Fosfomicina qualigen 3 g granulado para solucion oral efg

PATIENT INFORMATION LEAFLET

FOSFOMICIN QUALIGEN3 goral granule for solution EFG

Fosfomicina trometamol

Read this leaflet carefully before you start taking the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if they have similar symptoms, as it may harm them.
• If you think you have suffered a side effect, you can report it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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

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

3. How to take Fosfomicina Qualigen

4. Possible side effects

5. Storage of Fosfomicina Qualigen

6. Contents of the pack and additional information.

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

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

Fosfomicina Qualigen is used as antibiotic prophylaxis for transrectal prostate biopsies in adult men.

Do not take Fosfomicina Qualigen:

- if you are allergic to fosfomicina or to 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 Qualigen if you are in any of the following situations:

• have persistent urinary tract infections,

• have ever had diarrhea after taking any other antibiotic.

Symptoms to pay attention to:

Fosfomicina Qualigen may cause severe side effects. For example, allergic reactions and inflammation of the large intestine. You should pay attention to 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 Qualigen

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

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 Fosfomicina Qualigen 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 Qualigen contains sacarose, glucose, yellow S and sodium:

This medication contains sacarose. 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 medication may cause allergic reactions because it contains “Yellow S (E-110)”. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

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

Follow exactly the administration instructions indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.Consult your doctor or pharmacist again if you are unsure.

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

When used as antibiotic prophylaxis for transrectal prostate biopsy, the recommended dose is 1 packet of Fosfomicina Qualigen (3 g of fosfomicina) 3 hours before the procedure and 1 packet of Fosfomicina Qualigen (3 g of fosfomicina) 24 hours after the procedure.

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 moreFosfomicina Qualigenthan you should:

If you accidentally take a higher dose than prescribed, 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 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 Qualigen, 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 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 about the safety of this medication.

Keep out of the reach and sight of children.

Do not use Fosfomicina Qualigen after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

No special conditions are required for its conservation.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines that you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Composition ofFosfomicina Qualigen

- The active ingredient is Fosfomicina trometamol5,631 g(equivalent to3 gof fosfomicina).

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

Appearance of the product and contents of the packaging

Fosfomicina Qualigen3 gis presented in the form of sachets containing a granule to be dissolved in water.

There are packaging of 1 and 2 sachets of granule.

Holder of the marketing authorization and responsible for manufacturing

Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 – Sant Joan Despí

(Barcelona) Spain

Responsible for Manufacturing

SPECIAL PRODUCT’S LINE S.p.A.

Via Fratta Rotonda Vado Largo, 1

03012 – Anagni (FR)

Italy

Last review date of this leaflet: May 2021

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/