Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Premique Low Dose 0.3mg/1.5mg modified release tablets.
| Pharmaceutical Form |
|---|
|
Modified release tablet. Cream oval biconvex sugar coated tablet marked “PREMPRO 0.3/1.5” in black ink. |
Conjugated estrogens^†^ 0.3 mg and medroxyprogesterone acetate (MPA) 1.5 mg.
† Conjugated estrogens contain the sodium sulfate conjugates of estrone, equilin, 17α-dihydroequilin, 17α-estradiol, 17β-dihydroequilin, 17α-dihydroequilenin, 17β-dihydroequilenin, equilenin, 17β-estradiol and Δ8,9-dehydro-estrone.
Excipients: contains 61.7mg of lactose monohydrate and 40.69mg of sucrose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Estrogens, conjugated |
The active ingredients of conjugated estrogens are primarily the sulfate esters of estrone, equilin sulfates, 17α-estradiol and 17β-estradiol. These substitute for the loss of estrogen production in menopausal women, and alleviate menopausal symptoms. Estrogens prevent bone loss following menopause or ovariectomy. |
|
| Medroxyprogesterone |
Medroxyprogesterone acetate exerts anti-oestrogenic, anti-androgenic and antigonadotrophic effects. |
| List of Excipients |
|---|
|
Tablet core: Lactose Monohydrate Tablet coating: Sucrose Printing on tablet: Opacode WB NS-78-17821, Black Ink (Purified Water, Iron Oxide Black (E172), Isopropyl Alcohol, Propylene Glycol, Hypromellose 2910) a Contains: Hypromellose 2910, Titanium Dioxide (E171) and Yellow Iron Oxide (E172) |
Blister pack, consisting of a polyvinyl chloride (PVC)/Aclar film and aluminum foil with heat seal coating containing 28 tablets. Each carton contains 28 tablets (1 blister pack) or 84 tablets (3 blister packs).
Not all pack sizes may be marketed.
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
PL 00057/1288
14th September 2011
| Drug | Countries | |
|---|---|---|
| PREMIQUE | Ireland, United Kingdom |
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