Intibiotics vaginal 100,000,000 UFC hard vaginal capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Intibiotics vaginal 100000000CFU hard vaginal capsules

Lactobacillus plantarum P 17630

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

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

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

Leaflet contents

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 adverse effects
5. How to store Intibiotics vaginal
6. Contents of the pack and other information

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

Intibiotics vaginal is a medicinal product intended for vaginal use.

The bacterial strain Lactobacillus plantarum contained in Intibiotics vaginal is part of the natural vaginal microbial flora.

Intibiotics vaginal is used:

• To restore the vaginal microbiota after antibiotic treatment for bacterial vaginosis.
• To maintain 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 use of Intibiotics vaginal.

In bacterial vaginosis (bacterial vaginal infection), the normal bacterial balance of the vagina is disrupted. There is an overgrowth of certain types of bacteria, resulting in an elevated vaginal pH. Common symptoms include increased vaginal discharge with an unpleasant fishy odour, itching, and burning. Bacterial vaginosis (bacterial vaginal infection) is usually treated with antibiotics, and Intibiotics vaginal may be used as follow-up treatment.

Intibiotics vaginal 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 value in the vagina.

In addition, by adhering to the vaginal mucosa, the lactobacilli limit the ability of undesirable bacteria to grow.

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 only as an adjunct to such treatments. Intibiotics vaginal restores the normal (physiological) conditions of the vagina, especially at the end of specific infection treatment.

Do not use Intibiotics vaginal together with condoms or other local contraceptive methods (e.g., diaphragm), as a reduction in their effectiveness cannot be ruled out. Do not perform vaginal douching with antiseptic preparations during treatment with Intibiotics vaginal.

Other medicines and Intibiotics vaginal

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

No interactions between Intibiotics vaginal and other medicines are currently known.

Pregnancy and breastfeeding

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

Intibiotics vaginal may be used during pregnancy and breastfeeding, as no effects on pregnancy or the newborn/infant are expected, given that systemic exposure to Lactobacillus plantarum P17630 is negligible.

Driving and using machines

The use of Intibiotics vaginal does not affect the ability to drive or operate machinery.

3. How to use Intibiotics vaginal

Always use this medicine exactly as stated in this 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 (bacterial vaginal infection), for post-treatment: Insert 1 capsule deeply into the vagina at night before going to bed for 6 days.
• To maintain normal vaginal microbiota in case of recurrent vaginal infection: Insert 1 vaginal capsule per day deeply into the vagina at night before going to bed for 6 consecutive days. If necessary, the cycle may be repeated once a month for two additional 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 while lying down (in a supine position), at night before going to bed.

If you use more Intibiotics vaginal than you should

There have been no reported cases of overdose so far.

In case of accidental ingestion/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 the missed capsule.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Frequency:

Common (occurs in more than 1 in every 100 patients):

• Vulvovaginal burning sensation

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

• Vaginal discharge
• Vaginal irritation
• Vaginal pain
• Vaginal bleeding
• Vulvovaginal discomfort
• Vulvovaginal pruritus
• Allergic reaction
• Pruritus
• Skin rash
• Nausea
• Abdominal pain

Reporting of adverse effects

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

You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 expiry date stated on the packaging after «EXP». The expiry date refers to the last day of that month.

Store below 25 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other 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 plantarum P 17630.
• The other components are:

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

Appearance of Intibiotics vaginal and contents of the pack

Carton pack containing 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 medicinal product 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

Updated detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/