Normogin
Italy
Table of Contents
Package leaflet: Information for the user
NORMOGIN 40 mg vaginal tablets
Döderlein's bacillus
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice any improvement or if your symptoms worsen.
Contents of this leaflet:
- What NORMOGIN is and what it is used for
- What you need to know before using NORMOGIN
- How to use NORMOGIN
- Possible side effects
- How to store NORMOGIN
- Contents of the pack and other information
1. What NORMOGIN is and what it is used for
NORMOGIN contains lyophilized Döderlein's bacillus (Lactobacillus Rhamnosus). This
lactobacillus is normally present in the vagina of a healthy woman and represents the main
natural defense mechanism against the development of disease-causing agents (pathogenic microorganisms). NORMOGIN restores the normal (physiological) conditions of the vaginal
environment and is a useful adjunct at the end of antibiotic or other chemotherapeutic treatments.
NORMOGIN is indicated in the treatment of the following vaginal disorders:
- vaginal infections (vaginitis associated with ovarian insufficiency, infantile vaginitis, senile vaginitis);
- itching (vulvar pruritus);
- increased secretions (hypochloridic leucorrhoea);
- alteration of the vaginal mucosa (vaginal dystrophy);
- as an adjunct to other medicinal products (antibiotics and chemotherapeutics) in infections caused by specific microorganisms (Trichomonas vaginitis).
Consult your doctor if you do not feel better or if you feel worse.
2. What you need to know before using NORMOGIN
Do not use NORMOGIN
if you are allergic to the active substance or to any of the components of this medicinal product (listed in
section 6).
Do not use NORMOGIN as a substitute for antibiotic or chemotherapeutic treatment, but as a complementary therapy,
especially at the end of specific treatment for infection, since this medicinal product
restores the normal (physiological) conditions of the vagina.
Warnings and precautions
Consult your doctor or pharmacist before using NORMOGIN.
Other medicines and NORMOGIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicinal products, including those not requiring a prescription.
No interactions between NORMOGIN and other medicinal products are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding,
please seek advice from your doctor or pharmacist before using this medicinal product.
NORMOGIN may be used during pregnancy and breastfeeding because the Döderlein's bacillus
is a non-pathogenic bacterium normally present in the vagina of a healthy woman.
Driving and operating machinery
The use of NORMOGIN does not impair the ability to drive vehicles or operate machinery.
3. How to use NORMOGIN
Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Insert the tablet into the vagina.
The recommended dose is 1 vaginal tablet, 1 or 2 times a day.
If you use more NORMOGIN than you should
There have been no reports of overdose, therefore the effects associated with overdose are unknown.
If you forget to use NORMOGIN
Do not use a double dose to make up for the forgotten vaginal tablet.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
No side effects have been reported with the use of this medicine.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly through the national reporting system at the website
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store NORMOGIN
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What NORMOGIN contains
- The active substance is lyophilized culture of a selected strain of Döderlein's bacillus. Each vaginal tablet contains 40 mg of lyophilized culture of a selected strain of Döderlein's bacillus ( Lactobacillus rhamnosus ≥ 4 . 10 CFU ).
- The other components are: lactose, magnesium stearate.
Description of the appearance of NORMOGIN and contents of the pack
Box containing 6 vaginal tablets.
Marketing Authorization Holder and Manufacturer
Laboratori Baldacci S.p.A. - Via S. Michele degli Scalzi 73 - 56124 Pisa - Italy