DIANE 35

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

CYPROTERONE ACETATE; ETHINYLESTRADIOL

Dostopno od:

BAYER ISRAEL LTD

Koda artikla:

G03HB01

Farmacevtska oblika:

TABLETS

Sestava:

ETHINYLESTRADIOL 35 MCG; CYPROTERONE ACETATE 2 MG

Pot uporabe:

PER OS

Tip zastaranja:

Required

Izdeluje:

BAYER AG, GERMANY

Terapevtska skupina:

CYPROTERONE AND ESTROGEN

Terapevtsko območje:

CYPROTERONE AND ESTROGEN

Terapevtske indikacije:

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.

Datum dovoljenje:

2023-05-31

Navodilo za uporabo

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
Diane 35
Tablets
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,
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.
Diane 35 is not intended for use in adolescent girls who have not yet
begun menstruating.
Only take Diane 35 to treat acne if topical treatment or antibiotics
have not worked.
Therapeutic group: Diane 35 belongs to a group of medicines called
estrogens and
antiandrogens.
Androgens are hormones that stimulate hair growth and activity of the
sebaceous glands in
your skin. If your body produces too much androgen, or if you are
sensitive to the effect of
androgens, the sebaceous glands may produce too much sebum. As a
result, the sebaceous
glands may become blocked, infected and inflamed, causing acne spots.
Diane 35 stops the
androgens affecting your skin and reduces the amount of androgens
produced.
Although Diane 35 also acts as a contraceptive, it is not intended
only as a contraceptive,
unless your doctor has instructed you to use the medicine to treat
skin problems such as
acne, very oily skin and excessive hair growth in women of
reproductive age.
If you are taking Diane 35 to treat your skin, do not use another
ho

Lastnosti izdelka

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