Source: Health Products Regulatory Authority (IE) Revision Year: 2016 Publisher: Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24
HRT should not be initiated or continued to prevent cardiovascular disease or dementia.
The benefits and risks of HRT must always be carefully weighed, including consideration of the emergence of risks as therapy continues (see section 4.4). Oestrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-oestrogen medications are not considered to be appropriate.
The experience treating women older than 65 years is limited.
Treatment is a continuous combined regimen. One combined estradiol/trimegestone tablet is taken daily without interruption.
For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used (see also section 4.4). Patients should be re-evaluated periodically to determine if treatment for symptoms is still necessary.
In women who are not taking hormone replacement therapy or women who switch from another continuous combined hormone replacement therapy product, treatment may be started on any convenient day. In women transferring from a sequential hormone replacement therapy regimen, treatment should begin the day following completion of the prior regimen.
There are no special dosage requirements in case of mild to moderate renal insufficiency. Subjects with severe renal insufficiency (creatinine clearance <30 ml/min/1.73 m²) have not been studied extensively, therefore, dosage recommendations cannot be given for this patient population (see section 4.4).
Treatment is contraindicated in women with acute or chronic liver disease (see section 4.3).
If one tablet is forgotten, it should be taken within 12 hours of when normally taken; otherwise, the tablet should be discarded, and the usual tablet should be taken the following day. If one or several tablets are forgotten, the risk of break-through bleeding or spotting is increased.
For oral use.
The tablets are to be swallowed whole, with water and can be taken during or between meals.
Symptoms of overdosage of oestrogen-containing products in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment if necessary should be symptomatic.
2 years.
Do not store above 30°C.
28 tablets in blister (PVC/PE/ACLAR/Aluminium).
The package sizes are 1 × 28 tablets and 3 × 28 tablets. Not all pack sizes may be marketed.
No special requirements.
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