FLUOMIZIN

FLUOMIZIN 10 mg vaginal tablets

Important notes (mandatory information)

Fluomizin 10 mg vaginal tablets. Active ingredient: Dequalinium chloride. Areas of application: for the treatment of bacterial vaginosis.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Fluomizin 10 mg vaginal tablets
Active ingredient: Dequalinium chloride

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 6 days, talk to your doctor.

What this package leaflet contains

1. WHAT IS FLUOMIZIN AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING FLUOMIZIN?
3. HOW TO USE FLUOMIZIN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
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 in Fluomizin, belongs to the family of anti-infective and antiseptic medicines. Dequalinium chloride is effective against bacteria that cause bacterial vaginosis (a disorder of the vaginal flora with characteristic germ colonisation). Fluomizin is used to treat bacterial vaginosis. It is inserted into the vagina for treatment at the site of the infection.

2. WHAT SHOULD YOU CONSIDER BEFORE USING FLUOMIZIN?

Fluomizin must not be used:

• if you are allergic to the active ingredient dequalinium chloride or any of the other ingredients of this medicine listed in section 6.
• if you have ulcers in the vagina or on the cervix.
• if you have not yet had your first period.

Warnings and precautions

Intravaginal use of soaps, spermicides and vaginal douches (vaginal rinses) is not recommended during treatment with Fluomizin. As with all vaginal infections, unprotected sexual intercourse is not recommended during treatment with Fluomizin. Fluomizin does not reduce the effectiveness of latex condoms. This medicine may reduce the effectiveness of non-latex condoms or diaphragms. Therefore, you should use other contraceptive measures for up to 12 hours after treatment. Do not use Fluomizin within 12 hours before birth to reduce the newborn's exposure to dequalinium chloride. Otherwise, please inform your doctor. Treatment should be discontinued during the heavy bleeding phase of menstruation and then resumed. Please talk to your doctor if symptoms persist after the end of treatment or if symptoms recur.

Use of Fluomizin with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Pregnancy and breast-feeding

If you are pregnant, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Tell your doctor or pharmacist if you are breast-feeding or intend to breast-feed. Based on experience to date and the fact that Fluomizin acts locally, no harmful effects on pregnancy and/or the unborn child and the breast-fed infant are expected. Fluomizin should only be used during pregnancy and breast-feeding if there is a medical need for it. Ask your doctor or pharmacist for advice before taking/using any medicine.

Driving and using machines

Fluomizin should not affect your ability to drive and use machines. No studies have been conducted on this.

3. HOW TO USE FLUOMIZIN?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is 1 vaginal tablet daily for 6 days.

Instructions for use:

• Use Fluomizin every evening before going to bed.
• Wash your hands before opening the blister pack.
• Lie on your back with your legs slightly bent and insert one vaginal tablet deep into the vagina.
• Treatment should be discontinued during the heavy bleeding phase of menstruation and then resumed.
• Treatment should not be stopped prematurely, even if you no longer have any symptoms (e.g. itching, discharge, odour). Treatment for less than 6 days may lead to a recurrence of the condition.
• Fluomizin contains ingredients that do not dissolve completely, so tablet residues may occasionally be found in your underwear. This is irrelevant for the effectiveness of Fluomizin treatment. Your underwear will not be discoloured, but you can use pads or panty liners for your own well-being.
• If the vagina is very dry, the vaginal tablet may not dissolve and will be excreted from the vagina as an intact tablet. In such cases, the vaginal tablet can be moistened with a drop of water before insertion into a very dry vagina.

Please talk to your doctor or pharmacist if you have the impression that the effect of Fluomizin is too strong or too weak.

If you have used more Fluomizin than you should

Using higher daily doses or extending the recommended duration of treatment may increase the risk of vaginal ulcers. If you have accidentally used too many vaginal tablets, tell your doctor.

If you forget to use Fluomizin

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

If you stop using Fluomizin

Treatment for less than 6 days may lead to a recurrence of the condition. Therefore, treatment should not be stopped prematurely, even if you no longer have any symptoms (e.g. itching, discharge, odour).

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild and short-lived. Vaginal infections cause symptoms such as itching, burning and discharge, which usually disappear during treatment. However, these symptoms may occasionally increase at the beginning of treatment. Continue treatment. However, if the symptoms persist, contact your doctor as soon as possible.

Common (may affect up to 1 in 10 people):

• Vaginal discharge, itching or burning in the vagina;
• Vaginal yeast infection (thrush).

Uncommon (may affect up to 1 in 100 people):

• Vaginal bleeding, pain in the vaginal area;
• Vaginitis (inflammation of the vagina);
• Headache;
• Nausea.

Not known (frequency cannot be estimated from the available data):

• Ulceration of the vaginal mucosa in the case of pre-damaged mucosa;
• Uterine bleeding;
• Redness of the vagina, dryness of the vagina;
• Cystitis (inflammation of the bladder);
• Allergic reactions with symptoms such as rash, swelling and itching;
• Fever.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE FLUOMIZIN?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister pack. The expiry date refers to the last day of the month indicated. This medicinal product does not require any special storage conditions. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Fluomizin contains

The active substance is dequalinium chloride. Each vaginal tablet contains 10 mg dequalinium chloride. The other ingredients are lactose monohydrate, microcrystalline cellulose and magnesium stearate (Ph.Eur.) (vegetable).

What Fluomizin looks like and contents of the pack

Fluomizin vaginal tablets are white or almost white, oval, biconvex tablets with approximate dimensions of length: 19 mm, width: 12 mm and thickness: 6.3 mm. The vaginal tablets are available in packs of blister packs of 6 tablets (N1).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Pierre Fabre Pharma GmbH
Jechtinger Str. 13
79111 Freiburg

Manufacturer

Haupt Pharma Amareg GmbH
Donaustaufer Straße 378
93055 Regensburg

This package leaflet was last revised in July 2015.

Source: Information from the package leaflet
Version: 02/2018
Active ingredient: Dequalinium chloride. Areas of application: for the treatment of bacterial vaginosis.