Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2018 Publisher: Pfizer New Zealand Limited, P O Box 3998, Auckland, New Zealand, 1140, Toll Free Number: 0800 736 363
LOETTE 20 µg and 100 µg tablets.
| Pharmaceutical Form |
|---|
|
Each LOETTE calendar blister pack contains 21 pink active tablets and 7 white inactive tablets. |
Each tablet contains 20 µg Ethinylestradiol and 100 µg Levonorgestrel.
Excipients with known effects: Lactose monohydrate.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 17 alpha-Ethinylestradiol |
Ethinylestradiol is chemically and biologically identical to endogenous human oestradiol. It substitutes for the loss of estrogen production in menopausal women, and alleviates menopausal symptoms. Estrogens prevent bone loss following menopause or ovariectomy. |
|
| Levonorgestrel |
The precise mode of action of levonorgestrel as an emergency contraceptive is not known. At the recommended regimen, levonorgestrel is thought to work mainly by preventing ovulation and fertilisation if intercourse has taken place in the preovulatory phase, when the likelihood of fertilisation is the highest. |
| List of Excipients |
|---|
|
Each pink active tablet contains 100 µg levonorgestrel and 20 µg ethinylestradiol and the excipients: microcrystalline cellulose, lactose monohydrate, polacrilin potassium, magnesium stearate, macrogol 1450, glycol montanate and Opadry YS-1-14587-A Pale Pink. Each white inactive tablet contains lactose monohydrate, microcrystalline cellulose, magnesium stearate, polacrilin potassium, macrogol 1500, glycol montanate and Opadry Y-5-18024-A White (US version). |
One-month pack containing one blister tray or a three-month pack containing 3 blister trays. Each blister tray contains 21 pink active tablets, each containing levonorgestrel 100 µg and ethinylestradiol 20 µg, and 7 white inactive tablets.
Pfizer New Zealand Limited, P O Box 3998, Auckland, New Zealand, 1140, Toll Free Number: 0800 736 363
13 August 1998
| Drug | Countries | |
|---|---|---|
| LOETTE | Austria, Estonia, Spain, Hong Kong, Lithuania, New Zealand, South Africa |
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