Package leaflet: Information for the user

DANIFOS ADULTS 3 G GRANULES FOR ORAL SOLUTION

fosfomycin trometamol
Equivalent medicine
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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What DANIFOS is and what it is used for

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

2. What you need to know before taking DANIFOS

Do not take DANIFOS

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 or pharmacist before taking DANIFOS if you have any of the following conditions:

persistent bladder infections
previous episodes of diarrhoea after taking other antibiotics.

Conditions to be aware of
DANIFOS 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 to reduce the risk of potential problems. See "Serious side effects" in section 4.
Children and adolescents
Do not give 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 DANIFOS
Tell 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 intestines, 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.

DANIFOS 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 may be pregnant, planning to become pregnant, or are 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.
DANIFOS contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him/her before taking this medicine.
DANIFOS contains sunset yellow FCF (E110) dye
It may cause allergic reactions.
DANIFOS contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.

3. How to take DANIFOS

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 DANIFOS (3 g of fosfomycin).
If used as antibiotic prophylaxis for prostate biopsy, the recommended dose is 1 sachet of
DANIFOS (3 g of fosfomycin) 3 hours before the procedure and 1 sachet of DANIFOS (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, after emptying the bladder.
Dissolve the contents of one sachet in a glass of water and drink immediately.
If you take more DANIFOS 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

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
During treatment with DANIFOS, if you develop any of the following symptoms, you must stop taking the
medicine and contact your doctor immediately:

anaphylactic shock, a type of potentially life-threatening allergic reaction (frequency not known). 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 not known)
moderate to severe diarrhoea, abdominal cramps, blood in the stools and/or fever may indicate an infection of the large intestine (antibiotic-associated colitis) (frequency not known). Do not take anti-diarrhoeal medicines that inhibit intestinal motility (antiperistaltics).

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

headache
dizziness
diarrhoea
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
skin rash
urticaria
itching.

Rare (may affect up to 1 in 1,000 people):

severe bacterial infections (superinfections caused by resistant bacteria)
reduction in the number of red blood cells (aplastic anaemia).

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

allergic reactions
bronchial constriction (bronchospasm)
increase in white blood cells (eosinophils) and platelets
inflammation of the veins (phlebitis)
loss of appetite (anorexia)
visual disturbances.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You
can also report side effects directly via the national reporting system at: http://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 DANIFOS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging and sachet after
Exp. The expiry date refers to the last day of that month.
Store in the original packaging. After preparing the solution, the medicine must be taken immediately.
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 DANIFOS contains
The active substance is fosfomycin trometamol.
Each sachet of DANIFOS 3 g granules for oral solution contains 3.0 g fosfomycin (as fosfomycin
trometamol 5.631 g).
The other ingredients 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 DANIFOS and package contents
DANIFOS 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 Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmacare S.r.l.
Via Marghera, 29
20149 Milan
Italy
Manufacturer
LA.FA.RE. Farmaceutici S.r.l.
Via Sacerdote Benedetto Cozzolino, 77
80056 Ercolano (NA)
Italy