Fluomizin vaginal tablets for bacterial vaginosis, 6 tablets

Fluomizin 10 mg vaginal tablets. Active ingredient: Dequalinium chloride. Indications: 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 your doctor or pharmacist has told you.

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

What this leaflet contains:

1. WHAT IS FLUOMIZINE AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING FLUOMIZINE?
3. HOW IS FLUOMIZINE TO BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD FLUOMIZINE BE STORED?
6. PACKAGE CONTENTS AND FURTHER 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 drugs. Dequalinium chloride works against bacteria that cause bacterial vaginosis (a disruption of the vaginal flora with characteristic bacterial colonization). Fluomizin is used to treat bacterial vaginosis. It is inserted into the vagina for treatment at the site of infection.

2. WHAT SHOULD YOU KNOW BEFORE USING FLUOMIZIN?

Fluomizin must not be used:

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

Warnings and precautions:
The intravaginal use of soaps, spermicides, and douches 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 methods for up to 12 hours after treatment. Do not use Fluomizin within 12 hours of delivery to reduce the newborn's exposure to dequalinium chloride. Otherwise, please inform your doctor. Treatment should be stopped and then restarted during the heavy phase of menstruation. Please talk to your doctor if symptoms persist or recur after the end of treatment.

Using Fluomizin with other medicines:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding:
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Tell your doctor or pharmacist if you are breastfeeding or plan to breastfeed. Based on current experience and the fact that Fluomizin acts locally, no harmful effects on pregnancy and/or the unborn child and breastfed infant are expected. Fluomizin should only be used during pregnancy and breastfeeding if medically necessary. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines:
Fluomizin should not affect your ability to drive or use machines. No studies have been performed on this.

3. HOW TO USE FLUOMIZINE?

Always use this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you. 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:

• Apply 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 a vaginal tablet deep into the vagina.
• Treatment should be stopped during the heavy bleeding phase of menstruation and then resumed afterwards.
• Treatment should not be stopped prematurely, even if you no longer have any symptoms (e.g., itching, discharge, odor). Treatment lasting less than 6 days may lead to a recurrence of the condition.
• Fluomizin contains components that do not dissolve completely, so tablet residue may occasionally be found in underwear. This does not affect the effectiveness of the Fluomizin treatment. Underwear will not become discolored; however, for your comfort, you may wish to use sanitary pads or panty liners.
• In cases of vaginal dryness, the vaginal tablet may not dissolve and may be expelled intact. In such cases, the treatment is not optimal. If this occurs, 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 feel 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 treatment duration may increase the risk of vaginal ulcers. If you accidentally use too many vaginal tablets, inform your doctor.

If you forget to use Fluomizin:
Do not use a double dose to make up for a missed dose.

If you stop using Fluomizin:
Treatment of less than 6 days may cause the condition to recur. Therefore, treatment should not be stopped prematurely, even if you no longer have any symptoms (e.g., itching, discharge, odor).

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

4. POSSIBLE SIDE EFFECTS

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. Occasionally, however, these symptoms may worsen at the start of treatment. Continue treatment. If 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
• Yeast infection of the vagina (thrush).

Occasionally (may affect up to 1 in 10 people treated):

• Vaginal bleeding, pain in the vaginal area
• Vaginal inflammation (vaginitis)
• Headache
• Nausea.

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

• Ulceration of the vaginal mucosa in cases of pre-existing damage to the mucosa
• Uterine bleeding
• Vaginal redness, vaginal dryness
• Bladder infection (cystitis)
• Allergic reactions with symptoms such as rash, swelling and itching
• Fever.

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

5. HOW TO STORE FLUOMIZINE?

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 carton and blister pack. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines no longer required. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Fluomizin contains:
The active ingredient is dequalinium chloride. Each vaginal tablet contains 10 mg of 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 19 mm in length, 12 mm in width, and 6.3 mm in thickness. The vaginal tablets are available in packs of blisters containing 6 tablets (N1).

Pharmaceutical company and manufacturer:
Pharmaceutical company:
Pierre Fabre Pharma GmbH,
Jechtinger Str. 13,
79111 Freiburg, Germany.

Manufacturer:
Haupt Pharma Amareg GmbH,
Donaustaufer Straße 378,
93055 Regensburg, Germany.

(Apo) Usually ship out within 3-5 business days