Package leaflet: Information for the user

FOSFOMICINA DOC Adults 3 g granules for oral solution

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 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What FOSFOMICINA DOC is and what it is used for

Fosfomycin belongs to a group of medicines called urinary antimicrobial agents.
FOSFOMICINA DOC is indicated for the prevention and treatment of uncomplicated acute lower urinary tract infections caused by microorganisms sensitive to fosfomycin.

2. What you should know before taking FOSFOMICINA DOC

Do not take FOSFOMICINA DOC

if you are allergic to fosfomycin or to any of the other ingredients of this medicine (listed in section 6);
if you have severe kidney problems;
if you have difficulty urinating;
if you are undergoing haemodialysis. Children under 12 years of age must not take this medicine.

Warnings and precautions
Consult your doctor before taking FOSFOMICINA DOC if you are in any of the following conditions:

if you have previously experienced symptoms of allergic reactions to fosfomycin, because severe, life-threatening allergic reactions may occur during treatment. If such reactions occur, you must stop taking the medicine and consult a doctor immediately.
if you develop severe or prolonged diarrhoea during or after taking the medicine (even weeks after the last dose), as this may be a sign of a serious intestinal inflammation (pseudomembranous colitis).
if you think you may be pregnant or if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

Other medicines and FOSFOMICINA DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant administration of metoclopramide (a medicine that prevents vomiting) reduces the oral absorption of fosfomycin. Other medicines that increase gastrointestinal motility may produce similar effects.
Concomitant administration of antacids or calcium salts may reduce plasma and urinary concentrations of fosfomycin.
When using fosfomycin, an increase in the activity of certain anticoagulants (vitamin K antagonists) may occur. It is not clear whether this effect is due to the medicine or to the ongoing infection.

FOSFOMICINA DOC with food and drink
Food may delay the absorption of trometamol fosfomycin, resulting in reduced plasma peaks and urinary concentrations. Therefore, it is recommended to take FOSFOMICINA DOC on an empty stomach (one hour before or 2–3 hours after a meal).

Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. FOSFOMICINA DOC should be administered to pregnant or breastfeeding women only if clearly necessary for therapeutic reasons.

Driving and using machines
Dizziness may occur with the use of fosfomycin. This could affect your ability to drive or operate machinery.

Important information about certain excipients:
This medicine contains sucrose: patients with sugar intolerance should consult their doctor before taking this medicine; use with caution in patients with diabetes or those on a low-calorie diet.
This medicine contains the colouring agent sunset yellow FCF (E110), which may cause allergic reactions.
This medicine contains saccharin.

3. How to take FOSFOMICINA DOC

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Your doctor will determine the duration of treatment. Do not stop treatment earlier than prescribed,
as this may prevent achieving the expected results.
The contents of one sachet must be dissolved in half a glass (50–75 ml) of cold water or another beverage, stirred until completely dissolved, and taken immediately after preparation.
It is recommended to administer FOSFOMICINA DOC on an empty stomach (see "FOSFOMICINA DOC
with food and drink"), preferably before going to bed and after emptying the bladder.

Dosage
Adults and adolescents (12–18 years)
For uncomplicated acute lower urinary tract infections caused by microorganisms sensitive to fosfomycin, the dosage is one 3 g sachet as a single daily dose.
For prevention of urinary tract infections during surgical procedures and transurethral diagnostic procedures, treatment consists of two 3 g doses: the first sachet is administered 3 hours before the procedure, and the second sachet is administered 24 hours after the first dose.
Clinical symptoms usually disappear after 2–3 days.
The possible persistence of some local symptoms after treatment is not necessarily an indication of therapeutic failure, but more likely a consequence of previous inflammatory processes.

Elderly patients and other relevant clinical conditions:
In elderly patients and in more severe clinical situations (bedridden patients, recurrent infections), two 3 g doses administered 24 hours apart may be required.

If you take more FOSFOMICINA DOC than you should
If you accidentally take more FOSFOMICINA DOC than prescribed, contact your doctor or pharmacist immediately.
In case of overdose, urinary excretion of the active substance should be promoted by adequate fluid intake.

If you forget to take FOSFOMICINA DOC
If you forget to take a dose, do not take a double dose to make up for the missed dose.
If you forget to take a dose, take it as soon as you remember; however, if it is almost time for your next scheduled dose, skip the missed dose and take the next dose at the prescribed time.

If you have any doubts about the use of 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.
Contact your doctor as soon as possible if you experience even one of the following side effects.

Common (occur in 1 to 10 out of 100 patients):

vulvovaginitis, headache, dizziness, digestive problems such as diarrhoea, dyspepsia (feeling of fullness with gastric acidity), nausea.

Uncommon (occur in 1 to 10 out of 1,000 patients):

paraesthesia (altered sensation in certain parts of the body), vomiting, abdominal pain, skin rash, urticaria, itching, fatigue.

Rare (occur in 1 to 10 out of 10,000 patients):

superinfections due to resistant bacteria, tachycardia (rapid heartbeat), aplastic anaemia (reduction in the number of red blood cells).

Other side effects have been observed, but their frequency cannot be determined from the available data; these include:

skin reactions with redness, urticaria (reddish, itchy blisters), angioedema (swelling), and anaphylaxis (severe allergic reactions or hypersensitivity). If you experience reactions of this type, you must stop taking the medicine and consult your doctor or pharmacist immediately;
visual disturbances;
antibiotic-associated colitis (inflammation of the intestine);
loss of appetite;
phlebitis (formation of blood clots in veins);
hypotension (low blood pressure);
asthma;
dyspnoea (breathing difficulties);
bronchospasm (severe breathing difficulty);
liver problems with a transient increase in liver enzymes (transaminases);
angioedema (swelling);
slight increase in eosinophil leucocyte and platelet counts (blood cells), slight petechial reaction (small red spots on the skin).

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 “www.agenziafarmaco.gov.it/it/responsabili”. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store FOSFOMICINA DOC

Keep this medicine out of 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 FOSFOMICINA DOC contains

The active substance is trometamol fosfomycin. Each sachet contains 3.0 g of fosfomycin (equivalent to 5.631 g of trometamol fosfomycin).
The other ingredients are: sodium saccharin (E954), sucrose, calcium hydroxide (E526), orange flavour (containing: maltodextrin, glucose, gum arabic (E414), sunset yellow FCF (E110), butylated hydroxyanisole BHA (E320)).

Description of the appearance of FOSFOMICINA DOC and pack contents
FOSFOMICINA DOC 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 each.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan - Italy.
Manufacturer:
Special Product’s Line S.p.A. - Strada Paduni 240 - 03012 Anagni (Frosinone) – Italy.