DIANE 35

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CYPROTERONE ACETATE; ETHINYLESTRADIOL

Available from:

BAYER ISRAEL LTD

ATC code:

G03HB01

Pharmaceutical form:

TABLETS

Composition:

ETHINYLESTRADIOL 35 MCG; CYPROTERONE ACETATE 2 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

BAYER WEIMAR GMBH UND CO.KG, GERMANY

Therapeutic group:

CYPROTERONE AND ESTROGEN

Therapeutic area:

CYPROTERONE AND ESTROGEN

Therapeutic indications:

Treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age. For the treatment of acne, Diane-35 should only be used after topical therapy or systemic antibiotic treatments have failed.

Authorization date:

2013-05-31

Patient Information leaflet

PACKAGING TECHNOLOGY BERLIN SGQCL
Bayer AG
client: JS86
material-no.: 88729846
PZ: 2711W-4D
code-no.:
name: LF-BRO DIANE 35 TASC 21
country: IL/MULI/BAG
colors: BLACK /
version: 03.03.2022/01
Restricted Document
dimension: 98 X 31 MM
Page 1
1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
DIANE 35
TABLETS
PACKAGING TECHNOLOGY BERLIN SGQCL
Bayer AG
client: JS86
material-no.: 88729846
PZ: 2711W-4D
code-no.:
name: LF-BRO DIANE 35 TASC 21
country: IL/MULI/BAG
colors: BLACK /
version: 03.03.2022/01
Restricted Document
dimension: 98 X 31 MM
Page 2
2
Each tablet contains:
ethinylestradiol 35 mcg
cyproterone acetate 2 mg
Inactive ingredients and allergens: see section 6 “Further
Information” and section 2
“Important information regarding some of the ingredients of the
medicine”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THIS
MEDICINE. This leaflet
contains concise information about the medicine. If you have further
questions,
PACKAGING TECHNOLOGY BERLIN SGQCL
Bayer AG
client: JS86
material-no.: 88729846
PZ: 2711W-4D
code-no.:
name: LF-BRO DIANE 35 TASC 21
country: IL/MULI/BAG
colors: BLACK /
version: 03.03.2022/01
Restricted Document
dimension: 98 X 31 MM
Page 3
3
consult your doctor or pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may
harm them even if it seems to you that their medical condition is
similar.
1) WHAT IS THE MEDICINE INTENDED FOR?
Diane 35 is a medicine with hormonal activity (estrogenic and
anti-androgenic) and is
intended to treat skin problems such as acne, very oily skin and
excessive hair growth
in women of reproductive age.
PACKAGING TECHNOLOGY BERLIN SGQCL
Bayer AG
client: JS86
material-no.: 88729846
PZ: 2711W-4D
code-no.:
name: LF-BRO DIANE 35 TASC 21
country: IL/MULI/BAG
colors: BLACK /
version: 03.03.2022/01
Restricted Document
dimension: 98 X 31 MM
Page 4
4
Diane 35 is not intended for use in adolescent girls who have

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Diane
®
35
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Actives:
Cyproterone acetate
2.00 mg
Ethinylestradiol
35 micrograms
Excipients:
Lactose monohydrate
30.965mg
Sucrose
19.371 mg
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Sugar-coated tablets.
Beige, round tablet, with convex faces.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of moderate to severe acne related to androgen-sensitivity
(with or without seborrhoea)
and/or hirsutism, in women of reproductive age.
For the treatment of acne, Diane 35 should only be used after topical
therapy or systemic
antibiotic treatments have failed.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_METHOD OF ADMINISTRATION _
Oral use
_DOSAGE REGIMEN _
Diane 35 inhibits ovulation and thereby prevents conception. Patients
who are using Diane 35 should
not therefore use an additional hormonal contraceptive, as this will
expose the patient to an excessive
dose of hormones and is not necessary for effective contraception.
_First treatment course:_
One tablet daily for 21 days, starting on the first day of the
menstrual cycle
(the first day of menstruation counting as Day 1).
_Subsequent courses:_
Each subsequent course is started after 7 tablet-free days have
followed the
preceding course.
2
2
When the contraceptive action of Diane 35 is also to be employed, it
is essential that the above
instructions be rigidly adhered to. Should bleeding fail to occur
during the tablet-free interval, the
possibility of pregnancy must be excluded before the next pack is
started.
When changing from an oral contraceptive and relying on the
contraceptive action of Diane 35, follow
the instructions given below:
_Changing from 21-day combined oral contraceptives:_
The first tablet of Diane 35 should be taken on the first day
immediately after the end of the previous
oral contraceptive course. Additional contraceptive precautions are
not required.
_Changing from a combined Every Day pill (28 day tablets): _
Diane