Package leaflet: Information for the user

Fasflow, 3 g, granules for oral solution in sachet
Fosfomycin
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

What Fasflow is and what it is used for
What you need to know before taking Fasflow
How to take Fasflow
Possible side effects
How to store Fasflow
Contents of the pack and other information

1. What Fasflow is and what it is used for

Fasflow contains the active substance fosfomycin. It is an antibiotic that works by killing bacteria that may cause infections.
Fasflow is used in the treatment of uncomplicated urinary tract infections (cystitis) in women and adolescent girls.
Fasflow is also used as antibiotic prophylaxis in adult men undergoing transrectal prostate biopsy.

2. Important information before taking Fasflow

When not to take Fasflow:

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 Fasflow, consult a doctor or pharmacist if the patient has:

chronic bladder infections,
a history of diarrhoea after taking any other antibiotics.

Conditions to consider
Fasflow may cause serious adverse reactions, including allergic reactions and inflammation of the large intestine. During treatment, specific symptoms should be monitored to reduce the risk of complications. 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.
Fasflow and other medicines
Inform the 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 a prescription.
This is particularly important when taking:

metoclopramide or other medicinal products that increase gastrointestinal motility, as they may reduce the absorption of fosfomycin,
anticoagulant medicines, since fosfomycin and other antibiotics may affect their ability to prevent blood clotting.

Fasflow and food
Food may delay the absorption of fosfomycin. Therefore, this medicine should be taken on an empty stomach (2–3 hours before 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 baby, she should consult a doctor or pharmacist before using this medicine.
The doctor will prescribe this medicine during pregnancy only if absolutely 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:
Fasflow contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. it is considered "sodium-free".
Fasflow contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Fasflow

This medicine should always be taken as directed by a doctor or pharmacist. If in
doubt, consult a doctor or pharmacist.
For the treatment of uncomplicated bladder infections in women and adolescent girls, the recommended dose is one sachet of Fasflow (3 g of fosfomycin).
When used as prophylactic antibiotic therapy prior to transrectal prostate biopsy, the recommended dose is one sachet of Fasflow (3 g of fosfomycin) three hours before the procedure and one sachet of Fasflow (3 g of fosfomycin) 24 hours after completion of 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 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 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.
Accidental overdose of Fasflow
If more than the recommended dose has been taken by accident, contact a doctor or pharmacist.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Serious adverse reactions
Stop taking the medicine immediately and contact your doctor if any of the following symptoms occur during treatment with Fasflow:

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

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

Headache
Dizziness
Diarrhea
Nausea
Indigestion
Abdominal pain
Infection of female genital organs manifesting as inflammation, irritation and itching (vulvovaginitis).

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

Vomiting
Rash
Urticaria
Itching.

Unknown (frequency cannot be estimated from available data):

Allergic reactions.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Fasflow

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
sachet after: EXP. The expiry date refers to the last day of the stated month.
Store below 30°C.
Store in the original packaging to protect from light.
Medicines must 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 package and other information

What Fasflow contains

The active substance is fosfomycin. Each sachet contains 3 g of fosfomycin.

The other ingredients are: mandarin flavour (natural flavourings, corn maltodextrin and
triacetin INS 1518), orange flavour (flavouring preparations, flavouring substances,
natural flavouring substances, corn maltodextrin and alpha-tocopherol (E 307)), sodium saccharin,
colloidal anhydrous silica, sucrose.

What Fasflow looks like and contents of the pack

Granulate for oral solution, in a sachet.
Fasflow 3 g granulate for oral solution consists of white or almost white granules.
Fasflow 3 g granulate for oral solution is available in a cardboard box containing 1 or 2 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Fosfomicina Aurobindo Italia
Poland: Fasflow
Portugal: Fosfomicina Generis
Spain: Fosfomicina Aurovitas 3 g granulado para solución oral en sobre EFG