Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Marketing Authorisation Holder: Novo Nordisk Limited, 3 City Place, Beehive Ring Road, Gatwick, West Sussex, RH6 0PA
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women with at least 6 months since last menses.
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 (see also section 4.4).
The experience treating women older than 65 years is limited.
Novofem is a continuous sequential HRT product for oral use. The oestrogen is dosed continuously. The progestagen is added for 12 days of every 28 day cycle, in a sequential manner.
One tablet is taken daily in the following order: oestrogen therapy (red film-coated tablet) over 16 days, followed by 12 days of oestrogen/progestagen therapy (white film-coated tablet).
After intake of the last white tablet, treatment is continued with the first red tablet of a new pack on the next day. A menstruation-like bleeding usually occurs at the beginning of a new treatment cycle.
In women who are not taking HRT or women in transition from a continuous combined HRT product, treatment with Novofem may be started on any convenient day. In women in transition from another sequential HRT regimen, treatment should begin the day following completion of the preceding regimen.
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.
A switch to a higher dose combination product could be indicated if the response after 3 months is insufficient for symptom relief.
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 may increase the likelihood of breakthrough bleeding and spotting.
Symptoms of over dosage with oral oestrogens are breast tenderness, nausea, vomiting and/or metrorrhagia. Overdosage of progestagens may lead to a depressive mood, fatigue, acne and hirsutism. Treatment should be symptomatic.
3 years.
Do not store above 25°C. Do not refrigerate. Keep the container in the outer carton in order to protect it from light.
1 × 28 tablets or 3 × 28 tablets in calendar dial packs.
The calendar dial pack with 28 tablets consists of the following 3 parts:
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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