BELARA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CHLORMADINONE ACETATE; ETHINYLESTRADIOL

Available from:

TEC-O-PHARM-LIBRA LTD

ATC code:

G03AA01

Pharmaceutical form:

FILM COATED TABLETS

Composition:

ETHINYLESTRADIOL 0.03 MG; CHLORMADINONE ACETATE 2 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

GEDEON RICHTER PLC, HUNGARY

Therapeutic group:

ETYNODIOL AND ESTROGEN

Therapeutic area:

ETYNODIOL AND ESTROGEN

Therapeutic indications:

Oral hormonal contraceptive.

Authorization date:

2022-12-31

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed according to a physician's prescription only
BELARA
Film-coated tablets
ACTIVE INGREDIENTS: Ethinylestradiol 0.030 mg, Chlormadinone acetate
2.0 mg
INACTIVE AND ALLERGIC INGREDIENTS: List of the additional ingredients
detailed in section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains concise
information about the medicine. If you have any other questions, refer
to the physician or the
pharmacist. This medicine has been prescribed for you only. Do not
pass it on to others. It
may harm them even if it seems to you that their medical condition is
similar.
IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES
(CHCS):
-
They are one of the most reliable reversible methods of contraception
if used correctly.
-
They slightly increase the risk of having a blood clot in the veins
and arteries,
especially in the first year or when restarting a combined hormonal
contraceptive
following a break of 4 or more weeks.
-
Please be alert and see your physician if you think you may have
symptoms of a blood
clot (see section 2 “Blood clots”).
1.
WHAT IS THE MEDICINE INTENDED FOR?
Belara is a hormonal contraceptive to be taken by mouth.
If such hormonal contraceptives contain two hormones like Belara, they
are also called
“combined hormonal contraceptives” (CHCs). The 21 tablets of a
cycle pack contain the
same amounts of both hormones, and therefore Belara is also called a
"monophasic
preparation".
Belara, like other hormonal contraceptives, will not protect you
against AIDS (HIV infection)
or other sexually transmitted diseases. Only condoms help to do this.
THERAPEUTIC GROUP:
sex hormones and modulators of the genital system, progestogens and
estrogens, fixed combinations.
2.
BEFORE USING THE MEDICINE
GENERAL NOTES
Before you start using Belara you should read the information on blood
clots (thrombosis) in
section 2. It is particularly important to read the sympt

Summary of Product characteristics

BELARA
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Belara
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.030 mg ethinylestradiol and 2 mg
chlormadinone acetate (equivalent
to 1.71 mg chlormadinone).
Excipient with known effect: Each film-coated tablet contains 69.5 mg
of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Pale pink, round, biconvex film-coated tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral hormonal contraceptive.
The decision to prescribe Belara should be made taking into
consideration the individual woman's
currently existing risk factors, particularly those relating to venous
thromboembolism (VTE), and how
the risk of VTE with Belara compares with other combined hormonal
contraceptives (see sections 4.3
and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One film-coated tablet must be taken every day at the same time
(preferably in the evening) on 21
consecutive days, followed by a seven-day break in which no
film-coated tablets are taken.
Menstruation-like withdrawal bleeding should occur two to four days
after administration of the last
film-coated tablet. After the seven-day medication-free interval,
medication should be continued with
the next pack of Belara, regardless of whether bleeding has ceased or
not.
The film-coated tablets should be pressed out of the blister pack at
the position marked with the
corresponding weekday and swallowed whole, if necessary, with a little
liquid. The film-coated tablets
are to be taken daily following the direction of the arrow.
2
_Starting administration of the film-coated tablets_
_No previous administration of a hormonal contraceptive (during the
last menstruation cycle)_
The first film-coated tablet should be taken on day one of the
women’s natural cycle, i.e. on the first
bleeding day of the next menstruation. If the first film-coated tablet
is taken on the first day of
menstruation, contraception starts on