Dequalinium chloride, the active ingredient in Fluomizin, belongs to the family of anti-infective and antiseptic drugs. Dequalinium chloride is active against the bacteria which cause bacterial vaginosis. Fluomizin is used for the treatment of bacterial vaginosis. It is inserted into the vagina for treatment at the site of infection.

• Adult: The recommended dose is 1 vaginal tablet daily for 6 days.
• Children and adolescents: There is insufficient experience of the use of Fluomizin in children and adolescents under 18 years of age.
• Women above 55 years and elderly: There is insufficient experience of the use of Fluomizin in women above 55 years.

Administration

• Use every evening before bed.
• Wash your hands before opening the blister pack.
• Lie down in a reclining position with the legs slightly bent. Insert one vaginal tablet deeply into the vagina.
• You should stop the treatment during the heavy bleeding period of your menstruation and resume afterwards.
• Do not stop treatment early, even if you no longer have any discomfort (e.g. itching, discharge, smell). A treatment of less than 6 days may result in your symptoms returning.
• Dequalinium contains ingredients which do not dissolve completely, and the remains of the tablet are occasionally found in the underwear. This won’t affect the effectiveness of the treatment. The tablet will not stain your underwear but for your own comfort you can use a sanitary towel or panty liner.
• If your vagina is dry, the vaginal tablet might not dissolve and be discharged as an intact tablet. As a consequence, the treatment is not optimal. In this case the vaginal tablet can be moistened with a drop of water before insertion.

Do not use Dequalinium Chloride:

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

Sometimes the symptoms of vaginal infections (such as itching, burning and discharge) can get worse at the beginning of the treatment, before they start to get better. You should continue with the treatment, but if the complaints persist see your doctor for advice as soon as possible. Common side effects are Vaginal discharge; vaginal itching or vaginal burning; Vaginal yeast infection (thrush).

Overdose Effects

• Using a higher daily dose or increasing the recommended duration might increase the risk of vaginal ulcerations. If you have accidentally used too many vaginal tablets, tell your doctor.
• Do not use a double dose to make up for a forgotten tablet.
• A treatment of less than 6 days may result in a relapse. Therefore, do not stop treatment early, even when you have no discomfort (e.g. itching, discharge, smell) anymore.

• Intravaginal use of soaps, spermicides and vaginal douches (vaginal washes) is not recommended during treatment with Fluomizin.
• As with all vaginal infections, unprotected sexual intercourse during treatment with Fluomizin is not recommended.
• Fluomizin does not reduce the effectiveness of latex condoms.
• This product may reduce the effectiveness of non-latex condoms or diaphragms. Consequently, you should use alternative methods of contraception for at least 12 hours following the treatment.
• Do not use Fluomizin within 12 hours before birth to minimize exposure of the newborn to dequalinium chloride. Please inform your doctor otherwise.
• You should stop the treatment during the heavy bleeding period of your menstruation and resume afterwards.
• You should talk to your doctor if the symptoms persist at the end of the treatment or in case the symptoms return.

Pregnancy & Lactation

If you are pregnant, think you may be pregnant or plan to have a baby ask your doctor or pharmacist for advice before using Dequalinium. Tell your doctor or pharmacist if you are breast-feeding or if you plan to breast-feed. Based on previous experience and since Dequalinium acts locally, no harmful effects on pregnancy and/or the unborn and breast fed infant are expected. Dequalinium should only be used during pregnancy and during breast-feeding if medically needed. Ask your doctor or pharmacist for advice before taking any medicine.