VAGISAN

VAGISAN ProbioFlora Lactic Acid Bacteria Vaginal Capsules.

Important notes (mandatory information)

Vagisan ProbioFlora Lactic Acid Bacteria 108 CFU/108 CFU hard capsules for vaginal use. Areas of application: For normalising the disturbed vaginal flora after antibiotic treatment of bacterial vaginosis (bacterial vaginal infection) and/or for maintaining the normal vaginal flora in the case of recurrent vaginal infections.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR USERS

Vagisan ProbioFlora Lactic Acid Bacteria 108 CFU/108 CFU hard capsules for vaginal use
Active ingredients: Lactobacillus gasseri, strain DSM 14869/ Lactobacillus rhamnosus, strain DSM 14870

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse, talk to your doctor.

What this package leaflet contains

1. WHAT IS VAGISAN PROBIOFLORA LACTIC ACID BACTERIA AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE USING VAGISAN PROBIOFLORA LACTIC ACID BACTERIA?
3. HOW IS VAGISAN PROBIOFLORA LACTIC ACID BACTERIA USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD VAGISAN PROBIOFLORA LACTIC ACID BACTERIA BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS VAGISAN PROBIOFLORA LACTIC ACID BACTERIA AND WHAT IS IT USED FOR?

Vagisan ProbioFlora Lactic Acid Bacteria is a natural medicine for use in the vagina. The bacterial strains Lactobacillus gasseri and Lactobacillus rhamnosus contained in Vagisan ProbioFlora Lactic Acid Bacteria hard capsules for vaginal use are part of a healthy vaginal environment.

Vagisan ProbioFlora Lactic Acid Bacteria is used:

• To normalise the disturbed vaginal flora after antibiotic treatment of bacterial vaginosis (bacterial vaginal infection).
• To maintain the normal vaginal flora in the case of recurrent vaginal infections.

In bacterial vaginosis (bacterial vaginal infection), the normal bacterial balance of the vagina is out of balance: certain types of bacteria are present in increased numbers and as a result the vaginal pH value is increased. This can typically lead to the following symptoms: increased and unpleasant fishy-smelling discharge, itching and burning. Bacterial vaginosis (bacterial vaginal infection) is usually treated with antibiotics and Vagisan ProbioFlora Lactic Acid Bacteria can be used as a follow-up treatment. Vagisan ProbioFlora Lactic Acid Bacteria adds live lactic acid bacteria to the vagina, which are part of the natural vaginal flora. These bacteria multiply naturally in the vagina and support the protective mechanisms against vaginal infections. The bacteria produce lactic acid and thus help to restore the natural pH value in the vagina. By adhering to the vaginal mucosa, the bacteria limit the growth opportunities for unwanted bacteria. Lactobacillus gasseri produces hydrogen peroxide in addition to lactic acid and thus also has a positive effect on the vaginal flora. These properties of the lactic acid bacteria are important for restoring and maintaining a natural vaginal flora.

2. WHAT SHOULD YOU BE AWARE OF BEFORE USING VAGISAN PROBIOFLORA LACTIC ACID BACTERIA?

Vagisan ProbioFlora Lactic Acid Bacteria must not be used if you are allergic to lactobacilli (lactic acid bacteria, such as Lactobacillus gasseri or Lactobacillus rhamnosus) or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist if during the use of Vagisan ProbioFlora Lactic Acid Bacteria:

• symptoms reappear or worsen.
• bloody discharge occurs.

You should also see your doctor if symptoms recur. Vagisan ProbioFlora Lactic Acid Bacteria should not be used together with condoms or other local contraceptive methods (e.g. diaphragm), as a reduction in effectiveness cannot be ruled out. Vagisan ProbioFlora Lactic Acid Bacteria should not be used during menstruation.

Use of Vagisan ProbioFlora Lactic Acid Bacteria together with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. No interactions with other medicines are known to date.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Vagisan ProbioFlora Lactic Acid Bacteria can be used during pregnancy and breast-feeding.

Driving and using machines

Vagisan ProbioFlora Lactic Acid Bacteria has no or negligible influence on the ability to drive and use machines.

3. HOW IS VAGISAN PROBIOFLORA LACTIC ACID BACTERIA USED?

Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. It is possible that your doctor will recommend that you use Vagisan ProbioFlora Lactic Acid Bacteria in a different dosage than described in the package leaflet.

The recommended dose for adults and adolescents aged 12 years and over and in puberty is:

• After antibiotic treatment for bacterial vaginosis (bacterial vaginal infection): insert 1 vaginal capsule deep into the vagina every evening before going to bed for 6 to 8 days.
• To maintain the normal vaginal flora in the case of recurrent vaginal infections: insert 1 vaginal capsule deep into the vagina every evening before going to bed for 4 to 6 days immediately after menstruation.

Use in children

The use of Vagisan ProbioFlora Lactic Acid Bacteria is not recommended in children under 12 years of age.

Method of administration

For vaginal use. Hands must be washed thoroughly before inserting the capsule into the vagina. The capsule must be placed as deep as possible in the vagina with a finger.

If you have used more Vagisan ProbioFlora Lactic Acid Bacteria than you should

Consult your doctor or pharmacist if you feel unwell.

If you forget to use Vagisan ProbioFlora Lactic Acid Bacteria

Do not use double the amount to make up for a forgotten application. Continue treatment with 1 vaginal capsule before going to bed.

If you stop using Vagisan ProbioFlora Lactic Acid Bacteria

See your doctor if symptoms worsen after stopping use of Vagisan ProbioFlora Lactic Acid Bacteria.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Local skin reactions such as burning, itching, redness in the genital area may occur during use. In this case, you should stop using Vagisan ProbioFlora Lactic Acid Bacteria. Slight vaginal discharge may also occur, which is harmless as an individual complaint and is due to the discharge of the capsule components.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD VAGISAN PROBIOFLORA LACTIC ACID BACTERIA BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the aluminium multi-dose container after "Use by". The expiry date refers to the last day of the month indicated. Do not store above 25°C. Shelf life after opening: 3 months. Do not use this medicine if the packaging is damaged.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Vagisan ProbioFlora Lactic Acid Bacteria contains

The active ingredients are: Lactobacillus gasseri, strain DSM 14869 and Lactobacillus rhamnosus, strain DSM 14870. 1 hard capsule contains 400 mg powder with at least 108 CFU (colony-forming units) Lactobacillus gasseri, strain DSM 14869 (freeze-dried, live) and at least 108 CFU Lactobacillus rhamnosus, strain DSM 14870 (freeze-dried, live). The other ingredients are: Capsule contents: Lactitol, maize starch, xanthan gum, glucose, magnesium stearate (Ph. Eur.) [vegetable] Capsule shell: Gelatin, titanium dioxide (E171).

What Vagisan ProbioFlora Lactic Acid Bacteria looks like and contents of the pack

Hard capsules for vaginal use. The size 0 white capsules contain a white powder. Multi-dose container made of aluminium with a white snap-on lid (moisture-absorbing material (silica gel) inside the snap-on lid), in a cardboard box. Pack sizes: Pack of 8 hard capsules for vaginal use.

Pharmaceutical entrepreneur

Dr. August Wolff GmbH & Co. KG Arzneimittel
Sudbrackstraße 56
33611 Bielefeld
Germany
Telephone: +49 521 8808-05
Telefax: +49 521 8808-334
E-mail: aw-info@drwolffgroup.com

Manufacturer

Deerland Probiotics & Enzymes A/S
Bogbinderivej 6
3390 Hundested
Denmark

This package leaflet was last revised in March 2022.

Source: Information from the package leaflet
Status: 02/2023
Areas of application: For normalising the disturbed vaginal flora after antibiotic treatment of bacterial vaginosis (bacterial vaginal infection) and/or for maintaining the normal vaginal flora in the case of recurrent vaginal infections.