Ovestin

• Hormone replacement therapy (HRT) for the treatment of atrophy of the lower urinary tract mucosa associated with estrogen deficiency in postmenopausal women.
• Pre- and postoperative treatment of postmenopausal women with vaginal surgery.
• As an auxiliary tool for diagnosing in doubtful cases of an atrophic picture of a cervical smear (class IIIa according to the Papanicolaou test) in postmenopausal women, if pathological cells are detected that indicate epithelial atrophy.

Ovestin® contains only estrogen, so it can be administered vaginally to women with and without a uterus.

Doses

At the beginning or with continued treatment of the symptoms of estrogen deficiency in postmenopausal women, the minimum effective dose should be used for a short period.

With atrophy of the lower parts of the genitourinary tract, 1 suppository per day during the first weeks (no more than 4 weeks), followed by a gradual dose reduction to a maintenance dose (no more than 1 suppository 2 times a week), depending on the degree of symptom reduction.
For pre- and postoperative treatment of women in the postmenopausal period with vaginal surgery, 1 suppository per day for 2 weeks before surgery; 1 candle 2 times a week for 2 weeks after surgery.
As an auxiliary tool for diagnosis when receiving an atrophic picture of a cervical smear, 1 suppository every other day for a week before taking the next smear.
If you miss the next dose of the drug, you should enter the drug immediately after mentioning, if this did not happen on the day of the next dose. In the latter case, the missed dose should be skipped and treatment should be continued according to the usual schedule of administration. You can not enter 2 doses in one day.

Mode of application

Ovestin® Vaginal Suppositories should be administered into the vagina in the evening before bedtime. The patient should enter the suppository in a prone position as deep as possible in the vagina.

For women who are not undergoing hormone replacement therapy or who are being transferred from the continuous use of a combination drug for HRT, treatment with Ovestin® can be started any day. Women who switch to a cyclical or continuous sequential regimen for hormone replacement therapy should start treatment with Ovestin® the day immediately after the completion of the previous cycle.

Children

The drug is used in children.

• A history of or suspected breast cancer has been established.
• Established or suspected estrogen-dependent malignant tumors (e.g., endometrial cancer).
• Vaginal bleeding of unknown etiology.
• Untreated endometrial hyperplasia.
• Previous or existing venous thromboembolism (VTE) (deep vein thrombosis, pulmonary embolism).
• Identified thromboembolic disorders (e.g., protein C, protein S, or antithrombin deficiency).
• Active or recently transferred arterial thromboembolic disease (e.g., angina, myocardial infarction).
• An active liver disease or a history of liver disease, after which liver function indicators did not return to normal values.
• Hypersensitivity to the active substance or to any of the excipients.
• Porphyria.

Active substance: estriol;

1 suppository contains 0.5 mg estriol

Excipients: solid fat.

5 suppositories per blister; 3 blisters per carton.

Store at 2-25 °C in a dry, dark place. Keep out of the reach of children.

Uniter Industries, Le Malkourle Industrial Area 03800 Anna, France.

No. 2283 of 11/14/2019
Registration Certificate No. UA/2281/02/01