FOSFOMYCIN 3 g AUSTELL GRANULES

Nchi: Afrika Kusini

Lugha: Kiingereza

Chanzo: South African Health Products Regulatory Authority (SAHPRA)

Inapatikana kutoka:

Austell Pharmaceuticals (Pty) Ltd

Kipimo:

3,0 g

Dawa fomu:

GRANULES

Tungo:

EACH SACHET CONTAINS FOSFOMYCIN TROMETAMOL EQUIVALENT TO FOSFOMYCIN 3,0 g

Idhini hali ya:

Registered

Taarifa za kipeperushi

Austell Pharmaceuticals (Pty) Ltd, 54/20.1.1/0078.076, Fosfomycin 3 g
granules for oral solution
2023.05.23 (v3)
Page 1 of 8
APPROVED PATIENT INFORMATION LEAFLET FOR MEDICINES FOR HUMAN USE:
FOSFOMYCIN 3 G AUSTELL
SCHEDULING STATUS: S4
FOSFOMYCIN 3 G AUSTELL GRANULES FOR ORAL SOLUTION
FOSFOMYCIN TROMETAMOL
CONTAINS SUGAR (SUCROSE: 2,213 G PER SACHET)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING FOSFOMYCIN
3 G AUSTELL_ _
•
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 3 g AUSTELL 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 3 g AUSTELL is and what it is used for
2. What you need to know before you take FOSFOMYCIN 3 g AUSTELL
3. How to take FOSFOMYCIN 3 g AUSTELL
4. Possible side effects
5. How to store FOSFOMYCIN 3 g AUSTELL
6. Contents of the pack and other information
1. WHAT FOSFOMYCIN 3 G AUSTELL IS AND WHAT IT IS USED FOR
Austell Pharmaceuticals (Pty) Ltd, 54/20.1.1/0078.076, Fosfomycin 3 g
granules for oral solution
2023.05.23 (v3)
Page 2 of 8
FOSFOMYCIN 3 g AUSTELL contains fosfomycin trometamol. Fosfomycin
trometamol is an
antibiotic that works by killing bacteria which can cause infections.
FOSFOMYCIN 3 g AUSTELL is used to treat or prevent uncomplicated
bladder infections.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOSFOMYCIN 3 G AUSTELL
DO NOT TAKE FOSFOMYCIN 3 G AUSTELL
•
if you are hypersensitive (allergic) to fosfomycin or any of the other
ingredients of
FOSFOMYCIN 3 g AUSTELL (listed in section 6)
•
if you have severe kidney problems (creatinine clearance below 10
mL/min)
•
are undergoing haemodialysis.
If you are uncertain whether any of these apply to you, please discuss
this with your doctor or
pharmacist before taking FOSFOMYCIN 3 g AUSTELL.
WARNINGS AND PRECAUTIONS
Tell your doctor or healt

Tabia za bidhaa

Austell Pharmaceuticals (Pty) Ltd, 54/20.1.1/0078.076, Fosfomycin 3 g
granules for oral solution
2023.05.23 (v2)
Page 1 of 11
APPROVED PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE:
FOSFOMYCIN 3 G AUSTELL
NOTE: BOTH THE PI AND PIL WILL BE INCLUDED IN THE PACKAGING OF THIS
MEDICINE.
SCHEDULING STATUS
S4
1.
NAME OF THE MEDICINE
FOSFOMYCIN 3 g AUSTELL granules for oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One sachet contains fosfomycin trometamol equivalent to 3,0 g
fosfomycin.
Excipient with known effect:
Contains sugar (sucrose: 2,213 g per sachet), see section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Granules for oral solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FOSFOMYCIN 3 g AUSTELL 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 adolescents.
Austell Pharmaceuticals (Pty) Ltd, 54/20.1.1/0078.076, Fosfomycin 3 g
granules for oral solution
2023.05.23 (v2)
Page 2 of 11
•
for prophylaxis in diagnostic and surgical transurethral procedures in
adult men.
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 3 g AUSTELL is administered orally after reconstitution in
water. To be taken at least
two hours prior to the next meal.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to fosfomycin trometamol or to any of the excipients
listed in section 6.1.
•
severe renal insufficiency (creatinine clearance < 10 mL/min)
•
patients undergoing haemodialysis.
4.4
SPECIAL WARNINGS AND PRECAUTIONS F