What is a Patient Information Leaflet và why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

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Below is a text only representation of the Patient Information Leaflet.The original leaflet can be viewed using the liên kết above.


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need khổng lồ read it again.If you have any further questions, ask your doctor or your pharmacistThis medicine has been prescribed for you only. Vày not pass it on to others. It may harm them, even if their signs of illness are the same as yours.If you get any side effects, talk khổng lồ your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4

What is in this leaflet:

1. What Fluomizin is và what it is used for2. What you need lớn know before you use Fluomizin3. How to use Fluomizin4. Possible side effects5. How to store Fluomizin6. Contents of the pack và other information


1. WHAT FLUOMIZIN IS & WHAT IT IS USED FOR

Dequalinium chloride, the active ingredient in Fluomizin, belongs lớn 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.


2. WHAT YOU NEED lớn KNOW BEFORE YOU USE FLUOMIZIN


Do not use Fluomizin:

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

Warnings và precautions

Intravaginal use of soaps, spermicides và 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 hàng hóa 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 lớn minimize exposure of the newborn lớn dequalinium chloride. Please inform your doctor otherwise.

You should stop the treatment during the heavy bleeding period of your menstruation và resume afterwards.

You should talk lớn your doctor if the symptoms persist at the kết thúc of the treatment or in case the symptoms return.


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 và elderly

There is insufficient experience of the use of Fluomizin in women above 55 years.


Other fkhorizont-turnovo.com & Fluomizin

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other fkhorizont-turnovo.com, including fkhorizont-turnovo.com obtained without a prescription.


Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or plan khổng lồ have a baby ask your doctor or pharmacist for advice before using Fluomizin.

Tell your doctor or pharmacist if you are breastfeeding or if you plan to breast-feed.

Based on previous experience và since Fluomizin acts locally, no harmful effects on pregnancy and/or the unborn và breast fed infant are expected. Fluomizin should only be used during pregnancy và during breast-feeding if medically needed.

Ask your doctor or pharmacist for advice before taking any medicine.


Driving và using machines

Fluomizin is not likely to affect your ability to drive or operate any machinery. No studies have been performed.


3. HOW khổng lồ USE FLUOMIZIN

Always use this medicine exactly as your doctor 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

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.Fluomizin contains ingredients which do not dissolve completely, và 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 & 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.

If you have the impression that the effect of Fluomizin is too strong or too weak, talk to lớn your doctor or pharmacist.


If you use more Fluomizin than you should

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.


If you ffkhorizont-turnovo.comet to use Fluomizin

Do not use a double dose to biến hóa for a ffkhorizont-turnovo.comotten tablet.


If you stop using Fluomizin

A treatment of less than 6 days may result in a relapse. Therefore, vì chưng not stop treatment early, even when you have no discomfort (e.g. Itching, discharge, smell) anymore.


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


4. POSSIBLE SIDE EFFECTS

Like all fkhorizont-turnovo.com, this medicine can cause side effects, although not everybody gets them. Most of the side effects are mild & short lived.

Sometimes the symptoms of vaginal infections (such as itching, burning và 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 (may affect up lớn 1 in 10 people)

Vaginal discharge; vaginal itching or vaginal burning;Vaginal yeast infection (thrush).

Uncommon (may affect up to 1 in 100 people)

Vaginal bleeding; vaginal pain;Inflammation of the vagina (vaginitis) & vulva;Bacterial vaginosis;Fungal skin infections;Headache;Nausea.

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

Ulcerations of vaginal mucosa, if the lining of the vagina was already damaged before treatment;Uterine bleeding;Vaginal redness, vaginal dryness;Inflammation of the bladder (cystitis);Allergic reaction with symptoms like rash, swelling or itching;Fever.

Reporting of side effects

If you get any side effects, talk to lớn your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow thẻ Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.


5. HOW lớn STORE FLUOMIZIN

Keep this medicine out of the sight & reach of children.

Do not use this medicine after the expiry date which is stated on the carton và the blister. The expiry date refers lớn the last day of that month.

This medicine does not require any special storage conditions

Do not throw away any fkhorizont-turnovo.com via wastewater or household waste. Ask your pharmacist how to throw away fkhorizont-turnovo.com you no longer use. These measures will help protect the environment.


6. CONTENTS OF THE PACK và 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, cellulose, microcrystalline and magnesium stearate.

What Fluomizin looks like and contents of the pack

Fluomizin vaginal tablets are trắng or almost white, oval và biconvex with approximate dimension of length: 19 mm, width: 12 mm, & thickness: 6.3 mm.

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The vaginal tablets are available in packs containing a blister of 6 tablets.


Marketing Authorisation Holder và Manufacturer

Marketing Authorisation Holder:


Kora HealthcareSwords Business ParkSwordsCo. DublinIreland

Manufacturer:


Haupt Pharma Amareg GmbHDonaustaufer Strasse 37893055 RegensburgGermany

This medicinal product is authorised in the member States of the EEA under the following names: