PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Fosfomicina Zentiva 3 g granules for oral solution

Generic medicine
Please read 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, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

1. What Fosfomicina Zentiva is and what it is used for

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

2. What you need to know before taking Fosfomicina Zentiva

Do not take Fosfomicina Zentiva
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 the 3 g sachets.

Warnings and precautions
Talk to your doctor or pharmacist before taking Fosfomicina Zentiva if you are in any of the following
situations:
if you have previously experienced symptoms of allergic reactions to fosfomycin;
if you suffer from renal insufficiency;
if you think you are pregnant or if you are breastfeeding (see section “Pregnancy, breastfeeding and
fertility”);

if diarrhoea occurs during or after treatment with Fosfomicina Zentiva, particularly if the diarrhoea is persistent and/or bloody. In such cases, appropriate treatment must be started promptly. Do not take medicines that inhibit intestinal motility (antiperistaltics).

Other medicines and Fosfomicina Zentiva
Tell 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.
In patients treated with antibiotics, particularly fluorochinolones, macrolides, tetracyclines, cotrimoxazole, and some cephalosporins, numerous cases of increased activity of vitamin K antagonists have been reported.

Fosfomicina Zentiva with food and drink
Food may delay the absorption of fosfomycin trometamol, resulting in reduced plasma peaks and urinary concentrations. Therefore, Fosfomicina Zentiva is recommended to be taken 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, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Fosfomicina Zentiva should be given to pregnant or breastfeeding women only if clearly needed and under medical supervision.

Driving and using machines
Dizziness has been reported. This may affect the ability of some patients to drive or use machinery.

Important information about certain excipients:
Fosfomicina Zentiva contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine; use with caution in patients with diabetes or those on a low-calorie diet.
Fosfomicina Zentiva contains saccharin.

3. How to take Fosfomicina Zentiva

Take this medicine exactly as your doctor has instructed you. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine how long you should take this medicine. Do not stop treatment earlier than instructed, as this may prevent you from achieving the expected results.
The contents of one sachet should be dissolved in half a glass (50–75 ml) of cold water or another beverage, stirring until completely dissolved, and taken immediately after preparation.
It is recommended to administer Fosfomicina Zentiva on an empty stomach (see section “Fosfomicina Zentiva 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 germs sensitive to fosfomycin, the dosage is one 3 g sachet as a single daily dose.
For the prevention of urinary tract infections prior to surgical procedures or 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 within 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 clinically relevant 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 Zentiva than prescribed
If you accidentally take more Fosfomicina Zentiva than prescribed, contact your doctor or pharmacist immediately.
In case of overdose, elimination of the active ingredient through the urine should be promoted by adequate fluid intake.

If you forget to take Fosfomicina Zentiva
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 dose, skip the missed dose and take the next dose at the scheduled time.

If you have any questions 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 experiences them.
Contact your doctor as soon as possible if you experience even one of the following side effects:

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

Vulvovaginitis (inflammation of the vulva and vagina);
Headache, dizziness;
Digestive problems such as diarrhoea, dyspepsia (feeling of fullness with gastric acidity), nausea.

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

Abnormal sensations such as burning, tingling (paraesthesia);
Vomiting, abdominal pain;
Skin reactions with redness, urticaria (reddish, itchy blisters);
Fatigue.

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

Superinfections caused by resistant bacteria;
Increased heart rate (tachycardia);
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:

Angioedema (swelling) and anaphylaxis (severe allergic reactions and hypersensitivity);
Asthma;
Dyspnoea (breathing problems);
Bronchospasm (severe breathing difficulty);
Inflammation of the colon, a section of the intestine, associated with antibiotic use (pseudomembranous colitis);
Visual disturbances;
Loss of appetite;
Low blood pressure;
Phlebitis (formation of blood clots in veins);
Liver problems with a transient increase in liver enzymes (transaminases);
Slight increase in eosinophil leukocyte and platelet counts (blood cells), mild 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 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 Fosfomicina Zentiva

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 store above 30°C.
Medicines should not be disposed of 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 Zentiva contains
The active substance is fosfomycin trometamol.
Each sachet of Fosfomicina Zentiva 3 g granules for oral solution contains 3.0 g of fosfomycin
(as fosfomycin trometamol 5.631 g).
The excipients are:
tangerine flavour (containing: maltodextrin, acacia gum, ascorbic acid, butylated hydroxyanisole), orange flavour (containing: maltodextrin, acacia gum), sodium saccharin (E954), sucrose.
Description of the appearance of Fosfomicina Zentiva and the contents of the pack
Fosfomicina Zentiva is available in sachets containing white or almost white granules to be dissolved in water or another beverage.
The packs contain 1 or 2 sachets of 3 g.
Marketing Authorization Holder:
Zentiva Italia S.r.l.
Viale Bodio 37/b - 20158 Milano
Manufacturer
LABIANA Pharmaceuticals, S.L.U.
C/Casanova, 27-31
08757 Corbera de Llobregat (Barcelona)
Spain