Fluomizin 10 Mg Vaginal Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fluomizin 10 mg vaginal tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vaginal tablet contains 10 mg dequalinium chloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Vaginal tablet
The vaginal tablets are white or almost white, oval and biconvex with approximate dimension of length: 19mm, width: 12mm, and thickness: 6.3mm.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Fluomizin 10mg 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.
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 10mg 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 nonlatex condoms and other intravaginal devices is not recommended.
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) |
Frequency unknown1-* |
|
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 | |
|
Infections and infestations | |||
|
• vaginal candidiasis |
• bacterial vaginitis, • fungal skin infection, • vulvitis, • vulvovaginitis |
• cystitis | |
|
Nervous system disorder | |||
|
• headache | |||
|
Gastrointestinal disorders | |||
|
nausea | |||
|
General disorders and administration site conditions | |||
|
• allergic reactions with symptoms like urticarial, erythema, | |||
|
exanthema, swelling, rash or pruritus • fever, |
1) These undesirable effects have been reported during post-marketing experience
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 at: 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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Gynaecological anti-infective and antiseptic, Quinoline derivatives ATC code: G01A C05
Dequalinium chloride is an anti-infective and antiseptic agent belonging to the class of quaternary ammonium compounds.
Mechanism of Action
Dequalinium chloride is a surface-active substance. The primary mechanism of action is an increase in bacterial cell permeability and the subsequent loss of enzyme activity, finally resulting in cell death.
Dequalinium chloride exhibits a rapid bactericidal activity.
Dequalinium chloride in vaginal tablets exerts its action locally within the vagina.
Pharmacokinetic/pharmacodynamics relationship
No major PK/PD determinant of efficacy has been established for Fluomizin. As the bactericidal effect of dequalinium chloride occurs within 30 to 60 minutes, the maximum local concentration within the first hour after application is considered crucial for the efficacy.
Mechanism(s) of resistance
The mechanisms resulting in the inherent resistance of some pathogens are not known. No mechanisms of acquired resistance have been observed thus far.
Breakpoints
No Breakpoints for dequalinium chloride are available by any recommending body and no relationship between minimal inhibitory concentrations and the clinical efficacy has been established. Thus, the information on susceptibility in the table below is descriptive and is based on the concentrations achievable in the vagina (see section 5.2) and respective MIC data of the pathogens.
The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infection is questionable.
Commonly susceptible species Aerobic Gram-positive bacteria
Enterococcus faecalis Lactobacillus spp.
Staphylococcus aureus
Streptococcus agalactiae (Group B streptococci)
Streptococcus pyogenes (Group A streptococci)
Aerobic Gram-negative bacteria
Enterobacter spp.
Escherichia coli Klebsiella spp.
Pseudomonas spp.
Serratia spp.
Anaerobic bacteria
Atopobium vaginae Bacteroides spp.
Fusobacteria Gardnerella vaginalis Prevotella spp.
Peptostreptococci Poryphyromonas spp
Species for which acquired resistance may be a problem
None known
Inherently resistant organisms Gram-negative bacteria
Proteus sp.
Chlamydia trachomatis
Other micro-organisms
Trichomonas vaginalis
5.2 Pharmacokinetic properties
After dissolution of a Fluomizin vaginal tablet (10mg dequalinium chloride) in an estimated 2.5 to 5ml of vaginal fluid, the dequalinium chloride concentration in the vaginal fluid is 2000 - 4000mg/l.
Preclinical data indicate that dequalinium chloride is absorbed only to a very small amount after vaginal application.
Therefore, systemic exposure to Fluomizin is negligible and not further pharmacokinetic data are available.
5.3 Preclinical safety data
Systemic toxic effects of Fluomizin are unlikely on the basis of the negligible systemic exposure of dequalinium chloride administered intravaginally.
In vivo and in vitro studies with dequalinium chloride did not yield any indication of a potential to cause mutagenicity.
No reproduction toxicity studies have been conducted with dequalinium chloride.
A study in rabbits showed the good vaginal tolerance of Fluomizin.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose monohydrate Cellulose, microcrystalline Magnesium stearate
6.2 Incompatibilities
Fluomizin is incompatible with soaps and other anionic surfactants.
6.3 Shelf life
3 years
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
PVC/PE/PVdC/aluminium blisters Packs of 6 vaginal tablets
6.6 Special precautions for disposal
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.
7 MARKETING AUTHORISATION HOLDER
Kora Corporation Ltd t/a Kora Healthcare Swords Business Park Swords Co. Dublin Ireland
8 MARKETING AUTHORISATION NUMBER(S)
PL 39972/0004
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30/06/2015
10 DATE OF REVISION OF THE TEXT
30/06/2015