Fosfomycin Eg

Package leaflet: Information for the patient

FOSFOMICINA EG ADULTS 3 G GRANULES FOR ORAL SOLUTION

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:

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

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

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

2. What you should know before taking FOSFOMICINA EG

Do not take FOSFOMICINA EG
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 EG if you are in any of the following
situations:
if you have previously experienced symptoms of allergic reactions to fosfomycin; in this case, you must not take fosfomycin again.
if you think you may be pregnant or if you are breastfeeding (see section on 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 EG immediately and seek medical attention 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 EG, consult your doctor. Do not take medicines that inhibit intestinal motility (antiperistaltics).

Other medicines and FOSFOMICINA EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, take special care if you are taking the following medicines:
metoclopramide (a medicine used to prevent vomiting) and drugs that increase gastrointestinal motility, as they may reduce the amount of fosfomycin absorbed by the body;
antacids or calcium salts, as they may reduce the effectiveness of fosfomycin;
vitamin K antagonists (anticoagulant medicines), as fosfomycin may enhance their effect. If you need to have blood tests to monitor your blood clotting time (INR), inform your doctor, as taking FOSFOMICINA EG may in some cases alter test results.

FOSFOMICINA EG with food and drink
Food may delay the absorption of FOSFOMICINA EG. Therefore, it is recommended to administer FOSFOMICINA EG on an empty stomach, one hour before or approximately 2–3 hours after meals.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
FOSFOMICINA EG should be given to pregnant women only if clearly needed and under strict medical supervision.

Breastfeeding
FOSFOMICINA EG may be used during breastfeeding only after a single oral dose. However, during breastfeeding, the medicine should only be administered if clearly necessary and under direct medical supervision.

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

FOSFOMICINA EG contains sucrose and the colouring agent sunset yellow FCF (E110):
This medicine contains 1.923 g of sucrose per dose. This should be taken into account in patients with diabetes mellitus or those on a low-calorie diet. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
The colouring agent sunset yellow FCF (E110) may cause allergic reactions.

3. How to take FOSFOMICINA EG

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
instructed, as otherwise the expected results may not be 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 EG on an empty stomach (see "FOSFOMICINA EG with
food and drink"), preferably before going to bed and after emptying the bladder.

Dosage
Adults and adolescents (12–18 years):
For acute uncomplicated lower urinary tract infections caused by germs sensitive to fosfomycin,
the dosage is one 3 g sachet administered 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 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 relevant clinical conditions:
In elderly patients and in more clinically complex cases (bedridden patients, recurrent infections),
two 3 g doses administered 24 hours apart may be required.

If you take more FOSFOMICINA EG than you should
If you accidentally take more FOSFOMICINA EG than prescribed, contact your doctor or pharmacist immediately.
If you have taken an excessive dose of FOSFOMICINA EG, you may experience the following symptoms:
loss of balance, hearing problems, metallic taste, and general reduction in taste perception.
In case of overdose, elimination of the active substance via the urine should be promoted by adequate fluid intake.

If you forget to take FOSFOMICINA EG
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 the next dose,
skip the missed dose and take the next dose at the scheduled 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 everybody will get them.
Contact your doctor as soon as possible if you experience even just one of the following side effects.

Common (occur in 1 to 10 patients out of 100):
diarrhoea, feeling of fullness with gastric acidity (dyspepsia), nausea;
headache, dizziness;
inflammation of the vulva and vagina (vulvovaginitis).

Uncommon (occur in 1 to 10 patients out of 1,000):
vomiting and abdominal pain;
tingling sensation (paraesthesia);
skin rash, urticaria (reddish, itchy blisters) and itching;
fatigue.

Rare (occur in 1 to 10 patients out of 10,000):
superinfections (additional infections on top of an existing one) caused by bacteria resistant to this medicine;
increased heart rate (tachycardia);
reduction in the number of red blood cells (aplastic anaemia).

Not known (frequency cannot be estimated from the available data):
vision disorders;
loss of appetite;
phlebitis (formation of blood clots in veins);
low blood pressure (hypotension);
respiratory problems (dyspnoea, bronchospasm, asthma);
antibiotic-associated colitis;
liver problems with transient increase in liver enzymes (transaminases);
slight increase in eosinophil leukocyte and platelet counts (blood cells);
slight petechial reaction (small red spots on the skin);
swelling of the skin and mucous membranes (angioedema);
allergic reactions, including anaphylaxis and anaphylactic shock. In such cases, stop treatment with FOSFOMICINA EG immediately and consult a doctor straight away, as these reactions can be life-threatening.

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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FOSFOMICINA EG

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 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 EG contains
The active substance is fosfomycin trometamol.
Each 3 g sachet of FOSFOMICINA EG granules for oral solution contains 3.0 g of fosfomycin
(as 5.631 g of fosfomycin trometamol).
The other components are: sodium saccharin (E954), sucrose, calcium hydroxide (E526), orange flavour
(containing: maltodextrin, glucose, arabic gum (E414), sunset yellow FCF (E110), and
butylated hydroxyanisole (E320)).

Description of the appearance of FOSFOMICINA EG and the contents of the pack
FOSFOMICINA EG 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:
EG S.p.A. Via Pavia, 6 20136-Milano

Manufacturer:
Special Product’s line S.p.A. - Via Campobello, 15 - 00140 Pomezia (RM)

This summary of product characteristics was last approved on: