Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880, Bagsvaerd, Denmark
Treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women (see section 5.1).
The experience treating women older than 65 years is limited.
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) 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’).
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.
Vagifem is intended for intravaginal use and the dose of estradiol is very low. Overdose is therefore unlikely, but if it occurs, treatment is symptomatic.
3 years.
Do not refrigerate.
Each tablet is contained in a disposable single-use polyethylene/polypropylene applicator.
The applicators are packed separately in PVC/aluminium foil blisters.
18 vaginal tablets with applicators.
24 vaginal tablets with applicators.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
17β-estradiol is expected to pose a risk to the aquatic environment, especially to fish populations.
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