ANGELIQ

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DROSPIRENONE; ESTRADIOL AS HEMIHYDRATE

Available from:

BAYER ISRAEL LTD

ATC code:

G03CA03

Pharmaceutical form:

FILM COATED TABLETS

Composition:

DROSPIRENONE 2 MG; ESTRADIOL AS HEMIHYDRATE 1 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

BAYER AG, GERMANY

Therapeutic group:

ESTRADIOL

Therapeutic area:

ESTRADIOL

Therapeutic indications:

Angeliq is indicated for hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women more than 1 year post menopause. Prevention of postmenopausal osteoporosis in women with an increased risk of future osteoporosis fractures.

Authorization date:

2020-05-31

Patient Information leaflet

PACKAGING TECHNOLOGY BERLIN SGQCL
page 2
Bayer AG
client: 0021,GV15
material-no.: 89299268
PZ: 2688A-3A
code-no.:
name: LF-INS ANGELIQ 1/2 TAFI 28
country: IL/MULI/BAG
colors: BLACK
version: 15.09.2022/01
Restricted Document
dimension: 355 X 594 MM
ةيفاضإ تلااح
كانه .ةركاذلا نادقف عنمي لا ليدبلا
ينومروهلا جلاعلا نإ
●
ةركاذ نادقف ثودحل ربكأ ةروطخ دوجو ىلع
لدت دهاوش
دعب ليدب ينومروه جلاع لوانت نأدبي
يتاوللا ءاسنلا ىدل
.بيبطلا يريشتسإ .ةنس 65 رمع
ةعفترم بسن كيدلو ىلكلا يف ةلكشم نم
نيناعت تنك اذإ
●
ةيودأ نيلوانتت تنك اذإ صخلأاب ،مدلا يف
مويساتوﭙلا نم
زئاجلا
نمف ،مدلا
يف مويساتوﭙلا
ةيمك نم عفرت ةيفاضإ
رهشلا للاخ كمد يف مويساتوﭙلا ةبسن
بيبطلا صحفي نأ
.جلاعلا نم لولأا
جلاعلا نإف ،مدلا طغض يف عافترإ نم
نيناعت تنك اذإ
●
لامعتسإ زوجي لا .مدلا طغض نم ضفخي نأ
نكمي كيليجنأ ـب
.مدلا طغض عافترلإ جلاعك كيليجنأ
هجولا ىلع ةيبهذ ـ ةينب عقب ريوطتل
ةيلباق كيدل تناك اذإ
●
قوف ةعشلأا وأ سمشلل ضرعتلا نع عانتملإا
كيلعف ،)فلك(
.كيليجنأ ـب جلاعلا ءانثأ ةيجسفنبلا
:ةيودلأا نيب تلاعافتلا/تلاخادتلا امب ىرخأ ةيودأ ،
ً
ارخؤم تلوانت اذإ وأ نيلوانتت تنك اذإ يكحإ ،ةيئاذغ تافاضإو ةيبط ةفصو نودب
ةيودأ كلذ يف
.كلذ نع يلديصلا وأ بيبطلل
ريغ فزن ىلإ يدؤتو كيليجنأ لمع لقرعت دق
ةنيعم ةيودأ
:لمشت ةيودلأا هذه .مظتنم
،نوديميرپ ،نيئوتينيف ،تاروتيبراب لثم(
عرصلا جلاعل ةي�

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
ANGELIQ
Film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 1 mg Oestradiol (as Oestradiol
hemihydrate) and 2 mg
drospirenone.
Excipient with known effect: 48.2 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablet.
Medium red, round tablet with convex faces, one side embossed with the
letters DL in a regular
hexagon.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in
postmenopausal
women more than 1 year post menopause.
Prevention
of
postmenopausal
osteoporosis
in
women
with
an
increased
risk
of
future
osteoporosis fractures. (See also section 4.4)
The experience treating women older than 65 years is limited.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Women who do not take hormone replacement therapy (HRT) or women who
change from
another continuous combined product may start treatment at any time.
Women changing from
a
cyclic,
sequential
combined
HRT
regimen,
treatment
should
begin
the
day
following
completion of the prior regimen.
Posology
One tablet is taken daily. Each blister is for 28 days of treatment.
Method of administration
The tablets are to be swallowed whole with some liquid irrespective of
food intake. Treatment is
continuous, which means that the next pack follows immediately without
a break. The tablets
should preferably be taken at the same time every day. If a tablet is
forgotten it should be taken
as soon as possible. If more than 24 hours have elapsed no extra
tablet needs to be taken. If
several tablets are forgotten, vaginal bleeding may occur.
For treatment of post menopausal symptoms, the lowest effective dose
should be used.
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest effective
dose for the shortest duration (see also section 4.4) should be used.
ADDITIONAL INFORMATION ON SPECIAL POPULATIONS
Paediatric population
Angeliq is not indicated for