FOSFOMICINA ABAMED 3G ORAL SOLUTION GRANULES in SACHETS

Introduction

Package Leaflet: Information for the Patient

Fosfomicina Abamed 3 g Granules for Oral Solution in Sachets EFG

Fosfomicina (Trometamol)

Read this entire leaflet carefully before starting to take this medication, as 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 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 not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Fosfomicina Abamed and what is it used for
2. What you need to know before taking Fosfomicina Abamed
3. How to take Fosfomicina Abamed
4. Possible side effects
5. Storage of Fosfomicina Abamed
6. Package Contents and Additional Information

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

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

Fosfomicina Abamed is used to treat uncomplicated urinary tract 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 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 use Fosfomicina Abamed 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.

Symptoms to which you should pay attention

Fosfomicina Abamed 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 Abamed

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

This is especially important if you are taking:

• metoclopramideor 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 Abamed 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, think you may be pregnant, or plan to become 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.

Breastfeeding mothers may take a single oral dose of this medication.

Driving and Using Machines

You may experience side effects, such as dizziness, that could affect your ability to drive or use machines.

Fosfomicina Abamed contains saccharose, glucose, 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. Patients with glucose or galactose absorption problems should not take this medication.

This medication contains less than 1 mmol of sodium (23 mg) per sachet; it is essentially "sodium-free".

3. How to take Fosfomicina Abamed

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

In the case of treating an uncomplicated urinary tract infection in women and adolescent females, the recommended dose is 1 sachet of Fosfomicina Abamed (3 g of fosfomicina).

Use in patients with renal insufficiency

This medication should not be used in patients with severe renal insufficiency (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 Abamed 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.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Serious side effects

If you experience any of the following symptoms during treatment with Fosfomicina Abamed, 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 intestinal infection (antibiotic-associated colitis) (frequency not known). Do not take medications that stop intestinal movement (antiperistaltics).

Other side effects

Frequent (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

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 not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fosfomicina Abamed

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 thrown away down the drain or in the trash. Deposit the packaging and any unused medications in the SIGRE Point of your usual pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Fosfomicina Abamed

• The active ingredient is fosfomicina (as fosfomicina trometamol). Each sachet contains 3 grams of fosfomicina (as fosfomicina trometamol).
• The other components (excipients) are: saccharose, sodium saccharin (E-954), mandarin flavor (contains glucose from corn maltodextrin and sodium), and orange flavor (contains glucose from corn maltodextrin and sodium).

Appearance of the Product and Package Contents

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

Sachets made of surlyn/aluminum/low-density polyethylene/paper, packaged 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 leaflet was approved in: December 2020.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/