Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Fluomizin 10 mg vaginal tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Dequalinium chloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
FOR
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. 2.
What you need to know before you take it
E FLUOMIZIN
Do not use Fluomizin: 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 on your vagina or cervix. if you have not yet had your first period. Warnings and precautions 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.
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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. 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. Other medicines and Fluomizin Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding If you are pregnant, think you may be pregnant or plan to have a baby ask your doctor or pharmacist for advice before using Fluomizin. Tell your doctor or pharmacist if you are breast-feeding or if you plan to breast-feed. Based on previous experience and since Fluomizin acts locally, no harmful effects on pregnancy and/or the unborn and breast fed infant are expected. Fluomizin should only be used during pregnancy and during breast-feeding if medically needed. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Fluomizin is not likely to affect your ability to drive or operate any machinery. No studies have been performed. 3.
How to take it
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.
2/5
Fluomizin 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 intact tablet. As 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 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 forget to use Fluomizin Do not use a double dose to make up for a forgotten tablet. If you stop using Fluomizin 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. If you have any further questions on the use of this medicine, ask your doctor or your pharmacist. 4.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of the
Possible side effects
are mild and short lived. 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 (may affect up to 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) and 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.
3/5
Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card 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 to store it
FLUOMIZIN
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 the blister. 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 or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures 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 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 white or almost white, oval and biconvex with approximate dimension of length: 19 mm, width: 12 mm, and thickness: 6.3 mm. The vaginal tablets are available in packs containing a blister of 6 tablets. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Gedeon Richter Plc. Gyömrői út 19-21. Budapest H-1103 Hungary Manufacturer: Haupt Pharma Amareg GmbH Donaustaufer Strasse 378 93055 Regensburg Germany This medicinal product is authorised in the Member States of the EEA under the following names: Member StateMedicinal Product Name Germany Fluomizin 10 mg Vaginaltabletten The Czech Republic Naxyl 10 mg vaginálni tablety Belgium Fluomizin 10 mg tabletten voor vaginaal gebruik Fluomizin 10 mg comprimés vaginaux Fluomizin 10 mg Vaginaltabletten Italy Fluomizin 10 mg compresse vaginali Luxemburg Fluomizin 10 mg comprimés vaginaux 4/5
Austria Poland Portugal Slovakia Spain Finland Hungary The Netherlands Norway Sweden The United Kingdom Estonia France Croatia Lithuania Latvia Slovenia
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Fluomizin 10 mg Vaginaltabletten Fluomizin 10 mg tabletki dopochwowe Fluomizin 10 mg comprimidos vaginais Fluomizin 10 mg vaginálne tablety Fluomizin 10 mg comprimidos vaginales Donaxyl 10 mg emötinpuikko, tabletti Fluomizin 10 mg hüvelytabletta Fluomizin 10 mg tabletten voor vaginaal gebruik Donaxyl 10 mg vaginaltabletter Donaxyl 10 mg vaginaltabletter Fluomizin 10 mg vaginal tablets Donaxyl 10 mg vaginaalne tablett Vablys 10 mg comprimés vaginaux Fluomizin 10 mg tablete za rodnicu Donaxyl 10 mg makšties tabletės Donaxyl 10 mg vaginālās tabletes Fluomizin 10 mg vaginalne tablete
This leaflet was last revised in November 2022
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Frequently asked questions about Fluomizin 10 mg vaginal tablets
How do I take Fluomizin 10 mg vaginal tablets?
Fluomizin 10 mg vaginal tablets comes as tablet containing 10mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Fluomizin 10 mg vaginal tablets?
The active substance in Fluomizin 10 mg vaginal tablets is dequalinium chloride.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Fluomizin 10 mg vaginal tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Fluomizin 10 mg vaginal tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: dequalinium chloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Fluomizin 10 mg vaginal tablets are indicated for the treatment of Bacterial vaginosis (see section 4.4)
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
4.2. Posology and method of administration
Posology
One vaginal tablet daily for six days.
The vaginal tablets should be inserted deeply into the vagina in the evenings before retiring. This is best performed in a reclining position with the legs slightly bent.
The treatment should be interrupted during menstruation and resumed afterwards.
Although relief of discharge and inflammation generally occurs within 24 to 72 hours, the treatment should be continued even when there is no subjective discomfort (itching, discharge, smell) anymore. A treatment less than six days could result in a relapse.
Fluomizin contains excipients which do not dissolve completely, such that remains of the tablet are occasionally found in the underwear. This is of no importance for the efficacy of Fluomizin.
In rare cases of a very dry vagina, it is possible that the vaginal tablet does not dissolve and is discharged by the vagina as intact tablet. As consequence, the treatment is not optimal. For prevention, the vaginal tablet can be moistened with a drop of water before insertion into a very dry vagina.
Patients should use a sanitary towel or panty liner. There is no change in colour of the underwear.
Women more than 55 years and elderly
There is a lack of data on the efficacy and safety of dequalinium chloride in women above 55 years of age.
Paediatric population
There is a lack of data on the efficacy and safety of dequalinium chloride in children below 18.
Method of administration
For vaginal use
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Ulceration of the vaginal epithelium and the vaginal portion of the cervix.
Young girls who have not yet had their first menstruation, and thus did not reach sexual maturity must not use Fluomizin.
4.4. Special warnings and precautions for use
To minimise exposure of the newborn to dequalinium chloride, vaginal tablets should not be used within 12 hours before birth.
There are no efficacy and safety data available on the re-treatment of patients who did not respond to or relapsed immediately after initial therapy with Fluomizin. Patients should be advised to consult their physician if the symptoms persist at the end of the treatment or in case of recurrence.
Using a higher daily dose or increasing the recommended treatment duration might increase the risk of vaginal ulcerations.
No efficacy and safety data on the treatment of bacterial vaginosis in women aged less than 18 years or more than 55 years are available.
4.5. Interaction with other medicinal products and other forms of interaction
Anionic substances such as soaps, detergents and surfactants can reduce the antimicrobial activity of dequalinium chloride. Thus, concomitant intravaginal use of soaps, spermicides or vaginal douches (vaginal washes) is not recommended.
Fluomizin 10 mg vaginal tablets do not impair the functionality of latex condoms. There are no data on the interaction with non-latex condoms and other intravaginal devices such as diaphragms. Thus, concomitant use of non-latex condoms and other intravaginal devices is not recommended for at least 12 hours following the treatment.
4.6. Fertility, pregnancy and lactation
Pregnancy
Limited data from four clinical studies in 181 pregnant patients did not suggest adverse effects on the pregnancy or on the foetus / neonate.
No reproductive toxicity studies have been conducted in animals because of the expected low systemic exposure to dequalinium chloride after vaginal administration.
Fluomizin should only be used in pregnancy if clearly necessary.
Breast-feeding
Systemic exposure of the breast-feeding women to Fluomizin is negligible. Therefore, no harmful effects on the breastfed newborn/infant are anticipated.
Fluomizin can be used during lactation if clinically needed.
To minimise exposure of the newborn to dequalinium chloride, vaginal tablets should not be used within 12 hours before birth.
Fertility
No studies on effects on fertility have been conducted in animals.
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8. Undesirable effects
In clinical trials, the following undesirable effects possibly or probably related to dequalinum chloride have been reported.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
System Organ Class
Common
(≥1/100 to <1/10)
Uncommon
(≥1/1,000 to <1/100)
Not known (cannot be estimated from the available data)
Infections and infestations
• vaginal candidiasis
• bacterial vaginitis,
• fungal skin infection,
• vulvitis,
• vulvovaginitis
• cystitis
Nervous system disorder
• headache
Gastrointestinal disorders
• nausea
Reproductive system and breast disorders
• vaginal discharge,
• vulvovaginal pruritus,
• vulvovaginal burning sensation
• vaginal haemorrhage,
• vaginal pain
• ulceration and maceration of vaginal epithelium,
• uterine bleeding,
• redness,
• vaginal dryness
General disorders and administration site conditions
• allergic reactions with symptoms like urticarial, erythema, exanthema, swelling, rash or pruritus
• fever
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.
4.9. Overdose
No case of overdose has been reported. However, use of a higher daily dose might result in vaginal ulcerations. In case of overdose with adverse events, a vaginal lavage can be performed.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- FLUOMIZIN 10 mg prescriptionDEQUALINIUM · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- FluomizinDequalini chloridum · rectal / vaginal
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Fluomizin 10 mg vaginal tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.