Prospecto: information for the patient

Fosfomicina Tarbis3 g granulated for oral solution in EFG sachets

Fosfomicina

Readallthe prospect carefully before starting to take this medication, because it contains important information for you.

• Readthis prospect, as you may have to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist or nurse,even if they are not listed in this prospect. See section 4.

1. What isFosfomicina Tarbisand for what it is used.

2. What you need to know before starting to takeFosfomicina Tarbis.

3. How to takeFosfomicina Tarbis.

4. Possible adverse effects.

5. Storage ofFosfomicina Tarbis.

6. Contents of the package and additional information

Fosfomicina Tarbiscontains the active ingredient fosfomicina (as fosfomicina trometamol). It is an antibiotic that acts by eliminating the bacteria that can cause infections.

Fosfomicina Tarbis is used to treat uncomplicated urinary tract infection 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 to 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:

• You have persistent urinary tract infections,

• You have ever had diarrhea after taking any other antibiotic.

Be aware of the following symptoms

Fosfomicina Tarbis may cause severe side effects. For example, allergic reactions and inflammation of the large intestine. Be aware of certain symptoms while you are being treated with this medication, in order to reduce the risk of complications. See “severe side effects” in section 4.

Children and adolescents

This medication should not be administered 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

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

This is especially important if you are taking:

•metoclopramidaor other medications that increase the movement of food through the stomach and intestines, as they may reduce the absorption of fosfomicina in your body,

•anticoagulants, as fosfomicina and other antibiotics may alter your ability to prevent blood clotting.

Taking Fosfomicina Tarbis with 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, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be 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.

Mothers who are breastfeeding may take a single oral dose of this medication.

Driving and operating machinery

You may experience side effects, such as dizziness, which may affect your ability to drive or operate machinery.

Fosfomicina Tarbis contains sacarose, glucose, and sodium

This medication contains sacarose 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); that is, it is essentially ‘sodium-free’.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

For the treatment of uncomplicated urinary tract infections in women and female adolescents, the recommended dose is 1 packet of Fosfomicina Tarbis (3 g of fosfomicina).

When used as antibiotic prophylaxis for transrectal prostate biopsy, the recommended dose is 1 packet of Fosfomicina Tarbis (3 grams of fosfomicina) 3 hours before the procedure and 1 packet of Fosfomicina Tarbis (3 g of fosfomicina) 24 hours after the procedure.

Use in patients with renal insufficiency

This medication should not be used in patients with severe renal insufficiency (creatinine clearance <10

Use in children and adolescents

This medication should not be used in children under 12 years of age.

Administration form

For oral use.

This medication should be taken orally, with an empty stomach (approximately 2-3 hours before or 2-3 hours after a meal), preferably before going to bed and after urinating.

The contents of a packet should be dissolved in a glass of water and consumed immediately.

If you take more Fosfomicina Tarbis than you should

If you accidentally take a higher dose than prescribed, 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 medicationmay cause adverse effects, although not everyone will experience them.

Severe Adverse Effects

If you experience any of the following symptoms while taking Fosfomicina Tarbis, stop taking the medication and contact your doctor immediately:

- Anaphylactic shock, a potentially life-threatening allergic reaction (unknown frequency). Symptoms include sudden onset of hives, itching or urticaria, and/or shortness of breath, wheezing, or difficulty breathing,

- Swelling of the face, lips, tongue, or throat with difficulty breathing (angioedema) (unknown frequency),

- Moderate to severe diarrhea, abdominal cramps, bloody stools, and/or fever, which may indicate a large intestine infection (antibiotic-associated colitis) (unknown frequency). Do not take medications that prevent intestinal movement (antiperistaltics).

Other Adverse Effects

Frequent(may affect up to 1 in 10 people):

- Headache

- Dizziness

- Diarrhea

- Nausea

- Indigestion

- Abdominal pain

- Female genital organ infection with symptoms such as inflammation, irritation, and itching (vulvovaginitis).

Rare(may affect up to 1 in 100 people):

- Vomiting

- Hives

- Urticaria

- Itching (pruritus)

Unknown Frequency(cannot be estimated from available data):

- Allergic reactions.

Reporting Adverse Effects

Ifyou experienceany type of adverse effect,consult your doctor or pharmacist, even if it is apossibleadverse effect not listed in this prospectus.You can also report them directly to theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 usethis medicationafter the expiration date that appears on the packaging after “CAD.:””. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at your local SIGRE collection pointat your usual pharmacy. Ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Fosfomicina Tarbis

-The active ingredient is fosfomicina (as fosfomicina trometamol). Each sachet contains 3 grams of fosfomicina (as fosfomicina trometamol).

-The other components (excipients) are: sacarose, sodium saccharin, mandarin aroma (contains glucose derived from maize maltodextrin and sodium) and orange aroma (contains glucose derived from maize maltodextrin and sodium).

Appearance of the product and contents of the packaging

Oral solution granule in sachets. White or almost white granule.

Unit-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

Responsible for Manufacturing

Labiana Pharmaceuticals, S.L.U.

c/ Casanova 27-31

08757 Corbera de Llobregat

(Barcelona)

Last review date of this leaflet: January 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es/