Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**4.2 Posology and method of administration** Trisequens® is a continuous sequential HRT product. The oestrogen is dosed continuously. The progestagen is added for 10 days of every 28-day cycle, in a sequential manner. One tablet should be taken orally once a day without interruption, preferably at the same time of the day starting with oestrogen therapy (blue film-coated tablet) over 12 days, followed by 10 days of oestrogen/progestagen therapy (white film-coated tablet) and 6 days of oestrogen therapy (red film-coated tablet). A regular shedding of the endometrium is usually induced during the red tablet phase. After intake of the last red tablet, treatment is continued with the first blue tablet of a new pack on the next day. In women who are not taking HRT or women in transition from a continuous combined HRT product, treatment with Trisequens® 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 section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) should be used. 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.
ORAL
Medical Information
**4.1 Therapeutic indications** 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 section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The experience of treating women older than 65 years is limited.
**4.3 Contraindications** - Known, past or suspected breast cancer - Known, past or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer) - Undiagnosed genital bleeding - Untreated endometrial hyperplasia - Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism) - Active or previous arterial thromboembolic disease (e.g. angina, myocardial infarction) - Known thrombophilic disorders (e.g. protein C, protein S or antithrombin deficiency (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_)) - Acute liver disease or a history of liver disease as long as liver function tests have failed to return to normal - Known hypersensitivity to the active substances or to any of the excipients - Porphyria.
G03FB05
norethisterone and estrogen
Manufacturer Information
NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
Novo Nordisk A/S
Active Ingredients
Documents
Package Inserts
Trisequens Tablet PI.pdf
Approved: August 4, 2021