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FLUOMIZIN 10 MG VAGINAL TABLETS

Active substance(s): DEQUALINIUM CHLORIDE

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Fluomizin PIL 148x330_Fluomizin PIL 148x330 16/10/2015 14:29 Page 1

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fluomizin® 10 mg vaginal tablets
Dequalinium chloride
Read all of this leaflet carefully before you start using 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 your 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 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
Dequalinium chloride, the active ingredient in
Fluomizin, belongs to the family of anti-infective
and antiseptic drugs. Dequalinium chloride is
active against the bacteria which cause bacterial
vaginosis.
Fluomizin is used for the treatment of bacterial
vaginosis.
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 allergic to the active substance
dequalinium chloride or any of the other
ingredients of this medicine (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
Intravaginal use of soaps, spermicides and
vaginal douches (vaginal washes) is not
recommended during treatment with Fluomizin.
As with all vaginal infections, unprotected sexual
intercourse during treatment with Fluomizin is not
recommended.
Fluomizin does not reduce the effectiveness of
latex condoms.
This product may reduce the effectiveness of
non-latex condoms or diaphragms. Consequently,
you should use alternative precautions for at least
12 hours following the treatment.
Do not use Fluomizin within 12 hours before birth
to minimize exposure of the newborn to
dequalinium chloride. Please inform your doctor
otherwise.
You should stop the treatment during the heavy
bleeding period of your menstruation and resume
afterwards.
You should talk to your doctor if the symptoms
persist at the end of the treatment or in case the
symptoms return.
Using other medicines and Fluomizin
Please tell your doctor or pharmacist if you are
taking, have recently taken or might take any

other medicines, including medicines obtained
without a prescription.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or
plan to have a baby ask your doctor or
pharmacist for advice before using Fluomizin.
Tell your doctor or pharmacist if you are breastfeeding or if you plan to breast-feed.
Based on previous experience and since
Fluomizin acts locally, no harmful effects on
pregnancy and/or the unborn and breast fed
infant are expected. Fluomizin should only be
used during pregnancy and during breast-feeding
if medically needed.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
Fluomizin is not likely to affect your ability to drive
or operate any machinery. No studies have been
performed.

3. HOW TO USE FLUOMIZIN
Always use Fluomizin exactly as your doctor has
told you. Check with your doctor or pharmacist if
you are not sure.
The recommended dose is 1 vaginal tablet daily
for 6 days.
Instructions for use
• Use every evening before bed.
• Wash your hands before opening the blister
pack.
• Lie down in a reclining position with the legs
slightly bent. Insert one vaginal tablet deeply
into the vagina.
• You should stop the treatment during the
heavy bleeding period of your menstruation
and resume afterwards.
• Do not stop treatment early, even if you no
longer have any discomfort (e.g. itching,
discharge, smell). A treatment of less than 6
days may result in your symptoms returning.
• Fluomizin contains ingredients which do not
dissolve completely, and the remains of the
tablet are occasionally found in the underwear.
This won’t affect the effectiveness of the
treatment. The tablet will not stain your
underwear but for your own comfort you can
use a sanitary towel or panty liner.
• If your vagina is dry, the vaginal tablet might
not dissolve and be discharged as an intact
tablet. As a consequence, the treatment is not
optimal. In this case the vaginal tablet can be
moistened with a drop of water before
insertion.
If you have the impression that the effect of
Fluomizin is too strong or too weak, talk to your
doctor or pharmacist.

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If you use more Fluomizin than you should
Using a higher daily dose or increasing the
recommended duration might increase the risk of
vaginal ulcerations.
If you have accidentally used too many vaginal
tablets, tell your doctor.
If you forget to use Fluomizin
Do not use a double dose to make up for a
forgotten tablet.
If you stop using Fluomizin
A treatment of less than 6 days may result in a
relapse. Therefore, do not stop treatment early,
even when you have no discomfort (e.g. itching,
discharge, smell) anymore.
If you have any further questions on the use of
Fluomizin, ask your doctor or your pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Fluomizin can cause side
effects, although not everybody gets them. Most
of the side effects are mild and short lived.
Sometimes the symptoms of vaginal infections
(such as itching, burning and discharge) can get
worse at the beginning of the treatment, before
they start to get better. You should continue with
the treatment, but if the complaints persist see
your doctor for advice as soon as possible.

6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Fluomizin contains
• The active substance is dequalinium chloride.
• Each vaginal tablet contains 10 mg
dequalinium chloride.
• The other ingredients are lactose monohydrate,
cellulose, microcrystalline and magnesium
stearate.
What Fluomizin looks like and contents of the
pack
Fluomizin vaginal tablets are white or almost
white, oval and biconvex with approximate
dimension of length: 19 mm, width: 12 mm, and
thickness: 6.3 mm.
The vaginal tablets are available in packs
containing a blister of 6 tablets.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Kora Healthcare
Swords Business Park, Swords, Co. Dublin,
Ireland
Manufacturer:
Haupt Pharma Amareg GmbH
Donaustaufer Strasse 378
93055 Regensburg
Germany

Do not use Fluomizin after the expiry date which
is stated on the carton and the blister. The expiry
date refers to the last day of that month.

This medicinal product is authorised in the
Member States of the EEA under the
following names:
Member State:
Medicinal Product Name:
Germany
Fluomizin 10 mg
Vaginaltabletten
The Czech Republic Naxyl 10 mg vaginálni
tablety
Belgium
Fluomizin 10 mg tabletten
voor vaginaal gebruik
Fluomizin 10 mg
comprimés vaginaux
Fluomizin 10 mg
Vaginaltabletten
Italy
Fluomizin 10 mg compresse
vaginali
Luxemburg
Fluomizin 10 mg
comprimés vaginaux
Austria
Fluomizin 10 mg
Vaginaltabletten
Poland
Fluomizin 10 mg tabletki
dopochwowe
Portugal
Fluomizin 10 mg
comprimidos vaginais
Slovakia
Fluomizin 10 mg vaginálne
tablety
Spain
Fluomizin 10 mg
comprimidos vaginales
Finland
Donaxyl 10 mg
emötinpuikko, tabletti
Hungary
Fluomizin 10 mg
hüvelytabletta
The Netherlands
Fluomizin 10 mg tabletten
voor vaginaal gebruik
Norway
Donaxyl 10 mg
vaginaltabletter
Sweden
Donaxyl 10 mg
vaginaltabletter
The United Kingdom Fluomizin 10 mg vaginal
tablets

This medicine does not require any special
storage conditions

This leaflet was last revised in October 2015

Common (may affect up to 1 in 10 people)
- Vaginal discharge; vaginal itching or vaginal
burning;
- Vaginal yeast infection (thrush).
Uncommon (may affect up to 1 in 100 people)
- Vaginal bleeding; vaginal pain;
- Inflammation of the vagina (vaginitis);
- Headache;
- Nausea.
Not known (cannot be estimated from the
available data)
- Ulcerations of vaginal mucosa, if the lining of
the vagina was already damaged before
treatment;
- Uterine bleeding;
- Vaginal redness, vaginal dryness;
- Inflammation of the bladder (cystitis);
- Allergic reaction with symptoms like rash,
swelling or itching;
- Fever.
Reporting of side effects
If you get any side effects, talk to your doctor.
This includes any possible side effects not listed
in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.

5. HOW TO STORE FLUOMIZIN
Keep this medicine out of the sight and reach of
children.

Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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