Active ingredients: Bacillus of Doderlein
NORMOGIN 40 MG VAGINAL TABLETS
Indications Why is Normogin used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY:
Local gynecological therapy for the restoration of a normal vaginal flora.
THERAPEUTIC INDICATIONS:
Vaginitis associated with ovarian failure, hypofollicolinic leukorrhea, infantile vaginitis, senile vaginitis, vulvar pruritus, vaginal dystrophy. Adjuvant in the chemotherapy and antibiotic treatment of Trichomonas vaginitis.
Contraindications When Normogin should not be used
Hypersensitivity to the components of the product.
Precautions for use What you need to know before taking Normogin
NORMOGIN does not replace antibiotic or chemotherapy therapy, but represents a useful complement by restoring, especially at the end of the specific treatment, the physiological conditions of the vaginal environment.
The Döderlein bacillus is a habitual non-pathogenic host of the vagina, therefore NORMOGIN can be used during pregnancy or breastfeeding.
Interactions Which drugs or foods can modify the effect of Normogin
Not known.
Warnings It is important to know that:
Keep out of the reach of children.
Dose, Method and Time of Administration How to use Normogin: Posology
1 vaginal tablet, 1 or 2 times a day, to be introduced into the vagina.
Overdose What to do if you have taken too much Normogin
There are no known effects to be attributed to NORMOGIN overdose
Side Effects What are the side effects of Normogin
They were not reported.
The patient is invited to report any undesirable effects not described in the package leaflet to their doctor or pharmacist.
Expiry and Retention
Store between 2 ° C and 8 ° C. For the expiry date, please refer to the information on the package. Warning: do not use the medicine after the expiry date indicated on the package.
Composition and pharmaceutical form
COMPOSITION:
Each vaginal tablet of 1 g contains:
Active principle:
lyophilized culture of selected strain of Döderlein bacillus 40 mg.
Excipients: lactose, magnesium stearate.
PHARMACEUTICAL FORM:
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
NORMOGIN - 40 MG VAGINAL TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vaginal tablet contains:
Active principle:
lyophilized culture of selected strain of Döderlein bacillus 40 mg
(Lactobacillus rhamnosus BMX 54 ≥ 4 X 104 CFU).
Excipients: lactose 946 mg, magnesium stearate 14 mg.
03.0 PHARMACEUTICAL FORM
Vaginal tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Vaginitis associated with ovarian failure, hypofollicolinic leukorrhea, infantile vaginitis, senile vaginitis, vulvar pruritus, vaginal dystrophy. Adjuvant in the chemotherapy and antibiotic treatment of Trichomonas vaginitis.
04.2 Posology and method of administration
1 vaginal tablet, 1 or 2 times a day, to be introduced into the vagina.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
04.4 Special warnings and appropriate precautions for use
NORMOGIN does not replace antibiotic or chemotherapy therapy, but represents a useful complement by restoring, especially at the end of the specific treatment, the physiological conditions of the vaginal environment.
04.5 Interactions with other medicinal products and other forms of interaction
Not known.
04.6 Pregnancy and lactation
The Döderlein bacillus is a habitual non-pathogenic host of the vagina, therefore NORMOGIN can be used during pregnancy or breastfeeding.
04.7 Effects on ability to drive and use machines
Normogin does not affect the ability to drive or use machines.
04.8 Undesirable effects
No undesirable effects related to the use of the product have been reported.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
04.9 Overdose
There are no known effects to be attributed to overdose.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: gynecological anti-infectives and antiseptics.
ATC code: G01AX
The Döderlein bacillus is an integral part of the vaginal ecosystem in healthy women and represents the main natural defense mechanism against the development of pathogenic microorganisms.
This is mainly achieved through the transformation, operated by the Döderlein bacillus, of the glycogen of the epithelial cells into lactic acid, with lowering of the vaginal pH to values between 3.8 and 4.4, which are optimal for the growth of lactobacilli, but unfavorable for growth. of pathogenic microorganisms.
The balance of the vaginal ecosystem can be altered both in certain physiological or pathological situations and for iatrogenic causes.
Antibiotic or sulfonamide therapy for local or general application, although essential for the treatment of specific vaginitis, also causes the destruction of non-pathogenic flora and therefore exposes to the risk of relapse.
NORMOGIN, consisting of freeze-dried bacillus of Döderlein vivo, allows the natural bacterial flora to be reconstituted by applying a concentrated quantity of lactobacilli which, once introduced into the vagina, multiply rapidly, bringing the pH value back to acid.
NORMOGIN therefore offers the possibility of restoring an unfavorable habitat to the implantation and survival of pathogenic germs, reducing the number of strains and the concentration in non-specific forms of leucorrhea and represents a useful complement to chemotherapy therapy in specific vaginitis to restore, at the end of treatment , the physiological conditions of the vaginal environment.
The physiological nature of the therapeutic intervention implemented with NORMOGIN is the basis of the good tolerability of the preparation.
05.2 Pharmacokinetic properties
05.3 Preclinical safety data
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Lactose monohydrate, magnesium stearate.
06.2 Incompatibility
Incompatibilities with other medicines are unknown.
06.3 Period of validity
36 months. The period of validity indicated refers to the product in intact packaging, correctly stored.
06.4 Special precautions for storage
Store between 2 ° C and 8 ° C.
06.5 Nature of the immediate packaging and contents of the package
Silkscreened cardboard box containing glass bottle with rubber stopper and aluminum cap with: 6 vaginal tablets kept under vacuum.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
LABORATORI BALDACCI S.p.A. - Via S. Michele degli Scalzi 73 - 56100 PISA.
08.0 MARKETING AUTHORIZATION NUMBER
NORMOGIN - 6 vaginal tablets - A.I.C. n. 009132010.
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
14/7/1954 / 12/02/2014
10.0 DATE OF REVISION OF THE TEXT
27 October 2015
