Uroseptic 3 g granules for oral solution in sachets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
UROSEPTIC 3 g granules for oral solution in sachets EFG
Fosfomycin
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, consult 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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Uroseptic is and what it is used for
- What you need to know before taking Uroseptic
- How to take Uroseptic
- Possible adverse effects
- How to store Uroseptic
- Contents of the pack and other information
1. What Uroseptic is and what it is used for
Uroseptic contains the active substance fosfomycin (as fosfomycin trometamol). It is an antibiotic that works by eliminating bacteria that can cause infections.
Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold. It is important to follow your doctor's instructions regarding dosage, dosing intervals, and treatment duration. Do not store or reuse this medication. If you have any antibiotic left after completing treatment, return it to the pharmacy for proper disposal. Medicines should not be disposed of via the drain or in household waste. |
Uroseptic is used to treat uncomplicated urinary bladder infection in adult women and adolescents.
2. What you need to know before taking Uroseptic
Do not take Uroseptic:
- if you are allergic to fosfomycin or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting to use Uroseptic if any of the following apply to you:
- you suffer from persistent bladder infections,
- you have previously experienced diarrhea after taking any other antibiotic.
Symptoms to watch for
Uroseptic 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 effects” 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 Uroseptic
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 your blood's ability to clot.
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 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 if 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.
Uroseptic contains glucose and sulfites
This medicine contains glucose. If your doctor has informed you that you have an intolerance to certain sugars, consult him or her before taking this medicine.
Rarely, it may cause severe hypersensitivity reactions and bronchospasm (sudden sensation 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 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 Uroseptic (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 Uroseptic 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 can cause adverse effects, although not everyone will experience them.
Serious adverse effects
If you experience any of the following symptoms while taking Uroseptic, you must stop taking the medicine and contact your doctor immediately:
- anaphylactic shock, a 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
Common (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
- urticaria
- 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 Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Uroseptic
Do not store at temperatures 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 expiry date stated on the packaging, following “EXP”. The expiry date is the last day of the month indicated.
Medicines should 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 way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Uroseptic
The active substance is fosfomycin (as fosfomycin trometamol). Each sachet of granules contains 3 g of fosfomycin (as fosfomycin trometamol).
The other components are: glycine, sucralose, colloidal silicon dioxide, povidone, and lemon flavour [contains glucose (in maltodextrin derived from maize) and sulphites)].
Appearance of the medicinal product and contents of the pack
White or almost white granules with a characteristic lemon odour, for dissolution in water.
Each pack 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 the most recent revision of this leaflet March 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/