Package Insert:Patient Information

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

fosfomicina

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Fosfomicina Labiana and how is it used

2. What you need to know before starting to take Fosfomicina Labiana

3. How to take Fosfomicina Labiana

4. Possible adverse effects

5. Storage of Fosfomicina Labiana

6. Contents of the package and additional information

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

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

Do not take Fosfomicina Labiana:

• 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 Labiana 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 be aware of

Fosfomicina Labiana may cause severe side effects. For example, allergic reactions and inflammation of the large intestine. You should be aware of certain symptoms while you are being treated with 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 Labiana

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:

• metoclopramida or 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 Labiana 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 Labiana contains saccharose, glucose, and sodium

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

For the treatment of uncomplicated urinary tract infections in women and female adolescents, the recommended dose is 1 packet of Fosfomicina Labiana (3 g of fosfomicina).

Use in patients with renal insufficiency

This medication should not be used in patients with severe renal insufficiency (creatinine clearance <10ml/min).

Use in children and adolescents

This medication should not be used in children under 12years 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.

The reconstituted solution is a nearly white slightly turbid solution, with a citrus (orange-mandarin) aroma.

If you take more Fosfomicina Labianathan you should

If you accidentally take a higher dose than prescribed, contact your doctor or pharmacist.

In case of overdose or accidental ingestion, go to a medical center or call the Toxicological Information Service at 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 everyone will experience them.

Severe Adverse Effects

If you experience any of the following symptoms while taking Fosfomicina Labiana, 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 large intestine infection (antibiotic-associated colitis) (unknown frequency). Do not take medications that prevent intestinal movement (antiperistaltics).

Other Adverse Effects

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

• Headache
• Dizziness
• Diarrhea
• Nausea
• Indigestion
• Abdominal pain
• Female genital organ infection with symptoms such as inflammation, irritation, and itching (vulvovaginitis).

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

• Vomiting
• Hives
• Urticaria
• Itching

Unknown frequency (cannot be estimated from available data):

• Allergic reactions.

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 to the Spanish System for Pharmacovigilance of Medicines for Human Use: 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.

Do not store at a temperature above 86°F (30°C).

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 medicines you no longer need at your local SIGREcollection point at your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Fosfomicina Labiana

- The active ingredient is fosfomicina (as fosfomicina trometamol). Each sachet contains fosfomicina trometamol equivalent to 3 g of fosfomicina.

- The other ingredients are: sacarosa, saccharin sodium (E954), mandarin aroma (contains glucose derived from maize maltodextrin and sodium) and orange aroma (contains glucose derived from maize maltodextrin and sodium). See section 2. Fosfomicina Labiana contains sacarosa, glucose and sodium.

Appearance of the product and contents of the packaging

Oral solution granules in sachets. White or almost white granules without lumps or particles in single-dose sachets.

Each box contains 1 or 2 sachets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Labiana Pharmaceuticals, S.L.U.

C/ Casanova 27-31

08757 Corbera de Llobregat (Barcelona)

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany: Afosfol 3 g Granulat im Beutel zur Herstellung einer Lösung zum Einnehmen

Denmark: Cystifos

France: Fosfomycine Zydus 3 g, granulés pour solution buvable en sachet

Netherlands: Fosfomycine 3 g Focus, granulaat voor drank in sachet

Hungary: Afosfol 3 g granulátum belsoleges oldhatoz

Poland: Uromaste

Portugal: Fosfomicina Pharmakern

Sweden: Cystifos

Spain: Fosfomicina Labiana 3 g granulado para solución oral en sobres EFG

Last review date of this leaflet:December 2020

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