Source: Health Products Regulatory Authority (IE) Revision Year: 2016 Publisher: Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24
Totelle 1 mg/ 0.125 mg coated tablets.
| Pharmaceutical Form |
|---|
|
Coated tablet. Blue, round, biconvex, coated tablet printed with “1/0.125”. |
Each coated tablet contains 1.03 mg estradiol hemihydrate corresponding to 1.00 mg estradiol and 0.125 mg trimegestone.
Excipients with known effects: Lactose monohydrate and sucrose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Estradiol |
Estradiol, is chemically and biologically identical to endogenous human estradiol. It substitutes for the loss of oestrogen production in menopausal women, and alleviates menopausal symptoms. Oestrogens prevent bone loss following menopause or ovariectomy. |
|
| Trimegestone |
Trimegestone is a 19-norpregnane progestagen, with an in vitro affinity for the progesterone receptor approximately 6 times that of progesterone. As oestrogens promote the growth of the endometrium, unopposed oestrogens increase the risk of endometrial hyperplasia and cancer. The addition of a progestagen reduces, but does not eliminate the oestrogen-induced risk of endometrial hyperplasia in non-hysterectomised women. |
| List of Excipients |
|---|
|
Core: Lactose monohydrate Coating: Anhydrous calcium sulfate |
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.
Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24
PA0822/073/001
Date of first authorisation: 18 December 2003
Date of last renewal: 22 November 2009
| Drug | Countries | |
|---|---|---|
| TOTELLE | Brazil |
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