Leaflet: information for the patient

Fosfomicina Stada 3 g powder for oral solution EFG

Fosfomicina (trometamol)

Read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What you need to know before you start taking Fosfomicina Stada
2. How to take Fosfomicina Stada

1. Possible side effects
2. Storage of Fosfomicina Stada
3. Contents of the pack and additional information

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

Fosfomicina Stada is used to treat uncomplicated urinary tract infections in adult and adolescent women.

Fosfomicina Stada is used as antibiotic prophylaxis for transrectal prostate biopsies in adult men.

Do not take Fosfomicina Stada

• If you are allergic to fosfomicina or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Fosfomicina Stada if you are in any of the following situations:

• You have persistent urinary tract infections,
• You have had diarrhea after taking any other antibiotic.

Symptoms to pay attention to

Fosfomicina may cause severe side effects. For example, allergic reactions and inflammation of the large intestine. You should pay attention to certain symptoms while taking 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 Stada

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 Stada 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 using 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, that may affect your ability to drive or operate machinery.

Fosfomicina Stada contains saccharose, glucose, yellow orange S (E110), and sodium

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication may cause allergic reactions because it contains yellow orange S (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

This medication contains less than 23 mg of sodium (1mmol), which is essentially "sodium-free".

In case of treatment for an uncomplicated bladder infection in women and female adolescents, the recommended dose is 1 packet of Fosfomicina Stada (3 g of fosfomicina).

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

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

If you take more Fosfomicina Stada than you should

If you accidentally take a higher dose than prescribed, contact your doctor or pharmacist or consult the Toxicological Information Service, phone 91.562 04 20, indicating the medication and the amount ingested.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Severe Adverse Effects

If you experience any of the following symptoms during treatment with fosfomicina, stop taking the medication and contact your doctor immediately:

• anaphylactic shock, a potentially fatal allergic reaction (unknown frequency). Symptoms include sudden onset of hives, itching or urticaria, and/or shortness of breath, wheezing (emission of whistling sounds while breathing) 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 to prevent diarrhea that can impede intestinal movement (antiperistaltics).

Other Adverse Effects

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

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

Unknown frequency (cannot be estimated from available data):

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://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.

Do not use this medication after 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 the

medicines you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and the medicines you no longer need. In this way, you will help protect the environment.

Composition of Fosfomicina Stada

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

• The other components (excipients) are sacarosa, saccharin sodium, calcium hydroxide, orange aroma [contains glucose, glucose (in maltodextrin derived from corn) and yellow-orange S (E-110)].

Appearance of the product and contents of the packaging

Granulated for oral solution in sachet, of color white or almost white with a characteristic orange odor.

It is presented in cardboard boxes containing 1 or 2 sachets of 8 g of granulated oral solution.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

SPECIAL PRODUCT'S LINE S.P.A.

Via Fratta Rotonda Vado Largo, 1

03012 Anagni (FR)

Italy

or

Laboratori Fundaciò DAU

C/C, 12-14 Pol. Ind. Zona Franca

Barcelona - 08040

Spain

Last review date of this leaflet: February 2021

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