Fluomizin 10 mg vaginal tablets

Patient Information Leaflet

Introduction

PATIENT INFORMATION LEAFLET

Fluomizin 10 mg vaginal tablets

Dequalinium chloride

Package 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

Decquaternium chloride, the active substance in Fluomizin, belongs to the group of anti-infectives and antiseptics. Decquaternium chloride is active against bacteria causing bacterial vaginosis.

Fluomizin is used for the treatment of bacterial vaginosis.

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

Warnings and precautions

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

As with all cases of vaginal infection, unprotected sexual intercourse is not recommended 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 preceding childbirth to minimize exposure of the newborn to dequalinium chloride. Inform your doctor given these circumstances.

Discontinue treatment during the phase of heaviest menstrual bleeding and resume afterwards.

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

Children and adolescents

There is insufficient experience regarding the use of Fluomizin in children and adolescents under 18 years of age.

Women over 55 years of age

There is insufficient experience regarding the use of Fluomizin in women over 55 years of age.

Using Fluomizin with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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 experience and given that Fluomizin acts locally, harmful effects during pregnancy and/or on the health of the fetus or newborn during breastfeeding are not expected. 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

It is unlikely that Fluomizin will affect your ability to drive or operate machinery. No studies have been conducted.

3. How to use Fluomizin

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Instructions for use

• Use the product every night before going to sleep.

• Wash your hands before opening the blister.

• Lie on your back with your knees slightly bent. Insert one vaginal tablet deeply into the vagina.

• Stop treatment during the heaviest days of menstruation, and resume afterwards.

• Do not interrupt treatment prematurely, even if your symptoms (e.g. itching, discharge, odor) have already disappeared. A treatment shorter than 6 days may cause your symptoms to return.

• Fluomizin contains excipients that do not dissolve completely, so occasionally remnants of the tablet may be found in underwear. This does not affect the effectiveness of the treatment. The tablet will not stain underwear, but if preferred, you may use a sanitary pad or panty liner.

• If you suffer from vaginal dryness, the vaginal tablet may not dissolve and could be expelled intact. As a result, treatment may not be optimal. In this case, you may moisten the vaginal tablet with a drop of water before insertion.

If you feel that the effect of Fluomizin is too strong or too weak, consult your doctor or pharmacist.

If you use more Fluomizin than you should

Taking a higher daily dose or extending treatment beyond the recommended duration may increase the risk of vaginal ulceration.

In case of accidental overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 treatment

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

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Most of these effects are mild and transient.

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

Frequent (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 available data)

• Ulceration of the vaginal mucosa if it was previously damaged;
• Uterine bleeding;
• Redness, vaginal dryness;
• Inflammation of the vagina (cystitis);
• Allergic reaction with symptoms such as rash, swelling, or itching;
• Fever.

Reporting of adverse effects

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

5. Storage of Fluomizin

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fluomizin

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

Appearance of the product and pack contents of Fluomizin

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

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.

Gedeon Richter Ibérica S.A.

Sabino Arana, 28 4º 2ª

08028 Barcelona

+34 93 2034300

This medicinal product is authorized in the European Economic Area member states 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 vaginal tablets

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 the most recent review of this leaflet: April 2017

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