Simural

Package Leaflet: Information for the Patient

Symural

3 g, granules for oral solution

Fosfomycin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Symural and what is it used for
• 2. Important information before taking Symural
• 3. How to take Symural
• 4. Possible side effects
• 5. How to store Symural
• 6. Contents of the pack and other information

1. What is Symural and what is it used for

Symural contains the active substance fosfomycin (in the form of fosfomycin trometamol). It is an antibiotic that works by killing bacteria that can cause infections. Symural is used to treat uncomplicated urinary tract infections in women and adolescent girls.

2. Important information before taking Symural

When not to take Symural:

if you are allergic to fosfomycin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Symural, discuss it with your doctor, pharmacist, or nurse if you have:

• chronic urinary tract infections,
• diarrhea that has occurred after taking other antibiotics in the past.

Matters to be considered: Symural may cause severe side effects, including allergic reactions and inflammation of the colon. While taking the medicine, pay attention to specific symptoms to minimize the risk of problems. See "Severe side effects" in section 4.

Children and adolescents

Do not give this medicine to children under 12 years of age, as the safety and efficacy in this age group have not been established.

Symural and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and those you plan to take, including those available without a prescription. This is especially important when taking:

• metoclopramideor other medicines that increase the passage of food through the stomach and intestines, as they may reduce the absorption of fosfomycin by the body,
• anticoagulant medicines, as fosfomycin and other antibiotics may affect their ability to prevent blood clots.

Taking Symural with food

Food may delay the absorption of fosfomycin. Take this medicine on an empty stomach (2-3 hours before a meal 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 have a child, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will only prescribe this medicine during pregnancy if it is clearly necessary. Breastfeeding mothers may take a single oral dose of this medicine.

Driving and using machines

It is possible to experience side effects, such as dizziness, which may affect your ability to drive or operate machines.

Substances with known effects

Symural contains sucrose and glucose (in the form of anhydrous dextrose and maltodextrin)

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.

Symural contains the azo dye, orange yellow (E110)

The medicine may cause allergic reactions.

Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per sachet, which means it is considered "sodium-free".

3. How to take Symural

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. For the treatment of uncomplicated urinary tract infections in women and adolescent girls (over 12 years of age), the recommended dose is one sachet of Symural (3 g of fosfomycin). Use in patients with renal impairment: Do not use this medicine in patients with severe renal impairment (creatinine clearance <10 ml min).< p>

Use in children and adolescents

Do not use this medicine in children under 12 years of age.

Method of administration

Oral use. Take this medicine orally, on an empty stomach (2-3 hours before a meal or 2-3 hours after a meal), preferably before going to bed and after emptying the bladder. Dissolve the contents of one sachet in a glass of water and drink immediately.

Overdose of Symural

If you have taken more than the prescribed dose, contact your doctor or pharmacist. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe side effects

Stop taking the medicine and contact your doctor immediately if you experience any of the following symptoms while taking Symural:

• anaphylactic shock, a life-threatening allergic reaction (frequency not known). Symptoms include sudden onset of rash, itching, or hives on the skin, or difficulty breathing, wheezing, or shortness of breath,
• swelling of the face, lips, and tongue, or throat, and difficulty breathing - angioedema (frequency not known),
• diarrhea of moderate to severe intensity, abdominal cramps, bloody stools, and (or) fever may indicate infection of the colon - antibiotic-associated colitis (frequency not known). Do not take anti-diarrheal medicines that reduce intestinal peristalsis.

Other side effects

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

• headache,
• dizziness,
• diarrhea,
• nausea,
• indigestion,
• abdominal pain,
• vaginal infection, inflammation, irritation, itching (vulvovaginitis).

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

• vomiting,
• rash,
• hives,
• itching.

Unknown (frequency cannot be estimated from the available data):

• allergic reactions.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 30, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Symural

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the sachet and carton after: EXP. The expiry date refers to the last day of the month stated.
• No special storage precautions are required.
• The solution should be administered immediately after dissolution.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Symural contains

• The active substance is fosfomycin. Each sachet contains 3 g of fosfomycin, equivalent to 5.631 g of fosfomycin trometamol.
• The other ingredients are: sucrose, calcium hydroxide, orange flavor (containing: maltodextrin, anhydrous dextrose, gum arabic [E414], citric acid anhydrous [E330], orange yellow [E110], butylhydroxyanisole [E320], flavorings and flavoring preparations), sodium saccharin.

What Symural looks like and contents of the pack

Symural is available in packs containing 1 sachet of 8 g of white or off-white granules for oral solution.

Marketing authorization holder and manufacturer

Marketing authorization holder

Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw

Manufacturer

Special Product’s Line S.p.A
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy
Date of last revision of the leaflet:April 2025