Fosfomycin calcium Solufos 500 mg hard capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Fosfomicina cálcica Solufos 500 mg hard capsules
Fosfomicin calcium
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. 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 must not be given 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.
Leaflet contents:
- What Fosfomicina cálcica Solufos is and what it is used for
- What you need to know before taking Fosfomicina cálcica Solufos
- How to take Fosfomicina cálcica Solufos
- Possible adverse effects
- How to store Fosfomicina cálcica Solufos
Pack contents and other information
1. What Fosfomicina cálcica Solufos is and what it is used for
Fosfomicina cálcica Solufos contains the active substance fosfomycin (as fosfomycin calcium). It is an antibiotic that works by eliminating bacteria that may 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 interval, and duration of treatment. Do not store or reuse this medicine. If you have any antibiotic left over after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via the sink or in household waste. |
Calcium fosfomycin Solufos is used for the treatment of uncomplicated bladder infections in women.
2. Before taking Fosfomicina cálcica Solufos
Do not take Fosfomicina cálcica Solufos
- if you are allergic (hypersensitive) to fosfomycin or to 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 Fosfomicina cálcica Solufos if you are in any of the following situations:
- you have persistent bladder infections,
- you have ever had diarrhoea after taking any other antibiotic.
Symptoms to watch for
Fosfomicina cálcica Solufos 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 cálcica Solufos
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 fosfomycin in your body,
- anticoagulants, since fosfomycin and other antibiotics could alter their ability to prevent blood clotting.
Taking Fosfomicina cálcica Solufos with food and drink
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 or breastfeeding, your doctor will only prescribe this medicine when strictly necessary.
Driving and using machines
You may experience adverse effects such as dizziness, which could affect your ability to drive or operate machinery.
3. How to take Fosfomycin calcium Solufos
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
For the treatment of uncomplicated bladder infections in women, the recommended dose is 500 mg–1 g (1 or 2 capsules) every 8 hours.
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 individuals 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), with the last dose preferably taken at bedtime and after urination.
If you take more Fosfomycin calcium Solufos than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.
If you forget to take Fosfomycin calcium Solufos
Do not take a double dose to make up for forgotten doses.
If you miss a dose, take the next one as soon as possible and continue as before.
If you stop taking Fosfomycin calcium Solufos
Remember to take your medicine. Your doctor will indicate the duration of your treatment with Fosfomycin calcium Solufos. Do not interrupt the treatment, even if you feel better, unless your doctor tells you to do so.
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 during treatment with Fosfocina cálcica Solufos, 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 diarrhoea, 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-diarrhoeal medicines that inhibit intestinal movements (antiperistaltics).
Other adverse effects
Common (may affect up to 1 in 10 people):
- Headache
- Dizziness
- Diarrhoea
- Nausea
- Indigestion
- Abdominal pain
- Genital infection in women with symptoms such as inflammation, irritation, itching (vulvovaginitis)
Uncommon (may affect up to 1 in 100 people):
- Vomiting
- Rash
- Urticaria
- Itching
Rare (may affect up to 1 in 1,000 people):
- Anaemia
- Superinfections caused by antibiotic-resistant bacteria
Frequency not known (cannot be estimated from available data):
- Allergic reactions
- Visual disturbances
- Loss of appetite
- Inflammation of the veins
- Increase in the number of white blood cells and platelets
- Appearance of petechiae (small skin bleeding from blood vessels)
- Changes in liver enzymes
If any of these reactions or other discomforts that you think may be related to the treatment occur during therapy, you should inform your doctor as soon as possible.
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 Calcium Fosfomycin Solufos
Keep this medicine out of sight and reach of children.
Do not use Calcium Fosfomycin Solufos after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Additional Information
Composition of Fosfomicina Calcica Solufos
- The active substance is fosfomycin.
Each capsule contains 500 mg of fosfomycin in the form of the calcium salt.
- The other components are: polyethylene glycol 6000, sodium docusate, gelatin, red iron oxide (E-172), erythrosine (E-127), and titanium dioxide (E-171).
Appearance of the product and contents of the pack
Fosfomicina Calcica Solufos 500 mg hard capsules are presented as hard capsules for oral administration, available in packs containing 12 and/or 24 units.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorios Q pharma S.L.
C/ Portugal Entlo. C.
03003 Alicante. Spain
Manufacturer
Toll Manufacturing Services, S.L.
C/ Aragoneses, 2
28108 Alcobendas (Madrid). Spain.
Date of the most recent review of this package leaflet: October 2021
Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/