Instructions for use Femiclin vaginal tablets 10 mg blister No. 6
Composition
active ingredient: dequalinium chloride;
1 vaginal tablet contains 10 mg of dequalinium chloride;
Excipients: lactose monohydrate; microcrystalline cellulose; magnesium stearate.
Dosage form
Vaginal tablets.
Main physicochemical properties: oblong tablets, with a biconvex surface, white or almost white in color.
Pharmacotherapeutic group
Antimicrobial and antiseptic agents used in gynecology, except combinations with corticosteroids. Quinoline derivatives. Dequalinium. ATX code G01A C05.
Pharmacological properties
Pharmacodynamics.
Femiclin contains dequalinium chloride, a quaternary ammonium compound with a broad antimicrobial spectrum of activity against various gram-positive and gram-negative bacteria, fungi and protozoa (Trichomonas vaginalis). Dequalinium chloride has been shown to be active in vitro against the following microorganisms of relevance to the vaginal area. This activity is expressed as the minimum inhibitory concentration (MIC).
| MIC (mg/l) | | MIC (mg/l) |
| Gram-positive bacteria | | Gram-negative bacteria | |
| Group B Streptococci | 2–8 | Fusobacteria | 32–64 |
| Staphylococcus aureus | 0.2–10 | Gardnerella vaginalis | 2.0–256 |
| Group A Streptococci | 0.25–20 | E. coli | 1–400 |
| Listeria sp. | 4–32 | Serratia sp. | 3.1–400 |
| Peptostreptococci | 1–32 | Klebsiella sp. | 3.1–400 |
| Group D Streptococci | 0.2–64 | Pseudomonas sp. | 5–400 |
| Mushrooms | | Bacteroides sp./Prevotella sp. | 64–512 |
| Candida tropicalis | 0.2–50 | Proteus sp. | 20 – > 1024 |
| Candida albicans | 0.2–200 | The simplest single-celled organisms |
| Candida glabrata | 0.2–256 | Trichomonas vaginalis | 28.8–400 |
| Candida krusei | 128 | | |
After dissolving a vaginal tablet of Femiclin (10 mg dequalinium chloride) in approximately 2.5–5 ml of vaginal fluid, the concentration of dequalinium chloride in it is 4000–2000 mg/l, which is higher than the MIC90 for all tested pathogenic microorganisms. The development of resistance of microorganisms to dequalinium chloride has not been reported. As with other surfactants, the main mechanism of action of dequalinium chloride is to increase cell permeability and subsequent loss of enzyme activity, which leads to cell death. Dequalinium chloride in vaginal tablets exerts its effect locally in the vagina. A noticeable reduction in discharge and inflammation usually occurs after 24–72 hours.
Pharmacokinetics.
Since vaginal absorption is negligible, there are no data on the pharmacokinetics of dequalinium chloride in humans.
Indication
Vaginal infections of bacterial and fungal origin (e.g. bacterial vaginosis and candidiasis).
Trichomoniasis.
Sanitation before gynecological interventions and childbirth.
Contraindication
Hypersensitivity to the active substance or to any of the excipients.
Ulcers of the vaginal and cervical epithelium.
Childhood.
Interaction with other medicinal products and other types of interactions
Interaction with other drugs is unknown. If it is necessary to use any medications simultaneously, you should consult a doctor.
Femiclin is incompatible with soap and other anionic surfactants.
Application features
Femiclin contains excipients that do not dissolve completely. Tablet residues can sometimes be found on underwear. This does not affect the effectiveness of the drug.
Sometimes, in cases where vaginal dryness is observed, there is a possibility that the vaginal tablet does not dissolve and is released from the vagina whole. As a result, such treatment is not effective. To prevent this, before inserting the tablet into a dry vagina, you can moisten the tablet with a small amount of water.
Patients should use sanitary pads or daily pads. The drug does not discolor underwear. Patients should be advised to change underwear daily and wash it at a temperature of at least 80 °C.
Use during pregnancy or breastfeeding
Femiclin can be used during pregnancy or breastfeeding. However, as with all medicines, caution should be exercised when prescribing Femiclin to pregnant women in the first trimester of pregnancy. Data from the use of dequalinium chloride in pregnant women, including data from post-marketing studies, indicate that dequalinium chloride does not have any adverse effects on pregnancy or the health of the fetus/newborn.
There is no data on the penetration of dequalinium chloride into breast milk.
Given the low vaginal absorption of dequalinium chloride and the fact that treatment lasts only 6 days, adverse effects on the fetus or newborn are unlikely.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
It is recommended to use 1 vaginal tablet daily for 6 days. The vaginal tablet should be inserted deep into the vagina in the evening before going to bed. It is best to do this while lying on your back with your legs slightly bent.
Treatment should be stopped during menstruation and continued after menstruation has stopped.
It is necessary to continue treatment even if there is no longer any discomfort (itching, discharge, odor). Treatment lasting less than 6 days may lead to relapse. The course of treatment is 6 days.
Children
Since data on the safety and efficacy of dequalinium chloride in children (under 18 years of age) are limited, it is not recommended to prescribe the drug to patients in this age category.
Overdose
No cases of drug overdose have been reported.
Adverse reactions
General disorders and administration site reactions
In rare cases, itching, burning or redness may occur. However, these adverse reactions may also be associated with symptoms of a vaginal infection.
In individual cases, local irritation reactions, such as bleeding from vaginal erosions, are possible. In these cases, previous damage to the vaginal epithelial surface due to estrogen deficiency or local inflammation has been noted.
Fever has been reported very rarely.
Hypersensitivity reactions are possible.
If any adverse reactions occur, discontinue use of the drug and consult a doctor.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
6 tablets in a blister; 1 blister in a pack.
Vacation category
Without a prescription.
Producer
JSC "KYIV VITAMIN FACTORY".
Location of the manufacturer and address of its place of business.
04073, Ukraine, Kyiv, Kopylivska St., 38.
Website: www.vitamin.com.ua.
