Fosfomicina pensa 3 g granulado para solucion oral efg

Package Leaflet: Information for the User

Fosfomicina pensa3 gGranulated for Oral Solution EFG

Read this leaflet carefully before you start taking the medicine, 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 or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Fosfomicina Pensa

3. How to take Fosfomicina Pensa

4. Possible side effects

5. Storage of Fosfomicina Pensa

6. Contents of the pack and additional informationadditional

Pensa Fosfomicina contains the active ingredient fosfomicina, (as fosfomicina trometamol).

It is an antibiotic that acts by eliminating the bacteria that can cause infections.

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

Do not takeFosfomicinaThink

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 take Fosfomicina Pensaif you are in any of the following situations:

• have persistent urinary tract infections,

• have ever had diarrhea after taking any other antibiotic.

Be aware of the following symptoms

Fosfomicina Pensamay cause severe side effects. For example, allergic reactions and inflammation of the large intestine. 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 andFosfomicina Pensa

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:

•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.

TakingFosfomicina Pensawith 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.

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 could affect your ability to drive or operate machinery.

FosfomicinaPensa contains saccharose, glucose, and yellow orange S (E-110)

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

This medicationcontains yellow orange S (E-110). This medication may cause allergic reactions because it contains yellow orange S (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

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

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

For uncomplicated urinary tract infections in women and female adolescents, the recommended dose is 1 packet of Fosfomicina Pensa (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 Pensa than you should

If you accidentally take a quantity greater than the prescribed dose, contact your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 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 medicationcan produce adverse effects, although not all people will experience them.

Severe Adverse Effects

If you experience any of the following symptoms while taking Fosfomicina Pensa, 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 it directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

No special conservation conditions are required.

The medication must be administered immediately after its dissolution.

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

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the packaging is damaged or open.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Fosfomicina Pensa

The active ingredient is fosfomicina.Each sachet contains3 gof fosfomicina (as fosfomicina trometamol).

The other components are orange aroma[containsglucose (in maltodextrin from corn) and yellow-orange S, E-110], sodium saccharin, sucrose and calcium hydroxide.

Appearance of the product and content of the packaging

White or off-white granule. Packaging containing 1 or 2 sachets.

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Special Product’s Line S.p.A.

Via Fratta Rotonda Vado Largo 1–

03012 Anagni (FR)

Italy

This leaflet was approved in February 2021

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