MELIANE

Ülke: İsrail

Dil: İngilizce

Kaynak: Ministry of Health

Aktif bileşen:

ETHINYLESTRADIOL; GESTODENE

Mevcut itibaren:

BAYER ISRAEL LTD

ATC kodu:

G03AA10

Farmasötik formu:

COATED TABLETS

Kompozisyon:

ETHINYLESTRADIOL 0.020 MG; GESTODENE 0.075 MG

Uygulama yolu:

PER OS

Reçete türü:

Required

Tarafından üretildi:

BAYER AG, GERMANY

Terapötik grubu:

GESTODENE AND ESTROGEN

Terapötik alanı:

GESTODENE AND ESTROGEN

Terapötik endikasyonlar:

Oral contraceptive.

Yetkilendirme tarihi:

2021-02-28

Bilgilendirme broşürü

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS)
– 1986
The medicine is dispensed with a doctor’s
prescription only
MELIANE
®
COATED TABLETS
Each tablet contains:
gestodene 0.075 mg
ethinylestradiol 0.02 mg
Inactive ingredients and allergens: See section 2 under "Important
information about
some of this medicine’s ingredients" and
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 is important to take Meliane as instructed
and start each
new strip on time. Please make sure that you understand what to do if
you miss a
pill or if you think you are pregn

Ürün özellikleri

1
Prescribing Information
1.
NAME OF THE MEDICINAL PRODUCT
Meliane
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.075mg gestodene and 0.02mg ethinylestradiol
Excipients with known effect:
Lactose 37.155 mg per tablet.
Sucrose 19.660 mg per tablet.
For the full list of excipients, see section 6.1.
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.
2
_ _
_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.
_ _
_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 ambul