Desirett 75mcg film-coated tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DESOGESTREL

Boleh didapati daripada:

EURODRUG LABORATORIES (M) SDN. BHD.

INN (Nama Antarabangsa):

DESOGESTREL

Unit dalam pakej:

28tablet Tablets

Dikeluarkan oleh:

Laboratorios Leon Farma S.A.

Risalah maklumat

Consumer Medication Information Leaflet (RiMUP)
DESIRETT 75MCG FILM-COATED TABLETS
Desogestrel 75 µg film-coated tablets
IN THIS LEAFLET:
1.
WHAT DESIRETT IS
USED FOR
2.
HOW DESIRETT
WORKS
3.
BEFORE YOU USE
DESIRETT
4.
HOW TO USE
DESIRETT
5.
WHILE YOU ARE
USING DESIRETT
6.
SIDE EFFECTS
7.
STORAGE AND
DISPOSAL OF DESIRETT
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER
AND
PRODUCT
REGISTRATION
HOLDER
1.WHAT DESIRETT IS
USED FOR
DESIRETT
is used to prevent
pregnancy.
2.HOW DESIRETT WORKS
It works primarily by
preventing the sperm cells from
entering the womb but do not
always prevent the egg cell
from ripening, which is the
primary action of combined
pills.
3.BEFORE YOU TAKE
DESIRETT
WHEN YOU MUST NOT USE IT

If you are allergic to any of
the ingredients of
DESIRETT
.

If you have a thrombosis.
Thrombosis is the
formation of a blood clot in
a blood vessel (e.g. of the
legs (deep venous
thrombosis) or the lungs
(pulmonary embolism)).

If you have or have had
jaundice (yellowing of the
skin) or severe liver
disease and your liver
function is still not normal.

If you have or are
suspected to have a cancer
that is sensitive to
sex-steroids, such as certain
types of breast cancer.

If you have any unexplained
vaginal bleeding.

If you are allergic to
peanut or soya.
Consult your doctor
immediately if any of these
conditions appear for the first
time while using
DESIRETT
.
BEFORE YOU START TO USE IT
Tell your doctor before you
start to use
DESIRETT
, if

you have ever had cancer of
the breast.

you have liver cancer,
since a possible effect of
DESIRETT
cannot be
excluded.

you have ever had a
thrombosis.

you have diabetes.

you suffer from epilepsy
(see section ‘Taking other
medicines’).

you suffer from
tuberculosis (see section
‘Taking other medicines’).

you have high blood
pressure.

you have or have had
chloasma (yellowish-
brown pigmentation
patches on the skin,
particularly of the face); if
so avoid too much
exposure to the sun or
ultraviolet radiation.
When
DESIRETT
is

Ciri produk

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:
D
xxxx
12.02.19
-
PR DES DESIRETT 0,075MG X28 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
DESIRETT 75 MCG FILM COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Desirett 75mcg film- coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 microgram of desogestrel
For a full list of excipients, see section LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Round, plain, white tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: oral use
HOW TO USE DESOGESTREL
Tablets must be taken every day at about the same time with some
liquid as needed. One tablet is to be taken daily for 28 consecutive
days. Each subsequent pack is started immediately after finishing
the previous pack.
HOW TO START DESOGESTREL
_No preceding hormonal contraceptive use [in the past month] _
_ _
Tablet-taking has to start on day
1 of the woman’s natural cycle
(day 1 is the first day of her menstrual bleeding). Starting on days
2-5 is allowed, but
during the first cycle a barrier method is
recommended for the first 7 days of tablet-taking.
_Changing from a combined hormonal contraceptive