Muvagyn 10E8 CFU/10E8 CFU hard vaginal capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Muvagyn 108CFU/108CFU vaginal capsules
Lactobacillus gasseri (strain DSM 14869), Lactobacillus rhamnosus (strain DSM 14870)
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist, or nurse has told you to.
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Keep this leaflet, as you may need to read it again.
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If you need advice or more information, consult your pharmacist.
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If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.
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You should consult a doctor if your condition worsens or if you do not improve after 7 days.
Contents of this leaflet
- What Muvagyn is and what it is used for
- What you need to know before using Muvagyn
- How to use Muvagyn
- Possible side effects
5 Storage of Muvagyn
- Contents of the pack and other information
1. What Muvagyn is and what it is used for
Muvagyn is a medicinal product for vaginal use.
The bacterial strains Lactobacillus gasseri and Lactobacillus rhamnosus contained in Muvagyn are part of the natural vaginal microbial flora.
Muvagyn is used:
- For the normalization of disturbed vaginal microbial flora (vaginal microbiota) following antibiotic treatment of bacterial vaginosis (bacterial vaginal infections)
- To maintain a normal vaginal microbial flora (vaginal microbiota) in cases of recurrent vaginal infections
In bacterial vaginosis (bacterial vaginal infections), the normal bacterial balance of the vagina is disrupted: certain types of bacteria are present in higher amounts, resulting in an elevated vaginal pH value. The following symptoms may typically occur: increased discharge with a fishy unpleasant odour, pruritus, and burning. Bacterial vaginosis (bacterial vaginal infection) is usually treated with antibiotics, and Muvagyn can be used as follow-up treatment.
Muvagyn provides live lactic acid bacteria to the vagina, which are part of the natural vaginal flora. These bacteria multiply naturally in the vagina and support the body's natural defence mechanisms 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 ability of undesirable bacteria to grow.
In addition to lactic acid, Lactobacillus gasseri also produces hydrogen peroxide and thus exerts a positive influence on the vaginal flora. These properties of lactic acid bacteria are important for re-establishing and maintaining a natural vaginal flora.
2. What you need to know before using Muvagyn
Do not use Muvagyn
- if you are allergic to lactobacilli (lactic acid bacteria), such as Lactobacillus gasseri or Lactobacillus rhamnosus, or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist while using Muvagyn if:
- symptoms recur or worsen within one week
- bloody discharge occurs
Consult your doctor if symptoms recur.
You should not use Muvagyn in combination with condoms or other local contraceptive methods (e.g. diaphragms), as a reduction in their effectiveness cannot be ruled out. During treatment, vaginal douching with antiseptics should not be performed.
Do not use Muvagyn during menstruation.
Other medicines and Muvagyn
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. To date, no interactions with other medicines have been reported.
Pregnancy, breastfeeding and fertility
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.
Muvagyn can be used during pregnancy and breastfeeding.
Driving and using machines
The effect of Muvagyn on the ability to drive and use machines is none or negligible.
3. How to use Muvagyn
Follow exactly the instructions for administering this medicine provided in this leaflet or those given by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.
The recommended dose for adults and adolescents aged 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 normal vaginal microbial flora in cases 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.
Menstruating women should start treatment immediately after menstruation.
Consult your doctor or pharmacist during use of Muvagyn if symptoms recur, worsen, or do not improve within one week.
Use in children and adolescents
Muvagyn is not recommended for use in girls under 12 years of age.
Method of administration
For vaginal use.
Wash your hands thoroughly before inserting the capsule into the vagina. The capsule should be inserted into the vagina as deeply as possible using 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone: 91 562 04 20, indicating the medicine and the amount used or accidentally ingested.
If you forget to use Muvagyn
Do not use a double dose to make up for missed doses. Continue with the treatment using 1 vaginal capsule before bedtime.
If you stop using Muvagyn
Contact your doctor if symptoms worsen after stopping treatment with Muvagyn.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Frequency: not known (cannot be estimated from available data):
Local skin reactions in the intimate area such as burning, pruritus, or erythema may possibly occur during use. In such case, Muvagyn should be discontinued. A mild vaginal discharge may appear, which is harmless if it occurs in isolation and is due to the release of the capsule components.
Reporting of 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Muvagyn
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and container after EXP. The expiry date refers to the last day of the month indicated.
After first 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Composition of Muvagyn
The active substances are:
- Lactobacillus gasseri (strain: DSM 14869) and Lactobacillus rhamnosus (strain: DSM 14870).
One hard capsule with 400 mg of powder contains at least 108 CFU (Colony Forming Units) of Lactobacillus gasseri (strain DSM 14869) (live, lyophilized) and at least 108 CFU of Lactobacillus rhamnosus (strain DSM 14870) (live, lyophilized).
The other components are:
- Capsule contents: lactitol (E-966), corn starch, xanthan gum, glucose, magnesium stearate.
- Capsule coating: gelatin, titanium dioxide (E-171).
Appearance of the product and contents of the pack
White, size 0 hard gelatin capsules containing white powder.
Multidose aluminium pack closed with a white press-on cap (containing a moisture-absorbing material (silica gel) inside the cap), presented in a cardboard box.
Pack sizes: 8 or 10 vaginal hard capsules.
Only some pack sizes may be commercially available.
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 medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Belgium: Intigyne 108 CFU /108 CFU vaginal capsules
Cyprus: PARADIS 108 CFU /108 CFU Κολπικά Καψάκια, Σκληρά
Czech Republic: [PRODUCT] 108 JTK /108 JTK Tvrdé vaginální tobolky
Germany: Eqvag 108 KBE/108 KBE Hard capsules for vaginal use
Greece: PARADIS 108 CFU /108 CFU Κολπικά Καψάκια, Σκληρά
Spain: Muvagyn 108 UFC/108 UFC hard vaginal capsules
Date of the most recent review of this leaflet:
February 2023
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).