Levlen ED

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Ethinylestradiol 30ug; Levonorgestrel 150ug

Disponible desde:

Bayer New Zealand Limited

Designación común internacional (DCI):

Ethinylestradiol 30 µg

formulario farmacéutico:

Tablet

Composición:

Active: Ethinylestradiol 30ug Levonorgestrel 150ug Excipient: Calcium carbonate Glycerol Glycol montanate Iron oxide yellow Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Povidone   Purified talc   Sucrose Titanium dioxide Calcium carbonate Glycol montanate Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Povidone   Purified talc   Sucrose

Unidades en paquete:

Blister pack, 1 x 28 physician sample, 28 tablets

clase:

Prescription

tipo de receta:

Prescription

Fabricado por:

Bayer AG

indicaciones terapéuticas:

Oral contraception.

Resumen del producto:

Package - Contents - Shelf Life: Blister pack, 1 x 28 physician sample - 28 tablets - 60 months from date of manufacture stored at or below 25°C - Blister pack, 3 x 28 - 84 tablets - 60 months from date of manufacture stored at or below 25°C

Fecha de autorización:

1997-02-25

Información para el usuario

NZ LEVLEN ED CMI VX1.0
1
LEVLEN
® ED
(LEV
⋅
LEN EE
⋅
DEE)
Contraceptive tablets for women
_ethinylestradiol and levonorgestrel_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about Levlen
ED. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
Levlen ED against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS, OR ARE
UNSURE ABOUT TAKING THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST FOR MORE ADVICE.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT LEVLEN ED IS
USED FOR
Levlen ED is a combined oral
contraceptive, commonly known
as a ‘birth control pill’ or ‘the
Pill’.
Levlen ED is used to prevent
pregnancy.
You may also experience the
following benefits:
•
more regular and lighter periods
– potentially resulting in a
decrease in anaemia (iron
deficiency)
•
a decrease in period pain.
Some conditions such as pelvic
inflammatory disease, ovarian cysts,
ectopic pregnancy (where the foetus
is carried outside of your womb),
lumpy breasts, acne and cancer of
the uterus (womb) and ovaries may
be less common in women taking
the Pill.
When taken correctly, Levlen ED
prevents you from
becoming pregnant in several ways,
including:
•
inhibiting ovulation (egg release)
•
changing the cervical mucus
consistency, making it more
difficult for the sperm to reach the
egg
•
changing the lining of the uterus,
making it less suitable for
implantation.
When the Pill is taken by women
under close observation in clinical
trials, it is more than 99% effective
in preventing pregnancy. However,
in real life the Pill is around 92%
effective. This is because pills might
have been missed, may have been
taken with medicines that interfere
with their effectiveness, or may not
be absorbed due to vomiting or
diarrhoea.
Like all oral contraceptives, Levlen
ED is intended to preven

Ficha técnica

LEVLEN DS VX1.0
1
DATA SHEET
1.
LEVLEN® ED
Levlen ED 30 micrograms ethinylestradiol and 150 micrograms
levonorgestrel tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One active tablet contains 30 micrograms ethinylestradiol and 150
micrograms
levonorgestrel. Each blister pack contains 21 active tablets and 7
hormone-free tablets.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sugar-coated tablets
The active tablets are beige, biconvex, round and 5.7mm in diameter.
The hormone-free
tablets are white, biconvex, round and 6.8mm in diameter.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Oral contraception.
4.2.
DOSE AND METHOD OF ADMINISTRATION
Combined oral contraceptives (COCs), such as Levlen ED, when taken
correctly, have a
failure rate of approximately 1% per year. The failure rate may
increase when pills are
missed or taken incorrectly.
_HOW TO TAKE LEVLEN ED _
Tablets must be taken in the order directed on the package every day
at about the same time
with some water as needed. Tablet-taking is continuous following the
directional arrows. One
tablet is to be taken daily for 28 consecutive days. Each subsequent
pack is started the day
after the last tablet of the previous pack. Withdrawal bleeding
usually starts on day 2 - 3 after
starting the white hormone-free tablets and may not have finished
before the next pack is
started.
_HOW TO START LEVLEN ED _
START WITH THE FIRST TABLET FROM THE GREEN SECTION MARKED WITH THAT
DAY OF THE WEEK, in accordance with one of the following:
No preceding hormonal contraceptive use (in the past month)
Tablet-taking has to start on day 1 of the woman’s natural cycle
(i.e. the first day of her
menstrual bleeding). Starting on days 2 - 5 of the menstrual cycle is
allowed, but during the
LEVLEN DS VX1.0
2
first cycle an additional barrier contraceptive method is recommended
for the first 7 days of
tablet-taking._ _
Changing from another combined oral contraceptive (COC), vaginal ring
or transdermal
patch
The woman should start with Levlen ED