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Package Leaflet: Information for the Patient
Fosfomicina Tarbis3 g Granules for Oral Solution in Sachets EFG
Fosfomicina
Readthe entire package leaflet carefully before starting to take this medication, as it contains important information for you.
Contents of the Package Leaflet:
Fosfomicina Tarbis contains the active substance fosfomicina (as fosfomicina trometamol). It is an antibiotic that works by eliminating bacteria that can cause infections.
Fosfomicina Tarbis is used to treat uncomplicated urinary tract infections in adult and adolescent women.
Fosfomicina Tarbis is used as antibiotic prophylaxis for transrectal prostate biopsies in adult men.
Do not takeFosfomicina Tarbis
-If you are allergic (hypersensitive) to fosfomicina or any of the other components of this medication (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take this medication if you are in any of the following situations:
Symptoms to which you should pay attention
Fosfomicina Tarbis may cause serious side effects. For example, allergic reactions and inflammation of the large intestine. You should pay attention to certain symptoms while being treated with this medication to reduce the risk of problems. See "serious side effects" in section 4.
Children and adolescents
This medication should not be given to children under 12 years of age, as its safety and efficacy have not been established in this age group.
Other medications and Fosfomicina Tarbis
Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, even if it is a medication purchased without a prescription.
This is especially important if you are taking:
Taking Fosfomicina Tarbiswith food
Food may delay the absorption of fosfomicina. Therefore, this medication should be taken on an empty stomach (2-3 hours before or 2-3 hours after a meal).
Pregnancy, breastfeedingand fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.
If you are pregnant, your doctor will only prescribe this medication when it is strictly necessary.
Breastfeeding mothers may take a single oral dose of this medication.
Driving and using machines
You may experience side effects, such as dizziness, which may affect your ability to drive or use machines.
Fosfomicina Tarbiscontains saccharose, glucose, and sodium
This medication contains saccharose and glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.
This medication contains less than 23 mg of sodium (1 mmol) per sachet; it is essentially 'sodium-free'.
Follow the instructions for administration of this medication indicated by your doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist again.
In the case of treatment of an uncomplicated urinary tract infection in women and female adolescents, the recommended dose is 1 sachet of Fosfomicina Tarbis (3 g of fosfomicina).
When used as antibiotic prophylaxis for transrectal prostate biopsy, the recommended dose is 1 sachet of Fosfomicina Tarbis (3 grams of fosfomicina) 3 hours before the procedure and 1 sachet of Fosfomicina Tarbis (3 g of fosfomicina) 24 hours after the procedure.
Use in patients with renal impairment
This medication should not be used in patients with severe renal impairment (creatinine clearance <10 ml min).< p>
Use in children and adolescents
This medication should not be used in children under 12 years of age.
Method of administration
For oral use.
This medication should be taken orally, on an empty stomach (approximately 2-3 hours before or 2-3 hours after a meal), preferably before bedtime and after urinating.
The contents of one sachet should be dissolved in a glass of water and taken immediately.
If you take more Fosfomicina Tarbisthan you should
If you accidentally take a quantity greater than the prescribed dose, contact your doctor or pharmacist.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
Like all medications, this medication can cause side effects, although not everyone will experience them.
Serious side effects
If during treatment with Fosfomicina Tarbis you experience any of the following symptoms, you should stop taking the medication and contact your doctor immediately:
Other side effects
Common(may affect up to 1 in 10 people):
Uncommon(may affect up to 1 in 100 people):
Frequency not known(cannot be estimated from available data):
Reporting side effects
If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.
Keep this medication out of the sight and reach of children.
No special storage conditions are required. Store in the original packaging.
Do not use this medication after the expiration date stated on the packaging after "EXP:". The expiration date is the last day of the month indicated.
Medications should not be disposed of through wastewater or household waste. Dispose of packaging and unused medications at the SIGRE collection point in your usual pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. This will help protect the environment.
Composition of Fosfomicina Tarbis
-The active substance is fosfomicina (as fosfomicina trometamol). Each sachet contains 3 grams of fosfomicina (as fosfomicina trometamol).
-The other components (excipients) are: saccharose, sodium saccharin, mandarin flavor (contains glucose from corn maltodextrin and sodium), and orange flavor (contains glucose from corn maltodextrin and sodium).
Appearance and packaging of the product
Granules for oral solution in sachets. White or almost white granules.
Single-dose sachets of surlyn/aluminum/low-density polyethylene/paper packaged in cardboard boxes containing 1 or 2 sachets.
Marketing authorization holder
Tarbis Farma, S.L.
Gran Vía Carlos III, 94
08028 Barcelona
Manufacturer
Labiana Pharmaceuticals, S.L.U.
c/ Casanova 27-31
08757 Corbera de Llobregat
(Barcelona)
Date of last revision of this package leaflet: January 2021
Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) www.aemps.gob.es/
The average price of FOSFOMICINA TARBIS 3 G ORAL SOLUTION GRANULES EFG in October, 2025 is around 2.5 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
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