Package leaflet: Information for the patient

Fosfomycyna Aflofarm, 3 g, granulate 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, as 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 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.

Table of contents of the leaflet

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

1. What Fosfomycyna Aflofarm is and what it is used for

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

2. Information before taking Fosfomycyna Aflofarm

When not to take Fosfomycyna Aflofarm

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

Warnings and precautions
Before starting treatment with Fosfomycyna Aflofarm, consult a doctor,
pharmacist, or nurse if the patient has:

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

Considerations
Fosfomycyna Aflofarm may cause serious adverse reactions. These include
allergic reactions and inflammation of the large intestine. During treatment, patients should be aware of
specific symptoms in order to reduce the risk of complications. See “Serious adverse reactions” in section 4.
Children
The safety and efficacy of Fosfomycyna Aflofarm have not been established in children
under 12 years of age. Therefore, Fosfomycyna Aflofarm should not be used in this age group.
Fosfomycyna Aflofarm and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken,
as well as any medicines the patient intends to take, including those available without a prescription.
This is particularly important when taking:

metoclopramide or other drugs 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 clotting.

Fosfomycyna Aflofarm with food and drink
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 and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might 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 women may take a single oral dose of this medicine.
Driving and operating machinery
Adverse effects such as dizziness may occur, which could affect the ability to
drive or operate machinery. If dizziness occurs, driving and operating machinery should be avoided.
Fosfomycyna Aflofarm contains sodium and sucrose
Sodium
This medicine contains 15.4 mg of sodium per sachet.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning it is considered “sodium-free”.
Sucrose
This medicine contains 2.153 g of sucrose per sachet.
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 Fosfomycyna Aflofarm

This medicine should always be taken according to the doctor's or pharmacist's instructions. If in
doubt, consult your doctor or pharmacist.
For the treatment of uncomplicated bladder infections in women and adolescent girls (over 12 years
of age), the recommended dose is one sachet of Fosfomycyna Aflofarm (3 g of fosfomycin).
When used as antibiotic prophylaxis prior to transrectal prostate biopsy, the recommended dose
is one sachet of Fosfomycyna Aflofarm (3 g of fosfomycin) three hours before the procedure and
one sachet of Fosfomycyna Aflofarm (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
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 bladder.
Dissolve the contents of one sachet in a glass of water and drink immediately.
Overdose of Fosfomycyna Aflofarm
If more than the recommended dose has been taken by accident, contact your doctor or
pharmacist.
If you have any further doubts concerning 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 Fosfomycyna Aflofarm:

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

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

headache,
dizziness,
abdominal pain,
diarrhoea,
nausea,
indigestion,
fungal infection of the female genital tract presenting as inflammation, irritation, itching (vulvovaginal candidiasis).

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

vomiting,
rash,
urticaria,
pruritus (itching).

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

allergic reactions.

Reporting of adverse reactions
If any adverse reactions occur, including any 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 Authorisation Holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Fosfomycyna Aflofarm

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
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.
Period of validity of the prepared solution: use immediately after preparation.
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 packaging and other information

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

What Fosfomycyna Aflofarm looks like and contents of the pack
Fosfomycyna Aflofarm is an almost white granule for oral solution with a citrus flavour.
The immediate packaging consists of sachets made of Paper/Aluminium/LDPE, packed in a cardboard box.
Pack contents: 1 or 2 sachets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aflofarm Farmacia Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel. + 48 42 22-53-100

Manufacturer:
Adipharm EAD
130, Simeonovsko shose Blvd.
Sofia 1700
Bulgaria