Instructions for Belara (Ethinylestradiol, Chlormadinone) pills
English product name
Belara®
Release form
Coated tablets
Description:
The tablets, covered with a film shell of light pink color, round, double-convex; pill core color: white or almost white.
1 tab.
chloromadinone acetate 2 mg
ethinyl estradiol 0.03 mg
Auxiliary substances: povidon-K30, cornstarch, lactose monohydrate, magnesium stearate.
Film sheath composition: hypromellose-6mPa.s, lactose monohydrate, macrogol-6000, propylene glycol, talc, titanium dioxide, iron oxide red dye.
ATC codes
G03AA15 Ethinylestradiol and chloromadinone
Clinical-pharmacological groups / Group affiliation
Single-phase oral contraceptive with antiandrogenic properties
Active substance
- ethinyl estradiol
- chloromadinone acetate
Pharmacotherapy group Ethinylestradiol:
Contraceptive combined (estrogen + gestagen)
Storage Conditions
The drug should be stored in a place inaccessible to children at a temperature not higher than 25 ° C.
Best before date Belara
The shelf life is three years. Do not apply after the expiry date indicated on the package
Testimony:
- oral contraception.
- Before prescribing Belara®, the woman should be assessed for individual risk factors of thrombosis and thromboembolism,
- especially venous thromboembolism (VTE), and compare the risk of VTE when taking Belara® with other combined
- hormonal contraceptives (COCs) (see "Contraindications" and "Special Instructions").
Method of use, course and dosage:
The drug should be taken inside. The tablet, marked the corresponding day of the week, should be removed from the blister package and swallowed whole, without chewing and drinking a little water. Take 1 tab daily at the same time (preferably in the evening) for 21 consecutive days, then take a 7-day break in the pill; Menstrual bleeding should begin 2-4 days after the last pill. After the 7-day break, you should start taking the drug from the next package, regardless of whether the bleeding has stopped or not.
Terms of Sale Belara
The drug is prescription.
Use in children Ethinylestradiol
The use of the preparation at the age of 18 years is contraindicated (due to the lack of data on the effectiveness and safety of the use of the combination of chlormadinone + ethinylestradiol in adolescent girls under the age of 18 years).
Nosology Belara (ICD codes)
Z30.0
General advice and counselling on contraception
Pharmacological effect:
Belara® is a combination oral low-dose contraceptive drug (COC).
The contraceptive effect of the combination of chlormadinone + ethinylestradiol is achieved through complementary mechanisms: ovulation suppression, increased viscosity of cervical secretion (which makes it difficult for sperm to pass through the cervical canal), proliferation and secretory endometrial transformation (preventing implantation of the fertilized egg).
Chlormadinone, a compound of gestagen, has antiandrogenic properties. Its action is based on the ability to substitute androgens on specific receptors, preventing and attenuating the effect of endogenous and exogenous androgens.
When used correctly, the Pearl index (a measure of the pregnancy rate of 100 women during a year of contraceptive use) is less than 1 (0.291-0.698, depending on how closely the woman adheres to the regimen).