Regulon tablets film-coated

Riik: Armeenia

keel: inglise

Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Toimeaine:

desogestrel, ethinylestradiol

Saadav alates:

Gedeon Richter PLC

ATC kood:

G03AA09

INN (Rahvusvaheline Nimetus):

desogestrel, ethinylestradiol

Annus:

0,15mg+ 0,03mg

Ravimvorm:

tablets film-coated

Ühikuid pakis:

(21/1x21/) and (63/3x21/) in blister

Retsepti tüüp:

Prescription

Volitamisolek:

Registered

Loa andmise kuupäev:

2017-11-07

Toote omadused

1.
NAME OF THE MEDICINAL PRODUCT
Regulon 0.15 mg/0.03 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
0.15 mg of desogestrel and 0.03 mg of ethinylestradiol in each
film-coated tablet.
Excipient with known effect: The medicinal product contains 67.66 mg
of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
White, or almost white, round shaped, biconvex film-coated tablets
with “P8” sign on one side and
“RG” sign on other side.
4.
CLINICAL PARTICULARS
4.1
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 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
HOW TO TAKE REGULON
Tablets must be taken in the order directed on the package every day
at about the same time with
some liquid as needed. 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) _
It is preferable that tablet intake from the first pack is started on
the first day of menstruation in which
case no extra contraceptive precautions are necessary.
If menstruation has already begun, (that is 2, 3, or 4 days
previously), tablet taking should commence
on day 5 of the menstrual period. In this case additional
contraceptive precautions must be taken for
the first 7 days of tablet taking.
If menstruation began more than 5 days previously then the patient
should be advised to wait until her
next menstrual period before starting to take Regulon.
_CHANGING FROM A 21 DAY PILL OR ANOTH