VAGIFEM® VAGINAL TABLET 10MCG

4.1 Therapeutic indications

Treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The experience of treating women older than 65 years is limited.

4.3 Contraindications

• Known, past or suspected breast cancer
• Known, past or suspected oestrogen-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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)
• 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
• Porphyria.

4.2 Posology and method of administration

Vagifem® is administered intravaginally as a local oestrogen therapy by use of an applicator.

Initial dose: One vaginal tablet daily for two weeks.

Maintenance dose: One vaginal tablet twice a week.

Treatment may be started on any convenient day.

If a dose is forgotten, it should be taken as soon as the patient remembers. A double dose should be avoided.

For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) should be used.

For oestrogen products for vaginal application of which the systemic exposure to the oestrogen remains within the normal postmenopausal range, such as Vagifem®, it is not recommended to add a progestagen (but see section 4.4, ‘Special warnings and precautions for use’, ‘Endometrial hyperplasia and carcinoma’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Vagifem® may be used in women with or without an intact uterus.

Vaginal infections should be treated before start of the Vagifem® therapy.

Administration:

1. Open the blister pack at the plunger end.
2. Insert the applicator in the vagina until resistance is met (8–10 cm).
3. Release the tablet by pressing the plunger.
4. Withdraw the applicator and discard.