MELIANE

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

ETHINYLESTRADIOL; GESTODENE

Verfügbar ab:

BAYER ISRAEL LTD

ATC-Code:

G03AA10

Darreichungsform:

COATED TABLETS

Zusammensetzung:

ETHINYLESTRADIOL 0.020 MG; GESTODENE 0.075 MG

Verabreichungsweg:

PER OS

Verschreibungstyp:

Required

Hergestellt von:

BAYER PHARMA AG, GERMANY

Therapiebereich:

GESTODENE AND ESTROGEN

Anwendungsgebiete:

Oral contraceptive.

Berechtigungsdatum:

2019-12-08

Gebrauchsinformation

PACKAGING TECHNOLOGY BERLIN SGQCL
page 2
Bayer AG
client: 0021,GV15
material-no.: 87038688
PZ: 2773C-3
code-no.:
name: LF-INS-MELIANE SCT 21
country: IL/-/BPH
colors: BLACK
version: 14.05.2020/01
Restricted Document
dimension: 398 X 798 MM
87038688
MELIANE
®
MELIANE
®
COATED TABLETS
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a
doctor’s prescription only
Each tablet contains:
Gestodene 0.075 mg
Ethinylestradiol 0.02 mg
Inactive ingredients and allergens: See section 6 “Further
Information”.
READ THIS 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 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.
ESSENTIAL INFORMATION ABOUT COMBINED HORMONAL
CONTRACEPTIVES AND ABOUT THE MEDICINE
• When used properly, combined hormonal contraceptives
are considered one of the most reliable reversible methods
of contraception.
• They slightly increase the risk of a blood clot in the veins
and arteries, especially in the first year or when resuming
treatment with a combined hormonal contraceptive
following a break of 4 or more weeks.
• You must be alert and refer to the doctor if you think you
may have symptoms of a blood clot (see “Blood clots” in
section 2).
• If taken for prolonged periods, oral contraceptive pills
may reduce your risk of cancer of the ovaries and womb.
• Contraceptive pills do not protect against sexually
transmitted diseases, such as AIDS or chlamydia. Only a
condom can help with this.
• This medicine can increase your risk of effects such as
blood clots and breast cancer.
• Oral contraceptive pills are not suitable for some women
due to their medical condition. Please read this leaflet to
make sure Meliane is suitable for you.
• To prevent pregnancy, it i

Fachinformation

1
RESTRICTED
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Meliane
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.075mg gestodene and 0.02mg ethinylestradiol
3.
PHARMACEUTICAL FORM
Sugar - coated tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS.
Oral contraception.
The decision to prescribe Meliane should take into consideration the
individual
woman’s current risk factors, particularly those for venous
thromboembolism (VTE),
and how the risk of VTE with Meliane compares with other combined
hormonal
contraceptives (CHCs) (see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION.
_First treatment cycle: _
1 tablet for 21 days, starting on the first day of the menstrual
cycle. Contraceptive protection begins immediately.
_ _
_Subsequent cycles:_
Tablet taking from the next pack of Meliane is continued after a
7-day interval, beginning on the same day of the week as the first
pack.
_ _
_ _
_Changing from 21 day combined oral contraceptives: _
The first tablet of Meliane
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):_
Meliane should be started after taking the last active tablet from the
Every Day Pill
pack. The first Meliane tablet is taken the next day. Additional
contraceptive
precautions are not then required.
_ _
_Changing from a progestogen-only pill (POP):_
The first tablet of Meliane should be taken on the first day of
bleeding, even if a POP
has already been taken on that day. Additional contraceptive
precautions are not then
required. The remaining progestogen-only pills should be discarded.
2
RESTRICTED
_ _
_Post-partum and post-abortum use: _
After pregnancy, oral contraception can be
started 21 days after a vaginal delivery, provided that the patient is
fully ambulant
and there are no puerperal complications. Additional contraceptive
precautions will
be required for the first 7 da