ANGELIQ TABLET

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

ESTRADIOL HEMIHYDRATE; DROSPERINONE

Available from:

BAYER CO. (MALAYSIA) SDN. BHD.

INN (International Name):

ESTRADIOL HEMIHYDRATE; DROSPERINONE

Units in package:

28 Tablet Tablets

Manufactured by:

Bayer Weimar GmbH und Co. KG

Patient Information leaflet

NOT APPLICABLE

Summary of Product characteristics

Reference :
Angeliq / film-coated tablets / CCDS / Version 121 / 134 Jul Apr
20152021, Dosage
RESTRICTED
ANGELIQ
®
Film-Coated Tablet
1.
NAME OF THE MEDICINAL PRODUCT
Angeliq Tablet1 mg/2 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Angeliq-1 mg E2 / 2 mg DRSP: Each medium red film-coated tablet
contains: estradiol (E2) 1.0 mg (as estradiol
hemihydrate), drospirenone (DRSP) 2.0 mg
3.
PHARMACEUTICAL FORM
Film-coated tablet
4.
CLINICAL PARTICULARS
4.1
INDICATION(S)
Hormone replacement therapy (HRT) for the treatment of:
•
Climacteric syndrome in postmenopausal women including vasomotor
symptoms (such as hot flushes and
sweating attacks), sleep disorders, depressed moods, nervousness and
atrophic urogenital conditions caused by
deficient endogenous estrogen production due to natural menopause,
hypogonadism, castration or primary ovarian
failure in women with an intact uterus.
•
Prevention of postmenopausal osteoporosis.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
4.2.1
METHOD OF ADMINISTRATION
Oral use
4.2.2
DOSAGE REGIMEN
►
How to start Angeliq
Women who do not take estrogens or women who change from a continuous
combination product may start treatment at
any time.
Women changing from a continuous sequential or cyclic HRT should
complete the current cycle of therapy before initiating
Angeliq therapy.
►
Dosage
One tablet is taken daily.
►
Administration
Each pack covers 28 days of treatment. Treatment is continuous, which
means that the next pack follows immediately
without a break.
The tablets are to be swallowed whole with some liquid irrespective of
food intake.
The tablets should preferably be taken at the same time every day.
For treatment of postmenopausal symptoms, the lowest effective dose
should be used.
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest effective dose for the shortest duration
should be used.
►
Missed tablets
In case a tablet is forgotten, it should be taken as soon as possible.
If more than 24 hours have elapsed, no extra tab