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Microsoft word - spc-806_xp_en_ch2012-02.doc

English translation of the Product Information Hypersensitivity to estriol or any of the other constituents of Gynoflor; endometriosis (manifest or suspected); manifest, previous or Gynoflor® Vaginal Tablets
suspected hormone-dependent tumour of the breast, uterus or vagina; severely inflamed, suppurated, infiltrated vaginitis; bleeding of Composition
unknown origin. Gynoflor should not be used in girls who have not reached sexual maturity. Lactobacillus acidophilus cryodesiccatus Warnings and Precautions
Gynoflor contains only a small amount of estriol, and of this, only very little is absorbed. In addition, as this preparation is used for only Galenical forms and amount of active
a short period of time, there is minimal risk in substance per unit
the case of serious liver, heart and kidney 1 vaginal tablet contains at least 10 million function disturbances, epilepsy or migraine viable Lactobacillus acidophilus in lyophilised hypertonia, Diabetes mellitus, porphyria and hyperlipidemia. There is also minimal risk for patients with serious itching, rash or worsening otosclerosis during early pregnancy, and for Indications / Possibilities for use
those with thrombophlebitis or thromboembolic disorders in the anamnesis. However, during  Restoration of the physiological vaginal long-term treatment with Gynoflor, regular flora after local or systemic treatment with clinical check-ups should be performed for patients with the above disorders, as for Vaginal infections caused by mixed flora antibacterial or antimycotic treatment is disorder, recurrence of the above symptoms or  Atrophic vaginitis, Fluor during post- occurrence of thrombosis or jaundice, therapy If bleeding takes place, therapy should be discontinued and the reason for the bleeding Dosage / Application
Fluor, vaginal infections, restoration If Gynoflor is taken orally by mistake, no Insert 1 - 2 vaginal tablets deeply into the vagina in the evening before going to sleep. The treatment should take place for at least 6 Interactions
days and generally should take not longer than 12 days. Treatment should be interrupted Lactobacilli bacteria are sensitive to numerous during menstruation and resumed afterwards. anti-infective agents. Thus, simultaneous treatment with anti-infectives (local or Atrophic vaginitis, Fluor during post- systemic) could lead to a reduction in the Insert 1 vaginal tablet deeply into the vagina in the evening before going to sleep, for 12 days. hydantoins, carbamazepine, and rifampicin, The use of Fluomizin is contraindicated in can affect the activity of estrogens if used metabolism. However, interactions of this type are unlikely for Gynoflor due to the low dose and primarily local effect of this estrogen, and to the fact that the enterohepatic circulation is Overdosage
No side effects are to be expected for vaginal overdosage. The number of lactobacilli in the Pregnancy, Lactation
vaginal environment is simply increased, which Data on a limited number of exposed pregnant is in any case the desired effect of the women did not indicate adverse effects on preparation. With respect to estriol, a short- pregnancy or on the health of the foetus or new-born child. Experiences from epidemio- expected. However, due to the low dose of estriol per tablet and the fast elimination, no estriol has an adverse effect on the fetus. Properties / Effects
The physiological estriol-concentrations measured in the blood of women are 100 until The preparation contains components which 1000 times higher than during pregnancy. physiologically provide a healthy vaginal environment with important protection against Due to the facts that Gynoflor contains a very ascending infections. Lactobacillus acidophilus low dose of estriol and that estriol is only (Lactobacillus bacterium) is the indicator minimally absorbed (see “pharmacokinetics”), organism for a healthy vaginal flora. It ferments adverse effects on the fetus or newborn when glycogen from the vaginal epithelium to lactic the preparation is used during pregnancy are acid. The resulting acidic environment (pH 3.8 - 4.5) inhibits the growth of pathogenic organisms and is the optimal medium for the The most frequent causes of a disturbance or The patient should be told to inform her doctor destruction of the physiological vaginal flora, if she becomes pregnant during therapy with recognised by a shift in pH, are estrogen deficiency conditions (e.g. during menopause), local or systemic treatment with anti-infectives, There is not enough data on the application of improper hygienic measures, local infections estriol during lactation to be able to estimate and serious general infections. Through the possible risks for the newborn infant. However, it is known that estriol enters the mother's milk Lactobacilli bacteria contained in Gynoflor, and can reduce the production of milk, for lactic acid and other antibiotically-effective example. However, considering the low dose metabolic products (e.g. hydrogen peroxide) and the minimal absorption of this active are produced. As a result, foreign organisms ingredient after vaginal application, adverse are inhibited in their growth and eventually Effects on ability to drive and use machines
Not applicable.
especially at advanced age, there is a reduction in the number of glycogen-containing cells in the vaginal epithelium. Estriol, the Adverse Effects
General irritations and reactions on the hormone, specifically stimulates the epithelium of the vagina, cervix and vulva, and selectively Temporary mild burning and itching may occur after the first application. Rare cases of epithelium, even at the very low dose of intolerability reactions with redness and itching 0.03 mg contained in Gynoflor. In comparison have been reported. In one such case, an to other estrogens (e.g. estradiol), estriol has a relatively short duration of action, as it is bound to the target tissues for a short time only, has a low affinity to plasma proteins, and is quickly metabolised and eliminated. Application of Gynoflor in cases of atrophic vaginitis demonstrated a considerable restitution of the vaginal epithelium within one week. In this biologically inactive forms (glucuronidisation, manner, a long-term supply of substrate for the lactobacilli is ensured. Since estriol has only a weak endometriotrophic effect in contrast to other estrogens, proliferation of the Preclinical data
endometrium is not to be expected at this dose Preclinical studies with estriol on repeated- dose toxicity, genotoxicity and carcinogenicity provided no clear evidence regarding specific Lactose, included in the vaginal tablets as a risks for humans, even though epidemiological filler, can also be fermented by Lactobacillus studies as well as animal studies with estriol acidophilus to lactic acid. This fermentation demonstrated an increased carcinogenic risk. colonisation in the physiological vaginal flora Relevant preclinical studies considering the begins already after the first application. The low dose of estriol in Gynoflor and the topical common symptoms of fluor, pruritus, burning or dyspareunia improve within the first days of treatment. Gynoflor is not suitable for the systemic or local treatment of estrogen deficiency conditions, e.g. during menopause. Further Information
Incompletely dissolved tablets Gynoflor contains tablet excipients which do Pharmacokinetics
not dissolve completely, such that on occasion, the remains of the tablet can be As soon as the tablet comes into contact with found in the panties. This is of no importance the vaginal fluid, it begins to disintegrate and release the lyophilised bacteria. In vitro experiments have shown that the lactobacilli resume their metabolism within a few hours and bring about a reduction in pH in cases Stability
The absorption of estriol from Gynoflor has During the normal period of treatment of 1 - 2 weeks, the opened package does not have to After a single intravaginal application of Marketing Authorisation Number
Gynoflor, the plasma concentrations of unconjugated and total estriol rose slightly and reached a maximum after 3 hours. The plasma profile of unconjugated (biologically active) Package Sizes
estriol rose from 19.2 pg/mL (basal level) to a maximum of 34.7 pg/mL. After 8 hours, the plasma levels of unconjugated estriol were no longer raised above the basal level. Estriol has a low affinity for plasma albumin, and in Marketing Authorisation Holder
contrast to other estrogens, is only bound by After a 12-day therapy with Gynoflor using a Status of the information:
dose of 1 vaginal tablet daily, the estriol concentrations (unconjugated estriol) measured were not raised above the level at the start of therapy (basal level). Thus, accumulation of estriol is not to be expected. The plasma profiles of estrone and estradiol are not changed due to therapy with estriol, as estriol is their metabolic end-product. Estriol is quickly eliminated in the urine, primarily in


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