Package leaflet: Information for the user

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

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, 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.

Contents of the leaflet

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

1. What Fosfomycin US Pharmacia is and what it is used for

Fosfomycin US Pharmacia contains the active substance fosfomycin (in the form of trometamol fosfomycin). It is an antibiotic that works by killing bacteria that may cause infections.
Fosfomycin US Pharmacia is used to treat uncomplicated urinary tract infections in women and adolescent girls.
Fosfomycin US Pharmacia is used as antibiotic prophylaxis in adult men undergoing transrectal prostate biopsy.

2. Important information before taking Fosfomycin US Pharmacia
When not to take Fosfomycin US Pharmacia

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

Warnings and precautions
Before starting treatment with Fosfomycin US Pharmacia, discuss with your doctor, pharmacist or nurse if you have:

chronic urinary tract infections,
a history of diarrhoea after taking other antibiotics.

Other considerations
Fosfomycin US Pharmacia may cause serious adverse reactions. These include allergic reactions and inflammation of the large intestine. While taking this medicine, you should be aware of certain symptoms to reduce the risk of complications. See "Serious side effects" 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.
Fosfomycin US Pharmacia and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or plan to take any other medicines, including medicines obtained without a prescription.
This is particularly important if you are taking:

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

Taking Fosfomycin US Pharmacia with 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 you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Your doctor will prescribe this medicine during pregnancy only if clearly necessary.
Breastfeeding mothers may take a single oral dose of this medicine.
Driving and using machines
Adverse reactions such as dizziness may occur, which could affect your ability to drive or operate machinery.
Fosfomycin US Pharmacia contains sucrose, sunset yellow and sodium
Fosfomycin US Pharmacia contains 1.923 g of sucrose. If you have been previously diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.
Fosfomycin US Pharmacia contains sunset yellow, which may cause allergic reactions.
The medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. the medicine is considered "sodium-free".

3. How to use Fosfomycin US Pharmacia

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
For treatment of uncomplicated urinary bladder infections in women and adolescent girls, the
recommended dose is one sachet of Fosfomycin US Pharmacia (3 g of fosfomycin).
When used as prophylactic antibiotic therapy prior to transrectal prostate biopsy, the recommended
dose is one sachet of Fosfomycin US Pharmacia (3 g of fosfomycin) taken three hours before the
procedure and one sachet of Fosfomycin US Pharmacia (3 g of fosfomycin) 24 hours after the
procedure has ended.
Use in patients with impaired kidney function
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 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 Fosfomycin US Pharmacia
If you have taken more than the recommended dose by accident, contact your doctor or
pharmacist.
If you have any further questions about the use of this medicine, consult your 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 Fosfomycin US Pharmacia:

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

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

headache,
dizziness,
diarrhoea,
nausea,
indigestion,
abdominal pain,
infection of female genital organs manifesting as inflammation, irritation, 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, pharmacist or nurse.
Adverse reactions 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 21 301
Fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Fosfomycin US Pharmacia

Keep this medicine out of the sight and reach of children.
There are no special requirements for storage of this medicine.
Do not use this medicine after the expiry date stated on the outer carton and
immediate packaging (month / year). The labelling applied to the blister reads: EXP – expiry date, Lot – batch number.
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 pack and other information

What Fosfomycin US Pharmacia contains

The active substance is fosfomycin (in the form of fosfomycin trometamol). One sachet contains 8 g of granules, including 3 g of fosfomycin as fosfomycin trometamol (5,631 g).
Other ingredients: sucrose, calcium hydroxide, orange flavour (maltodextrin, monohydrate dextrose, gum arabic [E414], anhydrous citric acid [E330], sunset yellow [E110], butylated hydroxyanisole [E320], flavour and taste enhancing ingredients), sodium saccharin [E954].

What Fosfomycin US Pharmacia looks like and contents of the pack
Fosfomycin US Pharmacia is a white or almost white granule for oral solution.
The immediate packaging is a sachet made of paper/LDPE/Aluminium/LDPE foil.
Pack: 1 sachet in a cardboard box.
Marketing Authorisation Holder:
US Pharmacia Sp. z o.o.
Ziębicka Street 40, 50-507 Wrocław, Poland
Manufacturer:
SPECIAL PRODUCT’S LINE S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR), Italy
For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
USP Zdrowie Sp. z o.o.
Poleczki Street 35
02-822 Warsaw, Poland
Tel. +48 (22) 543 60 00