FOSFOMYCIN ADCO POWDER

Valsts: Dienvidāfrikas Republika

Valoda: angļu

Klimata pārmaiņas: South African Health Products Regulatory Authority (SAHPRA)

Pieejams no:

Adcock Ingram Limited

Deva:

Not Indicated

Zāļu forma:

POWDER

Kompozīcija:

None

Autorizācija statuss:

Registered

Lietošanas instrukcija

Date of approval: 10 May 2022
Page 1 of 6
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4
FOSFOMYCIN ADCO, 3 G, GRANULES
FOSFOMYCIN TROMETAMOL
CONTAINS SUGAR (SUCROSE): 2,213 G PER SACHET.
CONTAINS SWEETENER (SACCHARIN): 0,016 G PER SACHET.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING FOSFOMYCIN
ADCO
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health
care provider.
•
FOSFOMYCIN ADCO has been prescribed for you personally and you should
not share
your medicine with other people. It
may harm them, even if their symptoms are the same
as yours.
WHAT IS IN THIS LEAFLET
1. What FOSFOMYCIN ADCO is and what it is used for
2. What you need to know before you take FOSFOMYCIN ADCO
3. How to take FOSFOMYCIN ADCO
4. Possible side effects
5. How to store FOSFOMYCIN ADCO
6. Contents of the pack and other information
1. WHAT FOSFOMYCIN ADCO
IS AND WHAT IT IS USED FOR
FOSFOMYCIN ADCO is a broad-spectrum bactericidal antibiotic.
FOSFOMYCIN ADCO is used to treat urinary tract infections such as
bladder infections in women
Date of approval: 10 May 2022
Page 2 of 6
and female children over the age of five years.
FOSFOMYCIN ADCO is used to prevent infections in men receiving urinary
surgical procedures.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOSFOMYCIN ADCO
DO NOT TAKE FOSFOMYCIN ADCO:
•
if you are hypersensitive (allergic) to fosfomycin trometamol or any
of the other
ingredients of FOSFOMYCIN ADCO (listed in section 6).
•
if you have kidney disease: The effects of fosfomycin may be increased
because of
slower removal from the body.
WARNINGS AND PRECAUTIONS
TAKE SPECIAL CARE WITH FOSFOMYCIN ADCO:
CHILDREN
Safety and efficacy in children under the age of five years has not
yet been established.
OTHER MEDICINES AND FOSFOMYCIN ADCO
Always tell your health care provider if you are taking any other
medicine. (This includes all
complementary or traditional medicines.)
Tell your doctor if you are taking metoclopramide (used

Produkta apraksts

Date of approval: 10 May 2022
Page 1 of 7
PROFESSIONAL INFORMATION
SCHEDULING STATUS
S4
1. NAME OF THE MEDICINE
FOSFOMYCIN ADCO, 3 g, granules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 5,631 g fosfomycin trometamol equivalent to 3 g
fosfomycin.
Excipient(s) with known effect:
•
Contains sugar (sucrose): 2,213 g per sachet.
•
Contains sweetener (saccharin): 0,016 g per sachet.
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Granules.
White granular powder with a characteristic mandarin flavour.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
FOSFOMYCIN ADCO is indicated as a single dose in the treatment of
acute uncomplicated lower
urinary tract infections caused by sensitive _E. Coli_, in women and
female children over the age of
five years.
FOSFOMYCIN ADCO is indicated for prophylaxis in diagnostic and
surgical transurethral
procedures in adult men.
_ _
Date of submission: 31 July 2020
Page 2 of 7
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The recommended dose for uncomplicated urinary tract infections in
women, including the elderly
up to seventy-five years, is a single 3 g dose.
The recommended dose for prophylaxis prior to transurethral surgical
and diagnostic procedures
in adult men, including the elderly, is two doses of 3 g. The first
dose should be taken three hours
before surgery. The second dose should be taken twenty-four hours
after surgery.
METHOD OF ADMINISTRATION
FOSFOMYCIN ADCO is administered orally after reconstitution in water.
To be taken at least two
hours prior to the next meal.
4.3 CONTRAINDICATIONS
•
Known hypersensitivity to fosfomycin trometamol or to any of the
excipients listed in 6.1.
•
Severe renal insufficiency (creatinine clearance < 10 mL/min).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
PAEDIATRIC POPULATION
Safety and efficacy in children under the age of five years has not
yet been established.
_CONTAINS SUCROSE _
Contains sucrose. Patients with rare hereditary problems of fructose
intolerance, glucose-
galactose