LOETTE ethinylestradiol / levonorgestrel tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
ethinylestradiol,levonorgestrel
Available from:
Pfizer Australia Pty Ltd
INN (International Name):
ethinylestradiol,Levonorgestrel
Authorization status:
Registered
Patient Information leaflet
LOETTE
®
_Levonorgestrel and Ethinylestradiol Tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Loette.
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
Loette against the benefits this
medicine is expected to have for you.
IF YOU HAVE ANY QUESTIONS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT LOETTE IS USED
FOR
Loette is an oral contraceptive,
commonly known as a "birth control
pill" or "the Pill". Loette tablets
contain two hormones
(levonorgestrel and ethinylestradiol),
which prevent you from becoming
pregnant if taken correctly. They are
similar to the hormones that your
body normally produces.
Loette prevents pregnancy in several
ways:
•
It inhibits the egg release by
stopping it maturing
•
It changes the cervical mucus
consistency making it difficult for
the sperm to reach the egg
•
It changes the lining of the uterus
making it less suitable for
implantation.
Loette is also used to treat moderate
acne in women when this has not
improved with acne treatments
applied to the skin and who are also
willing to be on a contraceptive.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY LOETTE HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Loette for another reason.
This medicine is available only with
a doctor's prescription.
Loette is not habit-forming.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
BEFORE YOU TAKE LOETTE
_WHEN YOU MUST NOT TAKE_
_LOETTE_
DO NOT TAKE LOETTE IF YOU HAVE AN
ALLERGY TO:
•
Any medicine containing
ethinylestradiol or levonorgestrel
•
Any of the ingredients listed at
the end of this leaflet
•
Any other similar medicines
(such as other oral
contraceptives).
Some of the symptoms of an allergic
reaction may include:
•
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Summary of Product characteristics
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AUSTRALIAN PRODUCT INFORMATION -
LOETTE
(LEVONORGESTREL AND
ETHINYLESTRADIOL) TABLETS
1. NAME OF THE MEDICINE
Levonorgestrel and Ethinylestradiol
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pink tablet contains levonorgestrel 100
g and ethinylestradiol 20
g.
Each white tablet contains no active ingredients.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients, see section 6.1, List of Excipients.
3. PHARMACEUTICAL FORM
Tablet, film coated.
.
Pink tablet: Round, pink, biconvex, film coated tablets with "W"
debossed on one side and "912"
debossed on the other side.
White tablet: White film-coated round tablet with convex faces.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
LOETTE is indicated for:
The prevention of pregnancy.
The treatment of moderate acne vulgaris not controlled with topical
preparations in post-menarchal,
pre-menopausal women who accept contraception.
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4.2 DOSE AND METHOD OF ADMINISTRATION
HOW TO TAKE LOETTE
Each package of LOETTE contains 21 active pink tablets and 7 white
inactive tablets.
To achieve maximum contraceptive effectiveness, LOETTE must be
administered as directed and
at the same time every day, at intervals not exceeding 24 hours. The
recommended dose for the
prevention of pregnancy and the treatment of acne is the same.
Where poor compliance is a concern, an oral contraceptive with higher
levels of estrogens and
progestogens should be considered (see section 5.1, Pharmacodynamic
Properties, Clinical Trials).
HOW TO START LOETTE
_NO PRECEDING HORMONAL CONTRACEPTIVE USE (IN THE PAST MONTH) _
On the first day of the menstrual cycle, i.e. the first day of
bleeding, the woman is instructed to take
a pink active tablet corresponding to that day of the week from the
pink shaded section of the
LOETTE pack. Thereafter, one pink active tablet is taken daily,
following the arrows marked on
the package, until all 21 pin
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