Fosfomycin Mylan

PACKAGE LEAFLET

Fosfomicina Mylan adults 3 g granules for oral solution

Fosfomicin
Generic medicine
Read this leaflet carefully before taking this medicine.
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 any of the
side effects worsens, or if you notice any side effects not
listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

1. What Fosfomicina Mylan is and what it is used for
2. What you need to know before taking Fosfomicina Mylan
3. How to take Fosfomicina Mylan
4. Possible side effects
5. How to store Fosfomicina Mylan
6. Contents of the pack and other information

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

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

2. What you need to know before taking Fosfomicina Mylan

Do not take Fosfomicina Mylan
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 before taking Fosfomicina Mylan and if you are in any of the following
conditions:
if you have previously experienced symptoms of allergic reactions to fosfomycin;
if you think you may be pregnant or if you are breastfeeding (see section Pregnancy,
breastfeeding and fertility).

If any of the following conditions occur, follow the instructions provided:
if you experience allergic reactions, including anaphylaxis and anaphylactic shock, stop treatment with
Fosfomicina Mylan immediately and contact a doctor without delay, as these reactions can be life-threatening;
if you develop diarrhoea, especially if severe, persistent and/or bloody, even several weeks after treatment with
Fosfomicina Mylan, consult your doctor. Do not take medicines that inhibit intestinal motility (antiperistaltics).

Other medicines and Fosfomicina Mylan
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 drugs 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, numerous cases of increased activity of
vitamin K antagonists have been reported.
If you need to have blood tests to check your blood clotting time (INR), inform your
doctor, as taking Fosfomicina Mylan may in some cases alter the test results.

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

Pregnancy, breastfeeding and fertility
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding
with breast milk, consult your doctor or pharmacist before taking this medicine.
Fosfomicina Mylan should be administered to pregnant or breastfeeding women only when clearly needed and under direct medical supervision.

Driving and using machines
Dizziness has been reported. This may affect your ability to drive or operate machinery.

Fosfomicina Mylan contains Sunset Yellow FCF (E110) and sucrose
Sunset Yellow FCF (E110): may cause allergic reactions.
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.

3. How to take Fosfomicina Mylan

Take this medicine exactly as prescribed 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 instructed, as this may prevent the expected results from being achieved.
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 Mylan on an empty stomach (see "Fosfomicina Mylan 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 before 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 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 Mylan than prescribed
If you accidentally take more Fosfomicina Mylan than prescribed, contact your doctor or pharmacist immediately.
In case of overdose, elimination of the active substance through the urine should be promoted by adequate fluid intake.
Symptoms
If you have taken excessive doses of Fosfomicina Mylan, you may experience the following symptoms: loss of balance, hearing problems, metallic taste, and general reduction in taste perception.

If you forget to take Fosfomicina Mylan
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 stop treatment with Fosfomicina Mylan
If you have any questions 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 experiences them.
Contact your doctor as soon as possible if you experience even one of the following side effects.

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

• diarrhea, dyspepsia (feeling of fullness with gastric acidity), nausea;
• headache, dizziness;
• vulvovaginitis (inflammation of the vulva and vagina).

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

• vomiting, abdominal pain;
• paresthesia (tingling);
• skin rash, urticaria (reddish, itchy blisters) and pruritus (itching);
• fatigue.

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

• superinfections due to resistant bacteria;
• tachycardia (rapid heartbeat);
• aplastic anemia (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:

• visual disturbances;
• loss of appetite;
• phlebitis (formation of blood clots in veins);
• hypotension (low blood pressure);
• dyspnea (breathing difficulties);
• bronchospasm (severe breathing difficulty);
• asthma;
• antibiotic-associated colitis;
• liver problems with 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);
• angioedema (swelling), allergic reactions including anaphylaxis and anaphylactic shock. In such cases, do not continue treatment with Fosfomicina Mylan and seek immediate medical attention, as these reactions can be life-threatening.

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

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 after
Exp. The expiry date refers to the last day of that month.
Storage conditions:
This medicine does not require any special 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 Mylan contains
The active substance is fosfomycin trometamol.
Each sachet of Fosfomicina Mylan 3 g granules for oral solution for adults contains 3.0 g of fosfomycin
(as 5.631 g of fosfomycin trometamol).
The excipients are: sodium saccharin (E954), sucrose, calcium hydroxide (E526), orange flavour
(containing: maltodextrin, dextrose, gum arabic (E414), sunset yellow FCF (E110),
butylated hydroxyanisole BHA (E320)).
Description of the appearance of Fosfomicina Mylan and contents of the pack
Fosfomicina Mylan is available in sachets containing white or almost white granules to be dissolved
in water or another drink.
The pack contains 1 or 2 sachets of 3 g.
Marketing Authorization Holder:
Mylan S.p.A – Via Vittor Pisani, 20 – 20124 Milano
Manufacturer
Special Product’s Line S.p.A. - Via Campobello, 15 - 00040 Pomezia (Roma)
Special Product’s Line S.p.A. - Strada Paduni, 240 - 03012 Anagni (FR)