10 mg vaginal tablets 
dequalinium chloride

1. What Donaxyl is and what it is used for

Decvalinium chloride, the active substance in Donaxyl, belongs to the family of anti-infective and antiseptic drugs. Decvalinium chloride is active against the bacteria that cause bacterial vaginosis.

Donaxyl is used to treat bacterial vaginosis. It is inserted into the vagina for treatment at the site of infection.

Dequalinium chloride contained in Donaxyl may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you use Donaxyl

Do not use Donaxyl

  • if you are allergic to decvalinium chloride or any of the other ingredients of this medicine (listed in section 6).
  • if you have ulcers in the vagina or cervix.
  • if you have not yet had your first period.

Warnings and cautions

The use of soap, spermicides, and vaginal wash (vaginal wash) in the vagina is not recommended during treatment with Donaxyl.

As with all vaginal infections, it is recommended that you avoid unprotected intercourse when treated with Donaxyl.

Donaxyl does not reduce the effectiveness of latex condoms.

This product may reduce the effectiveness of condoms or pessaries of materials other than latex, therefore you should use alternative contraceptives for at least 12 hours after treatment.

Do not use Donaxyl within 12 hours before delivery to minimize the risk of newborn exposure to the newborn baby. Tell your doctor if you have used this medicine.

You should discontinue treatment during the period of greatest bleeding in the menstrual cycle and resume it afterward.

You should talk to your doctor if the symptoms persist or if the symptoms return.

Women over 55 and older

There is insufficient experience with the use of Donaxyl in women over 55 years of age.

Children and young people

There is insufficient experience with the use of Donaxyl in children and adolescents under 18 years of age.

Other medicines and Donaxyl

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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 taking Donaxyl.

Tell your doctor or pharmacist if you are breast-feeding or planning to breast-feed.

Based on previous experience and because Donaxyl acts locally, no adverse effects on pregnancy and/or the unborn or breastfed baby are expected. Donaxyl should only be used during pregnancy and lactation if there is a medical need for it.

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

Driving and using machines

Donaxyl is unlikely to affect your ability to drive or use machines. No studies have been performed.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Donaxyl

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is 1 vaginal tablet daily for 6 days.

Instructions for use

  • Use every night before bed.
  • Wash your hands before opening the blister pack.
  • Lie down in a resting position with your legs slightly extended. Insert a vaginal tablet deep into the vagina.
  • You should discontinue treatment during the period of greatest bleeding in the menstrual cycle and resume it afterward.
  • Do not end treatment prematurely even if you no longer experience any discomfort (eg itching, discharge, odor). If the treatment lasts for less than 6 days, these signs of the disease may recur.
  • Donaxyl contains ingredients that do not dissolve completely, and the remnants of the tablet can sometimes end up in the underwear. This does not affect the effectiveness of the treatment. The tablet does not discolor underwear, but for your own comfort, you can use a bandage or panty liner.
  • If the vagina is dry, the vaginal tablet may not dissolve and may come out completely. This means that the treatment is not optimal. In this case, the vaginal tablet can be moistened with a drop of water before being inserted into the vagina.

If you have the impression that Donaxyl is too big or too small, talk to your doctor or pharmacist.

If you use more Donaxyl then you should 

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you take a higher daily dose or use the medicine for longer than recommended, the risk of vaginal ulceration may increase.

If you forget to use Donaxyl

Do not take a double dose to make up for a forgotten tablet.

If you stop using Donaxyl

If the treatment lasts for less than 6 days, the signs of the disease may return. Therefore, do not end the treatment prematurely even if you no longer experience any discomfort (eg itching, discharge, odor).

If you have any further questions on the use of this product, 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.

Occasionally, signs of vaginal infection (such as itching, burning, and discharge) may worsen at the beginning of treatment before they begin to improve. You should continue with the treatment, but if the symptoms persist, you should contact your doctor as soon as possible.

Common side effects (may affect up to 1 in 10 people)

  • Discharge, itching, or burning in the vagina
  • Vaginal fungal infection

Uncommon side effects (may affect up to 1 in 100 people)

  • Vaginal bleeding, pain in the vagina
  • Inflammation of the vagina ( vaginitis ) and external genitalia
  • Bacterial vaginosis
  • Fungal infection of the skin
  • Headache
  • Nausea

Has been reported (occurs in an unknown number of users)

  • Ulceration of the vaginal mucosa, if it was already damaged when initiated
  • Bleeding in the uterus
  • Redness or dryness in the vagina
  • Inflammation of the bladder ( cystitis )
  • Allergic reaction with symptoms such as rash, swelling, and itching
  • Fever

5. How to store Donaxyl

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. The expiration date is the last day of the specified month.

No special storage instructions.

The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Other information

Content declaration

The active substance is dequalinium chloride.

Each vaginal tablet contains 10 mg of dequalinium chloride.

The other ingredients are lactose monohydrate, cellulose, microcrystalline, and magnesium stearate.

What the medicine looks like and the contents of the pack

Donaxyl vaginal tablets are white or almost white, oval, and biconvex with the approximate dimension, length: 19 mm, width: 12 mm, and thickness: 6.3 mm.

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

Manufacturer:

Haupt Pharma Amareg GmbH

Donaustaufer Strasse 378

93055 Regensburg

Germany

This medicinal product is authorized under the European Economic Area under the names:

Name of Member State Name of the medicine
Germany Fluomizine 10 mg Vaginal Tablets
Czech Republic Next 10 mg vaginal needle tablets
Belgium Fluomizine 10 mg tablets for vaginal use
Italy Fluomizine 10 mg vaginal compress
Luxembourg Fluomizine 10 mg compresses vaginally
Austria Fluomizine 10 mg Vaginal Tablets
Poland Fluomizine 10 mg tablets dopochwowe
Slovakia Fluomizine 10 mg vaginal tablets
Spain Fluomizine 10 mg vaginal compresses
Finland Donaxyl 10 mg emätinpuikko, tablets
Hungary Fluomizine
Netherlands Fluomizine
Norway Donaxyl 10 mg vaginal tablets
UK Fluomizine 10 mg vaginal tablets
Estonia Donaxyl 10 mg vaginal tablets
France Fluomizine 10 mg compresses vaginally
Croatia Fluomizine 10 mg tablets for rodents
Lithuania Donaxyl 10 mg tablets tablets
Latvia Donaxyl 10 mg vaginal tablets
Slovenia Fluomizine 10 mg vaginal tablets

Muhammad Nadeem

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