Ovestin Ointment

• Hormone replacement therapy (HRT) for the treatment of lower urinary tract atrophy associated with estrogen deficiency.
• Pre- and postoperative treatment of postmenopausal women with vaginal surgery.
• As an auxiliary tool for diagnosis in case of doubtful atrophic picture of the cervical smear.

The drug Ovestin® contains only estrogen, therefore it can be used both for women with a preserved uterus and for women after removal of the uterus.

Dosage

At the beginning of treatment or with continued treatment of the symptoms of estrogen deficiency in postmenopausal women, the lowest effective dose should be used for the shortest possible time.

With atrophy of the lower urinary tract:

• 1 dose of the drug per day during the first weeks (maximum – up to 4 weeks), followed by a gradual decrease to a maintenance dose (for example, a maximum of 1 dose 2 times a week) depending on the degree of symptom reduction.

For pre- and postoperative treatment of postmenopausal women with vaginal surgery:

• 1 dose of the drug per day for 2 weeks before surgery; 1 dose 2 times a week for 2 weeks after surgery.

As an auxiliary tool for diagnosis when obtaining an atrophic picture of a cervical smear:

• 1 dose 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 not be administered, and treatment should be continued according to the usual schedule of administration.

DO NOT DOSE 2 DOSES ONE DAY.

Mode of application

Ovestin® cream must be inserted into the vagina using a calibrated applicator. Apply in the evening before bedtime.

In 1 dose of the drug (applicator, filled to the ring mark) contains 0.5 g of Ovestin® cream, which corresponds to 0.5 mg of estriol.

Instructions for use by the patient

1. Remove the cap from the tube, turn the cap over and, using a sharp protrusion on it, open the tube.
2. Screw the end of the applicator to the tube. Make sure that the piston is fully inserted into the cylinder.
3. Slowly squeeze the tube to fill the applicator with cream until the piston stops at the red ring, see arrows in the figure below.
4. Unscrew the applicator from the tube and close it with a cap.
5. To enter the cream, you need to lie down and insert the end of the applicator deep into the vagina.
6. Slowly press the piston until the applicator is completely empty.
7. After use, remove the piston from the cylinder, overcoming noticeable resistance, and wash the cylinder and piston in warm soapy water. Do not use detergents. Rinse thoroughly after washing. DO NOT LAY APPLICATOR IN HOT OR BOILING WATER.
8. The applicator should be assembled by fully inserting the piston into the cylinder, overcoming the resistance where it is felt.

After emptying the tube, the applicator should be disposed of.

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 cyclic regimen for HRT should start treatment with Ovestin® 1 week after the cycle ends.

Children

The drug is not used in children.

• Hypersensitivity to the active substance or to any of the excipients of the drug.
• Identified, transferred, or suspected breast cancer.
• 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 recent thromboembolic artery disease (e.g., angina pectoris, myocardial infarction).
• Acute stage liver disease or a history of liver disease, after which liver function indicators did not return to normal values.
• Porphyria.

Active substance: estriol.

1 g of cream contains 1 mg estriol.

Excipients: octyldodecanol, cetyl palmitate, glycerin, cetyl alcohol, stearyl alcohol, polysorbate 60, sorbitan stearate, lactic acid, chlorhexidine, sodium hydroxide, purified water.

15 g of cream in an aluminum tube twisted with a plastic cap. The applicator consists of a styrene acrylonitrile cylinder and a polyethylene piston. On 1 tube complete with an applicator in a cardboard bundle.

Store at a temperature not exceeding 25 °C out of the reach of children. Do not freeze.

Aspen Bad-Oldesloh GmbH, Industrialstrasse 32 - 36, 23843 Bad Oldesloh, Germany.

No.2381 dated 12/05/2019
Registration Certificate No. UA/2281/03/01