Package leaflet: Information for the patient

Symural
3 g, granules for oral solution
Fosfomycinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Symural is and what it is used for
Important information before taking Symural
How to take Symural
Possible side effects
How to store Symural
Contents of the pack and other information

1. What Symural is and what it is 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 bladder infections in women and adolescent girls.

2. Important information before using Symural

When not to take Symural:
if the patient is allergic to fosfomycin or any of the other ingredients of this
medicine (listed in section 6).
Warnings and precautions
Before starting treatment with Symural, consult a doctor, pharmacist, or
nurse if the patient has:

chronic bladder infections,
diarrhoea that occurred in the past after taking other antibiotics.

Considerations
Symural may cause serious adverse reactions. These include allergic reactions and inflammation of the large intestine. While taking the medicine, be alert for specific symptoms to reduce the risk of problems. See "Serious adverse reactions" in section 4.
Children and adolescents
This medicine should not be given to children under 12 years of age, as safety and efficacy have not been established in this age group.
Symural and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without prescription.
This is particularly important when taking:

metoclopramide or other medicinal products that increase gastrointestinal motility, as they may reduce the absorption of fosfomycin by the body,
anticoagulants , because fosfomycin and other antibiotics may affect their ability to prevent blood clot formation.

Taking Symural with food
Food may delay the absorption of fosfomycin. This medicine should be taken on an empty stomach (2–3 hours before a meal or 2–3 hours after a meal).
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
The doctor will prescribe this medicine during pregnancy only if clearly necessary.
Breastfeeding mothers may take a single oral dose of this medicine.
Driving and operating machinery
Adverse reactions such as dizziness may occur, which could affect the ability to drive or operate machinery.
Excipients with known effects:
Symural contains sucrose and glucose (in the form of monohydrate dextrose and maltodextrin)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Symural contains an azo dye, sunset yellow (E110)
This medicine may cause allergic reactions.
Sodium
This medicine contains less than 1 mmol of sodium (23 mg) per sachet, i.e. the medicine is considered "sodium-free".

3. How to use Symural

This medicine should always be taken according to the instructions provided by your doctor or pharmacist. In case of
doubt, consult your doctor or pharmacist.
For the treatment of uncomplicated urinary bladder infections in women and adolescent girls (>12 years of age), the recommended dose is one Symural sachet (3 g of fosfomycin).
Use in patients with renal function impairment
This medicine must not be used in patients with severe renal impairment (creatinine clearance <10 ml/min).
Use in children and adolescents
This medicine should not be used in children under 12 years of age.
Method of administration
Oral administration.
This medicine should be taken orally on an empty stomach (2–3 hours before or 2–3 hours after a meal), preferably before going to bed and after emptying the urinary bladder.
Dissolve the contents of one sachet in a glass of water and drink immediately.
Overdose of Symural
If a dose higher than recommended has been taken by accident, contact your doctor or pharmacist.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Serious adverse effects
Immediately stop taking Symural and contact your doctor if you experience any of the following symptoms while taking the medicine:

Anaphylactic shock, a life-threatening allergic reaction (frequency not known). Symptoms include sudden onset of rash, itching, or hives on the skin, or shortness of breath, wheezing, or difficulty breathing;
Swelling of the face, lips, tongue, or throat with breathing difficulties – angioedema (frequency not known);
Diarrhoea ranging from moderate to severe, abdominal cramps, bloody stools and/or fever, which may indicate a serious bowel infection – antibiotic-associated colitis (frequency not known). Do not take antidiarrhoeal medicines that reduce intestinal motility (antiperistaltic agents).

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

Headache;
Dizziness;
Diarrhoea;
Nausea;
Indigestion;
Abdominal pain;
Inflammation, irritation, or itching indicating a genital infection in women (vulvovaginal inflammation or vaginitis).

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

Vomiting;
Rash;
Urticaria;
Itching.

Not known (frequency cannot be estimated from available data):

Allergic reactions.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 30, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported directly to the Marketing Authorisation Holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Symural

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

6. Contents of the packaging and other information

What the medicine Symural contains

The active substance is fosfomycin. Each sachet contains 3 g of fosfomycin, equivalent to 5.631 g of fosfomycin with trometamol.
The other ingredients are: sucrose, calcium hydroxide, orange flavour (containing: maltodextrin, monohydrate dextrose, gum arabic [E414], anhydrous citric acid [E330], sunset yellow [E110], butylated hydroxyanisole [E320], flavouring preparations and flavouring substances), 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 Authorisation Holder and Manufacturer
Marketing Authorisation 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