FLUOMIZIN 10 mg Vaginal Tablet

Зміст інструкції

1. Fluomizin 10 mg vaginal tablets
   1. WHAT IS FLUOMIZIN AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING FLUOMIZIN
   3. HOW TO USE FLUOMIZIN
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE FLUOMIZIN
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

Fluomizin 10 mg vaginal tablets

Dequalinium chloride
Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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 IS FLUOMIZIN AND WHAT IS IT USED FOR

Dequalinium chloride, the active ingredient of Fluomizin, belongs to the family of anti-infective and
antiseptic drugs.
Dequalinium chloride is active against the bacteria that cause bacterial vaginosis.
Fluomizin is indicated 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 USING FLUOMIZIN

Do not use Fluomizin:

• if you are allergic to the active ingredient dequalinium chloride or to any of the excipients of this medicine (listed in section 6);
• if you have vaginal or cervical ulcers;
• if you have not yet had your first menstruation.

Warnings and precautions
The use of soaps, spermicides or vaginal douches (irrigations) is not recommended during treatment with
Fluomizin.
As with all vaginal infections, it is advisable to avoid unprotected sexual intercourse during
treatment with Fluomizin.
Fluomizin does not reduce the effectiveness of latex condoms.
This product may reduce the effectiveness of condoms made of materials other than latex or
diaphragms. Consequently, you should use alternative methods of contraception for at least 12 hours after
treatment.
Do not use Fluomizin in the 12 hours immediately before delivery to minimize
exposure of the newborn to dequalinium chloride. Otherwise, inform your doctor.
You should suspend treatment during the days of heavier flow during your menstrual period, and
resume it afterwards.
Consult your doctor if symptoms persist at the end of treatment or if they recur.

Children and adolescents
The experience of using Fluomizin in girls and adolescents under 18 years of age is insufficient.

Women over 55 years of age and elderly women
The experience of using Fluomizin in women over 55 years of age is insufficient.

Other medicines and Fluomizin
Tell your doctor or pharmacist if you are taking, have recently taken or may take
any other medicines, including those without a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before using Fluomizin. Consult your doctor or pharmacist if you are breastfeeding or
planning to breastfeed.
Based on previous experience and since Fluomizin acts locally, no harmful effects on pregnancy and/or the
fetus and the breastfed infant are expected. Fluomizin should be used
during pregnancy and breastfeeding, only if necessary from a medical point of view.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
It is unlikely that Fluomizin will affect your ability to drive vehicles or operate machinery. No
studies have been conducted in this regard.

3. HOW TO USE FLUOMIZIN

Use this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The recommended dose is 1 vaginal tablet daily for 6 days.

Instructions for use

• Use the medicine every evening before going to bed.
• Wash your hands before opening the blister.
• Lie on your back in a reclined position with your legs slightly bent. Insert one vaginal tablet deep into the vagina.
• You should suspend treatment during days of heavier flow during menstruation and resume it afterwards.
• Do not stop treatment too early, even if the symptoms disappear (e.g. itching, discharge, unpleasant odour). A treatment duration of less than 6 days may cause a recurrence.
• Fluomizin contains excipients that do not dissolve completely and residues of the tablet may occasionally remain on underwear. This effect is not important for the effectiveness of the treatment. The tablet does not stain underwear, however, for safety, you can use a sanitary pad or panty liner.
• In case of excessive vaginal dryness, the vaginal tablet may not dissolve and may be expelled intact. This condition results in a suboptimal outcome of the treatment. In this case, you can moisten the vaginal tablet with a drop of water before inserting it into the vagina. If you feel that the effect of Fluomizin is too strong or too weak, ask your doctor or pharmacist for advice.

If you use more Fluomizin than you should
Using a higher daily dose or prolonging the treatment may increase the risk of
ulceration of the vaginal mucosa.
If you have inadvertently used too many vaginal tablets, contact your doctor.

If you forget to use Fluomizin
Do not use a double dose to make up for a missed tablet.

If you stop using Fluomizin
A treatment duration of less than 6 days may cause a recurrence. Therefore, do not stop the
treatment too early, even if the symptoms disappear (e.g. itching, discharge, unpleasant
odour).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most of these side effects are mild and of short duration.
Sometimes the symptoms of vaginal infections (such as itching, burning and discharge) may worsen
at the beginning of treatment, before you start to feel better. You should continue the treatment, but if the disorders
persist, ask your doctor for advice as soon as possible.

Common (may affect up to 1 in 10 people)

• Vaginal discharge; vaginal itching or burning;
• Vaginal yeast infection (candidiasis)

Uncommon (may affect up to 1 in 100 people)

• Vaginal bleeding; vaginal pain;
• Inflammation of the vagina (vaginitis) and vulva;
• Bacterial vaginosis;
• Fungal skin infections;
• Headache;
• Nausea;

Not known (frequency cannot be estimated from available data)
Ulceration of the vaginal mucosa, if the vaginal epithelium was already damaged before treatment;
Uterine bleeding;
Vaginal redness, vaginal dryness;
Inflammation of the bladder (cystitis);

• Allergic reaction with symptoms such as rash, swelling or itching; Fever.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor. Side effects can also be reported directly through the national reporting system, at http:// www.agenziafarmaco.gov.it/it/responsabili . Reporting
of side effects helps to 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 use this medicine after the expiry date which is stated on the package and on the blister. The expiry
date refers to the last day of the month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Fluomizin contains

• The active ingredient is dequalinium chloride.
• Each vaginal tablet contains 10 mg of dequalinium chloride.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, and magnesium stearate.

Description of the appearance of Fluomizin and contents of the pack
Fluomizin vaginal tablets are white or off-white in colour, and oval and biconvex in shape with
approximate dimensions of 19 mm in length, 12 mm in width and 6.3 mm in thickness.
The vaginal tablets are available in packs containing a blister of 6 tablets.

Marketing Authorisation Holder:
EXELTIS ITALIA S.R.L.
Via Lombardia 2/A, Peschiera Borromeo, MILAN

Manufacturer:
Haupt Pharma Amareg GmbH,
Donaustaufer Strasse 378,
93055 Regensburg,
Germany

This medicinal product is authorised in the Member States of the EEA with the following denominations:
Member State - Medicinal Product Name
Germany - Fluomizin 10 mg Vaginaltabletten
Czech Republic - Naxyl 10 mg vaginální tablety
Belgium - Fluomizin 10 mg tablets for vaginal use
Fluomizin 10 mg comprimés vaginaux
Fluomizin 10 mg Vaginaltabletten
Italy - Fluomizin 10 mg vaginal tablets
Luxembourg - Fluomizin 10 mg comprimés vaginaux
Austria - Fluomizin 10 mg Vaginaltabletten
Poland - Fluomizin 10 mg tabletki dopochwowe
Portugal - Fluomizin 10 comprimidos vaginais
Slovakia - Fluomizin 10 mg vaginálne tablety
Spain - Fluomizin 10 mg comprimidos vaginales
Finland - Donaxyl 10 mg emätinpuikko, tabletti
Hungary - Fluomizin 10 mg hüvelytabletta
Netherlands - Fluomizin 10 mg tablets for vaginal use
Norway - Donaxyl 10 mg vaginaltabletter
Sweden -- Donaxyl 10 mg vaginaltabletter
United Kingdom - Fluomizin 10 mg vaginal tablets
Estonia - Donaxyl 10 mg vaginaalne tablett
France - Fluomizin 10 mg comprimés vaginaux
Croatia - Fluomizin 10 mg tablete za rodnicu
Lithuania - Donaxyl 10 mg makšties tabletės
Latvia - Fluomizin 10 mg vaginālās tabletes
Slovenia - Fluomizin 10 mg vaginalne tablete