Patient Information Leaflet

INTERFOS 3 g granules for oral solution for adults

Fosfomycin
Generic medicine
Please read all of this leaflet carefully before taking this medicine, as it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

1. What INTERFOS is and what it is used for

INTERFOS contains the active substance fosfomycin (as fosfomycin trometamol). It is an antibiotic that
works by killing bacteria that can cause infections.
INTERFOS is used to treat uncomplicated bladder infections in women and adolescent girls (> 12
years of age).
INTERFOS is used as antibiotic prophylaxis for transrectal prostate biopsy in adult men.

2. What you need to know before taking INTERFOS

Do not take INTERFOS:

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using INTERFOS if you have any of the following
conditions:

persistent bladder infections
previous episodes of diarrhoea after taking other antibiotics

Conditions you should pay attention to
INTERFOS may cause serious side effects. These include allergic reactions and inflammation
of the large intestine. You should pay attention to certain symptoms while taking this
medicine in order to reduce the risk of potential problems. See "Serious side effects" in section 4.
Children and adolescents
Do not administer this medicine to girls under 12 years of age, as its safety and efficacy have not been established in this age group.
Other medicines and INTERFOS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
This is particularly important if you are taking:

metoclopramide or other medicines that increase the movement of food through the stomach and intestine, as they may reduce the absorption of fosfomycin by your body
anticoagulants, since their ability to prevent blood clotting may be altered by fosfomycin and other antibiotics

INTERFOS 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, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant, your doctor will prescribe this medicine only if clearly necessary.
Women who are breastfeeding may take a single oral dose of this medicine.
Driving and using machines
You may experience side effects such as dizziness, which could affect your ability to drive or operate machinery.
INTERFOS contains sucrose and sunset yellow FCF (E110):
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
The colouring agent sunset yellow FCF (E110) may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially 'sodium-free'.

3. How to take INTERFOS

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
For the treatment of uncomplicated bladder infection in women and adolescents, the recommended
dose is 1 sachet of INTERFOS (3 g of fosfomycin).
If used as perioperative antibiotic prophylaxis for prostate biopsy, the recommended dose is 1
sachet of INTERFOS (3 g of fosfomycin) 3 hours before the procedure and 1 sachet of INTERFOS (3 g of
fosfomycin) 24 hours after the procedure.
Use in patients with renal 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 must not be used in girls under 12 years of age.
Method of administration
For oral use.
Take this medicine by mouth, 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.
If you take more INTERFOS than you should
If you accidentally take more than the prescribed dose, contact your doctor or pharmacist.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Serious side effects
While taking INTERFOS, if you develop any of the following symptoms, you must stop taking the medicine and contact your doctor immediately:

Anaphylactic shock, a potentially life-threatening type of allergic reaction (frequency unknown). Symptoms include sudden onset of skin rash, itching or hives, and/or shortness of breath, wheezing or difficulty breathing
Swelling of the face, lips, tongue or throat with breathing difficulties (angioedema) (frequency unknown)
Moderate to severe diarrhea, abdominal cramps, blood in the stool and/or fever may indicate an infection of the large intestine (antibiotic-associated colitis) (frequency unknown). Do not take anti-diarrheal medicines that inhibit intestinal motility (antiperistaltics)

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

Headache
Dizziness
Diarrhea
Nausea
Indigestion
Abdominal pain
Genital infection in women with symptoms such as inflammation, irritation, itching (vulvovaginitis)

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

Vomiting
Rash
Urticaria
Itching

Rare (may affect up to 1 in 1000 people):

Severe bacterial infections (superinfections caused by resistant bacteria)
Reduction in the number of red blood cells in the blood (aplastic anaemia)

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

Allergic reactions
Bronchial constriction (bronchospasm)
Loss of appetite
Increase in white blood cells (eosinophils) and platelets
Visual disturbances
Inflammation of the veins (phlebitis)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store INTERFOS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and sachet. The expiry date refers to the last day of that month.
Storage conditions:
Store in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What INTERFOS contains
The active substance is trometamol fosfomycin.
Each sachet of INTERFOS 3 g granules for oral solution contains fosfomycin 3.0 g (as fosfomycin
trometamol 5.631 g).
The other ingredients (excipients) are: Orange flavour (containing: maltodextrin, gum arabic (E414), sunset yellow FCF
(E110), butylated hydroxyanisole BHA (E320)), sodium saccharin, sucrose, magnesium citrate.
Description of the appearance of INTERFOS and contents of the pack
INTERFOS is available in sachets containing white or almost white granules to be dissolved in water or
another beverage.
The pack contains 1 or 2 sachets of 3 g.
Marketing Authorisation Holder
PHARMEXTRACTA S.P.A. – Via G. Natta 28, 29010 Pontenure (PC)
Manufacturer
La.Fa.Re. SRL
Via Sacerdote Benedetto Cozzolino, n.77 – 80056 Ercolano (NA)
Special Product’s Line S.p.A
Via Fratta Rotonda Vado Largo, n.1, 03012 Anagni (FR)