OVESSE

Ovesse vaginal cream is a local oestrogen-only product for intravaginal use. Ovesse may be used in women with or without an intact uterus. 5g of cream) per day for two weeks.

Maintenance dose:

One application twice a week.

Restarting treatment:

For patients still experiencing symptom relief after a break from therapy, it is recommended that treatment is restarted at the maintenance dose. For patients experiencing bothersome symptoms again after a break from therapy, it is recommended to restart treatment at the initial daily dose regimen for 2 weeks, followed by the maintenance twice weekly dose.

Switching from other local vaginal oestrogen preparations:

Patients experiencing symptom relief from vaginal oestrogen preparations that are being used at the recommended dose can be switched to the maintenance dose of Ovesse vaginal cream provided: • The woman has used her current vaginal oestrogen product for more than 3 months, and; • Her symptoms are adequately controlled, and; • Her health status is unchanged since her last prescription.

Treatment with Ovesse cream may be started on any day. Treatment should be continued for as long as needed and symptoms often return if treatment is stopped. A missed dose should be administered as soon as remembered. However, two doses should not be administered on the same day.

Route of Administration Ovesse vaginal cream is administered intravaginally by means of a calibrated applicator. 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 red ring marked on the body. Fill the applicator up to the ring mark with Ovesse vaginal 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.

The following adverse reactions, associated with estrogen treatment may occur during estriol therapy or overdose: Nausea and vomiting, breast tenderness or pain in the breasts, vaginal bleeding or spotting during or on withdrawal of therapy, excessive production of cervical mucus, headache.

From Literature and safety surveillance monitoring, the following adverse reactions have been reported: Tabulated list of adverse reactions The following convention has been utilised for the classification of frequency: Very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).

0 These adverse reactions are usually transient, but may also be indicative of too high a dosage. Class effects associated with systemic HRT The following risks have been associated with systemic HRT and apply to a lesser extent for Estriol vaginal cream and pessaries of which the systemic exposure to estriol remains closely to the normal postmenopausal range when used in a twice weekly administration.

4). 56). For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2000 users. In women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period.

e. deep vein thrombosis or pulmonary embolism. 4). 5 fold increased relative risk of ischaemic stroke. The risk of haemorrhagic stroke is not increased during use of HRT. 4. 6) 3 (1-5) *no differentiation was made between ischaemic and haemorrhagic stroke.

g. endometrial cancer. 4 • Gall bladder disease. • Skin and subcutaneous disorders: chloasma, erythema multiforme, erythema nodosum, vascular purpura. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Treatment initiation or restarting and medical examination For the treatment of postmenopausal symptoms, HRT should only be initiated or reinstituted for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at every pharmacy visit for resupply and HRT should only be continued as long as the benefit outweighs the risk.

Continued suitability of treatment with Ovesse vaginal cream should be verified at each supply. Before initiating or reinstituting HRT, a complete personal and family medical history should be taken. Women should be referred to their doctor before or at any time during treatment if this, or the contraindications and warnings for use, indicate a need for a physical (including pelvic and breast) examination by a doctor.

Women should be advised to report any unexpected vaginal bleeding to their doctor or nurse. Women should be advised what changes in their breasts should be reported to their doctor or nurse (see “Breast cancer” below). mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.

Conditions requiring a doctor referral before treatment initiation • Women receiving hormonal therapy, including systemic HRT, unless she has previously received a prescription for a concurrent vaginal oestrogen product and her health status is unchanged since her last prescription.

• Women with a history of: - Endometriosis (see below) unless: o She has previously received a prescription for vaginal oestrogens and her health status is unchanged since her last prescription, and o she has no recent symptoms of endometriosis ; - Endometrial hyperplasia (see below) unless: o She has previously received a prescription for vaginal oestrogens and her health status is unchanged since her last prescription, or oshe has had a hysterectomy.

g. g. g. 4) • Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal • Porphyria