Daylina 3 mg0.02 mg film-coated tablets

Krajina: Malajzia

Jazyk: angličtina

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

Aktívna zložka:

DROSPIRENONE; ETHINYLESTRADIOL

Dostupné z:

PAHANG PHARMACY SDN. BHD.

INN (Medzinárodný Name):

DROSPIRENONE; ETHINYLESTRADIOL

Počet v balení:

3x(24+4)tablet Tablets; 1x(24+4)tablettablet Tablets

Výrobca:

Gedeon Richter Plc

Príbalový leták

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
DAYLINA 3MG/0.02MG FILM-COATED TABLETS
Drospirenone (3 mg) and Ethinylestradiol (0.02 mg)
1
WHAT IS IN THIS LEAFLET
1.
What _Daylina _is used for
2.
How _Daylina_ works
3.
Before you use _Daylina_
4.
How to use _Daylina_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of _Daylina_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _DAYLINA_ IS USED FOR
Oral contraception. _Daylina_ is used to
prevent pregnancy.
Treatment of moderate acne vulgaris in
women who elect to use oral
contraception.
Treatment of symptoms of
premenstrual dysphoric disorder
(PMDD – a severe and disabling form
of premenstrual syndrome (physical
and emotional symptoms including
acne, tender breasts, bloating, feeling
tired, irritability, and mood changes that
occur in the one to two weeks before a
woman’s period) in women who choose
to use an oral contraceptive as their
method of contraception.
HOW _DAYLINA_ WORKS
The contraceptive effect of _Daylina_ 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 endometrium.
BEFORE YOU USE _DAYLINA_
_ _
-
_When you must not use it _

if you have (or have ever had ) a
blood clot in a blood vessel of your
legs (deep vein thrombosis, DVT),
your lungs (pulmonary embolus,
PE) or other organs

if you know you have a disorder
affecting your blood clotting – for
instance, protein C deficiency,
protein S deficiency, antithrombin-
III deficiency, Factor V Leiden or
antiphospholipid antibodies

if you need an operation or if you
are off your feet for a long time (see
section ‘Blood clots’)

if you have ever had a heart attack
or a stroke

if you have (or have ever had)
angina pectoris (a condition that
causes severe chest pain and may be
a first sign of a heart attack) or
transient ischaemic attack (TIA –
temporary stroke symptoms)

if you have any of the following
diseases that may i

Súhrn charakteristických

PACKAGE INSERT
BRAND OR PRODUCT NAME
Daylina 3 mg/0.02 mg film-coated tablets
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
24 white or almost white _(active)_ film-coated tablets:
Each active film-coated tablet contains 3 mg drospirenone and 0.02 mg
ethinylestradiol.
Excipients with known effect: 48.53 mg of lactose monohydrate and
0.070 mg of soya lecithin.
4 green placebo _(inactive)_ film-coated tablets: The tablet does not
contain active substances.
Excipients with known effect: lactose anhydrous 37.26 mg, sunset
yellow (E110) 0.003 mg.
PRODUCT DESCRIPTION
Film-coated tablet.
The active tablet is white or almost white, round, biconvex
film-coated tablet, diameter about 6 mm.
Engraving on one side: “G73”, the other side is without engraving.
The placebo tablet is green, round, biconvex film-coated tablet,
diameter about 6 mm, without
engraving.
_Tablet core (active): _
Lactose monohydrate
Maize starch
Maize starch, pregelatinised
Macrogol poly(vinyl alcohol) grafted copolymer
Magnesium stearate
_Film-coating (active): _
Poly(vinyl alcohol)
Titanium dioxide (E171)
Talc
Macrogol 3350
Lecithin (soya)
_Tablet core (placebo): _
Cellulose, microcrystalline
Lactose anhydrous
Maize starch, pregelatinised
Magnesium stearate
Silica, colloidal anhydrous
_Film-coating (placebo): _
Polyvinyl-alcohol
Titanium dioxide (E171)
Macrogol 3350
Talc
Indigo carmine (E132)
Quinoline yellow (E104)
Iron oxide black (E172)
Sunset yellow FCF (E110)
PHARMACODYNAMICS/ PHARMACOKINETICS
_PHARMACODYNAMIC PROPERTIES _
Pharmacotherapeutic group: Sex hormones and modulators of the genital
system; Progestogens and
estrogens, fixed combinations, ATC code: G03AA12
Pearl Index for method failure: 0.41 (upper two-sided 95% confidence
limit: 0.85)
Overall Pearl Index (method failure + patient failure): 0.80 (upper
two-sided 95% confidence limit:
1.30)
Mechanism of action
The contraceptive effect of Daylina 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 endomet