Protrivagin

Leaflet attached to the packaging: patient information

Protrivagin, 100,000,000 CFU, vaginal hard capsules

Lactobacillus plantarumP 17630

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

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

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after a short period there is no improvement or you feel worse, contact your doctor.

Table of contents of the leaflet

• 1. What is Protrivagin and what is it used for
• 2. Important information before using Protrivagin
• 3. How to use Protrivagin
• 4. Possible side effects
• 5. How to store Protrivagin
• 6. Package contents and other information

1. What is Protrivagin and what is it used for

Protrivagin is a medicine used vaginally.
The bacterial strain Lactobacillus plantarumcontained in Protrivagin is part of the natural microbiological flora of the vagina.
Protrivagin is used to:

• normalize the disturbed microbiota of the vagina after antibiotic therapy for bacterial vaginosis,
• maintain the normal microbiota of the vagina in case of recurring infections.

If after a short period of using the medicine there is no improvement or you feel worse,
contact your doctor.
In the course of bacterial vaginosis (bacterial infection of the vagina), there is a disturbance of the physiological balance of bacteria in the vaginal environment. Some types of bacteria multiply excessively, leading to an increase in pH in the vagina. Typically, the following symptoms may occur:
increased amount of discharge with an unpleasant, fishy odor, itching, and burning. Bacterial vaginosis (bacterial infection of the vagina) is usually treated with antibiotics, and Protrivagin can be used as a complementary treatment.
Protrivagin delivers live lactic acid bacteria to the vagina, which are part of the natural flora of the vagina. These bacteria produce lactic acid, which helps restore the natural pH in the vagina.
Additionally, by adhering to the vaginal mucosa, the lactic acid bacteria limit the ability of unwanted bacteria to grow.

2. Important information before using Protrivagin

When not to use Protrivagin

• If you are allergic to any of the ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Protrivagin, consult your doctor or pharmacist.
Do not use Protrivagin to replace antibiotic or chemotherapeutic treatments for infections; it is only a supplement. Protrivagin restores the normal (physiological) conditions in the vaginal environment, especially at the end of specific infection treatment.
Do not use Protrivagin with condoms or other local contraceptive methods (e.g., diaphragm), as it cannot be excluded that the effectiveness of these products may be reduced. Do not perform vaginal irrigation with antiseptic preparations during the use of Protrivagin.

Protrivagin and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
No interactions between Protrivagin and other medicines have been reported so far.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Protrivagin can be used by pregnant and breastfeeding women. It is not expected to have any effect on pregnancy or the newborn/infant, as the systemic exposure to Lactobacillus plantarumP 17630 is negligible.

Driving and using machines

Using Protrivagin does not affect the ability to drive or operate machines.

3. How to use Protrivagin

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adult women is:

• After antibiotic therapy for bacterial vaginosis (bacterial infection of the vagina), as additional treatment: Insert 1 capsule deeply into the vagina at bedtime for 6 days.
• To maintain the normal microbiota of the vagina in case of recurring infections: Insert 1 vaginal capsule per day, deeply into the vagina at bedtime for 6 consecutive days. If necessary, the cycle can be repeated once a month for the next 2 months. Menstruating women should start treatment immediately after menstruation.

Children and adolescents
Do not use Protrivagin in children and adolescents under 18 years of age.
Insert the capsule deeply into the vagina, in a supine position, in the evening before bedtime.

Using a higher dose of Protrivagin than recommended

No cases of overdose have been reported so far.
In case of accidental ingestion of Protrivagin, resulting in an overdose, inform your doctor or contact the nearest hospital immediately.

Missing a dose of Protrivagin

Do not take a double dose to make up for a missed capsule.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Protrivagin can cause side effects, although not everybody gets them.
Frequency:
Frequent (occurring in more than 1 in 100 patients):

• Burning sensation of the vulva and vagina

Frequency not known (frequency cannot be estimated from the available data)

• Discharge
• Vaginal irritation
• Vaginal pain
• Vaginal bleeding
• Discomfort in the vulva and vagina
• Itching of the vulva and vagina
• Allergic reactions
• Itching
• Rash
• Nausea
• Abdominal pain

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Aleje Jerozolimskie 181C,
02-222 Warsaw,
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Protrivagin

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after the EXP symbol. The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Protrivagin contains

• The active substance is Lactobacillus plantarumP 17630. Each vaginal capsule contains 100,000,000 colony-forming units (CFU) of Lactobacillus plantarumP 17630.
• The other ingredients are: corn starch, mannitol, sodium croscarmellose, magnesium stearate, colloidal silicon dioxide. Capsule shell: gelatin, titanium dioxide (E 171).

What Protrivagin looks like and contents of the pack

Carton containing 3 or 6 vaginal hard capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder

Verco S.A.
Square of Cardinal Stefan Wyszyński 5, apt. 6U
01-015 Warsaw
Phone: +48 22 811 41 61
e-mail: biuro@verco.com.pl

Manufacturer

S.I.I.T S.r.l. - Via Ariosto 50/60 - Trezzano Sul Naviglio (MI) - Italy

This medicine is authorized in the Member States of the European Economic Area under the following names:

Portugal
Softigyn 100,000,000 UFC Cápsulas moles vaginais | Cápsulas vaginais
Estonia
Lysa 100,000,000 CFU vaginaalpehmekapslid | vaginaalkõvakapslid
Lithuania Cocil 10 KSV minkštosios makšties kapsulės | kietosios makšties kapsulės
Latvia
Carla 100,000,000 KVV mīkstās vaginālās kapsulas | cietās vaginālās kapsulas
Romania
Softigyn min. 100,000,000 UFC Capsule moi vaginale | Capsule vaginale
Poland
Protrivagin 100,000,000 CFU Kapsułki dopochwowe twarde
Greece
Softigyn 100,000,000 CFU κολπικά καψάκια, μαλακά | κολπικά καψάκια, σκληρά
Bulgaria
Softigyn 100,000,000 CFU меки вагинални капсули | твърди вагинални капсули
Cyprus
Softigyn 100,000,000 CFU κολπικά καψάκια, μαλακά | κολπικά καψάκια, σκληρά
Spain
Intibiotics vaginal 100,000,000 UFC cápsulas vaginales blandas | cápsulas vaginales duras
Germany
KadeFlora Milchsäurebakterien Vaginalkapseln 10 KBE Weichkapseln zur vaginalen Anwendung | Hartkapseln zur vaginalen Anwendung
Italy
Softigyn 100,000,000 UFC capsule molli vaginali | capsule rigide vaginali

Date of last revision of the leaflet:

• 25.09.2024