ESTRIFLOR

Estriflor

Ovules, 0.03 mg/10⁸ CFU

Each ovule contains estriol 0.03 mg, Lactobacillus rhamnosus and Lactobacillus reuteri — at least 10⁸ CFU.

Excipients: anhydrous lactose, anhydrous disodium hydrogen phosphate, semi-synthetic solid glycerides.

A combination medicine for vaginal use that helps restore the vaginal flora: for restoration of the vaginal Lactobacillus flora after local or systemic antibiotic treatment; as adjuvant therapy in vaginal atrophy caused by oestrogen deficiency in the pre- and postmenopause, in combination with hormone replacement therapy; for mild to moderate vaginal infections of unspecified aetiology, bacterial and candidal vaginitis, when anti-infective treatment is not strictly necessary.

Estriol in a low dose restores the atrophic vaginal epithelium and relieves symptoms of vulvovaginal atrophy. Lactobacillus rhamnosus and Lactobacillus reuteri are lactic-acid bacteria that re-establish the normal vaginal flora, produce lactic acid and maintain the acidic vaginal pH, preventing the proliferation of pathogenic microorganisms. The two components therefore act complementarily: estriol restores the mucosa, while the lactobacilli restore the normal flora. Systemic absorption of estriol is negligible.

Administer deep into the vagina in the evening before bedtime (preferably lying on the back with knees slightly bent). For vaginal infections or restoration of the vaginal Lactobacillus flora: 1 ovule per day for 6–12 days. For vaginal atrophy: 1 ovule per day for 12 days, then a maintenance dose of 1 ovule 2–3 times a week. Treatment is interrupted during menstruation. With long-term use, the patient should be re-evaluated by the doctor after 12 weeks.

Important to know

Use with caution in severe cardiac, hepatic or renal impairment, epilepsy, migraine (including past history), hypertension, diabetes, hyperlipidaemia, otosclerosis, and in patients with a history of severe pruritus or vesicular eruptions during pregnancy. Stop treatment immediately if abnormal vaginal bleeding occurs and consult your doctor to identify the cause.

When used as hormone replacement therapy for postmenopausal symptoms, the lowest effective dose should be used for the shortest possible time. The benefit-risk balance should be re-evaluated at least once a year. Long-term oestrogen therapy may increase the risk of endometrial, breast and ovarian cancer, thromboembolic events and stroke. Antibiotics taken at the same time (oral or vaginal) may reduce the effectiveness of the Lactobacillus component.

Read the package leaflet carefully before use.

Possible side effects

Local: vaginal irritation, itching or burning sensation.

Rare or with unknown frequency: hypersensitivity reactions, skin rashes, breast tenderness or pain, unexpected vaginal bleeding, pelvic pain, headache. Long-term oestrogen therapy has been associated with an increased risk of thromboembolic events, endometrial, breast and ovarian cancer.

If side effects occur, stop using the product and consult a doctor or pharmacist.

Store in a refrigerator at 2–8 °C, in the original packaging, protected from light and moisture. Keep out of the reach of children. Shelf life: 24 months.

For questions about the medicine, please consult your doctor or pharmacist. Manufacturer: FARMAPRIM SRL, 5 Crinilor str., Porumbeni village, Criuleni district, Republic of Moldova, MD-4829. Pharmacovigilance: safety@farmaprim.md.

Brief information prepared on the basis of the approved Summary of Product Characteristics. It does not replace consultation with a doctor or pharmacist and does not contain all information about the medicine. Always read the package leaflet.