BELARA 0.03 mg2 mg film-coated tablets

Land: Malaysia

Sprog: engelsk

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

Aktiv bestanddel:

Chlormadinone acetate; Ethinylestradiol

Tilgængelig fra:

PAHANG PHARMACY SDN. BHD.

INN (International Name):

Chlormadinone acetate; Ethinylestradiol

Enheder i pakken:

21tablet Tablets; 63tablet Tablets

Fremstillet af:

Gedeon Richter Plc

Indlægsseddel

BELARA
®
0.03 mg/2 mg film coated tablets (ethinylestradiol/chlormadionacetate;
0.03 mg/2 mg
1
_CONSUMER MEDICATION INFORMATION LEAFLET _
_(RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Belara is used for
2.
How Belara works
3.
Before you use Belara
4.
How to use Belara
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Belara
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT BELARA IS USED FOR
Oral contraception.
HOW BELARA WORKS
Belara works by inhibition of ovulation
and changes in the cervical secretion to
prevent pregnancy.
BEFORE YOU USE BELARA
-
_When you must not use it _
_ _
-
if you are allergic to ethinylestradiol
or chlormadinone acetate, or any of
the other ingredients of this medicine;
-
if you suffer from blood clots in the
veins or arteries or these have
occurred in the past;
-
if you notice the first stages or signs
of a blood clot, inflammation of the
veins or embolism, such as transient
brain circulatory disturbance, fleeting
stabbing pain, chest pain or feeling of
tightness in the chest;
-
if you are forced to rest for a long
period of time (e.g. on strict bed-rest
or due to a plaster cast) or if you plan
to have an operation;
-
if you have diabetes and your blood
sugar fluctuates uncontrollably;
-
if you have high blood pressure
which is difficult to control or if your
blood pressure rises considerably;
-
if you have (or have ever had) a
condition that causes severe chest
pain and may be a first sign of a heart
attack or temporary disturbance of
the blood flow of the brain, ;
-
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
-
a condition known as
hyperhomocysteinaemia
-
if you have a disturbance of blood
clotting;
-
if you suffer from inflammation of
the liver or from jaundice and your
liver values have not yet returned to
normal;
-
if you have itching all over your body
or yo

Produktets egenskaber

Brand or Product Name
Belara 0.03 mg/2 mg film -coated tablets
Name and Strength of Active Substance(s)
One film -coated tablet contains 0.030 mg ethinylestradiol and 2 mg chlormadinone acetate
(corresponding to 1.71 mg chlormadinone).
Excipient with known effect: lactose monohydrate 69.5 mg
Product Description
Film -coated tablet. Round, pale pink, biconvex film -coated tablet .
Inactive ingredients:
Tablet core: lactose monohydrate, maize starch, povidone K 30, magnesium stearate
Film -coating: hypromellose, lactose monohydrate, macrogol 6000, propylene glycol, talc,
titanium dioxide (E 171), red iron oxide ( E 172) .
Pharmacodynamics/ Pharmacokinetics
Pharmacodynamics
Pharmacotherapeutic group: Sex hormones and modulators of the genital system;
Progestogens and estrogens, fixed combinations, ATC code: G03AA15.
Mechanism of action
The continuous intake of Belara for 21 days inhibits pituitary FSH and LH secretion, and thus
ovulation. The endometrium proliferates and undergoes secretory transformation. The
consistency of the cervical mucus is changed. This prevents sperm migration through the
cervical canal and alters sperm motility.
The lowest daily dose of chlormadinone acetate for complete inhibition of ovulation is 1.7 mg.
The full endometrial transformation dose is 25 mg per cycle.
Chlormadinone acetate is an antiandrogenic progestogen. Its effect is b ased on its ability to
displace androgens from their receptors.
Clinical efficacy In clinical studies in which the administration of Belara was tested for up to 2 years in 1655
women and more than 22 000 menstruation cycles, there were 12 pregnancies. I n 7 women
administration errors, concomitant diseases causing nausea or vomiting, or concomitant
administration of medicines known to reduce the contraceptive effect of hormonal
contraceptives were present in the period of conception.
Type of use Number o f
pregnancies
Pearl index 95% confidence
interval
Typical use 12 0.698 [0.389; 1.183]
Perfect use 5 0.291 [0.115; 0.650]
Pharmacokinetics
Chlormadinone aceta