Fluomizin

Fluomizin

dequalinium

Manufacturer:

Medinova

Distributor:

DKSH
Full Prescribing Info
Contents
Dequalinium chloride.
Description
Each tablet also contains the following excipients: Lactose monohydrate, microcrystalline cellulose and magnesium stearate.
Action
Pharmacology: Fluomizin vaginal tablets have 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 quarternary ammonium compounds. It has a broad antimicrobial spectrum and is effective against bacteria, fungi (yeasts) and protozoa (Trichomonas) which can be the cause of vaginal infection.
Fluomizin exerts its action locally within the vagina. Marked relief with regard to discharge and inflammation generally occurs within 24-72 hrs.
Indications/Uses
Treatment of vaginal infections; relief from discharge and inflammation; achievement of asepsis before gynecological operations and deliveries.
Dosage/Direction for Use
Usual Dose: One (1) vaginal tablet daily for 6 days.
Administration: If the effect of Fluomizin is too strong or too weak, inform a physician or pharmacist.
Fluomizin contains excipients which do not dissolve completely, such that remains of the tablet are occasionally found in the panties. 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. However, this is not harmful to the vagina. For prevention, the vaginal tablet can be moistened with a little tap water before insertion into a very dry vagina.
Use a sanitary towel or panty liner. There is no change in colour of the underwear.
Change underwear and flannel daily and launder them at a temperature of at least 80°C.
Missed Dose: Do not take a double dose to make up for the forgotten individual doses. Continue with use of 1 vaginal tablet daily.
Discontinuation of Treatment: A treatment of <6 days may result in a relapse. The discomfort may disappear often before the infection is completely cured. Therefore, do not stop treatment early, even when there is no discomfort (eg, itching, discharge, smell) anymore.
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.
The treatment should be interrupted during menstruation and continued when menses is ceased.
Overdosage
Application of >1 vaginal tablet will not increase the efficacy of Fluomizin. This will rather result in an increase of adverse reactions. However, no severe adverse reactions after an overdosage of Fluomizin have been reported.
In the case of an overdosage, a vaginal lavage should be performed to remove the rest of the tablets.
Contraindications
Hypersensitivity to dequalinium chloride or any of the components of Fluomizin.
Ulceration of the vaginal epithelium or the neck of the uterine; if the patient has not reached sexual maturity and did not have their 1st menstruation yet.
Special Precautions
Use in pregnancy: Based on the present experience with Fluomizin during pregnancy, there is no evidence for adverse reactions of dequalinium chloride on pregnancy or on the health of foetus/newborn child.
Therefore, Fluomizin may be used during pregnancy but only after consultation with a physician.
Use in lactation: Fluomizin may be used during lactation but only after consultation with a physician.
Ask a physician or pharmacist for advice before taking any medicine.
Use In Pregnancy & Lactation
Use in pregnancy: Based on the present experience with Fluomizin during pregnancy, there is no evidence for adverse reactions of dequalinium chloride on pregnancy or on the health of foetus/newborn child. Therefore, Fluomizin may be used during pregnancy but only after consultation with a physician.
Use in lactation: Fluomizin may be used during lactation but only after consultation with a physician. Ask a physician or pharmacist for advice before taking any medicine.
Adverse Reactions
In individual cases where the vaginal surface (vaginal epithelium) was predamaged eg, in consequence of an oestrogen deficit or distinct inflammation, bleeding surface defects (erosions) in the vagina have been reported.
Some very rare cases of fever have been reported.
In these cases, the treatment should be stopped.
Vaginal infections cause complaints eg, itchiness, burning and discharge. These complaints disappear usually during treatment. In rare cases, the local complaints eg, itchiness, burning and reddening can increase at the beginning of the treatment. In these cases, it is not necessary to stop the treatment. However, if the complaints persist, consult a physician for advice as soon as possible.
If any adverse reactions not mentioned occurs, inform physician or pharmacist.
Drug Interactions
Inform a physician or pharmacist if taking or have recently taken any other medicines, even those not prescribed.
Storage
Do not store above 30°C.
ATC Classification
G01AC05 - dequalinium ; Belongs to the class of quinolone derivative antiinfectives. Used in the treatment of gynecological infections.
Presentation/Packing
Vag tab (white, oval, biconvex) 10 mg x 6's.
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