Fosfomycin Stada 3 g granules for oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Fosfomicina Stada 3 g granules for oral solution EFG

Fosfomycin (trometamol)

Read the entire 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, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should 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 adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

2. What you need to know before taking Fosfomicina Stada

3. How to take Fosfomicina Stada

4. Possible side effects

5. How to store Fosfomicina Stada

6. Contents of the pack and other information

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

Fosfomicina Stada contains the active substance fosfomycin (as fosfomycin trometamol). It is an antibiotic that works by eliminating bacteria that can cause infections.

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

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

2. What you need to know before taking Fosfomicina Stada

Do not take Fosfomicina Stada

• 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 Stada if you are in any of the following situations:

• You suffer from persistent bladder infections,
• You have ever had diarrhoea after taking any other antibiotic.

Symptoms to watch for

Fosfomycin 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 must 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 Stada

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 their ability to prevent blood clotting.

Taking Fosfomicina Stada 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, breast-feeding and fertility

If you are pregnant or breast-feeding, 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 when strictly necessary.

Breast-feeding 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 Stada contains sucrose, glucose, sunset yellow FCF (E110) and sodium

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains glucose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

This medicine may cause allergic reactions as it contains sunset yellow FCF (E110). 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 Stada

For the treatment of uncomplicated bladder infection in women and female adolescents, the recommended dose is 1 sachet of Fosfomicina Stada (3 g of fosfomycin).

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

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 Stada than you should

If you accidentally take more than the prescribed dose, contact your doctor or pharmacist, or consult the Toxicology Information Service, telephone 91.562 04 20, stating 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 may produce adverse effects, although not everyone will experience them.

Serious adverse effects

If you experience any of the following symptoms while being treated with fosfomycin, 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, bloody stools 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 through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fosfomicina Stada

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

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. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fosfomicina Stada

• The active substance is fosfomycin (as fosfomycin trometamol). Each sachet contains 3 grams of fosfomycin (as fosfomycin trometamol).

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

Nature of the product and contents of the pack

Granules for oral solution in sachet, white or almost white in colour, with a characteristic orange odour.

It is presented in cardboard packs containing 1 or 2 sachets of 8 g of granules for oral solution.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

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

Date of the most recent review of this leaflet: February 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/