FLUOMIZIN 10 mg Vaginal Tablets

1. What is Fluomizin and what is it used for

Decualinium chloride, the active substance of Fluomizin, belongs to the group of anti-infectives and antiseptics. Decualinium chloride is active against bacteria that cause bacterial vaginosis.

Fluomizin is used for the treatment of bacterial vaginosis.

It is inserted into the vagina to perform the 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 decualinium chloride or to any of the other ingredients of this medicine (listed in section 6).
• if you have an ulceration of the vaginal epithelium or cervix.
• if you have not yet had your first menstrual period.

Warnings and precautions

Intravaginal use of soaps, spermicides, or vaginal douches is not recommended during treatment with Fluomizin.

As in all cases of vaginal infection, it is not recommended to have unprotected sex during treatment with Fluomizin.

Fluomizin does not reduce the effectiveness of latex condoms.

This product may reduce the effectiveness of non-latex condoms or diaphragms. Therefore, alternative contraceptive methods should be used for at least 12 hours after treatment.

Do not use Fluomizin during the 12 hours prior to delivery to minimize exposure of the newborn to decualinium chloride. Given the circumstances, inform your doctor.

Stop treatment during the most profuse bleeding phase of menstruation and resume afterwards.

If symptoms persist at the end of treatment or recur later, consult your doctor.

Children and adolescents

There is not enough experience with the use of Fluomizin in children and adolescents under 18 years of age.

Women over 55 years of age

There is not enough experience with the use of Fluomizin in women over 55 years of age.

Use of Fluomizin with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

If you are breastfeeding or planning to breastfeed, consult your doctor or pharmacist before using this medicine.

Based on previous experiences and since Fluomizin acts locally, no harmful effects are expected on pregnancy and/or fetal or newborn health during breastfeeding. Fluomizin should only be used during pregnancy and breastfeeding if medically necessary.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Fluomizin is unlikely to affect your ability to drive or use machines. No studies have been conducted.

3. How to use Fluomizin

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 1 vaginal tablet per day for a period of 6 days.

Instructions for use

• Use the product every night before going to bed.
• Wash your hands before opening the blister.
• Lie on your back with your legs slightly bent. Insert a vaginal tablet deeply into the vagina.
• Stop treatment during the most profuse bleeding phase of menstruation, and resume afterwards.
• Do not interrupt treatment prematurely, even if you no longer have discomfort (e.g., itching, discharge, odor). A treatment of less than 6 days may cause your symptoms to recur.

• Fluomizin contains excipients that are not completely soluble, so occasionally remains of the tablet may be found in your underwear. This does not affect the effectiveness of the treatment. The tablet will not stain your underwear, but if you find it more comfortable, you can use a sanitary pad or panty liner.
• If you experience vaginal dryness, the vaginal tablet may not dissolve and may be expelled intact. As a result, the treatment will not be optimal. In this case, you can 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, consult your doctor or pharmacist.

If you use more Fluomizin than you should

Administration of a higher daily dose or prolongation of the recommended duration may increase the risk of vaginal ulceration.

In case of accidental use of too many vaginal tablets or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Fluomizin

Do not use a double dose to make up for forgotten doses.

If you stop using Fluomizin

If the treatment lasts less than 6 days, a relapse may occur. Therefore, do not interrupt treatment prematurely, even if you no longer notice any discomfort (such as itching, discharge, or odor).

If you have any other questions about the use of this product, 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 them are mild and temporary.

Sometimes the symptoms of vaginal infections (such as itching, burning, and discharge) may worsen at the start of treatment, before they start to improve. In these cases, you should continue with the treatment, but if the discomfort persists, consult your doctor as soon as possible.

Common (may affect up to 1 in 10 people)

• Vaginal discharge; vaginal itching or burning;
• Yeast infection (vaginal 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;

Frequency not known (cannot be estimated from the available data)

• Ulcerations of the vaginal mucosa if it was damaged before treatment;
• Uterine bleeding;
• Redness, vaginal dryness;
• Inflammation of the bladder (cystitis);
• Allergic reaction with symptoms such as rash, inflammation, or itching;
• Fever.

Reporting of side effects

If you experience any side effects, talk to your doctor, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of 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 packaging. The expiry date is the last day of the month stated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fluomizin

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

Appearance and packaging of Fluomizin

Fluomizin vaginal tablets are white or almost white, oval, and biconvex, with approximate dimensions of 19 mm in length, 12 mm in width, and 6.3 mm in thickness.

The vaginal tablets are presented in a pack containing a blister of 6 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Gedeon Richter Plc.

Gyömroi út 19-21.

1103 Budapest, Hungary

Manufacturer:

Haupt Pharma Amareg GmbH

Donaustaufer Strasse 378

93055 Regensburg, Germany

Gedeon Richter Plc.

Gyömroi út 19-21.

1103 Budapest, Hungary

You can request more information about this medicine from the local representative of the marketing authorisation holder.

Gedeon Richter Ibérica S.A.

Sabino Arana, 28 4º 2ª

08028 Barcelona

+34 93 2034300

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany - Fluomizin 10 mg Vaginaltabletten

Austria - Fluomizin 10 mg Vaginaltabletten

Belgium - Fluomizin 10 mg tabletten voor vaginaal gebruik

• Fluomizin 10 mg comprimés vaginaux
• Fluomizin 10 mg Vaginaltabletten

Croatia - Fluomizin 10 mg tablete za rodnicu

Slovakia - Fluomizin 10 mg vaginálne tablety

Slovenia - Fluomizin 10 mg vaginalne tablete

Spain - Fluomizin 10 mg comprimidos vaginales

Estonia - Donaxyl 10 mg vaginaalne tablett

Finland - Donaxyl 10 mg emätinpuikko, tabletti

France - Fluomizin 10 mg comprimés vaginaux

Hungary - Fluomizin 10 mg hüvelytabletta

Italy - Fluomizin 10 mg compresse vaginali

Latvia - Donaxyl 10 mg vaginalas tabletes

Lithuania - Donaxyl 10 mg makšties tabletes

Luxembourg - Fluomizin 10 mg comprimés vaginaux

Norway - Donaxyl 10 mg vaginaltabletter

Netherlands - Fluomizin 10 mg tabletten voor vaginaal gebruik

Poland - Fluomizin 10 mg tabletki dopochwowe

Portugal - Fluomizin 10 mg comprimidos vaginais

United Kingdom - Fluomizin 10 mg vaginal tablets

Sweden - Donaxyl 10 mg vaginaltabletter

Czech Republic - Naxyl 10 mg vaginálni tablety

Date of last revision of this leaflet: April 2017

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/