Fosfacin

Leaflet attached to the packaging: patient information

Fosfacin, 3 g, granules for oral solution

Fosfomycin

Read the 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 only. 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, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Fosfacin and what is it used for

Fosfacin contains the active substance fosfomycin (in the form of fosfomycin trometamol). It is an antibiotic that works by killing bacteria that can cause infections. Fosfacin is used to treat uncomplicated urinary tract infections in women and adolescent girls. Fosfacin is used as part of prophylactic antibiotic therapy in the case of transrectal prostate biopsy in adult men.

2. Important information before taking Fosfacin

When not to take Fosfacin:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);

Warnings and precautions

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

• chronic urinary tract infections,
• diarrhea that occurred after taking other antibiotics.

Matters to be considered:

You should stop taking the medicine and immediately consult a doctor or contact the emergency department of the nearest hospital if you experience the following symptoms:

allergic reactions, including anaphylactic reaction and anaphylactic shock.Cases of colitis and pseudomembranous colitis caused by Clostridioides difficile, ranging from mild to life-threatening, have been reported. Do not take medicines that inhibit peristalsis.When taking the medicine, pay attention to specific symptoms to reduce the risk of problems. See "Severe side effects" in section 4.

Children and adolescents

The safety and efficacy of Fosfacin in children under 12 years of age have not been established. Therefore, Fosfacin should not be used in this age group.

Fosfacin and other medicines

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

• metoclopramideor other medicines that increase gastric and intestinal passage, 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.

Fosfacin with food and drink

Food may delay the absorption of Fosfacin. Therefore, Fosfacin should be taken orally on an empty stomach or 2-3 hours after a meal, preferably before bedtime and after emptying the bladder. The contents of one sachet should be dissolved in a glass of water and taken immediately after preparation. In the case of acute, uncomplicated urinary tract infections in women and girls, the medicine should be taken on an empty stomach (about 2-3 hours before a meal or 2-3 hours after a meal), preferably before going to bed and after emptying the bladder. The contents of one sachet should be dissolved in a glass of water and taken immediately after preparation.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The doctor will prescribe this medicine to pregnant women only if it is clearly necessary. Breastfeeding women can take a single oral dose of this medicine. There are no available data on the effect on human fertility. Fosfomycin administered orally to male and female rats at a dose of up to 1000 mg/kg/day did not impair fertility.

Driving and using machines

It is possible to experience side effects such as dizziness, which may affect your ability to drive and use machines. If you experience dizziness, do not drive or operate machines.

Fosfacin contains excipients with known effects:

Sodium

Each sachet contains 15.4 mg of sodium. Fosfacin contains less than 1 mmol of sodium (23 mg) per dose, which means the medicine is considered "sodium-free".

Sucrose

One sachet contains 2.153 g of sucrose. If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Fosfacin

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, 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 Fosfacin (3 g of fosfomycin). In the case of prophylactic antibiotic therapy for transrectal prostate biopsy, the recommended dose is one sachet of Fosfacin (3 g of fosfomycin) 3 hours before the procedure and one sachet of Fosfacin (3 g of fosfomycin) 24 hours after the procedure. Use in patients with renal impairment This medicine should 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 under 12 years of age.< p>

Method of administration

Oral administration. The medicine should be taken orally, on an empty stomach (or 2-3 hours after a meal). In the case of acute, uncomplicated urinary tract infections in women and girls, the medicine should be taken on an empty stomach (about 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 Fosfacin

If you have taken more than the recommended dose of Fosfacin, contact your doctor or pharmacist immediately, taking the packaging with you. Experience with overdose of orally administered fosfomycin is limited. After parenteral administration of fosfomycin, cases of hypotension, drowsiness, electrolyte imbalance, thrombocytopenia, and hypoprothrombinemia have been reported. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Severe side effects:

You should stop taking the medicine and contact a doctor immediately if you experience the following symptoms while taking Fosfacin:

• 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, tongue, or throat, or difficulty breathing - angioedema (frequency not known),
• diarrhea of moderate to severe intensity, abdominal cramps, bloody stools, and/or fever, which may indicate colitis - post-antibiotic colitis (frequency not known). Do not take anti-diarrheal medicines that reduce peristalsis (anti-peristaltic medicines) (see section 2).

Other side effects:

Common(occurring in less than 1 in 10 people):

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

Uncommon(occurring in less than 1 in 100 people):

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

Frequency not known(frequency cannot be estimated from the available data):

• allergic reactions (see section 2).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: 22 49-21-301, Fax: 22 49-21-309, Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported 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 Fosfacin

Keep this medicine out of the sight and reach of children. Do not store above 25°C. Do not use this medicine after the expiry date stated on the carton and sachet after "Expiry date (EXP):". The expiry date refers to the last day of the month. Shelf life of the prepared solution: The contents of one sachet should be dissolved in a glass of water and taken immediately after preparation. 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 Fosfacin contains

The active substance is fosfomycin (in the form of fosfomycin trometamol). Each sachet (8g granules) contains 5.631g of fosfomycin trometamol (equivalent to 3g of fosfomycin). The other ingredients are: sucrose, sodium saccharin (E 954), orange flavor 87D645 (maltodextrin, gum arabic (E 414), citric acid monohydrate (E 330), sodium citrate (E 331), butylhydroxyanisole (E 320)); mandarin flavor WONF 87D646 (maltodextrin, gum arabic (E 414), citric acid monohydrate (E 330), sodium citrate (E 331)).

What Fosfacin looks like and contents of the pack

Almost white granules with a citrus flavor. Granules for oral solution. The immediate packaging is a paper/Aluminum/LDPE sachet in a cardboard box. The pack contains: 1 or 2 sachets

Marketing authorization holder and manufacturer

Marketing authorization holder Solinea Sp. z o.o. Sp.K. Elizówka 65 21-003 Ciecierzyn, Poland Tel. 81 463-48-82 (Solinea logo) Manufacturer: Mako Pharma Sp. z o.o. ul. Kolejowa 231 A 05-092 Dziekanów Polski Patient leaflet in a format suitable for the blind and partially sighted available at the marketing authorization holder's headquarters.

Date of last revision of the leaflet: