Novynette Tablet

Riik: Malaisia

keel: inglise

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

Toimeaine:

DESOGESTREL; Ethinylestradiol

Saadav alates:

PAHANG PHARMACY SDN. BHD.

INN (Rahvusvaheline Nimetus):

DESOGESTREL; Ethinylestradiol

Ühikuid pakis:

21 Tablets; 63 Tablets

Valmistatud:

Gedeon Richter Plc.

Infovoldik

_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
NOVYNETTE TABLET
Ethinylestradiol/Desogestrel (0.02 mg/0.15 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Novynette is used for
2.
How Novynette works
3.
Before you use Novynette
4.
How to use Novynette
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Novynette
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT NOVYNETTE IS USED FOR
Oral contraception.
HOW NOVYNETTE WORKS
_Novynette_ works by inhibition of
ovulation and changes in the cervical
secretion to prevent pregnancy.
BEFORE YOU _USE NOVYNETTE_
- _When you must not use it_
Do not take Novynette if you have any
of the conditions listed below:
-
if you have (or have ever had) a
blood clot in a blood vessel of your
legs, your lungs 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 and you
are off your feet for a long time;
-
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
temporary stroke symptoms;
-
if you have any of the following
diseases that may increase your risk
of a clot in the arteries:
-
severe diabetes with blood
vessel damage
-
very high blood pressure
-
a very high level of fat in the
blood (cholesterol or
triglycerides)
-
a condition known as
hyperhomocysteinaemia;
-
if you have (or have ever had)
‘migraine with aura’;
-
if you have (or have ever had) or if
you are suspected of having breast
cancer or cancer of the genital
organs;
-
if you have (or have ever had) a
liver disease and your liver function
is still not normal.
-
if you have (or have ever had) a
tumour in the liver;
-
if you have unexplained bleeding
from your vagina;
-
if you have a condition
characterised by the overgrowth of
the lining

Toote omadused

PACKAGE INSERT
NOVYNETTE
_FILM-COATED TABLETS_
COMPOSITION
Ethinylestradiol
0.02 mg
Desogestrel
0.15 mg per film-coated tablet
DESCRIPTION
Slightly yellow, round shaped, biconvex film-coated tablets of 6 mm
diameter, with P9
sign on one side and RG sign on other side.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Oral contraception
The
decision
to
prescribe
Novynette
should
take
into
consideration
the
individual
woman’s current risk factors, particularly those for venous
thromboembolism (VTE), and
how
the
risk
of
VTE
with
Novynette
compares
with
other
combined
hormonal
contraceptives (CHCs) (see Sections Contraindications and Special
warnings and special
precautions for use).
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
How to take Novynette
The tablets must be taken in the order directed on the package every
day at about the same
time. One tablet is to be taken daily for 21 consecutive days. Each
subsequent pack is
started after a 7-day tablet-free interval; during which time a
withdrawal bleed usually
occurs. This usually starts on day 2-3 after the last tablet and may
not have finished before
the next pack is started.
How to start Novynette
_No preceding hormonal contraceptive use [in the past month] _
The tablet intake must be started on the first day of the woman’s
natural cycle (i.e. on the
first day which the woman has a menstrual bleeding). Tablet intake is
also allowed to start
on day 2-5, but during the first cycle concurrent use of a barrier
method for the first 7 days
of tablet intake is advisable.
_Changing from a combined hormonal contraceptive (combined oral
contraceptive (COC), _
_combined contraceptive vaginal ring or transdermal patch) _
The woman should start taking Novynette on the day after the last
active tablet (the last
tablet containing the active substance) of her previous COC, but at
the latest on the day
following
the
usual
tablet-free
interval
or
following
the
last
placebo
tablet
(tablet
containing no active substance) of her previous COC.
In case a vaginal ring or a transdermal