Active Ingredient: Estetrol
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in non-hysterectomised postmenopausal women with at least 12 months since last menses.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A
Oral, 14.2 milligrams estetrol, once daily.
Regimen B, in case that there is poor response to treatment
Oral, 14.2 milligrams estetrol, once daily. Afterwards, oral, 18.9 milligrams estetrol, once daily. The maximum allowed total dose is 18.9 milligrams estetrol daily.
The treatment should be initiated with 14.2 mg. If there is insufficient response in the form of alleviated symptoms, the dose could be increased to 18.9 mg.
A progestogen approved for addition to oestrogen treatment should be added continuously.
The dose should be taken orally once daily at about the same time with or without food, if necessary, with a small amount of water.
Continuous administration is recommended.
For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used.
In women who are not taking HRT, or in women who switch from an oestrogen only HRT product or from a continuous combined HRT product, treatment may be started on any convenient day. In women changing from a cyclic or sequential HRT regimen, treatment should begin on the day following completion of the prior regimen.
If a tablet has been forgotten, it should be taken as soon as possible. If more than 12 hours have elapsed, treatment should be continued with the next tablet without taking the forgotten tablet.
Missed tablets may increase the likelihood of breakthrough bleeding or spotting in women with a uterus.
Estetrol has not been studied for safety and efficacy in women initiating treatment over 65 years of age.
No dose recommendation can be made for this population.
The dose should be taken orally once daily at about the same time with or without food, if necessary, with a small amount of water.
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