LIZELLE 0.02mg3mg film-coated tablet

Land: Malaysia

Sprog: engelsk

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

Aktiv bestanddel:

DROSPIRENONE; ETHINYLESTRADIOL

Tilgængelig fra:

EURODRUG LABORATORIES (M) SDN. BHD.

INN (International Name):

DROSPIRENONE; ETHINYLESTRADIOL

Enheder i pakken:

21tablet Tablets

Fremstillet af:

LABORATORIO LEON FARMA, S.A.

Indlægsseddel

Consumer Medication Information Leaflet (RiMUP)
_______________________________________________________________________________________
1
LIZELLE 0.02MG/3MG FILM-COATED TABLETS
_Ethinylestradiol 0.02mg + Drospirenone 3mg_
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
LIZELLE
0.02mg/3mg film-coated tablets.
Read
all
of
leaflet
carefully
before
you start taking this medicine. Keep
this leaflet, you may need to read it
again.
If
you
have
any
further
question,
ask
your
doctor
or
pharmacist. This medicine has been
prescribed for you, do not pass it on to
others. It may harm them. If any of
the side effects get serious, or if you
notice any side effects not listed in
this leaflet, please tell; your doctor or
pharmacist.
WHAT IS IN THIS LEAFLET:
1. WHAT LIZELLE IS USED FOR
2. HOW LIZELLE WORKS
3. BEFORE YOU TAKE LIZELLE
4. HOW TO TAKE LIZELLE
5. WHILE YOU ARE USING LIZELLE
6. SIDE EFFECTS
7. AFTER USING LIZELLE
8. PRODUCT DESCRIPTION
WHAT
LIZELLE
0.02MG/3MG
FILM-COATED TABLETS IS USED FOR
LIZELLE is a contraceptive
and is
used to prevent pregnancy.
HOW LIZELLE 0.02MG/3MG FILM-
COATED TABLETS WORKS
The
contraceptive
effect
of
LIZELLE 0.02mg/3mg film-coated
tablet 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.
LIZELLE 0.02mg/3mg film-coated
tablet
is
a
combined
oral
contraceptive with ethinylestradiol
and the progestogen drospirenone.
BEFORE
YOU
TAKE
LIZELLE
0.02MG/3MG
FILM-COATED
TABLETS
_WHEN YOU MUST NOT TAKE IT _
• if you have (or have had in the
past) blood clots (thrombosis) in
a blood vessel of the leg, lungs
(embolism) or other organs
• if you have (or have had in the
past) a heart attack or a stroke
• if you have (or have had in the
past)
any
illness
which
could
lead
to
a
heart
attack
(for
example, angina pectoris which
causes serious pain in the chest)
or
a
stroke
(for
example
a
temporary
or
minor
stroke
without residual effects).
• if you have any illness which
could
increa

Produktets egenskaber

Pharma Code
Read Directions
Pharma Code
Read Directions
FRONT SIDE / ANVERSO
222 X 510 1 MM
P031
100%
Dimensions:
Scale:
Material
type:
LEAFLET
Drawing #:
Date:
Version:
B
XXXXX
08.07.22
-
PR DREE LIZELLE 3-0,02 1X21 EXELTIS MY
Laetus #:
Folded:
YES
NO
Substitutes
mat. #:
Material #/
Product :
_LICONSA_
_LEON FARMA_ X
_Launch:_
_Internal change:_
_Customer change:_ X
Pantones:
170 X 37 MM
die cut
black
0000
Signature:
Date:
With the signed proof of this file you commit to have had reviewed and
agreed with the following points as part of your
review:
- Keyline used.
- Free varnish areas.
- Colors.
- Text.
- Prefixes order for variable info (If the order is changed you
commint to clearly comunicate this change to
Chemo's artworks department, otherwise Chemo will not be responsible).
- Any other info included in the file.
DRAWED BY:
APPROVED BY CUSTOMER (Regulatory Affair or Quality Assurance)
EXAMPLE / EJEMPLO
Pharma Code
Read Directions
xxxxx
LIZELLE 0.02MG/3MG
FILM-COATED TABLET
QUALITATIVE AND QUANTITATIVE COMPOSITION
21 PINK/PEACH FILM-COATED TABLETS:
Each film-coated tablet contains 0.02 mg of
ethinylestradiol and 3 mg of drospirenone
Excipient: Lactose monohydrate 44 mg
PHARMACEUTICAL FORM
Round, pink/peach film coated tablet.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Oral contraception.
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration
The tablets must be taken every day at about the same
time, if necessary with a little liquid in the order shown on
blister pack. LIZELLE 0.02MG/3MG FILM-COATED TABLET:
One tablet is to be taken daily for 21 consecutive days.
Each subsequent pack is started after 7-day tablet-free
interval, during which time withdrawal bleed occurs. This
usually starts on day 2-3 after the last tablet and may not
have finished before the next pack is started.
•
No preceding hormonal contraceptive use (in the past
month) Tablet-taking has to start on day 1 of the
woman’s natural cycle (i.e. the first day of her menstrual
bleeding).
•
Changing from a combined hormonal contra