INTIBIOTICS VAGINAL 100,000,000 CFU Vaginal Soft Capsules

Introduction

Package Leaflet: Information for the Patient

Intibiotics Vaginal 100000000000000UFC Soft Vaginal Capsules

Lactobacillus plantarum P 17630

Read this package leaflet carefully before you start using this medicine because it contains important information for you.

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

• Keep this package leaflet, 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 it is a side effect not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after a short period of time.

Contents of the Package Leaflet

1. What is Intibiotics Vaginal and what is it used for
2. What you need to know before you start 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 is Intibiotics Vaginal and what is it 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 antibiotic treatment of bacterial vaginosis.
• To maintain a normal vaginal microbiota in case 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 you start 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 of the vagina, especially at the end of specific infection treatment.

Do not use Intibiotics Vaginal with condoms or other local contraceptive methods (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 might use any other medicine.

No interactions between Intibiotics Vaginal and other medicines are known at this time.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you might 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 are expected during pregnancy or in the newborn/breastfed infant, as 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.

Intibiotics Vaginal Soft Vaginal Capsules contain para-hydroxybenzoates

This medicine contains para-hydroxybenzoates, which may cause allergic reactions (including delayed reactions).

3. How to use Intibiotics Vaginal

Always use this medicine exactly as described in this package leaflet or as directed by your doctor or pharmacist. Consult your doctor or pharmacist if you are unsure.

The recommended dose for adult women is:

• After antibiotic treatment of 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 case of recurrent vaginal infection: 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 more.

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

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 forgotten capsule.

If you have any further questions on 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

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

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

Reporting of Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this package leaflet.

You can also report side effects directly through the Spanish Medicines Monitoring System: 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 package after «EXP». The expiration date refers to the last day of that month.

Store in a refrigerator (+2°C - +8°C).

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

6. Package Contents and Additional Information

Composition of Intibiotics Vaginal

• The active substance is Lactobacillus plantarum P 17630. Each vaginal capsule contains 100,000,000 colony-forming units (CFU) of Lactobacillus plantarumP 17630.
• The other ingredients are: sodium ethyl p-hydroxybenzoate (E-215), sodium propyl p-hydroxybenzoate, medium-chain triglycerides, silica (Aerosil 300), gelatin, glycerol, dimethylpolysiloxane, titanium dioxide (E-171), lactose.

Appearance of Intibiotics Vaginal and Package Contents

Carton package with 3 or 6 soft vaginal capsules.

Marketing Authorization Holder

SEID, S.A.

Carretera de Sabadell a Granollers, Km. 15

08185 - Lliçà de Vall (Barcelona)

Spain

Manufacturer

CATALENT ITALY S.p.A. – Via Nettunense Km 20.100 - Aprilia (LT) - 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 Package 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/