Regulon Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Ethinylestradiol; DESOGESTREL

Boleh didapati daripada:

PAHANG PHARMACY SDN. BHD.

INN (Nama Antarabangsa):

Ethinylestradiol; DESOGESTREL

Unit dalam pakej:

21Tablet Tablets; 21Tablet Tablets; 63 Tablet Tablets; 126 Tablet Tablets

Dikeluarkan oleh:

Gedeon Richter Plc.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
REGULON TABLET
Ethinylestradiol/Desogestrel (0.03 mg/0.15 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Regulon is used for
2.
How Regulon works
3.
Before you use Regulon
4.
How to use Regulon
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Regulon
Product Description
8.
Manufacturer and Product
Registration Holder
9.
Date of revision
WHAT REGULON IS USED FOR
Oral contraception.
HOW REGULON WORKS
Regulon works by inhibition of
ovulation and changes in the cervical
secretion to prevent pregnancy.
BEFORE YOU USE REGULON
-
_When you must not use it _
You should not take Regulon 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 of the womb
(endometrial

Ciri produk

PACKAGE INSERT
REGULON
_FILM-COATED TABLETS _
COMPOSITION
Ethinylestradiol
0.03 mg
Desogestrel
0.15 mg per film-coated tablet
DESCRIPTION
White, or almost white, round shaped, biconvex film-coated tablets of
6 mm diameter, with P8 sign on
one side and RG sign on other side.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Regulon should take into consideration the
individual woman’s current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with Regulon
compares with other combined hormonal contraceptives (CHCs) (see
Sections Contraindications and
Special warnings and precautions for use).
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
How to take Regulon
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 Regulon
_ _
_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 Regulon 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 transderm