Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Novo Nordisk A/S, Novo Alle, DK-2880, Bagsvaerd, Denmark
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women.
Prevention of osteoporosis in postmenopausal women at high risk of future fractures, who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.
Estrofem is particularly for women who have been hysterectomised and therefore do not require combined oestrogen/progestagen therapy.
The experience treating women older than 65 years is limited.
Estrofem is an oestrogen-only product for hormonal replacement. Estrofem is administered orally, one tablet daily without interruption.For initiation and continuation of treatment of menopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used.
In women without a uterus, Estrofem may be started on any convenient day. In women with a uterus who present amenorrhoea and are being transferred from a sequential HRT, Estrofem may be initiated on day 5 of bleeding and only in combination with a progestagen for at least 12–14 days; if transferred from a continuous-combined HRT, Estrofem along with a progestin, may be started on any convenient day. The progestagen type and dose should provide sufficient inhibition of the oestrogen induced endometrial proliferation (see also section 4.4).
If the patient has forgotten to take a tablet, the tablet should be taken as soon as possible within the next 12 hours. If more than 12 hours have passed, the tablet should be discarded. Forgetting a dose for women with a uterus may increase the likelihood of breakthrough bleeding and spotting.
Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestagen in hysterectomised women.
Overdose may be manifested by nausea and vomiting. Treatment should be symptomatic.
4 years.
Store below 25ºC. Do not refrigerate.
1 × 28 tablets in a calendar dial pack.
The calendar pack with 28 tablets consists of the following 3 parts:
No special requirements.
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