Package leaflet: Information for the patient

Lactovaginal
Vaginal capsules, hard
Lactobacillus rhamnosus 573
approximately 10 CFU (including not less than 10 CFU*)
*CFU (Colony Forming Unit) – colony forming unit
Please read carefully the entire 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
a doctor or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, contact your doctor.

Table of contents of the leaflet

What Lactovaginal is and what it is used for
Important information before using Lactovaginal
How to use Lactovaginal
Possible side effects
How to store Lactovaginal
Contents of the pack and other information

1. What Lactovaginal is and what it is used for

The active substance in Lactovaginal is live lactic acid bacteria of the strain Lactobacillus rhamnosus 573.
These bacteria metabolize substances present in the vagina into lactic acid, thereby maintaining the appropriate acidity (pH) of the vaginal environment. The acidic pH of the vagina (pH 4.0–4.7) inhibits the growth of pathogenic bacteria. It has been demonstrated that use of Lactovaginal following prior treatment of vaginal infections with antibacterial, antiprotozoal, or antifungal agents reduces the number of pathogenic microorganisms, restores the natural microbiological balance in the vagina, and normalizes vaginal discharge.

Probiotic preparations containing live Lactobacillus bacteria are recommended for use in cases of vaginal bacterial flora imbalance, which may occur, for example, during antibiotic therapy, hormonal changes, stress, or due to poor hygiene or sexual habits.

Indications for use
Lactovaginal is indicated in women and girls who have started menstruating, for the restoration or supplementation of normal vaginal bacterial flora. The medicine is recommended for:

prophylactic use,
inflammatory conditions of the genital tract, following treatment with antibacterial, antiprotozoal, or antifungal agents,
presence of leucorrhoea (vaginal discharge).

2. Important information before using Lactovaginal

When not to use Lactovaginal

if the patient is allergic to Lactobacillus bacteria or any of the other ingredients of this medicine (listed in section 6), which may manifest for example as itching or burning after application of the product.

Warnings and precautions
Before starting to use Lactovaginal, discuss this with your doctor or pharmacist.
Exercise particular caution if the patient has a severe immunodeficiency disorder.

Children and adolescents
In girls who have started menstruation, the medicinal product may be used on medical advice.

Lactovaginal and other medicines
Lactovaginal should not be used simultaneously with antibacterial, antiprotozoal, or antifungal medicines (with the exception of metronidazole and cotrimoxazole), as they may kill L. rhamnosus 573 or inhibit their growth.
Resistance of Lactobacillus rhamnosus 573 to cotrimoxazole and metronidazole has been confirmed; therefore, Lactovaginal can be used during treatment with these medicines.
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines she plans to take.

Pregnancy and breastfeeding and effect on fertility
Lactovaginal may be used during pregnancy and breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
Lactovaginal has no effect or has a negligible effect on the ability to drive or operate machinery.

3. How to use Lactovaginal

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a 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, treatment may be repeated after consulting a doctor. The capsule should be inserted deep into the vagina, observing personal hygiene rules.
Use in children and adolescents
In girls who have started menstruating, this medicine may be used on a doctor's advice, at the same doses as in adults.
Use of a higher than recommended dose of Lactovaginal
A higher dose of the medicine does not pose any risk to the patient.
Missed dose of Lactovaginal
If a dose of Lactovaginal is missed, take the next dose at the usual time.
Do not use a double dose to make up for the missed dose.
Stopping treatment with Lactovaginal
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The medicine is well tolerated. Very rarely, i.e. less frequently than in 1 out of 10,000 patients, local adverse reactions may occur, such as: itching, burning sensation, increased vaginal discharge.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of using this medicine.

5. How to store Lactovaginal

Store in a refrigerator (2°C - 8°C). During its shelf life, the medicine may be stored outside the refrigerator, at temperatures up to 25°C, for a limited period of up to 4 weeks.
Keep the medicine out of the 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 stated month.

6. Package contents and other information

What Lactovaginal contains
The active substance is live lactic acid bacteria strain Lactobacillus rhamnosus 573,
approximately 10 (containing not less than 10 CFU).
The other ingredients are: skimmed milk powder, sucrose, sodium L-glutamate, potato starch,
magnesium stearate, mannitol, and the capsule coating ingredient: hypromellose.

What Lactovaginal looks like and contents of the pack
Lactovaginal is a hard, transparent capsule filled with powder.
Lactovaginal is available in the following pack sizes:

1 blister containing 7 capsules, packed in a cardboard box,
1 blister containing 10 capsules, packed in a cardboard box,
2 blisters containing 7 capsules each, packed in a cardboard box,
4 blisters containing 7 capsules each, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Institute of Biotechnology of Sera and Vaccines BIOMED Joint Stock Company
Al. Sosnowa 8, 30-224 Kraków, Poland
Tel.: +48 12 37 69 200, e-mail: [email protected]