MICROGYNON 30

国: イスラエル

言語: 英語

ソース: Ministry of Health

有効成分:

ETHINYLESTRADIOL; LEVONORGESTREL

から入手可能:

BAYER ISRAEL LTD

ATCコード:

G03AA

医薬品形態:

COATED TABLETS

構図:

LEVONORGESTREL 150 MCG; ETHINYLESTRADIOL 30 MCG

投与経路:

PER OS

処方タイプ:

Required

製:

BAYER AG, GERMANY

治療群:

PROGESTOGENS AND ESTROGENS, FIXED COMBINATIONS

適応症:

Oral contraceptive.

承認日:

2022-07-31

情報リーフレット

22
Description
MICROGYNON
Size
103x38 mm
(W) x (H)
Customer
Font
(type
& min.
size /
language)
BayerSans 7 p (eng)
Arial 7 p (heb)
89520002_template_01.pdf
Arial 7 p (arb)
Color
BLACK (inside pages)
Type
LEAFLET
Pantone 368 c
Date
02/08/23
Artwork operator
Sima Agam_Oso Bayo Studio
Job no
.
SO23000703
Technical reference
MICROGYNON
® 30
LEVONORGESTREL 0.15 MG
ETHINYLESTRADIOL 0.03 MG
89520002
1
MICROGYNON 30
1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
MICROGYNON
® 30
Film-coated Tablets
2
Each tablet contains:
levonorgestrel 0.15 mg
ethinylestradiol 0.03 mg
Inactive and allergenic ingredients: see section 6 “Further
information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THIS
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.
3
ESSENTIAL INFORMATION ABOUT COMBINED HORMONAL CONTRACEPTIVES AND ABOUT
THE MEDICINE
When used correctly, 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
after a break of
4 or more weeks.
Be alert and refer to a doctor if you think you have symptoms of a
blood clot (see “Blood
clots” in section 2).
4
When taken for an extended period, oral contraceptive pills may reduce
your risk of cancer of
the ovaries and womb.
Oral contraceptive pills do not protect against sexually transmitted
diseases such as AIDS
(HIV) or chlamydia; only a condom can help with this.
This medicine may increase your risk of effects such as blood clots
and breast cancer.
There are some women for whom oral contrace

製品の特徴

1.
NAME OF THE MEDICINAL PRODUCT
Microgynon 30
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Actives:
Levonorgestrel
150 mcg
Ethinylestradiol
30 mcg
Excipients:
Lactose monohydrate
32.820 mg
Sucrose
19.371 mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Sugar-coated tablets
Each tablet is beige
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Microgynon 30 should take into consideration
the individual
woman’s current risk factors, particularly those for venous
thromboembolism (VTE), and
how the risk of VTE with Microgynon 30 compares with other combined
hormonal
contraceptives (CHCs) (see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Tablets must be taken orally in the order directed on the blister
package at about the same time
every day, with some liquid if necessary.
_ _
_First treatment cycle: _
1 tablet daily 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 Microgynon 30 is continued after a
7-day
tablet-free interval, beginning on the same day of the week as the
first pack. A
withdrawal bleed usually occurs during the tablet-free interval.
_ _
_Changing from 21-day combined oral contraceptives: _
The first tablet of Microgynon 30
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): _
2
Microgynon 30 should be started after taking the last active tablet
from the Every Day Pill
pack. The first Microgynon 30 tablet is taken the next day. Additional
contraceptive
precautions are not then required.
_Changing from a progestogen-only pill (POP): _
The first tablet of Microgynon 30 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