Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women with more than 1 year 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.
The experience treating women older than 65 years is limited.
Activelle is a continuous combined HRT product intended for use in women with an intact uterus.
One tablet should be taken orally once a day without interruption, preferably at the same time every day.
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.
In women with amenorrhoea and not taking HRT or women in transition from another continuous combined HRT product, treatment with Activelle may be started on any convenient day. In women in transition from a sequential HRT regimen, treatment should start right after their withdrawal bleeding has ended.
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.
Overdose may be manifested by nausea and vomiting. 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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