Lactovaginal

Leaflet attached to the packaging: information for the patient

Lactovaginal

Vaginal capsules, hard
Sticks of Lactobacillus rhamnosus573
about 10 (of which at least 10 CFU*)
*CFU (English: Colony Forming Unit) - colony-forming unit

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Lactovaginal and what is it used for
• 2. Important information before using Lactovaginal
• 3. How to use Lactovaginal
• 4. Possible side effects
• 5. How to store Lactovaginal
• 6. Contents of the packaging and other information

1. What is Lactovaginal and what is it used for

The active substance of Lactovaginal is live lactic acid bacteria of the Lactobacillus
rhamnosus573 strain.
These bacteria break down compounds present in the vagina into lactic acid, thus maintaining
the appropriate acidity (pH) of the vagina. The acidic environment of the vagina (pH 4.0-4.7) inhibits the growth of pathogenic bacteria.
It has been shown that the use of Lactovaginal after prior treatment of vaginal inflammatory conditions with antibacterial, anti-trichomonas, and antifungal medications
results in a reduction in the number of pathogenic microorganisms, restoration of the natural microbiological balance in the vagina, and normalization of vaginal discharge.
Probiotic preparations containing live Lactobacillusbacteria are recommended for use in cases of
disturbances of the vaginal bacterial flora, which can occur, for example, during the use of antibiotics,
hormonal changes, stress, or in cases of poor hygiene and sexual habits.

Indications for use

Lactovaginal is used in women and girls who have started menstruating, to restore or supplement the normal bacterial flora of the vagina. The medicine is recommended for use:

• prophylactically,
• in inflammatory conditions of the genital organs, after treatment with antibacterial, anti-trichomonas, or antifungal medications,
• in cases of vaginal discharge.

2. Important information before using Lactovaginal

When not to use Lactovaginal

Lactobacillussticks or any of the other ingredients of this medicine (listed in section 6), manifested by, for example, itching or burning after using the medicine.

Warnings and precautions

Before starting to use Lactovaginal, you should discuss it with your doctor or pharmacist.
Particular caution should be exercised if the patient has a severe immune system disorder.

Children and adolescents

In girls who have started menstruating, the medicinal product can be used after a doctor's recommendation.

Lactovaginal and other medicines

Lactovaginal should not be used at the same time as antibacterial, anti-trichomonas, or antifungal medications (except for metronidazole and cotrimoxazole),
as they may kill L. rhamnosus573 sticks or inhibit their growth.
Resistance of Lactobacillus rhamnosus573 sticks to cotrimoxazole and metronidazole has been confirmed,
so Lactovaginal can be used during treatment with these medications.
You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

Lactovaginal can be used during pregnancy and breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.

Driving and using machines

Lactovaginal has no influence or negligible influence on the ability to drive and use machines.

3. How to use Lactovaginal

This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.
The recommended dose is 1 to 2 capsules per day (one in the morning and one at night) for 1 week. If necessary, the treatment can be repeated after consulting a doctor. The capsule should be inserted
deep into the vagina, following the principles of personal hygiene.

Use in children and adolescents

In girls who have started menstruating, the medicine can be used after a doctor's recommendation, in the same doses as for adults.

Using a higher dose of Lactovaginal than recommended

A higher dose of the medicine does not pose any risk to the patient.

Missing a dose of Lactovaginal

If you forget to use Lactovaginal, you should take the next dose at the usual time.
You should not take a double dose to make up for the missed dose.

Stopping the use of Lactovaginal

In case of any further doubts regarding the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The medicine is well tolerated. Very rarely, i.e. less often than in 1 in 10,000 patients, local side effects may occur, such as: itching, burning, increased vaginal discharge.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lactovaginal

Store in a refrigerator (2°C - 8°C). During the shelf life, the medicine can be stored outside the refrigerator, at a temperature up to 25°C, for a limited period, up to 4 weeks.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister. The expiry date refers to the last day of the month stated.

6. Contents of the packaging and other information

What Lactovaginal contains

The active substance of the medicine is live lactic acid bacteria of the Lactobacillusrhamnosus573 strain,
about 10 (of which at least 10 CFU).
The other ingredients are: skimmed milk powder, sucrose, sodium L-glutamine, potato starch, magnesium stearate, mannitol, and the capsule shell ingredient: hypromellose.

What Lactovaginal looks like and what the pack contains

Lactovaginal is in the form of hard, transparent capsules, filled with powder.
Lactovaginal is available in the following pack sizes:

• 1 blister pack of 7 capsules, packaged in a cardboard box,
• 1 blister pack of 10 capsules, packaged in a cardboard box,
• 2 blister packs of 7 capsules, packaged in a cardboard box,
• 4 blister packs of 7 capsules, packaged in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

BIOMED S.A. Biotechnology Institute of Serum and Vaccines
Al. Sosnowa 8, 30-224 Krakow, Poland
tel.: +48 12 37 69 200, e-mail: [email protected]

Date of last revision of the leaflet: