ZOELY

Ülke: İsrail

Dil: İngilizce

Kaynak: Ministry of Health

Aktif bileşen:

ESTRADIOL AS HEMIHYDRATE; NOMEGESTROL ACETATE

Mevcut itibaren:

TRUEMED LTD.

ATC kodu:

G03CA03

Farmasötik formu:

FILM COATED TABLETS

Kompozisyon:

NOMEGESTROL ACETATE 2.5 MG; ESTRADIOL AS HEMIHYDRATE 1.5 MG

Uygulama yolu:

PER OS

Reçete türü:

Required

Tarafından üretildi:

THERAMEX IRELAND LIMITED, IRELAND

Terapötik alanı:

ESTRADIOL

Terapötik endikasyonlar:

Oral contraception

Yetkilendirme tarihi:

2018-09-30

Bilgilendirme broşürü

ضيحلا هتني مل اذإ ىتح ،ريخلأا رفصلأا
لفغلا صرقلا دعب
ً
اروف ةيلاتلا ةحيوللا ةوبعب يئدبا
،عوبسلأا نم مويلا سفن يف ةديدج ةحيول
ةوبعب
ً
امئاد يئدبت نأ وه ىنعملا .كب صاخلا
.رهش لك يف مويلا سفن يلاوح ضيح
ً
اضيأ يقلتت نأو
لف
ُ
غلا صارقلأا لامعتسإ للاخ رهش لك يف ضيح
نيقلتي نل ءاسنلا نم
ً
اددع نأ لمتحملا نم
يرظنأ( لماح كنأب حجرملا ريغ نم
،تاميلعتلا هذهل
ً
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.)"رثكأ وأ
ً
ادحاو
ً
اضيح
ِّ
توف اذإ" 3 دنبلأ
ً
اضيأ
يليإوز نم ىلولأا ةوبعلا ةيادب
قباسلا رهشلا يف ة
ّ
ينومروه لمح عنم ةليسو يلمعتست مل كنأ
لاح يف
.)ضيحلا فيزن نم لولأا مويلا يف يأ( ة
ّ
يرهشلا ةرودلا نم لولأا مويلا يف يليإوز
لوانتب يئدبا
لمحلا نم ةيمحم تنأف كيدل يثمطلا فزنلا
نم لولأا مويلا يف يليإوز لوانتب تأدب
اذإ
.ة
ّ
يفاضإ لمح عنم لئاسو لامعتسلإ ةجاحب تسل
تنأ .
ً
اروف
ة
ّ
يلبهم ةقلح ،ةجمد
ُ
م لمح عنم ةبح( ىرخأ ةجمد
ُ
م ة
ّ
ينومروه لمح عنم ةليسو نم لاقتنلإا
)ة
ّ
يدلج ةقصل وأ
ةلاعفلا لمحلا عنم ةبح لوانت نم كئاهتنا
نم موي دعب لضف
ُ
ي ،يليإوز لوانتب ءدبلا كناكمإب
ةبحب ةصاخلا ةحيوللا ةوبع نم )ةلاعف
ةدام ىلع ةيواحلا ةريخلأا لمحلا عنم
ةبح( ةريخلأا
عنم ةبحب ةصاخلا ةحيوللا ةوبع تناك اذإ
.)فقوت نودب يأ( كب صاخلا ة
ّ
يلاحلا لمحلا عنم
يليإوز لوانتب ءدبلا نيعيطت�

Ürün özellikleri

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zoely
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each white active film-coated tablet contains 2.5 mg nomegestrol
acetate and 1.5 mg
estradiol (as hemihydrate).
Each yellow placebo film-coated tablet does not contain active
substances.
Excipients with known effect:
Each white active tablet contains 57.71 mg of lactose monohydrate.
Each yellow placebo tablet contains 61.76 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
The active tablet is white, round and coded ‘ne’ on both sides.
The placebo tablet is yellow, round and coded ‘p’ on both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Zoely should take into consideration the
individual woman’s current
risk factors, particularly those for venous thromboembolism (VTE), and
how the risk of VTE
with Zoely compares with other combined hormonal contraceptives (CHCs)
(see sections 4.3
and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One tablet is to be taken daily for 28 consecutive days. Each pack
starts with 24 white active
tablets, followed by 4 yellow placebo tablets. A subsequent pack is
started immediately after
finishing the previous pack, without a break in daily tablet intake
and irrespective of presence
or absence of withdrawal bleeding. Withdrawal bleeding usually starts
on day 2-3 after intake
of the last white tablet and may not have finished before the next
pack is started. See ‘Cycle
control’ in section 4.4.
_Special populations _
_Renal impairment_
Although data in renal impaired patients are not available, renal
impairment is unlikely to
affect the elimination of nomegestrol acetate and estradiol.
_Hepatic impairment_
No clinical studies have been performed in patients with hepatic
insufficiency. Since the
metabolism
of steroid hormones might be impaired in patients with severe hepatic
disease,
the use of Zoely in thes