DYAZIDE TABLETS

국가: 남아프리카

언어: 영어

출처: South African Health Products Regulatory Authority (SAHPRA)

제공처:

LITHA PHARMA (PTY) LTD

복용량:

See ingredients

약제 형태:

TABLET

구성:

EACH TABLET CONTAINS HYDROCHLOROTHIAZIDE 25 mg TRIAMTERENE 50 mg

승인 상태:

Canceled

승인 날짜:

1976-01-09

환자 정보 전단

CCDS13/19.07/2011/SA3/02.2012
Page 1 of 9
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S4
PROPRIETARY NAME AND PHARMACEUTICAL FORM:
YAZ®
Film-coated tablets
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING YAZ.

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or your
pharmacist.

YAZ has been prescribed for you personally and you should not share
your medicine with other
people. It may harm them, even if their symptoms are the same as
yours.
WHAT YAZ CONTAINS:
ACTIVE SUBSTANCES: The active substances are ethinylestradiol (0,02
mg) as betadex clathrate and
drospirenone (3 mg).
THE OTHER INGREDIENTS ARE: Ferric oxide (E172), hypromellose 5 cP,
lactose monohydrate, magnesium
stearate, maize starch, povidone K25, talc, titanium dioxide (E171).
WHAT YAZ IS USED FOR:
YAZ is a combined oral contraceptive (“the combined Pill”)
consisting of 24 pink tablets with active
ingredients and 4 white inactive tablets (bottom row of the blister
pack). Each active tablet contains a
small amount of two different female hormones. These are drospirenone
(a progestogen) and
ethinylestradiol (an oestrogen). Because of the small amounts of
hormones, YAZ is considered a low-
dose oral contraceptive. As all active tablets in the pack combine the
same hormones in the same dose,
it is considered a monophasic combined oral contraceptive.

YAZ is used to prevent pregnancy.

YAZ is used for the treatment of moderate acne vulgaris in women
seeking oral contraception.

YAZ is also used for the treatment of symptoms of premenstrual
dysphoric disorder (PMDD) in
women who have chosen oral contraceptives as their method of birth
control. The efficacy of YAZ
for PMDD was not assessed beyond 3 cycles.

Each of the 24 light pink film-coated tablets contains an amount of
the female hormones
ethinylestradiol and drospirenone.

Contraceptive pills that contain two hormones are called ‘combined
pills’ or ‘combined oral
contraceptives’.
BEFORE YOU USE YA

제품 특성 요약

CCDS13/19.07.2011//SA3/02.2012
1
SCHEDULING STATUS:
S4
PROPRIETARY NAME AND DOSAGE FORM:
YAZ®
Film-coated tablets
COMPOSITION:
The 28-day pack (Every-Day pack) contains 24 hormonal tablets each
with 3 mg drospirenone and
0,02 mg ethinylestradiol as betadex clathrate, plus 4 inactive
tablets.
EXCIPIENTS:
Ferric oxide red (E172), hypromellose 5 cP, lactose monohydrate,
magnesium stearate, maize starch,
povidone K25, talc, titanium dioxide (E171).
PHARMACOLOGICAL CLASSIFICATION:
A 21.8.2 Progesterones with estrogens
PHARMACOLOGICAL ACTION:
PHARMACOLOGICAL PROPERTIES:
The contraceptive effect of combined oral contraceptives is based on
the interaction of various factors,
the most important of which are seen as the inhibition of ovulation
and the changes in the cervical
secretion.
Drospirenone exerts antiandrogenic activity.
Drospirenone is devoid of androgenic, oestrogenic, glucocorticoid and
antiglucocorticoid activity.
PHARMACOKINETIC PROPERTIES:

DROSPIRENONE
_Absorption: _
Orally administered drospirenone is rapidly and almost completely
absorbed. Maximum concentrations
of the active substance in serum of about 35 ng/ml are reached at
about 1 to 2 hours after single
ingestion. Bioavailability is between 76 and 85 %. The intake of food
had no influence on the extent of
absorption of drospirenone, but the maximum concentration was reduced
in comparison to intake on an
empty stomach.
_Distribution: _
After oral administration, serum drospirenone levels decrease in two
phases which are characterised by
half-lives of 1,6 ± 0,7 hours and 27,0 ± 7,5 hours, respectively.
Drospirenone is bound to serum albumin
and does not bind to sex hormone binding globulin (SHBG) or corticoid
binding globulin (CBG). Only 3
to
5
%
of
the
total
serum
active
substance
concentrations
are
present
as
free
steroid.
The
ethinylestradiol-induced increase in SHBG does not influence the serum
protein binding of drospirenone.
The mean apparent volume of distribution of drospirenone is 3,7 ± 1,2
l/kg.
_ _
_Metabolism: _
Drospirenone is exten