The instruction for medical use
of GINOFLOR medicine
the Trade name
Mezhdunarodnoye the unlicensed name
Is not present
the Dosage form
of the Tablet vaginal
One tablet contains
active agents: not less than 1 & middot, 108, WHICH
viable bacteria of Lactobacillus acidophilus,
estriol of 0.03 mg,
excipients: lactoses monohydrate, cellulose microcrystalline, magnesium stearate, starch of sodium glikolit (type A), sodium dihydrophosphate anhydrous.
Oval, spotty, biconvex tablets of slightly beige color.
of Antiseptics and antimicrobial drugs for treatment of gynecologic diseases.
Antiseptic agents and antimicrobial drugs for treatment of gynecologic diseases (excepting combinations with corticosteroids). Other antiseptic agents and antimicrobial drugs. Lactobacilli.
ATX G01AX14 code
Pharmacokinetics As soon as properties vaginal tablets enter interaction with a vaginal secret, the tablet begins to be split and the lyophilized bacteria and estriol are released. Experiments of in vitro showed that in result of metabolism of Lactobacillus acidophilus the size rn decreases within several hours.
The positive estrogenic effects caused by estriol also begin quickly, and throughout a course of treatment (612 days) the condition of a proliferative mature vaginal epithelium gradually improves.
Absorption of estriol from Ginoflor was investigated at healthy women in the postclimacteric period with an atrophied epithelium. After one intravaginalny use of Ginoflor the slight increase of concentration of untied estriol (biologically active form) in plasma compared with basic level was observed, the maximum concentration of estriol were reached in 3 hours. In 8 hours the concentration of untied estriol was at the normal level.
However, after 12-day use of vaginal tablets (once a day) at the end of treatment by Ginoflor the peak level of untied estriol in plasma compared with basic level was not raised.
Throughout 12-day treatment the accumulation of estriol was not observed. Concentration in plasma which were observed after repeated use of Ginoflor were in normal limits of endogenous level of untied estriol in plasma for the postmenopause period.
Therapy by estriol does not affect concentration in plasma of estrone and oestradiol as, mainly, estriol is the final product of their metabolism. Estriol is quickly removed with urine, mainly, in biologically inactive forms (glucuronides, sulfates).
Thanks to a low dose of estriol (0.03 mg), topical administration and limited duration of treatment (6 12 days) of accumulation of estriol does not occur, and system influences of estrogen are improbable.
of Lactobacillus acidophilus are some of the dominating microorganisms in a vagina of the healthy woman. Lactobacillus acidophilus are nonpathogenic bacteria which perform protective function in a vagina. They ferment a glycogen of a vaginal epithelium to lactic acid. Acidic environment (rn 3,8 4,5) which is formed as a result of it, creates unfavorable conditions for colonization and development of pathogenic microorganisms and provides the optimum environment for proliferation of Lactobacillus acidophilus. Except lactic acid, Lactobacillus acidophilus produce peroxide of hydrogen and bacteriocines which also oppress development of pathogenic microorganisms.
Estriol is endogenous estrogenic hormone which selectively influences a vagina and has no impact on endometrium. Estriol in Ginoflor provides proliferation of a vaginal epithelium. A proliferating and mature epithelium are a physiological barrier and contain a glycogen – nutritious substrate for Lactobacillus acidophilus. In hormonal disorders which arise at women of advanced age more often the vaginal epithelium is injured and the quantity of a glycogen decreases. Vaginal infections can lead to disturbances of a vaginal epithelium also.
Exogenous estriol, even in the small dose which is contained in Ginoflor leads to recovery of a proliferating and mature epithelium and, thus, provides optimal conditions for restoration of vaginal flora of Lactobacillus acidophilus.
Disturbance or destruction of physiological vaginal flora, mainly, happens owing to topical or system treatment by anti-infective agents, serious general diseases, the wrong methods of hygiene and vaginal infections. In not physiological vaginal environment the quantity of Lactobacillus acidophilus can decrease or they can even disappear completely, their protective function is not guaranteed any more.
The therapeutic effect of Ginoflor consists in restoration of vaginal microflora by introduction of exogenous Lactobacillus acidophilus and improvement of a condition of a vaginal epithelium by administration of exogenous estriol. Restoration of physiological balance in a vagina and recovery of a vaginal epithelium is result of it.
Lactobacillus acidophilus and estriol work locally, is exclusive in a vagina.
Lactose which contains in vaginal tablets as filler, can be also fermented by Lactobacillus acidophilus in lactic acid. Reproduction of Lactobacillus acidophilus and recolonization of a vagina these bacteria begins after the first use of drug.
– for restoration of microflora of Lactobacillus after topical and/or system treatment by antimicrobic means
– an atrophic vaginitis owing to deficiency of estrogen during a menopause and a postmenopause or as supportive application during system gormonozamestitelny therapy
– vaginal discharges (Fluor vaginalis) or lungs and moderate severity cases of a bacterial vaginosis and candidiasis at which use of anti-infectious therapy is not exclusively necessary.
Route of administration and doses
Recovery treatment, Fluor vaginalis (vaginal discharges), vaginal infections:
1 2 vaginal tablets daily for 6 12 days. Vaginal tablets need to be entered deeply into a vagina before going to bed. It is better to make it lying on spin, having slightly bent legs in knees.
Treatment should be stopped during periods and to renew after its termination.
In case of an atrophic vaginitis the recommended dose makes 1 vaginal tablet daily for 6 – 12 days.
– easy burning or feeling of heat on an introduction fate
– reddening and an itching on the site of introduction
– allergic reactions.
– hypersensitivity to active and auxiliary components of drug
– estrogenzavisimy malignant new growths of mammary glands, a uterus or vaginas
– the endometriosis (suspected or diagnosed)
– vaginal bleedings of unknown origin
– a purulent infiltrirovanny vaginitis with the significant inflammation
– the girls who did not reach puberty.
of Lactobacillus acidophilus are sensitive to numerous anti-infective agents (topical or system administration). The accompanying treatment by such means can lead to reduction of efficiency of Ginoflor.
The substances causing induction of liver enzymes as, for example, barbiturates, hydantoins, carbamazepine and rifampicin at a concomitant use can affect activity of estrogen, accelerating their metabolism.
However interactions of this kind are improbable for Ginoflor because of a low dose and mainly local effect of this estrogen and also that drug does not get to enterohepatic circulation.
The insignificant amount of estriol contains the special instructions Ginoflor owing to what the dose of absorption is small. Besides, as drug is used only during the short span, there is a minimal risk for persons with heavy disturbances of functions of a liver, heart and kidneys, in epilepsy, migraine (also in the anamnesis), a hypertension, diabetes, a porphyria and a lipidemia. There is also minimal risk for patients with a severe itching, rash or at exacerbations of an otosclerosis in the early stages of pregnancy and also for patients with thrombophlebitis or thromboembolic disturbances in the anamnesis. However for safety reasons at prolonged use of Ginoflor such patients have to undergo the regular clinical control provided for drugs with a high dosage of estrogen.
In case of exacerbation of the above-mentioned diseases, or repeated emergence of the above-stated symptoms, as well as in case of developing of thrombosis or jaundice, treatment by Ginoflor should be stopped.
If during use of drug there was bleeding, treatment should be stopped before clarification of the reasons.
Ginoflor contains components which can not be dissolved completely, the tablet remains sometimes it is possible to find on underwear. It does not affect efficiency of drug.
In isolated cases when a vagina very dry, the vaginal tablet can not be dissolved and leave a vagina in primary look. In this case treatment is not optimum, however and does not do harm. For prevention of such cases before introduction to very dry vagina the tablet can be moistened with a small amount of water.
Patients should use hygienic napkins or laying.
At accidental oral administration of Ginoflor no undesirable effects were noted.
Ginoflor’s storage at the room temperature for 1 2 weeks does not reduce its efficiency.
Pregnancy and feeding by a breast
Ginoflor can be applied during pregnancy and a lactation. It is necessary to be careful, appointing Ginoflor to women in the first trimester of pregnancy.
The limited amount of data on an occasion of use of drug during pregnancy do not demonstrate undesirable influences of estriol and Lactobacillus acidophilus on a course of pregnancy and health of the fruit/newborn.
The feature of influence on ability to run the vehicle or potentially dangerous Ginoflor mechanisms does not affect ability to run vehicles and mechanisms.
Overdose by drug was not observed.
A form of release and packing
On 6 tablets in blister strip packaging from a film of PVH/PE/PVDH and aluminum foil.
On 1 or 2 planimetric packs together with the instruction for medical use in the state and Russian languages in a cardboard box.
To Store storage conditions in the fridge at a temperature from 2C to 8C.
To store out of children’s reach!
not to apply a period of storage after an expiration date!
According to the prescription
of Proizvoditel Haupt Pharm Amareg GmbH,
the Owner of the registration certificate
of Medinova AG,
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods):
Representative office of Delta Medikel Promoushnz AG
(Switzerland) 050040, Almaty, Bostandyksky district, Bayzakov St., 280
Ph./fax +7 (727) 332 20 79
To Develop PVG@deltamedical.com.ua