Patient Information Leaflet

Fosfomicina Aurobindo 3 g granules for oral solution

Adults
Generic 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 they have the same symptoms as you, because it may 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 Aurobindo is and what it is used for
What you need to know before taking Fosfomicina Aurobindo
How to take Fosfomicina Aurobindo
Possible side effects
How to store Fosfomicina Aurobindo
Contents of the pack and other information

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

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

2. What you need to know before taking Fosfomicina Aurobindo

Do not take Fosfomicina Aurobindo:

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 Fosfomicina Aurobindo if you have any of the
following conditions:

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

Conditions to which you should pay attention
Fosfomicina Aurobindo may cause serious side effects. These include allergic reactions and inflammation of the large intestine. You should be aware of 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 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 Fosfomicina Aurobindo
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 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.

Fosfomicina Aurobindo and 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, are 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.
Important information about certain excipients:
Fosfomicina Aurobindo contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine. Use with caution in patients with diabetes or those on a low-calorie diet.
Fosfomicina Aurobindo contains the colour sunset yellow FCF (E110), which may cause allergic reactions.
Fosfomicina Aurobindo contains sodium. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Fosfomicina Aurobindo

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 Fosfomicina Aurobindo (3 g of fosfomycin).
When used as antibiotic prophylaxis for prostate biopsy, the recommended dose is 1 sachet of
Fosfomicina Aurobindo (3 g of fosfomycin) taken 3 hours before the procedure and 1 sachet of
Fosfomicina Aurobindo (3 g of fosfomycin) taken 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 Fosfomicina Aurobindo 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Serious adverse effects
If you experience any of the following symptoms while taking Fosfomicina Aurobindo, you must stop taking the medicine and contact your doctor immediately:

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

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

headache;
dizziness;
diarrhoea;
nausea;
indigestion;
abdominal pain;
genital fungal infection with symptoms such as inflammation, irritation, itching (vulvovaginitis).

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

vomiting;
skin rash;
urticaria;
pruritus.

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

superinfections with resistant bacteria;
aplastic anaemia (reduction in the number of red blood cells).

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

allergic reactions;
phlebitis (formation of blood clots in veins);
bronchospasm (severe breathing difficulty);
slight increase in eosinophil leukocyte and platelet counts (blood cells).

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

5. How to store Fosfomicina Aurobindo

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.
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 Aurobindo contains
The active substance is fosfomycin trometamol.
Each sachet of Fosfomicina Aurobindo 3 g granules for oral solution contains fosfomycin 3.0 g (as
fosfomycin trometamol 5.631 g).
The excipients 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 Aurobindo and package contents
Fosfomicina Aurobindo 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:
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe, 102 – 21047 Saronno (VA)
Manufacturer
Special Product’s Line S.p.A. - via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)