Ecofemin (Capsules) Instructions for Use

Marketing Authorization Holder

Darscare, A/S (Denmark)

Manufactured By

Deerland Probiotics & Enzymes, A/S (Denmark)

ATC Code

G01AX14 (Lactobacilli)

Active Substance

Lactobacillus acidophilus (Grouping name)

Dosage Form

Ecofemin

Vaginal capsules 108 CFU: 6 or 12 pcs.

Dosage Form, Packaging, and Composition

Vaginal capsules are hard gelatin, size No. 0, transparent; the capsule contents are a white or white with a grayish tint powder with beige inclusions.

Excipients: magnesium stearate – 2.25 mg, lactose monohydrate – 449 mg.

Capsule shell composition: gelatin – 100 mg.

6 pcs. – aluminum containers (1) with a plug containing a desiccant – cardboard packs.
12 pcs. – aluminum containers (1) with a plug containing a desiccant – cardboard packs.

Clinical-Pharmacological Group

Drug regulating the balance of vaginal microflora

Pharmacotherapeutic Group

Eubiotic

Pharmacological Action

Eubiotic. Live cells of Lactobacillus acidophilus have high antagonistic activity against pathogenic and opportunistic microorganisms, including staphylococci, shigella, enteropathogenic Escherichia coli, Proteus, which determines the corrective action of the drug in cases of bacteriosis of the oral cavity, intestines, and vagina.

They have high antagonistic activity against pathogenic and opportunistic microbes, including Staphylococcus spp, Escherichia coli, Proteus spp, which determines the corrective action in cases of vaginal microbiocenosis disorders. It is not recommended to use for candidiasis, as in some cases, shifting the vaginal pH to the acidic side promotes fungal growth.

Indications

Treatment of oral cavity diseases: inflammatory diseases of the oral mucosa (glossitis, aphthous stomatitis, ulcerative necrotizing gingivitis); pathological changes of the oral mucosa accompanying systemic diseases (lichen planus, multiform exudative erythema, Sjögren’s disease); other oral diseases associated with dysbiosis (galvanism, multiple dental caries, periodontitis), preparation for planned maxillofacial surgeries for the prevention of purulent-inflammatory complications.

Treatment of gastrointestinal tract diseases: acute intestinal infections, food toxicoinfections caused by opportunistic microorganisms or of unknown etiology, rotavirus gastroenteritis; prolonged intestinal disorders, especially in young children; protracted and chronic colitis and enterocolitis of infectious and non-infectious etiology, accompanied by microflora disturbance; moderate and mild forms of nonspecific ulcerative colitis in adults; debilitated, frequently ill children and adults with manifestations of dysbiosis, including those accompanied by an immunodeficiency state; complex therapy of atopic dermatitis in children with intestinal dysbiosis.

Treatment of patients with vaginal dysbiosis and nonspecific inflammatory processes of the vagina: colpitis (except for cases of gonococcal, trichomonal, and candidal etiology); vaginal dysbiosis accompanying inflammatory processes of the cervix, body, and uterine appendages – after completing a course of antibacterial therapy; preparation for planned gynecological surgeries for the prevention of postoperative infectious complications; prenatal preparation of pregnant women at risk for developing purulent-septic complications.

ICD codes

Dosage Regimen

Administer orally or intravaginally as directed by a physician.

For oral administration, swallow capsules whole with a sufficient amount of water.

For intravaginal administration, insert one capsule deeply into the vagina at bedtime.

For treatment of vaginal dysbiosis, use one capsule intravaginally once daily for 6 to 12 days.

For preparation for gynecological surgery, use one capsule intravaginally daily for 5 to 7 days prior to the procedure.

For prenatal preparation in pregnant women, use one capsule intravaginally daily for 1 to 2 weeks as determined by a physician.

For treatment of oral cavity diseases, administer one capsule orally two to three times daily for 3 to 4 weeks.

For treatment of gastrointestinal diseases, administer one capsule orally three times daily for 3 to 4 weeks or until symptoms resolve.

In children and adolescents under 18 years, use only age-appropriate dosage forms.

Complete the full prescribed course of treatment even if symptoms improve earlier.

Do not use for vulvovaginal candidiasis.

Adverse Reactions

Possible allergic reactions.

Contraindications

Hypersensitivity to this product, vulvovaginal candidiasis.

Use in Pregnancy and Lactation

Can be used if indicated.

Pediatric Use

In children and adolescents under 18 years of age, this product should be used in the dosage forms intended for the corresponding age group.

Special Precautions

The use of suppositories can be combined with the simultaneous administration of antibacterial, antiviral, and immunomodulatory drugs.

Drug Interactions

This product can be used simultaneously with antibacterial, antiviral, and immunomodulatory therapy.

Corrective therapy with this product can be prescribed after a course of treatment with specific bacteriophages intended for the elimination of opportunistic bacteria.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.