Fosfomycin Sandoz
Italy
Table of Contents
PACKAGE LEAFLET: Information for the patient
FOSFOMICINA Sandoz Adults 3 g granules for oral solution
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. Never give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist.
Contents of this leaflet:
- What FOSFOMICINA Sandoz is and what it is used for
- What you need to know before taking FOSFOMICINA Sandoz
- How to take FOSFOMICINA Sandoz
- Possible side effects
- How to store FOSFOMICINA Sandoz
- Contents of the pack and other information
1. What FOSFOMICINA Sandoz is and what it is used for
FOSFOMICINA Sandoz contains the active substance fosfomycin (as fosfomycin trometamol). It is an
antibiotic that works by killing bacteria that can cause infections.
FOSFOMICINA Sandoz is used to treat uncomplicated bladder infections in women and adolescent girls (>12 years of age).
FOSFOMICINA Sandoz is used for perioperative antibiotic prophylaxis in adult men undergoing transrectal prostate biopsy.
2. What you need to know before taking FOSFOMICIN Sandoz
Do not take FOSFOMICIN Sandoz
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 FOSFOMICIN Sandoz 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
Fosfomycin Sandoz 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.
Other medicines and FOSFOMICIN Sandoz
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.
FOSFOMICIN Sandoz with food and drink
Food may delay the absorption of fosfomycin trometamol. Therefore, this medicine should be taken on an empty stomach (2–3 hours before or 2–3 hours after a meal).
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, your doctor will only prescribe this medicine if clearly necessary.
Women who are breast-feeding 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.
Fosfomycin Sandoz contains sucrose and sodium:
This medicine contains 2.213 g of sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, please consult him/her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially ‘sodium-free’.
3. How to take FOSFOMICINA Sandoz
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 Sandoz (3 g of fosfomycin).
When used as antibiotic prophylaxis for prostate biopsy, the recommended dose is 1 sachet of Fosfomicina Sandoz (3 g of fosfomycin) taken 3 hours before the procedure and 1 sachet of Fosfomicina Sandoz (3 g of fosfomycin) taken 24 hours after the procedure.
Use in patients with renal impairment
This medicine must not be taken by 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 Sandoz 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 experiences them.
Serious side effects
While taking Fosfomicina Sandoz, if you develop any of the following symptoms, you must stop taking the medicine and contact your doctor immediately:
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 may indicate an infection of the large intestine (antibiotic-associated colitis) (frequency not known). Do not take anti-diarrhoeal medicines that inhibit intestinal motility (antiperistaltics).
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
Hives
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 (aplastic anaemia)
Not known (frequency cannot be estimated from the available data):
Allergic reactions
Vision disorders
Bronchial constriction (bronchospasm)
Increase in white blood cells (eosinophils) and platelets
Loss of appetite
Inflammation of the veins (phlebitis)
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 Sandoz
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.
Keep the medicine in the original packaging. Store at a temperature not exceeding 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.
6. Package contents and other information
What FOSFOMICINA Sandoz contains
The active substance is trometamol fosfomycin.
Each sachet of FOSFOMICINA Sandoz 3 g granules for oral solution for adults contains 3.0 g of
fosfomycin (as trometamol fosfomycin 5.631 g).
The other components 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 Sandoz and package contents
FOSFOMICINA Sandoz 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:
Sandoz S.p.A. - Largo U. Boccioni, 1 - 21040 Origgio (VA)
Manufacturers
Fosfomicina Sandoz 3 g for adults: Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR)