Fluomizin

Package Leaflet: Information for the User

Fluomizin, 10 mg, Vaginal Tablets

Dequalinium Chloride

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed to you by a doctor. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
See section 4.

Table of Contents of the Leaflet

• 1. What is Fluomizin and what is it used for
• 2. Important information 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 is Fluomizin and what is it used for

Dequalinium chloride, the active substance of Fluomizin, belongs to the group of anti-infective and antiseptic medicines. Dequalinium chloride acts on bacteria that can cause bacterial vaginitis.
Fluomizin is used to treat bacterial vaginitis.
The medicine is administered into the vagina for local treatment of the infection.

2. Important information before using Fluomizin

When not to use Fluomizin:

• if you are allergic to dequalinium chloride or any of the other ingredients of this medicine (listed in section 6);
• if you have ulcers on the vaginal mucosa or cervix;
• if you have not had your first menstrual period.

Warnings and precautions

During treatment with Fluomizin, it is not recommended to use vaginal douches, spermicides, or perform vaginal irrigation.
As with all vaginal infections, during treatment with Fluomizin, it is not recommended to have sexual intercourse without protection.
Fluomizin does not reduce the effectiveness of latex condoms.
This medicine may reduce the effectiveness of non-latex condoms or vaginal rings.
Therefore, you should use other protective methods for at least 12 hours after using the medicine.
To minimize the exposure of the newborn to dequalinium chloride, vaginal tablets should not be used 12 hours before delivery. Otherwise, you should inform your doctor.
You should stop taking Fluomizin during heavy menstrual bleeding and then resume treatment.
You should inform your doctor if symptoms persist at the end of treatment or if symptoms recur after treatment.

Children and adolescents

There is not enough data on the use of Fluomizin in children and adolescents under 18 years of age.

Women over 55 years of age and elderly

There is not enough data on the use of Fluomizin in women over 55 years of age.

Fluomizin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those obtained without a prescription.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
Based on previous experience and the fact that Fluomizin acts locally, it is not expected to have a harmful effect on pregnancy, fetus, or newborn. Fluomizin should be used during pregnancy and breastfeeding only if medically indicated.
Before using any medicine, consult your doctor or pharmacist.

Driving and using machines

It is unlikely that Fluomizin will affect your ability to drive or use machines. No studies have been conducted in this regard.

3. How to use Fluomizin

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is 1 vaginal tablet per day for 6 days.

Instructions for use

• Use every evening before going to bed.
• Wash your hands before removing the tablet from the blister.
• Lie down with your legs slightly bent. Insert one tablet of the medicine deep into the vagina.
• During menstruation, during heavy bleeding, stop using the medicine and resume after it has stopped.
• Do not stop using the medicine too early, even if symptoms have disappeared (e.g., itching, discharge, odor). Treatment for less than 6 days may cause symptoms to recur.
• Fluomizin contains excipients that do not dissolve completely, so sometimes residues of the tablet may remain on your underwear. This does not affect the effectiveness of Fluomizin. The tablets do not cause discoloration of underwear, but for your convenience, you can use sanitary pads or tampons.
• In rare cases of significant vaginal dryness, it is possible that the tablet will not dissolve and will be expelled from the vagina intact. As a result, the treatment is not optimal. To avoid this, it is recommended to moisten the tablet with a drop of water before inserting it into a very dry vagina.

If you think that Fluomizin is too strong or too weak, tell your doctor or pharmacist.

Using more than the recommended dose of Fluomizin

Using a higher daily dose or extending the recommended treatment time may increase the risk of vaginal ulcers.
If you accidentally use too many vaginal tablets, tell your doctor.

Missing a dose of Fluomizin

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

Stopping the use of Fluomizin

Treatment for less than 6 days may cause symptoms to recur. Therefore, do not stop using the medicine too early, even if you no longer experience symptoms (e.g., itching, discharge, odor).
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Fluomizin can cause side effects, although not everybody gets them.
Most of them are mild and temporary.
Sometimes symptoms of vaginitis (such as itching, burning, and discharge) may worsen at the beginning of treatment before improvement. Continue treatment, but if symptoms do not improve, consult your doctor as soon as possible.

Common (may affect up to 1 in 10 people)

Discharge; itching of the vagina or a burning sensation in the vaginal area.
Vaginal yeast infection.

Uncommon (may affect up to 1 in 100 people)

Vaginal bleeding; vaginal pain.
Vaginitis and vulvitis.
Bacterial vaginitis,
Fungal skin infection,
Headache.
Nausea.

Frequency not known (frequency cannot be estimated from the available data)

Ulcers of the vaginal mucosa, if the vaginal mucosa was already damaged before treatment.
Genital bleeding.
Vaginal redness, vaginal dryness.
Urinary tract infection.
Allergic reactions with symptoms such as rash, swelling, and itching.
Fever.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected].
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Fluomizin

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the month.
The batch number is stated on the carton and blister.
This medicine does not require any special storage precautions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help 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 of dequalinium chloride.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, and magnesium stearate.

What Fluomizin looks like and contents of the pack

Fluomizin vaginal tablets are white or almost white, oval, and biconvex, with dimensions of approximately length: 19 mm, width: 12 mm, and thickness: 6.3 mm.
The carton contains a blister pack with 6 vaginal tablets.

Marketing authorization holder

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland

Manufacturer

Haupt Pharma Amareg GmbH
Donaustaufer Strasse 378
93055 Regensburg
Germany
To obtain more detailed information about the medicine and its names in other EU member states, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
[email protected]
fax: +48 (22) 755 96 24

Date of last revision of the leaflet: