Estriol (Ovanelia) vaginal 0.5 mg – [15 suppositories]

Description

Ovanelia Pharmacodynamics
The active ingredient of the drug is estriol – an analogue of the natural female hormone. It replenishes estrogen deficiency in postmenopausal women and relieves postmenopausal symptoms.
Estriol is most effective in the treatment of urogenital disorders. It has a selective effect, mainly on the cervix, vagina, vulva, it helps to restore urogenital tract, vagina and cervix epithelium during its atrophic changes in postmenopause, to restore normal microflora and physiological pH in the vagina. As a result, estriol increases resistance of urinary and genital tract epithelium to infection and inflammation, reduces vaginal mucosal dryness and itching in the vagina, pain during intercourse, the possibility of vaginal infections and infections of the urogenital tract; estriol also helps to normalize urination and prevents urinary incontinence. Unlike other estrogens, estriol interacts with endometrial-sensitive structures for short periods of time, and a single daily dose is not expected to cause endometrial proliferation. Therefore, no additional cyclic progestagen administration is required and no “withdrawal” bleeding occurs.

Indications
– Substitutive hormonal therapy (HRT) for the treatment of lower urinary and genital tract mucosal atrophy associated with estrogen deficiency in postmenopausal women.
– Pre- and postoperative therapy of postmenopausal women during surgical intervention with vaginal access.
– As an auxiliary diagnostic tool in obtaining atrophic cervical smear pattern.

Contraindications
– Hypersensitivity to estriol or any of the excipients of the drug.
– Diagnosed in the history or suspected of breast cancer (BC).
– Diagnosed estrogen-dependent tumors or suspected (including endometrial cancer).
– Bleeding from the vagina of unknown etiology.
– Untreated endometrial hyperplasia.
– Congenital or acquired predisposition to arterial or venous thrombosis (including resistance to activated protein C, deficiency of protein C, protein S, antithrombin III, hyperhomocyteinemia, presence of antibodies to phospholipids).
– Current or history of venous thromboembolism (VTE) (deep vein thrombosis, pulmonary embolism).
– Arterial thrombosis or thromboembolism (ATE), including myocardial infarction, stroke, cerebrovascular disorders; or prodromal states (including transient ischemic attack, angina pectoris).
– Acute liver disease or a history of liver disease after which liver function has not returned to normal.
– Porphyria.
– Pregnancy.
– Breastfeeding period.

Dosage and administration

• Intravaginally, in the evening before going to bed. The suppository should be inserted deep into the vagina.
  – In treatment of atrophy of mucous coat of the bottom urinary and genital tracts, connected with deficiency of oestrogens at women in postmenopause – on 1 suppository (0,5 mg) daily during the first 2-3 weeks (maximum – 4 weeks), then the dose gradually reduces, based on dynamics of symptoms, on 1 suppository – 2 times a week.
  – Pre- and postoperative therapy of women in the postmenopausal period at surgical intervention by vaginal access: 1 suppository (0,5 mg) a day during 2 weeks before surgery; 1 suppository twice a week during 2 weeks after surgery.
  – As an adjunctive diagnostic tool for cervical smear atrophy: 1 suppository (0.5 mg) every other day for a week before the next smear is taken.
• If a suppository is missed, it should be administered as soon as the patient remembers it (two suppositories should not be administered in one day), afterwards the drug is administered according to the usual dosing regimen.
• If after treatment there is no improvement, or if symptoms worsen, or new symptoms appear, it is necessary to consult a doctor.
• The lowest effective dose should be used for the shortest time possible when initiating or continuing treatment for postmenopausal symptoms.
• In women who are not receiving MHT or who are transitioning from continuous oral combination MHT, treatment with estriol can be started on any day.
• Women who are switching from a cyclical regimen of MHT drugs should begin treatment with estriol one week after withdrawal of the MHT drugs.
• Use the drug only according to those indications, that way of application and in those doses which are specified in the instruction.