FLUOMIZIN

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fluomizin 10 mg vaginal tablets

Dequalinium chloride
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, 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 using 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 substance in Fluomizin, belongs to the family of anti-infective and
antiseptic medicinal products.
Dequalinium chloride is active against bacteria causing 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 SHOULD KNOW BEFORE USING FLUOMIZIN

Do not use Fluomizin:

• if you are allergic to the active substance, dequalinium chloride, or to any of the excipients of this medicinal product (listed in section 6);
• if you have vaginal or cervical ulcerations;
• if you have not yet had your first menstrual period.

Warnings and precautions
The use of soaps, spermicides, or vaginal douching (irrigations) is not recommended during treatment with Fluomizin.
As with all vaginal infections, unprotected sexual intercourse should be avoided during treatment with Fluomizin.
Fluomizin does not reduce the effectiveness of latex condoms.
This product may reduce the effectiveness of condoms made from materials other than latex or of diaphragms. Therefore, you should use alternative contraceptive methods for at least 12 hours after treatment.
Do not use Fluomizin within the 12 hours immediately preceding childbirth, in order to minimize the newborn's exposure to dequalinium chloride. Otherwise, inform your doctor.
You should interrupt treatment during the days of heaviest menstrual flow and resume treatment afterwards.
Consult your doctor if symptoms persist after the end of treatment or if they recur.
Children and adolescents
Experience with the use of Fluomizin in girls and adolescents under 18 years of age is insufficient.
Women over 55 years of age and elderly women
Experience with the use of Fluomizin in women over 55 years of age is insufficient.
Other medicines and Fluomizin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before using Fluomizin. Consult your doctor or pharmacist if you are breastfeeding or planning to breastfeed.
Based on previous experience and given that Fluomizin acts locally, harmful effects on pregnancy and/or on the fetus and breastfed newborn are not expected. Fluomizin should be used during pregnancy and breastfeeding only if considered medically necessary.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
It is unlikely that Fluomizin affects your ability to drive or operate machinery. No studies have been conducted on this subject.

3. HOW TO USE FLUOMIZIN

Use this medicine exactly as your doctor has told you. If you have any doubts, consult 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 knees bent slightly. Insert one vaginal tablet deeply into the vagina.
• You must suspend treatment during days with heavy menstrual flow and resume it afterwards.
• Do not stop the treatment too early, even if symptoms disappear (e.g. itching, discharge, unpleasant odour). A treatment shorter than 6 days may lead to recurrence.
• Fluomizin contains excipients that do not dissolve completely, and tablet residues may occasionally remain on underwear. This effect is irrelevant regarding the effectiveness of the treatment. The tablet does not stain underwear; however, as a precaution, you may 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 may result in suboptimal treatment outcome. In such cases, it may be helpful to moisten the vaginal tablet with a drop of water before insertion.

If you think 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 vaginal mucosal ulceration.
If you have accidentally used too many vaginal tablets, contact your doctor.
If you forget to use Fluomizin
Do not use a double dose to make up for the forgotten tablet.
If you stop using Fluomizin before the end of treatment
A treatment shorter than 6 days may lead to recurrence. Therefore, do not stop the treatment too early, even if symptoms disappear (e.g. itching, discharge, unpleasant odour).
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Most of these adverse reactions are mild and short-lived.
Sometimes symptoms of vaginal infections (such as itching, burning, and discharge) may worsen at the beginning of treatment, before improvement starts. You should continue treatment, but if discomfort persists, consult your doctor as soon as possible.

Common (may affect up to 1 in 10 people)

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

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 the available data)

• Ulceration of the vaginal mucosa, if the vaginal epithelium was already damaged before treatment;
• Uterine bleeding;
• Vaginal redness, vaginal dryness;
• Bladder inflammation (cystitis);
• Allergic reaction with symptoms such as skin rash, swelling, or itching;
• Fever.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor. Adverse reactions can also be reported directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. Reporting adverse reactions helps 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 stated on the carton and blister. The expiry date refers to the
last day of the month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. PACK CONTENT AND OTHER INFORMATION

What Fluomizin contains

• The active substance 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 pack contents
Fluomizin vaginal tablets are white or almost white, oval-shaped, biconvex tablets 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 one blister with 6 tablets.

Marketing Authorisation Holder
DOC Generici S.r.l. - Via Turati, 40 - 20121 Milan, Italy

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

This medicinal product is authorised in EEA Member States under the following names:
Member State - Name of the medicinal product
Germany - Fluomizin 10 mg Vaginaltabletten
Czech Republic - Naxyl 10 mg vaginální tablety
Belgium - Fluomizin 10 mg tabletten voor vaginaal gebruik
Fluomizin 10 mg comprimés vaginaux
Fluomizin 10 mg Vaginaltabletten
Italy - Fluomizin 10 mg compresse vaginali
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 tabletten voor vaginaal gebruik
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 - Donaxyl 10 mg vaginālās tabletes
Slovenia - Fluomizin 10 mg vaginalne tablete