FLUOMIZIN VAGINAL TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Adcock Ingram Limited

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS DEQUALINIUM CHLORIDE 10,0 mg

Authorization status:

Registered

Patient Information leaflet

ADCOCK INGRAM LIMITED
FLUOMIZIN 10 mg vaginal tablets
Contains 10 mg dequalinium chloride per tablet
PATIENT INFORMATION LEAFLET
Version: 0001
_ _
_ _
_ _
Page 1 of 9
22 February 2022
PATIENT INFORMATION LEAFLET FOR FLUOMIZIN
SCHEDULING STATUS:
FLUOMIZIN, 10 MG VAGINAL TABLET
DEQUALINIUM CHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
FLUOMIZIN
is
available
without
a
doctor’s
prescription,
for
you
to
treat
a
mild
illness.
Nevertheless, you still need to use FLUOMIZIN carefully to get the
best results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share FLUOMIZIN with any other person.
•
Ask your healthcare provider or pharmacist if you need more
information or advice.
•
You must see a doctor if your symptoms worsen or do not improve after
6 days.
WHAT IS IN THIS LEAFLET
1. What FLUOMIZIN is and what it is used for
2. What you need to know before you use FLUOMIZIN
3. How to use FLUOMIZIN
4. Possible side effects
5. How to store FLUOMIZIN
6. Contents of the pack and other information
1. WHAT FLUOMIZIN IS AND WHAT IT IS USED FOR
S2
ADCOCK INGRAM LIMITED
FLUOMIZIN 10 mg vaginal tablets
Contains 10 mg dequalinium chloride per tablet
PATIENT INFORMATION LEAFLET
Version: 0001
_ _
_ _
_ _
Page 2 of 9
22 February 2022
Dequalinium chloride is active against the bacteria which cause
bacterial vaginosis. It acts by
either slowing down or stopping the growth of the germs or spread of
an infection or killing the
germ that caused the infection.
FLUOMIZIN is used for the treatment of vaginal infections of bacterial
origin.
It is inserted into the vagina for treatment at the site of infection.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FLUOMIZIN
DO NOT USE FLUOMIZIN:
•
if you are hypersensitive (allergic) to dequalinium chloride or to any
of the other ingredients
of FLUOMIZIN (listed in section 6).
•
if you have ulcers on your vagina or cervix.
•
if you have not yet had your first period.
WARNINGS AND PRECAUTIONS
Special care should be taken with FL

Summary of Product characteristics

ADCOCK INGRAM LIMITED
FLUOMIZIN 10 mg vaginal tablets
Contains 10 mg dequalinium chloride per tablet
PROFESSIONAL INFORMATION
Version: 0001
_ _
22 February 2022
Page 1 of 13
PROFESSIONAL INFORMATION FOR FLUOMIZIN
SCHEDULING STATUS
1 NAME OF THE MEDICINE
FLUOMIZIN, 10 mg vaginal tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
FLUOMIZIN: Each vaginal tablet contains 10 mg dequalinium chloride.
_ _
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Vaginal tablets
FLUOMIZIN vaginal tablets are white or almost white, oval, biconvex
tablets.
The tablet has the following dimensions: length of 19,1 mm; width of
12,2 mm; height of 6,4
mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
FLUOMIZIN is indicated for the treatment of bacterial vaginosis in
adult patients (see section
4.4).
S2
ADCOCK INGRAM LIMITED
FLUOMIZIN 10 mg vaginal tablets
Contains 10 mg dequalinium chloride per tablet
PROFESSIONAL INFORMATION
Version: 0001
_ _
22 February 2022
Page 2 of 13
Consideration should be given to official guidance on the appropriate
use of antibacterial
medicines.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
One vaginal tablet daily for six days.
The vaginal tablets should be inserted deeply into the vagina in the
evenings before retiring.
This is best performed in a reclining position with the legs slightly
bent.
The treatment should be interrupted during menstruation and resumed
afterwards.
Although relief of discharge and inflammation generally occurs within
24 to 72 hours, the
treatment should be continued even when there is no subjective
discomfort (itching, discharge,
smell) anymore. A treatment less than six days could result in a
relapse.
FLUOMIZIN contains excipients which do not dissolve completely, such
that remains of the
tablet are occasionally found on underwear. This will not affect the
efficacy of FLUOMIZIN.
In rare cases of a very dry vagina, it is possible that the vaginal
tablet does not dissolve and is
discharged by the vagina as intact tablet. As consequence, the
treatment is n