Fosfocine 500 mg hard capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Fosfocina 500 mg hard capsules
Fosfomycin calcium
Read all of this 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, 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.
Contents of the leaflet:
- What Fosfocina is and what it is used for
- What you need to know before taking Fosfocina
- How to take Fosfocina
- Possible adverse effects
- How to store Fosfocina
- Contents of the pack and other information
1. What Fosfocina is and what it is used for
Fosfocina contains the active substance fosfomycin (as calcium fosfomycin). 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, administration interval, and duration of treatment. Do not store or reuse this medicine. If you have any antibiotic left after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste. |
Fosfocin is used for the treatment of uncomplicated bladder infections in women.
2. What you need to know before starting to take Fosfocina
Do not take Fosfocina
If you are allergic 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 Fosfocina 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
Fosfocina 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 problems occurring. 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 Fosfocina
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 Fosfocina 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 Fosfocina
Follow exactly the administration instructions for this medicine as indicated 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.
For the treatment of patients with swallowing difficulties (difficulty swallowing food or medication), Fosfocina 250 mg/5 ml powder for oral suspension is recommended.
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 before going to bed and after urination.
If you take more Fosfocina than you should
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, stating the medicine and the amount taken.
If you forget to take Fosfocina
Do not take a double dose to make up for missed doses.
If you forget to take a dose, take the next one as soon as possible and continue as before.
If you stop taking Fosfocina
Remember to take your medicine. Your doctor will indicate the duration of your treatment with Fosfocina.
Do not stop the treatment, even if you feel better, unless your doctor tells you to.
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 Fosfocina, you must stop taking the medicine and contact your doctor immediately:
- anaphylactic shock, a potentially life-threatening type of 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
Rare (may affect up to 1 in 1,000 people):
- anemia
- 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 hemorrhages)
- changes in liver enzymes
If any of these reactions or other symptoms you believe 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. Conservation of Fosfocina
Keep this medicine out of the sight and reach of children.
Store at room temperature.
Do not use this medicine after the expiry date stated on the container, after 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 containers and medicines at the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Fosfocina
- The active substance is calcium fosfomycin. Each capsule contains 500 mg of fosfomycin in the form of the calcium salt.
- The other components are: macrogol 6000.
Appearance of the product and contents of the container
Fosfocina is presented as red, hard gelatin capsules for oral administration. Each package contains 12, 24, or 500 capsules.
Marketing Authorization Holder
LABORATORIOS ERN, S.A.
Perú, 228 - 08020 Barcelona, Spain.
Manufacturer
LABORATORIOS ERN, S.A.
Gorgs Lladó, 188 – 08210 Barberà del Vallès, Barcelona, Spain.
Date of the most recent review of this leaflet: September 2021.
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) https://www.aemps.gob.es/.