Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880, Bagsværd, 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 (see section 4.4).
The experience treating women older than 65 years is limited.
Kliogest 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 section 4.4) should be used.
In women with amenorrhoea and not taking HRT or women in transition from another continuous combined HRT product, treatment with Kliogest 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.
Symptoms of over dosage with oral oestrogens are breast tenderness, nausea, vomiting and/or metrorrhagia. Over dosage of progestagens may lead to a depressive mood, fatigue, acne and hirsutism. Treatment should be symptomatic.
4 years.
Store below 25ºC. Do not refrigerate. Keep the container in the outer carton in order to protect it from light.
1 × 28 tablets in calendar dial packs.
The calendar dial pack with 28 tablets consists of the following 3 parts:
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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