INTIBIOTICS VAGINAL 100,000,000 CFU VAGINAL HARD CAPSULES

Introduction

Patient Information Leaflet

Intibiotics Vaginal 100,000,000 UFC Hard Vaginal Capsules

Lactobacillus plantarum P 17630

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

Follow the administration instructions for the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after a short period of time.

Contents of the Leaflet

1. What Intibiotics Vaginal is and what it is used for
2. What you need to know before using Intibiotics Vaginal
3. How to use Intibiotics Vaginal
4. Possible side effects
5. Storage of Intibiotics Vaginal
6. Package contents and additional information

1. What Intibiotics Vaginal is and what it is used for

Intibiotics Vaginal is a medicine for vaginal use.

The bacterial strain Lactobacillus plantarumcontained in Intibiotics Vaginal is part of the natural vaginal microbial flora.

Intibiotics Vaginal is used:

• For the normalization of altered vaginal microbiota after treatment with antibiotics for bacterial vaginosis.
• To maintain a normal vaginal microbiota in cases of recurrent vaginal infections.

You should consult your doctor if you do not feel better or if you feel worse after a short period of time using Intibiotics Vaginal.

In bacterial vaginosis (vaginal bacterial infection), the normal bacterial balance of the vagina is disrupted. There is a greater presence of certain types of bacteria, and as a result, the vaginal pH value is elevated. The following symptoms usually appear: increased discharge with an unpleasant fishy odor, itching, and burning. Bacterial vaginosis (vaginal bacterial infection) is usually treated with antibiotics, and Intibiotics Vaginal can be used for follow-up treatment.

Intibiotics Vaginal supplies the vagina with live lactic acid bacteria, which are part of the natural vaginal flora. These bacteria produce lactic acid, helping to restore the natural pH value in the vagina.

Additionally, by adhering to the vaginal mucosa, lactobacilli limit the growth capacity of unwanted bacteria.

2. What you need to know before using Intibiotics Vaginal

Do not use Intibiotics Vaginal

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Intibiotics Vaginal.

Do not use Intibiotics Vaginal as a substitute for any antibiotic or chemotherapeutic treatment used to treat infections, but as a complement to them. Intibiotics Vaginal restores normal (physiological) conditions in the vagina, especially at the end of specific infection treatment.

Do not use Intibiotics Vaginal with condoms or other local contraceptives (e.g., diaphragm), as their functionality cannot be ruled out. Do not perform vaginal irrigations with antiseptic preparations during treatment with Intibiotics Vaginal.

Other medicines and Intibiotics Vaginal

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

So far, no interactions between Intibiotics Vaginal and other medicines are known.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Intibiotics Vaginal can be used during pregnancy and breastfeeding because no effects during pregnancy or on the newborn/infant are expected, as the systemic exposure to Lactobacillus plantarumP17630 is insignificant.

Driving and using machines

The use of Intibiotics Vaginal does not affect the ability to drive and use machines.

3. How to use Intibiotics Vaginal

Always use this medicine exactly as indicated in this leaflet or as your doctor or pharmacist has told you. Consult your doctor or pharmacist if you are unsure.

The recommended dose for adult women is:

• After antibiotic treatment for bacterial vaginosis (vaginal bacterial infection), for follow-up treatment: Insert 1 capsule deeply into the vagina at night before bedtime for 6 days.
• To maintain a normal vaginal microbiota in cases of recurrent vaginal infections: Insert 1 vaginal capsule/day deeply into the vagina at night before bedtime for 6 consecutive days. If necessary, the cycle can be repeated once a month for 2 consecutive months.

Menstruating women should start treatment immediately after menstruation.

Use in children and adolescents

Do not use Intibiotics Vaginal in children and adolescents under 18 years of age.

Insert the capsule deeply into the vagina, lying down (in a supine position), at night before bedtime.

If you use more Intibiotics Vaginal than you should

So far, no cases of overdose are known.

In case of accidental ingestion of an overdose of Intibiotics Vaginal, inform your doctor immediately or contact the nearest hospital.

If you forget to use Intibiotics Vaginal

Do not use a double dose to make up for a missed capsule.

If you have any other questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Frequency:

Common (affects more than 1 in 100 patients):

• Vulvovaginal burning sensation

Unknown (frequency cannot be estimated from available data).

• Vaginal discharge
• Vaginal irritation
• Vaginal pain
• Vaginal bleeding
• Vulvovaginal discomfort
• Vulvovaginal itching
• Allergic reaction
• Itching
• Rash
• Nausea
• Abdominal pain

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

You can also report them directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Intibiotics Vaginal

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after "EXP". The expiration date refers to the last day of that month.

Store at a temperature below 25°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Intibiotics Vaginal

• The active ingredient is Lactobacillus plantarumP 17630. Each vaginal capsule contains 100,000,000 colony-forming units (CFU) of Lactobacillus plantarumP 17630.
• The other ingredients are:

Cornstarch, mannitol, sodium croscarmellose, magnesium stearate, hydrated silica. Capsule components: gelatin, titanium dioxide (E171).

Appearance of Intibiotics Vaginal and package contents

Carton package with 3 or 6 hard vaginal capsules.

Marketing authorization holder

SEID, S.A.

Carretera de Sabadell a Granollers, Km. 15

08185 - Lliçà de Vall (Barcelona)

Spain

Manufacturer

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

This medicine has been authorized in the Member States of the European Economic Area under the following names

Date of the last revision of this leaflet:September 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/