ANDROCUR 10

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CYPROTERONE ACETATE

Available from:

BAYER ISRAEL LTD

ATC code:

G03HA01

Pharmaceutical form:

TABLETS

Composition:

CYPROTERONE ACETATE 10 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

BAYER WEIMAR GMBH UND CO.KG, GERMANY

Therapeutic group:

CYPROTERONE

Therapeutic area:

CYPROTERONE

Therapeutic indications:

Treatment of pronounced signs of virilisation in women, which make hormone therapy necessary:• severe forms of acne, when it is accompanied by inflammation and the formation of nodes (Acne papulopustulosa, Acne nodulocystica) or if there is a risk of scarring,• moderate to severe forms of hirsutism,• moderate to severe forms of androgenic alopecia.Cyproterone acetate 10 mg is indicated for pronounced signes of virilisation in women, which make hormone therapy necessary if satisfactory results could not be obtained with medicinal products containing low-dose cyproterone or with other treatment options. When treating acne, hormone treatment should be weighed against systemic antibiotic treatment

Authorization date:

2020-09-30

Patient Information leaflet

PACKAGING TECHNOLOGY BERLIN SHNEB
page 3
Bayer AG
client: JS86
material-no.: 87994953
PZ: 2589W-3B
code-no.:
name: LF-INS-ANDROCUR 10MG TAB IL
country: IL/-/BPH
colors: BLACK
version: 17.06.2021/02
Restricted Document
dimension: 297 X 594 MM
87994953
87994953
ANDROCUR
® 10
EACH TABLET CONTAINS:
Cyproterone acetate 10 mg
Inactive ingredients and allergens: see section 6 “Further
Information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet
contains concise information about the medicine. If you have further
questions, refer
to the doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them even if it seems to you that their condition is similar.
The medicine is not intended for children and adolescents before
completion of puberty.
ESSENTIAL INFORMATION ABOUT ANDROCUR 10:
This section mentions the most essential information about treatment
with Androcur
10, summarized from the leaflet. Even if you do not carefully read the
entire leaflet,
be sure to carefully read this short section:
• Use Androcur 10 in combination with a medicine that contains
estrogen or an
estrogen-progesterone combination.
• A treatment cycle is 21 days long. On the first day, start
treatment with Androcur
10 together with a medicine that contains estrogen or an
estrogen-progesterone
combination for 15 days. After 15 days, Androcur 10 treatment will end
and you will
have to continue treatment with a medicine that contains estrogen or
an estrogen-
progesterone combination for 6 additional days. After completion of
the treatment
cycle, you will have to stop treatment for 7 days, during which
bleeding is expected
to occur. Begin the next treatment cycle after the 7-day break,
irrespective of bleeding
(see section 3 “How should you use the medicine?”).
• Do not use Androcur 10 as an exclusive contraceptive (see
“Special warnings regarding
use of the medicine” in section 2).
1) WHAT IS THE MEDICINE INTENDED FOR?
Androcur 10 is intended for anti

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Androcur 10
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Cyproterone acetate
One tablet contains 10 mg cyproterone acetate (CPA).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to pale yellow tablets with a breaking score line on one side
and embossed with ‘BW’
in a regular hexagon on the other. The score line is to break the
tablet for ease of
swallowing; not to divide the tablet into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of pronounced signs of virilisation in women, which make
hormone
therapy necessary:
• severe forms of acne, when it is accompanied by inflammation and
the formation
of nodes (Acne papulopustulosa, Acne nodulocystica) or if there is a
risk of
scarring,
• moderate to severe forms of hirsutism,
• moderate to severe forms of androgenic alopecia.
Cyproterone acetate 10 mg is indicated for pronounced signs of
virilisation in women, which
make hormone therapy necessary if satisfactory results could not be
obtained with
medicinal products containing low-dose cyproterone or with other
treatment options. When
treating acne, hormone treatment should be weighed against systemic
antibiotic treatment
4.2
POSOLOGY AND METHOD oF ADMINISTRATION
_Method of administration _
Oral administration
_Dosage _
Pregnant women may not take Androcur. Consequently, pregnancy has to
be excluded
prior to the start of therapy (see section 4.4). Androcur 10 mg has to
be used in
combination with a suitable oestrogen or a suitable
progestogen-oestrogen combination
(combined oral contraceptive ‘pill’), in order to ensure necessary
contraceptive protection
and to avoid irregular bleeding.
This combination therapy shall be carried out as follows:
Both products have to be started on day 1 of the cycle (day 1 of
menstruation).
One Androcur 10 mg tablet has to be taken daily from day 1 to day 15
of the combination
therapy. Additionally, from day 1 to day 21, a suitable oestrogen or a
suitable progest