda Vado Largo, 1

03012 Anagni (FR)

Italy

or

Laboratori Fundaciò DAU

C/C, 12-14 Pol. Ind. Zona Franca

Barcelona - 08040

Spain

Date of the last revision of this package leaflet:February 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/