MUVAGYN 10E8 CFU/10E8 CFU HARD VAGINAL CAPSULES

Introduction

Patient Information Leaflet

Muvagyn 108UFC/108UFC hard vaginal capsules

Lactobacillus gasseri(strain DSM 14869), Lactobacillus rhamnosus(strain DSM 14870)

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

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

• 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, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

• You should consult a doctor if your symptoms worsen or do not improve after 7 days.

Contents of the Leaflet

1. What is Muvagyn and what is it used for
2. What you need to know before using Muvagyn
3. How to use Muvagyn
4. Possible side effects

5 Conservation of Muvagyn

1. Package contents and additional information

1. What is Muvagyn and what is it used for

Muvagyn is a medicine for vaginal use.

The bacterial strains Lactobacillus gasseriand Lactobacillus rhamnosuscontained in Muvagyn are part of the natural vaginal microbial flora.

Muvagyn is used:

• For the normalization of the altered vaginal microbial flora (vaginal microbiota) after antibiotic treatment of bacterial vaginosis (vaginal infections caused by bacteria)
• To maintain a normal vaginal microbial flora (vaginal microbiota) in cases of recurrent vaginal infections

In bacterial vaginosis (vaginal infections caused by bacteria), the normal bacterial balance of the vagina is altered: there is a greater presence of certain types of bacteria, and as a result, the vaginal pH value is elevated. Typically, the following symptoms may occur: increased discharge with an unpleasant fishy odor, itching, and burning. Bacterial vaginosis (vaginal bacterial infection) is usually treated with antibiotics, and Muvagyn can be used as follow-up treatment.

Muvagyn provides the vagina with living lactic acid bacteria, which are part of the natural vaginal flora. These bacteria multiply naturally in the vagina and support the mechanisms of protection against vaginal infections. The bacteria produce lactic acid and thus help restore the natural pH value in the vagina. By adhering to the vaginal mucosa, the lactobacilli limit the growth capacity of unwanted bacteria.

In addition to lactic acid, Lactobacillus gasserialso produces hydrogen peroxide and thus has a positive influence on the vaginal flora. These properties of lactic acid bacteria are important for restoring and maintaining a natural vaginal flora.

2. What you need to know before using Muvagyn

Do not use Muvagyn

Lactobacillus gasserior Lactobacillus rhamnosus) or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist during the use of Muvagyn if:

• symptoms recur or worsen within a week
• bloody discharge appears

Consult your doctor if symptoms recur.

You should not use Muvagyn in combination with condoms or other local contraceptives (e.g., diaphragms), as it cannot be ruled out that the functionality may be reduced. During treatment, you should not perform vaginal irrigations with antiseptics.

You should not use Muvagyn during menstruation.

Other medicines and Muvagyn

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine. To date, no interactions with other medicines have been described.

Pregnancy, breastfeeding, and fertility

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.

Muvagyn can be used during pregnancy and breastfeeding.

Driving and using machines

The influence of Muvagyn on the ability to drive and use machines is zero or insignificant.

3. How to use Muvagyn

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.

The recommended dose for adults and adolescents from 12 years is:

• After antibiotic treatment of bacterial vaginosis (vaginal infection caused by bacteria), for follow-up treatment:

Insert 1 vaginal capsule deeply into the vagina at night before bedtime for a period of 6 to 8 days.

• To maintain a normal vaginal microbial flora in cases of recurrent vaginal infections:

Insert 1 capsule deeply into the vagina at night before bedtime for a period of 4 to 6 days.

Menstruating women should start treatment immediately after menstruation.

Consult your doctor or pharmacist during the use of Muvagyn if symptoms recur, worsen, or do not improve within a week.

Use in children and adolescents

Muvagyn is not recommended for use in girls under 12 years.

Method of administration

Vaginal route.

Wash your hands thoroughly before inserting the capsule into the vagina. The capsule should be inserted into the vagina as deeply as possible with the help of a finger.

If you use more Muvagyn than you should

Consult your doctor or pharmacist if you do not feel well.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone: 91 562 04 20, indicating the medicine and the amount used or ingested by mistake.

If you forget to use Muvagyn

Do not use a double dose to make up for forgotten doses. Continue with the treatment of 1 vaginal capsule before bedtime.

If you interrupt treatment with Muvagyn

Contact your doctor if symptoms worsen after interrupting the use of Muvagyn.

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

4. Possible side effects

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

Frequency: unknown (cannot be estimated from the available data):

Local reactions on the skin of the intimate area, such as burning, itching, or erythema, may occur during use. In this case, the use of Muvagyn should be discontinued. A mild vaginal discharge may appear, which is harmless if it occurs in isolation and is due to the secretion of the capsule components.

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Muvagyn

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

Do not use this medicine after the expiration date stated on the carton and on the blister pack after CAD. The expiration date is the last day of the month indicated.

After opening: the capsules should be used within 3 months.

Do not store above 25°C.

Do not use this medicine if you notice that the packaging is damaged.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Muvagyn

The active substances are:

• Lactobacillus gasseri(strain: DSM 14869) and Lactobacillus rhamnosus(strain: DSM 14870).

1 hard capsule with 400 mg of powder contains at least 10^8 CFU (Colony-Forming Units) of Lactobacillus gasseri(strain DSM 14869) (live, lyophilized) and at least 10^8 CFU of Lactobacillus rhamnosus(strain DSM 14870) (live, lyophilized).

The other ingredients are:

• Capsule content: lactitol (E-966), corn starch, xanthan gum, glucose, magnesium stearate.
• Capsule coating: gelatin, titanium dioxide (E-171).

Appearance of the product and package contents

White hard gelatin capsules, size 0, containing white powder.

Aluminum multidose container closed with a white pressure cap (with a desiccant material, silica gel, inside the pressure cap) presented in a cardboard box.

Package sizes: 8 or 10 hard vaginal capsules.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Casen Recordati, S.L.,

Autovía de Logroño, km 13,300

50180 Utebo

Zaragoza

Spain

Manufacturer

ADM Denmark A/S

Bogbinderivej 6

3390 Hundested

Denmark

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Belgium: Intigyne 10^8 CFU /10^8 CFU vaginal capsules

Cyprus: PARADIS 10^8 CFU /10^8 CFU Κολπικ? Καψ?κια, Σκληρ?

Czech Republic: [PRODUCT] 10^8 JTK /10^8 JTK Tvrdé vaginální tobolky

Germany: Eqvag 10^8 KBE/10^8 KBE Hartkapseln zur vaginalen Anwendung

Greece: PARADIS 10^8 CFU /10^8 CFU Κολπικ? Καψ?κια, Σκληρ?

Spain: Muvagyn 10^8 UFC/10^8 UFC hard vaginal capsules

Date of the last revision of this leaflet:

February 2023

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