Label: information for the patient

Muvagyn 108UFC/108Vaginal hard capsules

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

Read this label carefully before starting to use this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this label or those indicated by your doctor, pharmacist, or nurse.

• Keep this label, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.

• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

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

1.What is Muvagyn and what it is used for

2.What you need to know before starting to use Muvagyn

3.How to use Muvagyn

4.Possible adverse effects

5Storage of Muvagyn

6.Contents of the package and additional information

Muvagyn is a medication for vaginal use.

The bacterial strainsLactobacillus gasseriandLactobacillus rhamnosuscontained in Muvagyn are part of the natural vaginal microbiota.

Muvagyn is used:

• For normalization of the altered vaginal microbiota (vaginal microbiota) after antibiotic treatment for bacterial vaginosis (bacterial vaginal infections)
• To maintain a normal vaginal microbiota (vaginal microbiota) in cases of recurrent vaginal infections

In bacterial vaginosis (bacterial vaginal infections), the normal bacterial balance of the vagina is altered: there is an increased presence of certain types of bacteria, and as a result, the vaginal pH value is elevated. Common symptoms may include increased discharge with an unpleasant fishy odor, itching, and burning. Bacterial vaginosis (bacterial vaginal infection) is generally treated with antibiotics, and Muvagyn can be used as a continuation treatment.

Muvagyn provides the vagina with live 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 therefore help to restore the natural pH value in the vagina. By adhering to the vaginal mucosa, lactobacilli limit the growth capacity of unwanted bacteria.

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

Do not use Muvagyn

• if you are allergic to lactobacilli (bacteria of lactic acid, such as for exampleLactobacillus gasseriorLactobacillus rhamnosus) or to any of the other components of this medication (listed in section 6).

Warnings and precautions

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

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

Consult with your doctor if symptoms recur.

Do not use Muvagyn in combination with condoms or other local contraceptive methods (e.g. diaphragms) as it cannot be ruled out that functionality may be reduced. During treatment, do not perform vaginal irrigations with antiseptics.

Do not use Muvagyn during menstruation.

Other medications and Muvagyn

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, believe you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Muvagyn may be used during pregnancy and breastfeeding.

Driving and operating machines

The influence of Muvagyn on the ability to drive and operate machines is negligible or insignificant.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

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

• After antibiotic treatment for bacterial vaginosis (bacterial vaginal infection), for post-treatment:

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

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

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

Women who are menstruating 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 old.

Administration form

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 feel unwell.

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

If you forgot to use Muvagyn

Do not use a double dose to compensate for the missed dose. Continue with the treatment of 1 vaginal capsule before going to bed.

If you interrupt the treatment with Muvagyn

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

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directlythrough theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and on the packaging after CAD. The expiration date is the last day of the month indicated.

Once opened: capsules must be used within 3 months.

Do not store at a temperature above 25°C.

Do not use this medication if you observe that the packaging is damaged.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Muvagyn

The active principles are:

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

1 hard capsule with 400 mg of powder contains at least 108UFC (Colony-Forming Units) ofLactobacillus gasseri(strain DSM 14869) (live, lyophilized) and at least 108UFC ofLactobacillus rhamnosus(strain DSM 14870) (live, lyophilized).

The other components are:

• Content of the capsule: lactitol (E-966), cornstarch, xanthan gum, glucose, magnesium stearate.
• Coating of the capsule: gelatin, titanium dioxide (E-171).

Appearance of the product and contents of the package

Hard gelatin capsules of white color, size 0, containing white powder.

Multi-dose aluminum package closed with a white pressure lid (with a humidity-absorbing material (silica gel) inside the pressure lid) presented in a cardboard box.

Package sizes: 8 or 10 vaginal hard capsules.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Casen Recordati, S.L.,

Autovía de Logroño, km 13,300

50180 Utebo

Zaragoza

Spain

Responsible for manufacturing

ADM Denmark A/SBogbinderivej 6

3390 Hundested

Denmark

This medicine is authorized in the member states of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

Bélgica: Intigyne 108UFC/108UFC vaginal gelatin capsules

Chipre: PARADIS 108CFU /108CFU Κολπικ?Καψ?κια, Σκληρ?

República Checa: [PRODUCT] 108JTK /108JTKTvrdé vaginální tobolky

Alemania: Eqvag 108KBE/108KBE Hartkapseln zur vaginalen Anwendung

Grecia: PARADIS 108CFU /108CFU Κολπικ?Καψ?κια, Σκληρ?

España: Muvagyn 108UFC/108UFC vaginal hard capsules

Last review date of this leaflet:

February 2023

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