LIZ 0.02mg3mg film-coated tablet

מדינה: מלזיה

שפה: אנגלית

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

מרכיב פעיל:

DROSPIRENONE; ETHINYLESTRADIOL

זמין מ:

EURODRUG LABORATORIES (M) SDN. BHD.

INN (שם בינלאומי):

DROSPIRENONE; ETHINYLESTRADIOL

יחידות באריזה:

28tablet Tablets

תוצרת:

LABORATORIO LEON FARMA, S.A.

עלון מידע

_ _
_ _
PATIENT INFORMATION
LEAFLET
LIZ 0.02 MG/3 MG FILM-COATED
TABLET
ETHINYLESTRADIOL/DROSPIRENONE
READ ALL OF THIS INFORMATION
SHEET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE.
-
Keep this information
sheet. You may need to read it
again.
-
If you have any further
questions, ask your doctor or
pharmacist.
-
This medicine has been
prescribed for you. Do no pass it
on to others. It may harm them.
-
If any of the side
effects get serious, of if you
notice any side effects not listed
in this leaflet, please tell your
doctor or pharmacist.
WHAT IS IN THIS LEAFLET:
1. WHAT LIZ IS USED FOR
2. HOW LIZ WORKS
3. BEFORE YOU USE LIZ
4. HOW TO TAKE LIZ
5. WHILE YOU ARE USING LIZ
6. SIDE EFFECTS
7. AFTER USING LIZ
8. PRODUCT DESCRIPTION
1. WHAT LIZ USED FOR
LIZ is a contraceptive pill and is
used to prevent pregnancy.
Contraceptive pills that contain
two hormones are called
“combination” pills.
LIZ is indicated as a treatment
of moderate acne vulgaris in
women seeking oral
contraception.
LIZ is also indicated in the
treatment of symptoms of
premenstrual dysphoric disorder
(PMDD) in women who choose
to use an oral contraceptive as
their method of contraception.
The effectiveness of LIZ for
PMDD when used for more than
three menstrual cycles has not
been evaluated.
Each of the 24 peach-pink
tablets contains a small quantity
of two different female
hormones, called ethinylestradiol
and drospirenone.
The 4 white tablets do not
contain active ingredients and
are called placebo tablets.
2. HOW LIZ WORKS
The contraceptive effect of
LIZ 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.
3. BEFORE YOU TAKE
LIZ
_ _
_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
(pulmonary 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 h

מאפייני מוצר

FRONT SIDE / ANVERSO
222 x 680 1 mm
P032
100%
Dimensions:
Scale:
Material
type:
Leaflet
Drawing #:
Date:
Version:
A
xxxxx
29.04.19
-
PR DREE LIZ 3-0,02MG 1X24+4 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
xxxx
Pharma Code
Read Directions
Pharma Code
Read Directions
LIZ 0.02MG/3MG
FILM-COATED TABLET
QUALITATIVE AND QUANTITATIVE COMPOSITION
24 PEACH-PINK FILM-COATED TABLETS (ACTIVE TABLETS):
Each film-coated tablet contains 0.02 mg of ethinylestradiol and
3 mg of drospirenone
Excipient: Lactose monohydrate 44 mg
4 WHITE PLACEBO (INACTIVE) FILM-COATED TABLETS:
The tablet does not contain active substances
Excipient: Lactose, anhydrous 89.5 mg
PHARMACEUTICAL FORM
Film-coated tablet.
Active tablets: Round, peach-pink, film-coated tablets
Placebo tablets:White, round film-coated tablets.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Oral contraceptive.
Treatment of moderate acne vulgaris in women seeking oral
contraception.
Treatment of symptoms of premenstrual dysphoric disorder
(PMDD) in women who choose to use an oral contraceptive as
their method of contraception. The effectiveness of LIZ for PMDD
when used for more than three menstrual cycles has not been
evaluated. LIZ has not been evaluated for the treatment of
premenstrual syndrome (PMS).
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration
The tablets must be taken every day at about th