Ovestin 1 mg cream

Description

As pre-surgery therapy for vaginal operations and during subsequent convalescence.

4.2 Posology and method of administration
Ovestin cream is an estrogen-only product for intravaginal use.

Adults and Elderly

• Treatment of atrophic vaginitis

1 application per day for the first weeks (maximally 4 weeks), followed by a gradual reduction, based on relief of symptoms, until a maintenance dosage (e.g. 1 application twice a week) is reached.

• Pre-surgery therapy

One applicator-dose per day should begin 2 weeks before the operation.

• Post-surgery therapy

Following surgery a period of at least 2 weeks should be allowed before resuming therapy using one applicator-dose twice a week.

A missed dose should be administered as soon as remembered, unless it is more than 12 hours overdue. In the latter case the missed dose should be skipped and the next dose should be administered at the normal time. Two doses should never be administered on the same day.

Route of Administration

Ovestin cream is administered intravaginally by means of a calibrated applicator.

One applicator-dose (applicator filled to the red mark) is 0.5g Ovestin cream containing 0.5 mg estriol.

The following ‘Instructions for Use’ should be given to the patient and are included in the Patient Information Leaflet:

How to Apply the Cream

Use the applicator to apply the cream in the vagina. A good time to do this is before going to bed.

The applicator has a ring marked on the body. Fill the applicator up to the ring mark with Ovestin cream to get the correct dose.

1. Remove the cap from the tube and turn it upside down. Then use the sharp point to open the tube.

2. Screw the end of the applicator onto the tube.

3. Squeeze the tube to fill the applicator with the cream up to the red ring mark (the plunger will stop at the ring mark).

4. Unscrew applicator from the tube and put the cap back on the tube.

5. To apply the cream, lie down, put the end of the applicator deep into the vagina and slowly push plunger all the way in.

Cleaning the applicator

After use, pull the plunger out of the barrel. Wash the plunger and barrel in hand hot, soapy water. Do not use detergents. Rinse well with clean water afterwards.

DO NOT PUT THE APPLICATOR IN BOILING WATER.

For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used.

For Ovestin vaginal cream and pessaries, the systemic exposure of estriol remains closely to the normal postmenopausal range when used in a twice weekly administration, it is not recommended to add a progestagen (but see section 4.4).

In women not taking HRT or women who switch from another continuous combined HRT product, treatment with Ovestin cream may be started on any day. Women who switch from cyclic HRT regimen should start Ovestin cream treatment one week after completion of the cycle.

Children

There are no clinical trials to support the use in children.

4.3 Contraindications
– Known, past or suspected breast cancer;

– Known or suspected estrogen-dependent malignant tumours (e.g endometrial cancer);

– Undiagnosed genital bleeding;

– Untreated endometrial hyperplasia;

– Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism);

– Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency, see section 4.4);

– Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction);

– Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal;

– Known hypersensitivity to the active substances or to any of the excipients listed in section 6.1;

– Porphyria.

4.4 Special warnings and precautions for use
• For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.

• Evidence regarding the risks associated with HRT in the treatment of premature menopause is limited. Due to the low level of absolute risk in younger women, however, the balance of benefits and risks for these women may be more favorable than in older women.