PATIENT INFORMATION LEAFLET

Fluomizin 10 mg vaginal tablets

Decqualinium Chloride

1.What is Fluomizin and what it is used for

2.What you need to know before starting to use Fluomizin

3.How to use Fluomizin

4.Possible side effects

5Storage of Fluomizin

6.Contents of the pack and additional information

The chlorhexidine digluconate, active principle of Fluomizin, belongs to the group of anti-infectives and antiseptics. Chlorhexidine digluconate is active against the 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 the infection.

Do not use Fluomizin:

-if you are allergic to the active ingredient chlorhexidine or to any of the other components of this medication (listed in section 6).

-if you have vaginal or uterine cervix ulceration.

-if you have not yet had your first menstruation.

Warnings and precautions

Do not recommend the use of intravaginal soaps, spermicides, or vaginal washes during treatment with Fluomizin.

As with all cases of vaginal infection, do not recommend 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 12 hours before delivery to minimize exposure of the newborn to chlorhexidine. Inform your doctor under the circumstances.

Stop treatment during the most profuse menstrual bleeding phase and restart it afterwards.

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

Children and adolescents

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

Women over 55 years

There is insufficient experience with the use of Fluomizin in women over 55 years old.

Use ofFluomizinwith other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Pregnancy and breastfeeding

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

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

Based on previous experiences and since Fluomizin acts locally, no adverse effects are expected in pregnancy and/or fetal or newborn health during breastfeeding. Fluomizin should be used only during pregnancy and during breastfeeding, if necessary from a medical point of view.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Follow exactly the administration instructions for this medication as indicated 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 sleep.
• Wash your hands before opening the blister pack.
• Lie on your back with your legs slightly bent. Insert a vaginal tablet deeply into the vagina.
• Stop treatment during the most profuse menstrual days, and resume it afterwards.
• Do not interrupt treatment before time, even if you no longer have discomfort (e.g. itching, discharge, odor). A treatment of less than 6 days may cause your symptoms to reappear.

• Fluomizin contains excipients that do not fully dissolve, so you may occasionally find remnants of the tablet in your underwear. This does not affect the efficacy of the treatment. The tablet will not stain your underwear, but if you find it more comfortable, you can use a compress or a sanitary napkin.
• If you experience vaginal dryness, the vaginal tablet may not dissolve and 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 the effect of Fluomizin is too strong or too weak, consult your doctor or pharmacist.

If you use more Fluomizin than you should

The 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Fluomizin

Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with Fluomizin

If treatment lasts less than 6 days, a relapse may occur. Therefore, do not interrupt treatment prematurely, not 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.

Like all medications, this medication may produce adverse effects, although not everyone will experience them. Most of them are mild and temporary.

At times, symptoms of vaginal infections (such as itching, burning, and discharge) may worsen at the beginning 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.

Frequent(may affect up to 1 in 10 people)

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

Rare(may affect up to 1 in 100 people)

• Vaginal bleeding;
• Vaginal pain
• Vaginal inflammation (vaginitis) and vulvar inflammation
• Bacterial vaginosis
• Fungal skin infections
• Headache;
• Nausea;

Unknown frequency (cannot be estimated from available data)

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

Reporting 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 prospectus.You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medicationafter the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Fluomizin

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

Appearance of the product and contents of the 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 apackaging containing a blister of 6 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Gedeon Richter Plc.

Gyömroi út 19-21.

1103 Budapest, Hungary

Responsible formanufacturing:

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 medication by contacting the local representative ofthe holder of the marketing authorization.

Gedeon Richter Ibérica S.A.

Sabino Arana, 28 4º 2ª

08028 Barcelona

+34 93 2034300

This medication is authorized in the member states of the European Economic Area with 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

SpainFluomizin 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

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

Last review date of this leaflet: April 2017

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/