Package Insert: Information for the Patient

Fosfomicina Abamed 3 g Powder for Oral Solution in EFG Blister Packs

Fosfomicina (trometamol)

Read this package insert carefully before starting to take this medication, as it contains important information for you.

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

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

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

Do not takeAbamed Fosfomicina

• 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 useAbamed Fosfomicina 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 pay attention to

Abamed 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 Abamed Fosfomicina

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

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 Abamed Fosfomicina 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.

Abamed Fosfomicina 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 absorption problems or galactosemia should not take this medication.

This medication contains less than 1 mmol of sodium (23 mg); that is, it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

In case of treatment for uncomplicated urinary tract infection in women and female adolescents, the recommended dose is 1 packet 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)

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 going to bed and after urinating.

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

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

Severe side effects

If you experience any of the following symptoms while taking Fosfomicina Abamed, stop taking the medication and contact your doctor immediately:

• anaphylactic shock, a potentially life-threatening allergic reaction (unknown frequency). Symptoms include sudden onset of hives, itching or urticaria, and/or shortness of breath, wheezing, 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 gastrointestinal infection (antibiotic-associated colitis) (unknown frequency). Do not take medications that prevent intestinal movement (antiperistaltics).

Other side effects

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

• headache
• dizziness
• diarrhea
• nausea
• indigestion
• abdominal pain
• vulvovaginitis, a genital infection in women characterized by inflammation, irritation, and itching

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

• vomiting
• hives
• urticaria
• itching

Unknown frequency (cannot be estimated from available data):

• allergic reactions

Reporting side effects

Ifyou experienceany type of side effect,consult your doctor or pharmacist, even if it is apossibleside effect not listed in this leaflet.You can also report them directly to theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side 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. Store in the original packaging.

Do not usethis medicationafter 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 unused medications at your local SIGRE collection pointat your usual pharmacy. Ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

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: sacarose, sodium saccharin (E-954), mandarin aroma (contains glucose derived from corn maltodextrin and sodium) and orange aroma (contains glucose derived from corn maltodextrin and sodium).

Appearance of the product and contents of the packaging

Oral solution granules 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

Qualix Pharma, S.L.

c/ Botánica, 137-139

08908 L’Hospitalet de Llobregat

(Barcelona)

Responsible for Manufacturing

Labiana Pharmaceuticals, S.L.U.

c/ Casanova 27-31

08757 Corbera de Llobregat

(Barcelona)

This leaflet was approved in: December 2020.

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/