UROSEPTIC 3 G ORAL SOLUTION GRANULES IN SACHETS

Introduction

Leaflet: information for the user

UROSEPTIC 3 g granules for oral solution in EFG sachets

Fosfomycin

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine 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 not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Uroseptic is and what it is used for
2. What you need to know before taking Uroseptic
3. How to take Uroseptic
4. Possible side effects
5. Storage of Uroseptic
6. Package contents and additional information

1. What Uroseptic is and what it is used for

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

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

2. What you need to know before taking Uroseptic

Do not take Uroseptic:

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Uroseptic 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

Uroseptic may cause severe side effects. For example, allergic reactions and inflammation of the large intestine. You should pay attention to certain symptoms while being treated with this medicine to reduce the risk of problems. See "severe side effects" in section 4.

Children and adolescents

This medicine 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 medicines and Uroseptic

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

This is especially important if you are taking:

• metoclopramideor 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, as fosfomycin and other antibiotics may alter your ability to prevent blood clotting.

Taking Uroseptic 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

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

Driving and using machines

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

Uroseptic contains glucose and sulfites

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

It may rarely cause severe hypersensitivity reactions and bronchospasm (sudden feeling of suffocation) because it contains sulfites.

This medicine contains less than 23 mg of sodium (1 mmol) per sachet, which is essentially "sodium-free".

3. How to take Uroseptic

Follow the administration instructions for this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Use in patients with renal insufficiency

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

Use in children and adolescents

This medicine should 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 bedtime and after urinating.

The contents of one sachet should be dissolved in a glass of water and taken immediately.

If you take more Uroseptic 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 medicine and the amount taken.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Severe side effects

If you experience any of the following symptoms during treatment with Uroseptic, stop taking the medicine 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 an infection of the large intestine (antibiotic-associated colitis) (frequency not known). Do not take anti-diarrheal medicines 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 not listed in this leaflet.

You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Uroseptic

Do not store above 30°C.

The medicine should be administered immediately after dissolution.

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

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Uroseptic

The active ingredient is fosfomycin (as fosfomycin trometamol). Each sachet of granules contains 3 g of fosfomycin (as fosfomycin trometamol).

The other ingredients are: glycine, sucralose, colloidal silicon dioxide, povidone, and lemon flavor [contains glucose (in maltodextrin from corn) and sulfites].

Appearance and package contents

White or almost white granules with a characteristic lemon odor to be dissolved in water.

Each package contains 1 or 2 sachets of granules.

Marketing authorization holder

ARAFARMA GROUP, S.A.

C/ Fray Gabriel de San Antonio, 6-10

Pol. Ind. del Henares 19180 Marchamalo (Guadalajara). Spain.

Manufacturer

ARAFARMA GROUP, S.A.

C/ Fray Gabriel de San Antonio, 6-10

Pol. Ind. del Henares 19180 Marchamalo (Guadalajara). Spain.

Date of last revision of this leafletMarch 2025

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