FOSFOMICINA TARBIS 3 G ORAL SOLUTION GRANULES EFG

Introduction

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.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What Fosfomicina Tarbis is and what it is used for.
2. What you need to know before taking Fosfomicina Tarbis.
3. How to take Fosfomicina Tarbis.
4. Possible side effects.
5. Storage of Fosfomicina Tarbis.
6. Contents of the pack and further information

1. What Fosfomicina Tarbis is and what it is used for

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.

2. What you need to know before taking Fosfomicina Tarbis

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:

• suffer from persistent urinary tract infections,
• have ever had diarrhea after taking any other antibiotic.

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:

• metoclopramide or 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 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'.

3. How to take Fosfomicina Tarbis

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.

4. Possible side effects

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:

• Anaphylactic shock, a potentially life-threatening allergic reaction (frequency not known). Symptoms are sudden onset of a rash, itching, or hives, and/or shortness of breath, wheezing, or difficulty breathing,
• Swelling of the face, lips, tongue, or throat with difficulty breathing (angioedema) (frequency not known),
• Moderate to severe diarrhea, abdominal cramps, bloody stools, and/or fever, which may indicate that you have an infection of the large intestine (antibiotic-associated colitis) (frequency not known). Do not take medications against diarrhea that stop intestinal movement (antiperistaltics).

Other side effects

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

• Headache
• Dizziness
• Diarrhea
• Nausea
• Indigestion
• Abdominal pain
• Infection of the female genital organs with symptoms such as inflammation, irritation, itching (vulvovaginitis).

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

• Vomiting
• Rash
• Hives
• Itching (pruritus)

Frequency not known(cannot be estimated from available data):

• Allergic reactions.

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.

5. Storage of Fosfomicina Tarbis

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.

6. Contents of the pack and further information

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/