Femivag

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FEMIVAG (FEMIVAG)

Composition:

Active substances: strains of live lactic acid bacteria Lactobacillus gasseri (L. gasseri), Lactobacillus rhamnosus (L. rhamnosus);

1 vaginal capsule contains not less than 10⁸ CFU of L. gasseri and not less than 10⁸ CFU of L. rhamnosus;

Excipients: lactitol monohydrate (E 966), maize starch, xanthan gum, anhydrous glucose, magnesium stearate, titanium dioxide (E 171), gelatin.

Pharmaceutical form. Vaginal capsules.

Main physicochemical properties: white gelatin capsules containing a white or almost white powder with a slight characteristic odor and taste.

Pharmacotherapeutic group. Antimicrobial and antiseptic agents used in gynecology. Other antimicrobial and antiseptic agents. Lactobacillus fermentum.

ATC code G01A X14.

Pharmacological properties.

Pharmacodynamics.

Femivag vaginal capsules contain two strains of live lactic acid bacteria that normally predominate in the vaginal microflora of healthy women: L. gasseri and L. rhamnosus.

Although the mechanism of action of vaginal lactic acid bacteria is still under investigation, it has been shown to be multifactorial and associated with the effect of several factors. Due to the enzymatic production of lactic acid by lactic acid bacterial strains that predominate in the vagina of healthy women, low pH values of the surrounding environment are maintained, which inhibits the colonization and growth of pathogenic microorganisms. In addition, due to their adhesive properties and ability to produce hydrogen peroxide and bacteriocins, lactic acid bacteria counteract the invasion of undesirable microorganisms.

Clinical characteristics.

Indications.

• Prevention and treatment of imbalance of vaginal bacterial flora, the symptoms of which include itching, dryness, discharge, irritation, and unpleasant odor;
• treatment of mild to moderate bacterial vaginosis;
• protection and restoration of the natural balance of vaginal microflora after antimicrobial therapy.

Contraindications.

The use of the drug is contraindicated in case of hypersensitivity to the active substances or to any of the other components of the drug.

Interaction with other medicinal products and other forms of interaction.

There is no information regarding interactions with other vaginal preparations.

No specific studies on interactions between Femivag and other medicinal products have been conducted. However, since the lactic acid bacteria contained in the drug are sensitive to the action of local and systemic antimicrobial agents, such combined therapy is not recommended.

Special precautions for use.

If symptoms worsen or do not improve after a seven-day course of treatment, patients should consult a physician. In case of recurrence, medical advice should also be sought.

Use during pregnancy or breastfeeding.

Pregnancy

Femivag can be used during pregnancy (for example, for the treatment of bacterial vaginosis in pregnant women).

Breastfeeding

Femivag can be used during breastfeeding.

Ability to influence reaction speed when driving or operating machinery.

Has no effect.

Dosage and Administration.

Treatment

One vaginal capsule is administered deep into the vagina every evening before bedtime for 6–8 days.

Prophylaxis

Immediately after the end of menstruation: one vaginal capsule is administered deep into the vagina every evening before bedtime for 4–6 days.

After antibiotic therapy: one vaginal capsule is administered deep into the vagina every evening before bedtime for 6–8 days.

Children.

The drug should not be used for the treatment of children under 12 years of age.

Overdose.

Information is not available.

Side effects.

There have been isolated reports of allergic reactions associated with the use of the drug.

Shelf life. 2 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 vaginal capsules in an aluminum tube closed with a plastic cap containing a desiccant.

1 tube per cardboard box.

Availability category. Over-the-counter.

Manufacturer. ADM Denmark A/S.

Manufacturer's address.

Bogbinderivej 6, DK-3390 Hundested, Denmark.