EVELYN 150/30 ED levonorgestrel 150 microgram and ethinylestradiol 30 microgram tablet blister pack

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

levonorgestrel, Quantity: 150 microgram; ethinylestradiol, Quantity: 30 microgram

Beszerezhető a:

Lupin Australia Pty Limited

INN (nemzetközi neve):

ethinylestradiol,Levonorgestrel

Gyógyszerészeti forma:

Tablet, film coated

Összetétel:

Excipient Ingredients: magnesium stearate; maize starch; lactose monohydrate; pregelatinised maize starch; titanium dioxide; hypromellose; macrogol 400

Az alkalmazás módja:

Oral

db csomag:

4 blisters x 28 tablets (21 active and 7 placebo in each blister), 2 blisters x 28 tablets (21 active and 7 placebo in each blister), 3 blisters x 28 tablets (21 active and 7 placebo in each blister), 1 blister x 28 tablets (21 active and 7 placebo in each blister)

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

ORAL CONTRACEPTION

Termék összefoglaló:

Visual Identification: White to Off-white, round shaped, biconvex film coated tablets, plain on both side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Engedélyezési státusz:

Licence status A

Engedély dátuma:

2014-02-03

Betegtájékoztató

CONSUMER MEDICINE INFORMATION
EVELYN 150/30 ED
(LEVONORGESTREL AND ETHINYLESTRADIOL) FILM-COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about Evelyn
150/30 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
Evelyn 150/30 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 EVELYN 150/30 ED IS
USED FOR
Evelyn 150/30 ED is a combined
oral contraceptive, commonly
known as a ‘birth control pill’ or
‘the Pill’.
Evelyn 150/30 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, Evelyn
150/30 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,
Evelyn 150/30 ED is intended to
prevent pregna

Termékjellemzők

AUSTRALIAN PRODUCT INFORMATION – EVELYN 150/30 ED
(LEVONORGESTREL AND ETHINYLESTRADIOL) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Levonorgestrel and ethinylestradiol.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Evelyn 150/30 ED is a combined oral contraceptive (COC) tablet
containing the synthetic progestogen
levonorgestrel and the synthetic estrogen ethinylestradiol.
Each yellow film-coated active tablet contains 30 micrograms
ethinylestradiol and 150 micrograms
levonorgestrel.
List of excipients with known effects: Lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ACTIVE TABLET:
Yellow, round biconvex film-coated tablets debossed with LE4 on one
side and plain on other side.
PLACEBO TABLET:
White to off-white, round shaped, biconvex film-coated tablets, plain
on both sides.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception.
4.2 DOSE AND METHOD OF ADMINISTRATION
HOW TO TAKE EVELYN 150/30 ED
Combined oral contraceptives (COCs), when taken correctly, have a
failure rate of approximately 1% per
year. The failure rate may increase when pills are missed or taken
incorrectly.
One tablet is to be taken daily. The tablets must be taken in the
order directed on the package at about
the same time every day, with some liquid as needed. Daily
tablet-taking should be continuous for
28 consecutive days, starting with a tablet corresponding to that day
of the week from the coloured
section of the Evelyn 150/30 ED pack.
If a woman starts on a Monday, Tuesday, Wednesday, Thursday or Friday,
her first tablet is a white
placebo one, while if she starts on a Saturday or Sunday her first
tablet will be a yellow active one.
Evelyn 150/30 ED v4
Page 2 of 20
(levonorgestrel and ethinylestradiol) film-coated tablet
Thereafter, one tablet is taken daily, following the arrows marked on
the pack, until all tablets have been
taken. Each subsequent pack is started the day after the last tablet
of the previous pack. Withdrawal
bleeding usually starts on day 2 t