Fosfoseptic granules for oral solution

País: Armenia

Idioma: inglés

Fuente: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredientes activos:

fosfomycin (fosfomycin trometamol)

Disponible desde:

ADIPHARM EAD

Código ATC:

J01XX01

Designación común internacional (DCI):

fosfomycin (fosfomycin trometamol)

Dosis:

3000mg

formulario farmacéutico:

granules for oral solution

Unidades en paquete:

(1) sachet

tipo de receta:

Prescription

Estado de Autorización:

Registered

Fecha de autorización:

2020-07-23

Información para el usuario

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FOSFOSEPTIC 3 G GRANULES FOR ORAL SOLUTION
Fosfomycin trometamol
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 further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What FOSFOSEPTIC is and what it is used for
2.
What you need to know before you use FOSFOSEPTIC
3.
How to use FOSFOSEPTIC
4.
Possible side effects
5.
How to store FOSFOSEPTIC
6.
Contents of the pack and other information
1.
WHAT FOSFOSEPTIC IS AND WHAT IT IS USED FOR
Your medicine contains the active substance fosfomycin trometamol.
FOSFOSEPTIC is an antibiotic used
for the treatment of acute, uncomplicated lower urinary tract
infections (UTI) caused by pathogens
sensitive to fosfomycin in women and girls over the age of 12 years.
Fosfomycin is used for prophylaxis of urinary tract infections in
diagnostic and surgical procedures
involving the lower urinary tract in adult men and women.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOSFOSEPTIC
_ _
DO NOT TAKE FOSFOSEPTIC:
-
if you are allergic to fosfomycin trometamol or any of the other
ingredients of this medicine
(listed in section 6);
-
If you have severe renal insufficiency (creatinine clearance <
10ml/min);
-
If you are on hemodialysis.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking FOSFOSEPTIC.
In association with the use of almost all broad-spectrum antibacterial
agents, including fosfomycin
trometamol, there have been reports of antibiotic-associated diarrhea.
It is important to consider this
in patients developing severe diarrhea during or after fosfomycin
tromet

Ficha técnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
FOSFOSEPTIC 3 G GRANULES FOR ORAL SOLUTION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance in one sachet: Fosfomycin trometamol 5,631 g
Excipients with known effect:
Each sachet contains 2,153 g sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Granules for oral solution
Almost white granules with citrus flavour
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FOSFOSEPTIC 3 g granules for oral solution is indicated for the
treatment of acute, uncomplicated
lower urinary tract infections (UTI) caused by pathogens sensitive to
fosfomycin in women and
girls above 12 years.
Prophylaxis of urinary tract infections in diagnostic and surgical
procedures involving the lower
urinary tract in adult men and women.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
FOSFOSEPTIC 3 g granules for oral solution
The recommended dose for the treatment of uncomplicated lower urinary
tract infections in
women and girls over the age of 12 years is a single dose FOSFOSEPTIC
3 g sachet.
The recommended dose for prophylaxis of urinary tract infections in
diagnostic and surgical
procedures involving the lower urinary tract in adult men and women is
two doses of FOSFOSEPTIC
3 g sachet; the first dose of FOSFOSEPTIC 3 g sachet should be taken 3
hours before the surgical
procedure, and one dose Fosfomycin 3 g sachet should be taken 24 hours
after surgery
Method of administration
FOSFOSEPTIC is for oral administration and should be taken on an empty
stomach, preferably
before bedtime, after emptying the bladder. The contents of one sachet
should be dissolved in a
glass of water and taken immediately after that.
2
4.3
CONTRAINDICATIONS
- Hypersensitivity to fosfomycin trometamol or to any of the
excipients listed in section 6.1.
- Patients with severe renal insufficiency (creatinine clearance < 10
ml/min).
- Patients undergoing haemodialysis.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Hypersensitivity reactions including ana