RIGEVIDON COATED TABLET

Ország: Malajzia

Nyelv: angol

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

Aktív összetevők:

ETHINYLESTRADIOL; LEVONORGESTREL

Beszerezhető a:

PAHANG PHARMACY SDN. BHD.

INN (nemzetközi neve):

ETHINYLESTRADIOL; LEVONORGESTREL

db csomag:

21Tablet Tablets; 63Tablet Tablets

Gyártó:

Gedeon Richter Plc.

Betegtájékoztató

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
RIGEVIDON COATED TABLETS
Ethinylestradiol/Levonorgestrel (0.03 mg/0.15 mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Rigevidon is used for
2.
How Rigevidon works
3.
Before you use Rigevidon
4.
How to use Rigevidon
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Rigevidon
Product Description
8.
Manufacturer and Product
Registration Holder
9.
Date of revision
WHAT RIGEVIDON IS USED FOR
Oral contraception.
HOW RIGEVIDON WORKS
Rigevidon works by inhibition of
ovulation and changes in the cervical
secretion to prevent pregnancy.
BEFORE YOU USE RIGEVIDON
-
_When you must not use it _
-
If you have (or have ever had) a
blood clot in a blood vessel of your
legs (deep vein thrombosis), your
lungs (pulmonary embolism) or
other organs.
-
If 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 stroke.
-
If you have (or have ever had)
angina (a condition that causes
severe chest pain and may be a first
sign of a heart attack) or temporary
stroke symptoms).
-
If you have (or have ever had) a
type of migraine called ‘migraine
with aura’.
-
If you have any of the following
disease that may increase the risk of
a clot in the blood vessel:
-
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) 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 are allergic to ethinylestradiol
or levonorgestrel or any of the other
ingredien

Termékjellemzők

PACKAGE INSERT
BRAND OR PRODUCT NAME
Rigevidon _coated tablets _
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Composition: Each tablet contains ethinylestradiol 0.03 mg and
levonorgestrel 0.15 mg
PRODUCT DESCRIPTION
Film-coated tablet
White, biconvex, circular sugar-coated tablets of 6 mm diameter
_Full list of excipients _
Each tablet contains 33 mg of lactose monohydrate and 22.46 mg of
sucrose.
Core:
silica, colloidal anhydrous, magnesium stearate, talc, maize starch,
lactose monohydrate
Coating:
sucrose, talc, calcium carbonate, titanium dioxide (E171), copovidone
K90,
Macrogol 6000, silica, colloidal anhydrous, povidone K30, carmellose
sodium
PHARMACODYNAMICS/PHARMACOKINETICS
_PHARMACODYNAMIC PROPERTIES _
Pharmacotherapeutic group: Progestogens and estrogens, fixed
combinations, ATC code: G03AA07.
Combined, estrogen-progestogen mini-pill.
Pearl index: 0.1 per cent women years.
The contraceptive efficacy of Rigevidon arises from 3 complementary
actions:
-
at the hypothalamic-pituitary axis by means of inhibition of
ovulation,
-
at the cervical mucus which becomes impermeable to migration of
spermatozoids,
-
at the endometrium, which becomes inappropriate for implantation
_PHARMACOKINETIC PROPERTIES _
_Levonorgestrel _
Absorption
Levonorgestrel is rapidly and completely absorbed after oral
administration of
Rigevidon. The
bioavailability is approximately 100% and levonorgestrel is not
subject to first-pass metabolism.
Distribution
Levonorgestrel is to a large extent bound to albumin and SHBG (Sex
Hormon Binding Globulin) in
plasma.
Biotransformation
Metabolism is mainly by reduction of the

4-3-oxo group and hydroxylation at the positions 2

, 1

and 16

, followed by conjugation. The majority of the metabolites circulating
in the blood are
sulphates of 3

, 5

-tetrahydro-levonorgestrel, while excretion mainly takes place as
glucuronides.
Some of the original levonorgestrel is also circulating as 17

-sulphate. Metabolic clearance is subject
to marked inter-individual variation which may part