Fosfomycin Labiana 3 g granules for oral solution in sachets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Fosfomicina Labiana 3 g granules for oral solution in sachets EFG
fosfomycin
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet Contents
- What Fosfomicina Labiana is and what it is used for
- What you need to know before taking Fosfomicina Labiana
- How to take Fosfomicina Labiana
- Possible side effects
- How to store Fosfomicina Labiana
- Contents of the pack and other information
1. What Fosfomicina Labiana is and what it is used for
Fosfomicina Labiana contains the active substance fosfomicin (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 flu or colds.
It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.
Do not store or reuse this medicine. If you have any leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via the wastewater system or household waste.
Fosfomicina Labiana is used to treat uncomplicated urinary bladder infection in adult and adolescent females.
2. What you need to know before starting Fosfomicina Labiana
Do not take Fosfomicina Labiana:
- if you are allergic to fosfomicin or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting to use Fosfomicina Labiana if you are in any of the following situations:
- you suffer from persistent bladder infections,
- you have ever had diarrhoea after taking any other antibiotic.
Symptoms to watch for
Fosfomicina Labiana 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 must 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 Fosfomicina Labiana
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, even if they are medicines 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 fosfomicin in your body,
- anticoagulants, since fosfomicin and other antibiotics could alter your blood's ability to clot.
Taking Fosfomicina Labiana with food
Food may delay the absorption of fosfomicin. 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 when strictly necessary.
Breastfeeding mothers may take a single oral dose of this medicine.
Driving and use of machines
You may experience adverse effects such as dizziness, which could affect your ability to drive or operate machinery.
Fosfomicina Labiana contains sucrose, glucose and sodium
If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per sachet; this is essentially “sodium-free”.
3. How to take Fosfomicina Labiana
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 Fosfomicina Labiana (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.
The reconstituted solution is a slightly cloudy, almost white solution with a fruity aroma (orange-mandarin).
If you take more Fosfomicina Labiana than you should
If you accidentally take more than the prescribed dose, contact your doctor or pharmacist.
In case of overdose or accidental ingestion, go to a medical center 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 Fosfomicina Labiana, you must stop taking the medicine and contact your doctor immediately:
- anaphylactic shock, a type of 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, blood in the stool 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 via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Fosfomicin Labiana
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging after “EXP.:” . The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point in your usual pharmacy. Ask your pharmacist how to properly discard containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Fosfomicina Labiana
- The active substance is fosfomicin (as fosfomycin trometamol). Each sachet contains fosfomycin trometamol equivalent to 3 g of fosfomycin.
- The other ingredients are: sucrose, sodium saccharin (E954), mandarin flavour (contains glucose derived from corn maltodextrin and sodium), and orange flavour (contains glucose derived from corn maltodextrin and sodium). See section 2. Fosfomicina Labiana contains sucrose, glucose, and sodium.
Appearance of the product and pack contents
Granules for oral solution in sachets. White or almost white granules, free from lumps or particles, in single-dose sachets.
Each box contains 1 or 2 sachets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Labiana Pharmaceuticals, S.L.U.
C/ Casanova 27-31
08757 Corbera de Llobregat (Barcelona)
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: Afosfol 3 g Granulat im Beutel zur Herstellung einer Lösung zum Einnehmen
Denmark: Cystifos
France: Fosfomycine Zydus 3 g, granulés pour solution buvable en sachet
Netherlands: Fosfomycine 3 g Focus, granulaat voor drank in sachet
Hungary: Afosfol 3 g granulátum belsoleges oldhatoz
Poland: Uromaste
Portugal: Fosfomicina Pharmakern
Sweden: Cystifos
Spain: Fosfomicina Labiana 3 g granulado para solución oral en sobres EFG
Date of the most recent revision of this leaflet: December 2020
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) www.aemps.gob.es/.