Patient Information Leaflet

Fosfomicina ratiopharm 3 g granules for oral solution

fosfomycin trometamol
Generic medicine
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 effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet

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

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

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

2. What you need to know before taking Fosfomicina ratiopharm

Do not take Fosfomicina ratiopharm
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 ratiopharm if you have any of the
following conditions:
persistent bladder infections;
previous episodes of diarrhoea after taking other antibiotics.
Conditions you should pay attention to
Fosfomicina ratiopharm 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 administer this medicine to girls under 12 years of age, as its safety and efficacy have not been established in this age group.
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Other medicines and Fosfomicina ratiopharm
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 intestine, 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 ratiopharm 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
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
If you are pregnant or breastfeeding, your doctor will only prescribe this medicine if clearly necessary.
Breastfeeding women 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
use machinery.
Important information about certain excipients:
Fosfomicina ratiopharm contains sucrose: If your doctor has diagnosed you with an intolerance to certain
sugars, contact him/her before taking this medicine.
Fosfomicina ratiopharm contains the colour sunset yellow FCF (E110), which may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially “sodium-free”.

3. How to take Fosfomicina ratiopharm

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Dosage
For the treatment of uncomplicated bladder infection in women and adolescents, the recommended dose
is 1 sachet of Fosfomicina ratiopharm (3 g of fosfomycin).
If used as perioperative antibiotic prophylaxis for prostate biopsy, the recommended dose is 1
sachet of Fosfomicina ratiopharm (3 g of fosfomycin) 3 hours before the procedure and 1 sachet of Fosfomicina
ratiopharm (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
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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 ratiopharm than you should
If you accidentally take more than the prescribed dose, contact your doctor or pharmacist.
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 gets them.

Serious side effects
During treatment with Fosfomicina ratiopharm, if you develop any of the following symptoms, you must stop taking the medicine immediately and contact your doctor without delay:

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, which may indicate an infection of the large intestine (antibiotic-associated colitis) (frequency not known). Do not take anti-diarrhoeal medicines that inhibit intestinal motility (antiperistaltic agents).

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 in the blood (aplastic anaemia)

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

Allergic reactions
Visual disturbances
Loss of appetite 3/4
Phlebitis (inflammation of the veins)
Bronchial constriction (bronchospasm)
Slight increase in eosinophil leukocyte and platelet counts (blood cells)

Reporting of side effects
If you experience any side effects, 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.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 ratiopharm

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, following “Exp.”.
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 ratiopharm contains
The active substance is fosfomycin trometamol.
Each sachet of Fosfomicina ratiopharm 3 g granules for oral solution contains 3.0 g fosfomycin
(as fosfomycin trometamol 5.631 g).
The other components are: sodium saccharin (E954), sucrose, calcium hydroxide (E526), orange flavour
(containing: maltodextrin, glucose, arabic gum (E414), sunset yellow FCF (E110), butylated hydroxyanisole
BHA (E320)).
Description of the appearance of Fosfomicina ratiopharm and package contents
Fosfomicina ratiopharm is available in sachets containing white or almost white granules to be dissolved in
water or another beverage.
The package contains 1 or 2 sachets of 3 g.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder
ratiopharm GmbH Graf-Arco Strasse, 3 – 89079 Ulm Germany
Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
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