BELARA film-coated tablet 0.03mg2mg

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Aktiivinen ainesosa:

Chlormadinone acetate; Ethinylestradiol

Saatavilla:

PHARMLINE MARKETING PTE. LTD.

ATC-koodi:

G03AA15

Lääkemuoto:

TABLET, FILM COATED

Koostumus:

Chlormadinone acetate 2.000 mg; Ethinylestradiol 0.030 mg

Antoreitti:

ORAL

Prescription tyyppi:

Prescription Only

Valmistaja:

Gedeon Richter Plc.

Valtuutuksen tilan:

ACTIVE

Valtuutus päivämäärä:

2015-10-14

Valmisteyhteenveto

PACKAGE INSERT
1.
BRAND OR PRODUCT NAME
BELARA 0.03 MG/2 MG FILM-COATED TABLETS
2.
NAME AND STRENGTH OF ACTIVE SUBSTANCE
ethinylestradiol and chlormadinone acetate
3.
PRODUCT DESCRIPTION
Round, pale pink, biconvex film-coated tablet.
One film-coated tablet contains 0.030 mg ethinylestradiol and 2 mg
chlormadinone acetate
(corresponding to 1.71 mg chlormadinone).
List of excipients:
_Tablet core: _
lactose monohydrate
maize starch,
povidone K 30,
magnesium stearate
_Film-coating: _
hypromellose,
lactose monohydrate,
macrogol 6000,
propylene glycol,
talc,
titanium dioxide (E 171),
red iron oxide (E 172)
4.
HARMACODYNAMICS/PHARMACOKINETICS
4.1
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Progestogens and estrogens, fixed
combinations, ATC code: G03AA.
The continuous intake of Belara for 21 days inhibits pituitary FSH and
LH secretion, and thus
ovulation. The endometrium proliferates and undergoes secretory
transformation. The consistence of
the cervical mucus is changed. This prevents sperm migration through
the cervical canal and alters
sperm motility.
The lowest daily dose of chlormadinone acetate for complete inhibition
of ovulation is 1.7 mg. The
full endometrial transformation dose is 25 mg per cycle.
Chlormadinone acetate is an antiandrogenic progestogen. Its effect is
based on its ability to displace
androgens from their receptors.
Clinical efficacy
2
In clinical studies in which the administration of Belara was tested
for up to 2 years in 1655 women
and more than 22 000 menstruation cycles, there were 12 pregnancies.
In 7 women administration
errors, concomitant diseases causing nausea or vomiting, or
concomitant administration of medicines
known to reduce the contraceptive effect of hormonal contraceptives
were present in the period of
conception.
PEARL INDEX
NUMBER OF
PREGNANCIES
PEARL INDEX
95% CONFIDENCE
INTERVAL
Typical use
12
0.698
[0.389; 1.183]
Perfect use
5
0.291
[0.115; 0.650]
4.2
PHARMACOKINETIC PROPERTIES
_Chlormadinone acetate (CMA) _
Absorption
After oral administration CMA is rapidly