Protrivagin

Package leaflet: Information for the patient

Protrivagin, 100,000,000 CFU, vaginal capsules, hard
Lactobacillus plantarum P 17630
Please read this leaflet carefully 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, as you may need to read it again.
• 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 after a short period of use, consult your doctor.

Table of contents

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

1. What Protrivagin is and what it is used for

Protrivagin is a medicine intended for vaginal use.
The bacterial strain Lactobacillus plantarum contained in Protrivagin is part of the natural microbiological flora of the vagina.
Protrivagin is used:

• to normalize the disturbed vaginal microbiota following antibiotic treatment for bacterial vaginosis,
• to maintain normal vaginal microbiota in cases of recurrent infections.

If there is no improvement or if the patient feels worse after a short period of use, medical advice should be sought.
Bacterial vaginosis (bacterial infection of the vagina) is characterized by a disruption of the physiological bacterial balance in the vaginal environment. Certain types of bacteria multiply excessively, leading to an increase in vaginal pH. Typical symptoms may include increased vaginal discharge with an unpleasant, fishy odor, itching, and burning. Bacterial vaginosis (bacterial infection of the vagina) is usually treated with antibiotics, and Protrivagin may be used as adjunctive therapy.
Protrivagin delivers live lactic acid bacteria to the vagina, which are part of the natural vaginal flora. These bacteria produce lactic acid, helping to restore the natural pH level in the vagina. In addition, by adhering to the vaginal mucosa, lactic acid bacteria limit the ability of undesirable bacteria to grow.

2. Information before using Protrivagin

When not to use Protrivagin

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

Warnings and precautions
Before starting treatment with Protrivagin, consult a doctor or pharmacist.
Do not use Protrivagin as a substitute for antibiotic or chemotherapeutic treatment of infections; it is intended only as an adjunct. Protrivagin helps restore normal (physiological) conditions in the vaginal environment, especially at the end of specific infection treatment.
Do not use Protrivagin together with condoms or other local contraceptive methods (e.g. diaphragm), as reduced effectiveness of these products cannot be excluded. Vaginal douching with antiseptic preparations should not be performed during treatment with Protrivagin.

Protrivagin and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.
To date, no interactions between Protrivagin and other medicines have been observed.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Protrivagin may be used in pregnant and breastfeeding women. Systemic exposure to Lactobacillus plantarum P 17630 is negligible; therefore, no effects on pregnancy or on the newborn/infant breastfed are expected.

Driving and operating machinery
The use of Protrivagin does not affect the ability to drive or operate machinery.

3. How to use Protrivagin

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose for adult women is:

• After antibiotic treatment of bacterial vaginosis (bacterial infection of the vagina), as additional therapy: Insert 1 capsule deeply into the vagina at night before bedtime for 6 days.
• To maintain normal vaginal microbiota in cases of recurrent infections: Insert 1 vaginal capsule per day, deeply into the vagina at night before bedtime for 6 consecutive days. If necessary, the cycle may be repeated once a month for the following 2 months. Women of menstruating age should start treatment immediately after menstruation.

Children and adolescents
Protrivagin should not be used in children and adolescents under 18 years of age.
Insert the capsule deeply into the vagina while lying on your back, in the evening before bedtime.
Use of more Protrivagin than recommended
There have been no cases of overdose reported so far.
In case of accidental ingestion/swallowing of Protrivagin leading to overdose, contact your doctor immediately or go to the nearest hospital.
If you forget to use Protrivagin
Do not use a double dose to make up for a missed capsule.
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 will experience them.

Frequency:

Common (occurring in more than 1 out of 100 patients):

• Burning sensation in the vulva and vagina

Frequency unknown (frequency cannot be determined from available data):

• Vaginal 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 of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.

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.: +48 22 49 21 301
Fax: +48 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 the medicine.

5. How to store the medicine Protrivagin

Keep this 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 stated month.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Protrivagin contains

• The active substance in Protrivagin is Lactobacillus plantarum P 17630. Each vaginal capsule contains 100,000,000 colony-forming units (CFU) of Lactobacillus plantarum P 17630 bacteria.
• Other ingredients are: maize starch, mannitol, sodium croscarmellose, magnesium stearate, colloidal anhydrous silica. Capsule shell: gelatin, titanium dioxide (E 171).

What Protrivagin looks like and contents of the pack
A cardboard box containing 3 or 6 hard vaginal capsules.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Verco S.A.
Skwer kard. S. Wyszyńskiego 5, lok. 6U
01-015 Warsaw
Tel.: +48 22 811 41 61
e-mail: [email protected]

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

This medicinal product is authorised 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
25.09.2024