Logynon Tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Levonorgestrel; Ethinylestradiol; Ethinylestradiol; Levonorgestrel; Levonorgestrel

זמין מ:

Imbat Limited

קוד ATC:

G03AB; G03AB03

INN (שם בינלאומי):

Levonorgestrel; Ethinylestradiol; Ethinylestradiol; Levonorgestrel; Levonorgestrel

כמות:

*** AWAITING VALUE ***

טופס פרצבטיות:

Tablet

סוג מרשם:

Product subject to prescription which may be renewed (B)

איזור תרפויטי:

Progestogens and estrogens, sequential preparations; levonorgestrel and ethinylestradiol

מצב אישור:

Authorised

תאריך אישור:

2014-07-04

עלון מידע

T: INFORMATION FOR THE USER
GYNON
® TABLETS
estradiol / levonorgestrel)
ble using the name Logynon Tablets
as Logynon throughout this leaflet.
EAFLET CAREFULLY BEFORE YOU
MEDICINE.
You may need to read it again.
urther questions, ask your doctor or
s been prescribed for you. Do not pass it
ay harm them, even if their symptoms
yours.
effects gets serious, or if you notice
ot listed in this leaflet, please tell your
cist.
O KNOW ABOUT COMBINED HORMONAL
CS):
he most reliable reversible methods of
sed correctly
ease the risk of having a blood clot in
eries, especially in the first year or
combined hormonal contraceptive
of 4 or more weeks
d see your doctor if you think you may
f a blood clot (see section 2 "Blood
AFLET:
and what it is used for
know before you take Logynon
non
ts
non
ack and other information
N IS AND WHAT IT IS USED FOR
raceptive pill and is used to prevent
ins a small amount of two different
, namely levonorgestrel and
s that contain two hormones are called
ED TO KNOW
BEFORE YOU TAKE
Logynon you should read the
ots in section 2. It is particularly
symptoms of a blood clot – see section
aking Logynon, your doctor will ask you
your personal health history and that of
he doctor will also measure your blood
ng upon your personal situation, may
her tests for example a breast exam or
opriate.
situations are described where you
non, or where the reliability of Logynon
such situations you should either not
d take extra non-hormonal
ons, e.g., use a condom or another
t use rhythm or temperature methods.
unreliable because Logynon alters the
dy temperature and of cervical mucus.
combined oral contraceptives have a
mately 1% per year. The failure rate
s are missed or taken incorrectly, if you
or when you take certain other
medies.
HORMONAL CONTRACEPTIVES, DOES NOT
INFECTION (AIDS) OR ANY OTHER DISEASE.
OGYNON
gynon if you have any of the conditions
have any of the conditions listed below

if you need an operation, or you are off your feet for a
long time (see in section 2 "Blood clots")

if you have j

מאפייני מוצר

Health Products Regulatory Authority
03 October 2019
CRN0093FN
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Logynon Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH LIGHT BROWN TABLET CONTAINS:
Ethinylestradiol 30 micrograms
Levonorgestrel 50 micrograms
EACH WHITE TABLET CONTAINS:
Ethinylestradiol 40 micrograms
Levonorgestrel 75 micrograms
EACH OCHRE-COLOURED TABLET CONTAINS:
Ethinylestradiol 30 micrograms
Levonorgestrel 125 micrograms
Excipients of known effect: lactose and sucrose – see leaflet for
further information.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet.
_Product imported from the UK:_
Each calendar blister contains 6 light brown sugar-coated tablets, 5
white sugar-coated tablets and 10 ochre-coloured
sugar-coated tablets.
4 CLINICAL PARTICULARS
As per PA1410/005/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1410/005/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
lactose
maize starch
povidone
talc
sucrose
magnesium stearate (E572)
polyethylene glycol 6000
calcium carbonate (E170)
glycerin (E422)
titanium dioxide (E171)
ferric oxide pigment yellow (E172)
ferric oxide pigment red (E172)
montan glycol wax
6.2 INCOMPATIBILITIES
Health Products Regulatory Authority
03 October 2019
CRN0093FN
Page 2 of 2
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the blister strips and outer carton of the product as marked
in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard outer containing blister strips.
Pack size: 1 x 21 tablets
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Imbat Limited
Unit L2
North Ring Business Park
Santry
Dublin 9
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1151/218/001
9 DATE OF FIRST AUTHORISATION/