Logynon Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levonorgestrel; Ethinylestradiol; Ethinylestradiol; Levonorgestrel; Levonorgestrel

Available from:

PCO Manufacturing Ltd.

ATC code:

G03AB; G03AB03

INN (International Name):

Levonorgestrel; Ethinylestradiol; Ethinylestradiol; Levonorgestrel; Levonorgestrel

Dosage:

milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Progestogens and estrogens, sequential preparations; levonorgestrel and ethinylestradiol

Authorization status:

Authorised

Authorization date:

2013-07-19

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
LOGYNON
® TABLETS
levonorgestrel and ethinylestradiol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others.
It may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side
effects
not listed in this leaflet, please tell your doctor or pharmacist.
IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES
(CHCS):

They are one of the most reliable reversible methods of contraception
if
used correctly

They slightly increase the risk of having a blood clot in the veins
and
arteries, especially in the first year or when restarting a combined
hormonal contraceptive following a break of 4 or more weeks

Please be alert and see your doctor if you think you may have
symptoms of a blood clot (see section 2 “Blood clots”)
WHAT IS IN THIS LEAFLET:
1.
What Logynon is and what it is used for
2.
What you need to know before you take Logynon
3.
How to take Logynon
4.
Possible side effects
5.
How to store Logynon
6.
Further information
1.
WHAT LOGYNON IS AND WHAT IT IS USED FOR

Logynon is a contraceptive pill and is used to prevent pregnancy.

Each tablet contains a small amount of two different female hormones,
namely levonorgestrel and ethinylestradiol.

Contraceptive pills that contain two hormones are called
‘combined’
pills.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOGYNON
General notes
Before you start using Logynon you should read the information on
blood
clots in section 2. It is particularly important to read the symptoms
of a blood
clot – see Section 2 “Blood clots”.
Before you can begin taking Logynon, your doctor will ask you some
questions about your personal health history and that of your close
relatives.
The doctor will also measure yo

Summary of Product characteristics

Health Products Regulatory Authority
03 October 2019
CRN00977H
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
Excipient(s) with known effect: Each tablet contains lactose and
sucrose.
_For the full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Coated tablet
_Product imported from the UK_:
Calendar pack containing 6 round light brown sugar-coated tablets, 5
round white sugar-coated tablets and 10 round
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
Tablet core:
Lactose
Maize Starch
Povidone
Magnesium stearate (E572)
Talc
Tablet coating:
Sucrose
Polyethylene glycol 6000
Calcium carbonate (E170)
Talc
Montan glycol wax
Glycerin (E422)
Health Products Regulatory Authority
03 October 2019
CRN00977H
Page 2 of 2
Titanium dioxide (E171)
Ferric oxide pigment (red and yellow) (E172)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
container and outer package of the product in the country of
origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30 °C.
6.5 NATURE AND CONTENTS OF CONTAINER
Logynon tablets are contained in blister packs. Each calendar-blister
contains 6 light brown sugar-coated tablets, 5 white
sugar-coated tablets and 10 ochre-coloured sugar-coated tablets.
Presentation
Carton containing 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 HOLDE