Active ingredients: Estriol, Lactobacillus acidophilus
DONAFLOR 50 mg + 30 micrograms vaginal tablets
Why is Donaflor used? What is it for?
Donaflor contains the active ingredients lactobacillus acidophilus (which has - towards the vagina - a protective function) and estriol (a sex hormone).
Donaflor is used for:
- vaginal discharge of unknown origin (vaginal discharge) or mild or moderate cases of bacterial infection of the vagina (vaginosis) if the use of antibiotic medicines is not entirely necessary.
- restoration of the vaginal bacterial flora (lactobacillus) after local and / or systemic treatment with antibiotic or chemotherapeutic drugs.
- inflammation of the vaginal mucosa due to the deficiency of the sex hormone estrogen in menopause and postmenopause (atrophic vaginitis), or as a concomitant treatment with systemic hormone replacement therapy.
Donaflor can also be used as a preventative treatment for the reappearance of candida (a fungus) infections.
Contraindications When Donaflor should not be used
Do not use Donaflor
- if you are allergic to estriol or any of the other ingredients of this medicine.
- if you suffer from malignant changes (estrogen-dependent tumors) of the breast, uterus or vagina.
- in case of abnormal presence (ascertained or presumed) of the tissue that lines the inner wall of the uterus in other organs (endometriosis).
- in case of bleeding from the vagina (vaginal haemorrhage) of unknown origin. The product should not be used in young women who have not reached sexual maturity.
Precautions for use What you need to know before taking Donaflor
Talk to your doctor or pharmacist before using Donaflor.
The use, especially if prolonged, of medicines for local use can give rise to allergic manifestations. In this case, stop the treatment and inform your doctor who will prescribe a suitable therapy.
Children
Donaflor should not be used in young women who have not reached sexual maturity.
Interactions Which drugs or foods can modify the effect of Donaflor
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Simultaneous treatment with antibiotic medicines is strongly discouraged as it can lead to a reduction in the activity of Donaflor.
Wait at least 24 hours after the end of antibiotic therapy before using Donaflor.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Like all medications Donaflor should only be used during pregnancy if the therapeutic benefits outweigh the risks. However, special caution should be taken if prescribed during the first trimester of pregnancy. Since estriol is present in a very low dose in Donaflor and is only slightly absorbed, adverse effects on the fetus are unlikely when the medicine is used during pregnancy.
Animal studies have shown adverse effects of estriol on male fetuses. The safety of Donaflor during pregnancy has not been studied in humans, but the product has been used for many years with no apparent negative consequences.
Donaflor can be used during breastfeeding.
Driving and using machines
Donaflor has no effect on the ability to drive or use machines.
Dose, Method and Time of Administration How to use Donaflor: Posology
Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
Vaginal discharge, vaginal infections, vaginal bacterial flora restoration therapy:
the recommended dose is:
- 1-2 vaginal tablets a day for 6-12 days.
Inflammation of the vaginal mucosa (atrophic vaginitis), postmenopausal vaginal discharge:
the recommended dose is:
- 1 vaginal tablet daily for the first week, followed by a maintenance dose of 1 vaginal tablet once or twice a week.
Stop treatment during menstruation and resume treatment soon after.
Use in children and adolescents
Donaflor should not be used in young women who have not reached sexual maturity.
Method of administration
For vaginal use.
Vaginal tablets should be inserted deeply into the vagina in the evening before bedtime. It is best to insert in a lying position with the legs slightly bent. If the vagina is very dry, before being inserted, the vaginal tablets can be moistened with a little water to help disintegrate.
Not completely dissolved tablets:
Donaflor contains components that do not dissolve completely; Tablet residues can rarely be found in underwear. This does not affect the effectiveness of the medicine.
Overdose What to do if you have taken too much Donaflor
In case of accidental use of an overdose of Donaflor, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Donaflor
Like all medicines, this medicine can cause side effects, although not everybody gets them.
- Mild stinging or burning may be felt immediately after the administration of Donaflor.
- In rare cases, allergic reactions such as redness and itching have occurred.
- In one case allergy was found to the lyophilisate of lactobacillus contained in Donaflor.
- If Donaflor is accidentally ingested orally no adverse reactions are expected.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package.
The expiry date refers to the last day of that month.
Store in a refrigerator (2 ° C - 8 ° C) in the original package in order to protect from light and moisture.
Storing Donaflor at room temperature during the treatment period (1-2 weeks) does not affect the efficacy of the product.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other information
What Donaflor contains
- The active ingredients are lactobacillus acidophilus ATCC 4356: 50.0 mg of lyophilisate containing at least 100 million live bacteria and estriol 30 micrograms.
- The other ingredients are lactose, microcrystalline cellulose, magnesium stearate, sodium starch glycolate, dibasic sodium phosphate.
Description of what Donaflor looks like and contents of the pack
Vaginal tablets. Packs of 6 and 12 vaginal tablets.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
DONAFLOR 50 mg + 30 mcg VAGINAL TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vaginal tablet contains:
Active principles:
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Vaginal tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
• Vaginal discharge of unknown origin (vaginal discharge) or cases of mild or moderate bacterial vaginosis, if the use of antibiotic therapy is not entirely necessary.
• Restoration of the vaginal flora (lactobacillus) after local and / or systemic treatment with antibiotic or chemotherapeutic drugs;
• Estrogen deficiency atrophic vaginitis in menopause and postmenopause, or as concomitant treatment with systemic hormone replacement therapy.
A further possible indication is in the prophylactic treatment of relapses of candida infections.
04.2 Posology and method of administration
Vaginal discharge, vaginal infections, flora restoration therapy
1-2 vaginal tablets a day for 6-12 days. The vaginal tablets should be inserted deeply into the vagina in the evening before bedtime. It is best to insert in a lying position with the legs slightly bent.
Treatment should be stopped during menstruation and resumed immediately thereafter.
Atrophic vaginitis, postmenopausal vaginal discharge
In case of atrophic vaginitis a dose of 1 vaginal tablet per day is recommended for the first week, followed by a maintenance dose of 1 vaginal tablet once or twice a week. If the vagina is very dry, before being inserted the vaginal tablets can be moistened with a little water to help disintegrate.
04.3 Contraindications
• Hypersensitivity to estriol or to any of the excipients.
• Malignant changes (estrogen dependent tumors) of the breast, uterus or vagina.
• Endometriosis (known or suspected).
• Vaginal bleeding of unknown origin.
• The product should not be used in young women who have not reached sexual maturity.
04.4 Special warnings and appropriate precautions for use
The use, especially if prolonged, of medicines for topical use can give rise to sensitization phenomena. In this case it is necessary to suspend the treatment and start a suitable therapy.
04.5 Interactions with other medicinal products and other forms of interaction
Concomitant treatment with antibiotics is strongly discouraged as it may lead to a reduction in the activity of Donaflor. Donaflor vaginal tablets can be used at least 24 hours after the end of antibiotic therapy.
04.6 Pregnancy and breastfeeding
Animal studies have shown adverse effects of estriol on male fetuses. In humans the safety of Donaflor during pregnancy has not been studied, but the product has been used for many years with no apparent negative consequences. Like all medications Donaflor should be used during pregnancy if the therapeutic benefits outweigh the risks, however, particular caution should be exercised if prescribed during the first trimester of pregnancy.
Estriol is a specific sex hormone of the human species and is not found in other mammalian species. For this reason the toxicological data obtained from experiments conducted in animals (usually in rodents) are of limited use and cannot be extrapolated to the species. Human.
Since in Donaflor estriol is present in a very low dose and is only slightly absorbed, when the preparation is used during pregnancy the appearance of negative effects on the fetus is unlikely.
Donaflor can be used during breastfeeding.
04.7 Effects on ability to drive and use machines
Donaflor has no effect on the ability to drive or use machines.
04.8 Undesirable effects
Mild stinging or burning may be felt immediately after the administration of Donaflor.
In rare cases, intolerance reactions such as redness and itching have been reported. In one case allergy was found to the lyophilisate of lactobacillus contained in Donaflor. If Donaflor is accidentally ingested orally no adverse reactions are expected.
04.9 Overdose
Overdose with this product is not to be expected.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: combination of sex hormone and lactobacillus acidophilus; ATC code: G03CC06
Lactobacillus acidophilus is the predominant constituent of the bacterial flora of the vagina of the healthy woman. Lactobacillus is a non-pathogenic bacterium that has - towards the vagina - a protective function. It transforms the glycogen stored in the cells of the vaginal epithelium into lactic acid. The resulting acid environment (pH 3.8-4.5) creates unfavorable conditions for the colonization and growth of pathogenic microorganisms and constitutes an optimal means for proliferation of the lactobacillus itself. In addition to lactic acid, lactobacillus produces hydrogen peroxide and bacteriocins which also inhibit the growth of pathogenic microorganisms.
Estriol is an endogenous estrogen hormone which has a specific effect on the vagina. The presence of estriol in Donaflor is used to ensure the proliferation of the vaginal epithelium. The cells of a proliferative vaginal epithelium are capable of storing glycogen, the nutritional substrate of lactobacillus. In the case of hormonal disorders, more commonly observed in old age, the number of cells of the vaginal epithelium containing glycogen decreases. Even at very low doses, estriol restores the epithelium, providing glycogen, nourishment of the lactobacillus.
Alterations or destruction of the physiological vaginal flora can occur mainly as a consequence of local or systemic treatments with antibiotic drugs, serious general illnesses, inappropriate hygiene measures and local infections. In a non-physiological vaginal environment, lactobacillus may be present in small quantities or be completely absent, and its protective function is no longer ensured. The therapeutic principle of Donaflor includes the restoration of the biological balance of the vagina and the vaginal epithelium through the reimplantation of the lactobacillus and the local effect of estriol on the cells of the epithelium.
Lactose, an excipient of vaginal tablets, can also be transformed into lactic acid by the lactobacillus. The reproduction of lactobacillus and the recolonization of the vagina by this bacterium takes place immediately after the first application of the preparation.
Lactobacillus acidophilus and estriol exert their action locally in the vagina.
05.2 Pharmacokinetic properties
As soon as it comes into contact with the vaginal discharge, the vaginal tablet disintegrates and releases the lyophilized lactobacillus. In vitro studies have shown that the lactobacillus resumes its metabolism and causes a reduction in pH within a few hours.
The positive estrogenic effect induced by estriol also begins promptly and the proliferative state of the vaginal epithelium progressively improves over the course of treatment (6-12 days).
The absorption of estriol from Donaflor has been studied in healthy postmenopausal women with atrophic epithelium. After a single intravaginal application of Donaflor there was only a slight increase in the plasma concentration of unconjugated estriol (biologically active form) from baseline; the maximum concentration of estriol was reached after 3 hours. After 8 hours, the plasma concentration of unconjugated estriol was no longer elevated.
After 12 days of Donaflor therapy, at a dose of 1 tablet per day, the peak plasma levels of unconjugated estriol had not risen from baseline.
No accumulation of estriol was observed during the 12 days of treatment.
Plasma concentrations of estrone and estradiol are not affected by estriol therapy as estriol is their final metabolite. Estriol is rapidly eliminated in the urine, especially in biologically inactive forms (glucuronides, sulphates). After treatment with Donaflor the physiological conditions of the vagina can remain unchanged for weeks or months.
The low dosage of estriol (0.03 mg), the use for local application and the limited duration of treatment (usually 6-12 days) avoid a systemic estrogenic effect.
05.3 Preclinical safety data
Two toxicological aspects must be considered when administering drugs by the vaginal route: local tolerance and the possibility of systemic toxicity due to absorption of the components.
Lactobacillus is the predominant microorganism in the vagina of a healthy woman and is considered non-pagoteno. For this reason the introduction of this bacterium into the vagina is not expected to cause any local irritation or damage to the epithelium.
The results of experiments on animals (Wistar rats) have shown that estriol can lead to feminization of male fetuses only at high dosages.
It should be noted that the toxicological data obtained in rodents have a limited value and cannot be extrapolated to the human species, as estriol is a specific hormone in humans and is not found in other mammalian species.
Given the low dose of estriol contained in Donaflor, no acute or chronic toxicity is expected.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Lactose; microcrystalline cellulose; magnesium stearate; sodium starch glycolate; dibasic sodium phosphate.
06.2 Incompatibility
No incompatibility is known.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Store at a temperature between 2 ° C and 8 ° C (in the refrigerator) in the original package to protect the medicine from light and humidity.
Storing Donaflor at room temperature during the treatment period (1-2 weeks) does not affect the activity of the product.
06.5 Nature of the immediate packaging and contents of the package
Donaflor vaginal tablets are packaged in aluminum blisters, which are in turn placed in a cardboard box.
Packs of 6 and 12 vaginal tablets are available.
06.6 Instructions for use and handling
Not completely dissolved tablets: Donaflor contains excipients that do not dissolve completely; Tablet residues may rarely be found in underwear. This does not matter for the effectiveness of the preparation.
07.0 MARKETING AUTHORIZATION HOLDER
Bruno Farmaceutici S.p.a., via delle Ande, 15, 00144 Rome.
Under license from: Medinova Ltd. Eggbuhlstrasse 14, CH-8052 Zurich, Switzerland
08.0 MARKETING AUTHORIZATION NUMBER
Donaflor 6 vaginal tablets - AIC n. 034027019
Donaflor 12 vaginal tablets - AIC n. 034027021
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
March 19, 2001
10.0 DATE OF REVISION OF THE TEXT
February 2012
