Fosfomycin Pensa 3 g granules for oral solution EFG
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Fosfomicina Pensa is and what it is used for
- 2. What you need to know before taking Fosfomicina Pensa
- 3. How to take Fosfomicina Pensa
- 4. Possible adverse effects
- 5. Storage of Fosfomicina Pensa
- 6. Contents of the container and additional information
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Fosfomycin Pensa 3 g granules for oral solution EFG
Read the entire 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, consult your doctor or pharmacist.
- This medicine has been prescribed for you only; do 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 effects not listed in this leaflet. See section 4.
Leaflet contents
- What Fosfomycin Pensa is and what it is used for
- What you need to know before taking Fosfomycin Pensa
- How to take Fosfomycin Pensa
- Possible adverse effects
- How to store Fosfomycin Pensa
- Contents of the pack and other information
1. What Fosfomicina Pensa is and what it is used for
Fosfomicina Pensa 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 influenza or the common cold. It is important that you follow the instructions regarding dosage, dosing interval, and duration of treatment as indicated by your doctor. Do not store or reuse this medication. If you have any leftover antibiotics after completing the treatment, return them to the pharmacy for proper disposal. Medicines must not be disposed of via the sewage system or in household waste. |
Fosfomycin Pensa is used to treat uncomplicated urinary bladder infections in adult and adolescent females.
2. What you need to know before taking Fosfomicina Pensa
Do not take Fosfomicina Pensa
If you are allergic to fosfomycin 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 taking Fosfomicina Pensa 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 Pensa 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 Fosfomicina Pensa
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, even those not prescribed, including over-the-counter medicines.
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 Fosfomicina Pensa 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 it is 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.
Fosfomicina Pensa contains sucrose, glucose and orange yellow S (E-110)
This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
This medicine contains glucose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
This medicine contains orange yellow S (E-110). This medicine may cause allergic reactions because it contains orange yellow S (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.
This medicine contains less than 23 mg of sodium (1 mmol) per sachet; this is essentially “sodium-free”.
3. How to take Fosfomicina Pensa
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
For the treatment of uncomplicated bladder infection in women and female adolescents, the recommended dose is 1 sachet of Fosfomicina Pensa (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 Fosfomicina Pensa 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 during treatment with Fosfomicina Pensa, 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Fosfomicina Pensa
No special storage conditions are required.
The medicine should be administered immediately after reconstitution.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month indicated.
Do not use this medicine if you notice that the packaging is damaged or opened.
Medicines should 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 in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the container and additional information
Composition of Fosfomicina Pensa
The active substance is fosfomycin. Each sachet contains 3 g of fosfomycin (as fosfomycin trometamol).
The other components are orange flavour [contains glucose (in maltodextrin derived from maize) and sunset yellow S, E-110], sodium saccharin, sucrose and calcium hydroxide.
Appearance of the medicine and contents of the container
White or almost white granules. Pack containing 1 or 2 sachets.
Marketing Authorization Holder
Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain
Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo 1–
03012 Anagni (FR)
Italy
This leaflet was approved in February 2021
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/