Each tablet also contains the following inactive ingredients: Lactose cellulose (E460a) and magnesium stearate (E470b).
Pharmacology: Fluomizin has an anti-infective and antiseptic effect. After insertion into the vagina, Fluomizin dissolves and releases the active substance dequalinium chloride. Dequalinium chloride belongs to the group of active substance called quaternary ammonium compounds. It has a broad antimicrobial spectrum and is effective against bacteria and fungi (yeasts), which can be the cause of vaginal infections.
Fluomizin is used for the treatment of vaginal infections. It exerts its action locally within the vagina. Marked relief with regard to discharge and inflammation generally occurs within 24-72 hrs.
Usual Dose: One vaginal tablet daily for 6 days.
Always use Fluomizin as prescribed by the physician. Check with the physician or pharmacist if in doubt.
Administration: Insert the vaginal tablet deeply into the vagina in the evening before retiring. This is best performed in a reclining position with the legs slightly bent.
Interrupt the treatment during menstruation and resume afterwards.
If the patient have the impression that the effect of Fluomizin is too strong or too weak, consult the physician or pharmacist.
The discomfort (eg, itching, discharge, smell) may disappear often before the infection is completely cured. Therefore, do not stop treatment early, even when the patient does not experience any discomfort.
Fluomizin contains ingredients 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 is not dissolved and is discharged by the vagina as intact tablet. As a consequence, the treatment is not optimal. However, this is not harmful to the vagina. For prevention, the vaginal tablet can be moistened with a drop of water before insertion into a very dry vagina.
The patient should use a sanitary towel or panty liner. There is no change in colour of the underwear.
Change the underwear and towel daily and launder them at a temperature of at least 80°C.
Do not double the dose to make up for the missed dose.
No case of overdose has been reported.
If the patient have accidentally used >1 tablet/day, seek medical advice.
Hypersensitivity to dequalinium chloride or any of the inactive ingredients of Fluomizin.
Ulceration of the vaginal epithelium or on the neck of the uterus.
Patients who have not reached sexual maturity and did not yet have their 1st menstruation.
Avoid vaginal douche or rinses during treatment with Fluomizin.
Seek medical advice before taking any medicine.
Use in pregnancy: Fluomizin may be used during pregnancy.
Consult the physician for an assessment of the benefits and risks of Fluomizin during the 1st trimester.
No reproduction toxicity studies have been conducted with Fluomizin. However, developmental toxicity studies with quaternary ammonium compounds did not reveal evidence of embryofoetal toxicity. In a clinical study with dequalinium chloride and in a drug utilization study with Fluomizin, no toxic effects on the foetuses were observed after vaginal application.
Data from post-marketing surveillance on a estimated use of Fluomizin in approximately a million pregnant women provide no evidence for adverse effects of dequalinium chloride on pregnancy or on the health of the foetus/newborn child.
Use in lactation: Fluomizin may be used during lactation.
No data regarding the uptake of dequalinium chloride into breast milk are available. Based on the absorption data and the fact that the duration of the treatment is only 6 days, adverse affects on the foetus or newborn are improbable.
Use in pregnancy: Fluomizin may be used during pregnancy.
Consult the physician for an assessment of the benefits and risks of Fluomizin during the 1st trimester.
No reproduction toxicity studies have been conducted with Fluomizin. However, developmental toxicity studies with quaternary ammonium compounds did not reveal evidence of embryofoetal toxicity. In a clinical study with dequalinium chloride and in a drug utilization study with Fluomizin, no toxic effects on the foetuses were observed after vaginal application.
Data from post-marketing surveillance on a estimated use of Fluomizin in approximately a million pregnant women provide no evidence for adverse effects of dequalinium chloride on pregnancy or on the health of the foetus/newborn child.
Use in lactation: Fluomizin may be used during lactation.
No data regarding the uptake of dequalinium chloride into breast milk are available. Based on the absorption data and the fact that the duration of the treatment is only 6 days, adverse affects on the foetus or newborn are improbable.
In rare cases, pruritus, burning or redness can be observed. However, these adverse reactions can also be associated with the symptoms of the vaginal infection. In these cases it is not necessary to stop the treatment.
Bleeding surface defects (erosions) in the vagina were reported in individual cases. In these cases, the vaginal surface (vaginal epithelium) was predamaged eg, in consequence of oestrogen deficiency or distinct inflammation.
Some very rare cases of fever have been reported. In these cases, the treatment should be stopped and inform the physician.
Inform the physician or pharmacist when taking/using or have recently taken/used any other medicines, including medicines obtained without a prescription.
G01AC05 - dequalinium ; Belongs to the class of quinolone derivative antiinfectives. Used in the treatment of gynecological infections.
Fluomizin vag tab 10 mg
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