Fosfomycin Abamed 3 g granules for oral solution in sachets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Fosfomicina Abamed 3 g granules for oral solution in sachets EFG

Fosfomicin (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, consult your doctor, pharmacist, or nurse.
• 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 may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

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

2. What you need to know before taking Fosfomicina Abamed

Do not take Fosfomicina Abamed

• if you are allergic to fosfomycin or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

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

• you have persistent bladder infections,
• you have ever had diarrhoea after taking any other antibiotic.

Symptoms to watch for

Fosfomicina Abamed 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 Abamed

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, even if they are medicines obtained without a prescription.

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 your ability to prevent blood clotting.

Taking Fosfomicina Abamed 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, breastfeeding and fertility

If you are pregnant or breastfeeding, 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 if strictly necessary.

Breastfeeding 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 Abamed contains sucrose, glucose and sodium

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

This medicine contains glucose. Patients with glucose-galactose malabsorption should not take this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per sachet; hence, it is essentially “sodium-free”.

3. How to take Fosfomicina Abamed

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

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 patients 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 Abamed than you should

If you accidentally take more than the prescribed dose, contact your doctor or pharmacist.

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 can cause adverse effects, although not everyone will experience them.

Serious adverse effects

If you experience any of the following symptoms while being treated with Fosfomicina Abamed, 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 while 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 via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fosfomicina Abamed

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

No special storage conditions are required. Store in the original packaging.

Do not use this medicine after the expiry date stated on the container after "EXP.:" . The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your usual pharmacy. Ask your pharmacist how to properly 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 Abamed

• The active substance is fosfomicin (as fosfomycin trometamol). Each sachet contains 3 grams of fosfomycin (as fosfomycin trometamol).
• The other components (excipients) are: sucrose, sodium saccharin (E-954), tangerine flavour (contains glucose derived from corn maltodextrin and sodium), and orange flavour (contains glucose derived from corn maltodextrin and sodium).

Appearance of the medicinal product and contents of the pack

Granules for oral solution in sachets. White or almost white granules.

Single-dose sachets made of surlyn/aluminum/low-density polyethylene/paper, packed in cardboard boxes containing 1 or 2 sachets.

Marketing Authorization Holder

Qualix Pharma, S.L.

c/ Botánica, 137-139

08908 L’Hospitalet de Llobregat

(Barcelona)

Manufacturer

Labiana Pharmaceuticals, S.L.U.

c/ Casanova 27-31

08757 Corbera de Llobregat

(Barcelona)

This patient information leaflet was approved in: December 2020.

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