Loette

Ülke: Yeni Zelanda

Dil: İngilizce

Kaynak: Medsafe (Medicines Safety Authority)

Aktif bileşen:

Ethinylestradiol 20ug; Levonorgestrel 100ug; Ethinylestradiol 0.02mg; Levonorgestrel 0.1mg

Mevcut itibaren:

Pfizer New Zealand Limited

INN (International Adı):

Ethinylestradiol 20 µg

Farmasötik formu:

Film coated tablet

Kompozisyon:

Active: Ethinylestradiol 20ug Levonorgestrel 100ug Excipient: Glycol montanate Lactose monohydrate Macrogols Magnesium stearate Microcrystalline cellulose Opadry pink YS-1-14587-A Polacrilin potassium Glycol montanate Lactose monohydrate Macrogol 1500 Magnesium stearate Microcrystalline cellulose Opadry white Y-5-18024-A Polacrilin potassium AquaPolish P white 010.66 Magnesium stearate StarLac Active: Ethinylestradiol 0.02mg Levonorgestrel 0.1mg Excipient: Wax E Pharma Lactose Magnesium stearate Microcrystalline cellulose Opadry pink YS-1-14587-A Polacrilin potassium Polyethylene glycol 1450 Purified water Wax E Pharma Lactose Macrogol 1500 Magnesium stearate Microcrystalline cellulose Opadry white Y-5R-18024-A Polacrilin potassium Purified water

Paketteki üniteler:

Calendar pack, PVC/AL 1x28 tablets starter pack, 28 tablets

Sınıf:

Prescription

Reçete türü:

Prescription

Tarafından üretildi:

Bayer AG

Terapötik endikasyonlar:

LOETTE is indicated for the prevention of pregnancy.

Ürün özeti:

Package - Contents - Shelf Life: Calendar pack, PVC/AL 1x28 tablets starter pack Pfizer Ireland - 28 tablets - 24 months from date of manufacture stored at or below 25°C - Calendar pack, PVC/AL 1x28 tablets starter pack inside Al foil pouch with desiccant Haupt Pharma Munster GmbH - 28 tablets - 24 months from date of manufacture stored at or below 25°C - Calendar pack, PVC/AL 3x28 tablets Pfizer Ireland - 84 tablets - 24 months from date of manufacture stored at or below 25°C - Calendar pack, PVC/AL 3x28 tablets inside Al foil pouch with desiccant Haupt Pharma Munster GmbH - 84 tablets - 24 months from date of manufacture stored at or below 25°C

Yetkilendirme tarihi:

1996-12-13

Bilgilendirme broşürü

LOETTE
®
PAGE 1 OF 8
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.
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:

shortness of breath

wheezing or difficulty
breathing

swelling of the face, lips,
tongue or other parts of the
body

rash, itching

Ürün özellikleri

Version: pfdloett11118
Supersedes: pfdloett10518
Page 1 of 18
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
LOETTE

20 µg and 100 µg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 µg Ethinylestradiol and 100 µg
Levonorgestrel
Excipients with known effects:
•
Lactose monohydrate
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Each LOETTE calendar blister pack contains 21 pink active tablets and
7 white inactive tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
LOETTE is indicated for the prevention of pregnancy.
4.2 DOSE AND METHOD OF ADMINISTRATION
HOW TO TAKE LOETTE
To achieve maximum contraceptive effectiveness, LOETTE must be
administered as directed and
at the same time every day, at intervals not exceeding 24 hours.
HOW TO START LOETTE
Each package of LOETTE contains 21 active pink tablets and 7 white
inactive tablets.
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 pink active tablets have been taken. The
woman is then instructed to
take one white inactive tablet daily for the next seven days following
the arrows marked on the
LOETTE pack. Withdrawal bleeding should usually occur within 2 to 4
days after the last pink
active tablet is taken.
LOETTE is effective from the first day of therapy if the tablets are
begun on Day 1 as described.
Starting on Days 2-7 is allowed, but during the first cycle a back-up
method of contraception is
recommended for the first 7 days of tablet taking.
Version: pfdloett11118
Supersedes: pfdloett10518
Page 2 of 18
The back-up method of contraception must be an additional non-hormonal
barrier method such as
condoms or a diaphragm with a spermicide. Back-up contraception does
not include