Berny
Italy
Table of Contents
Patient Information Leaflet
BERNY 3 g granules for oral solution
Fosfomycin
Generic medicine
Please read all of this leaflet carefully before you start 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 others, 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, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What BERNY is and what it is used for
- What you need to know before taking BERNY
- How to take BERNY
- Possible side effects
- How to store BERNY
- Contents of the pack and other information
1. What BERNY is and what it is used for
BERNY contains the active substance fosfomycin (as fosfomycin trometamol). It is an antibiotic that works
by killing bacteria that can cause infections.
BERNY is used to treat uncomplicated bladder infections in women and adolescent girls (>12 years of age).
BERNY is also used for perioperative antibiotic prophylaxis in adult men undergoing transrectal prostate biopsy.
2. What you need to know before taking BERNY
Do not take BERNY:
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 BERNY if you suffer from any of the following conditions:
persistent bladder infections,
episodes of diarrhoea after taking other antibiotics.
Conditions to which you should pay attention
BERNY may cause serious side effects. These include allergic reactions and inflammation of the large intestine (colitis). You should pay attention to certain symptoms while taking this medicine in order 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 BERNY
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines 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.
BERNY with food and drink
Food may delay the absorption of fosfomycin. Therefore, it is recommended to take BERNY 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, 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.
BERNY contains:
- Sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine;
- Sunset yellow FCF (E110) dye: may cause allergic reactions;
- Sodium: this medicine contains 65.35 mg of sodium (a main component of table salt) per sachet. This corresponds to 3.3% of the maximum daily recommended dietary intake for an adult.
3. How to take BERNY
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 BERNY (3 g of fosfomycin).
If used as antibiotic prophylaxis for prostate biopsy, the recommended dose is 1 sachet of BERNY (3 g of fosfomycin) taken 3 hours before the procedure and 1 sachet of BERNY (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.
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 BERNY than you should
If you accidentally take more than the prescribed dose, contact your doctor or pharmacist.
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 experience them.
Serious side effects
If, while taking BERNY, 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.
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):
- infections caused by non-susceptible bacteria (superinfections)
- reduction in the number of red blood cells (aplastic anaemia)
Not known (frequency cannot be estimated from the available data):
- allergic reactions (hypersensitivity)
- bronchial constriction (bronchospasm)
- loss of appetite
- increase in a type of white blood cells (eosinophils) and platelets
- visual disturbances
- 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 BERNY
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.
The expiry date indicated refers to the medicine in its original, undamaged packaging, when correctly stored.
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 BERNY contains
The active substance is fosfomycin trometamol.
Each sachet of BERNY 3 g granules for oral solution contains fosfomycin 3 g (as fosfomycin trometamol 5,631 g).
The excipients are: sodium saccharin (E954), sucrose, sodium citrate dihydrate, orange flavour (containing: maltodextrin, glucose, gum arabic (E414), sunset yellow FCF (E110), butylated hydroxyanisole BHA (E320)).
Description of the appearance of BERNY and contents of the pack
BERNY is available as sachets containing white or almost white granules to be dissolved in water or another beverage.
Pack contents:
- 3 g granules for oral solution for adults – 1 sachet of 3 g
- 3 g granules for oral solution for adults – 2 sachets of 3 g
Marketing Authorization Holder:
So.Se.PHARM S.r.l. - Via dei Castelli Romani, 22 – 00071 Pomezia (RM) - Italy
Manufacturer:
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado largo, 1 – 03012 Anagni (FR) - Italy