LOGYNON

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LEVONORGESTREL ; ETHINYLESTRADIOL ; LEVONORGESTREL ; ETHINYLESTRADIOL ; LEVONORGESTREL ; ETHINYLESTRADIOL

Available from:

LTT Pharma Limited

ATC code:

G03AB03

INN (International Name):

LEVONORGESTREL ; ETHINYLESTRADIOL ; LEVONORGESTREL ; ETHINYLESTRADIOL ; LEVONORGESTREL ; ETHINYLESTRADIOL

Dosage:

Unknown

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

levonorgestrel and ethinylestradiol

Authorization status:

Authorised

Authorization date:

2014-10-17

Patient Information leaflet

LOGYNON TABLETS
WHEN TO TAKE SPECIAL CARE WITH LOGYNON
TELL YOUR DOCTOR IF ANY OF THE FOLLOWING CONDITIONS APPLY TO YOU.
In some situations you need to take special care while using Logynon
or any
other combined pill, and it may be necessary that you are regularly
checked
by your doctor. If the condition develops or gets worse while you are
using
Logynon, you should also tell your doctor.
•
if a close relative has had breast cancer
•
if you have liver or gallbladder disease
•
if you have diabetes
•
if you have depression
•
if you have Crohn’s disease or ulcerative colitis (chronic
inflammatory
bowel disease)
•
if you have systemic lupus erythematosus (SLE - a disease affecting
your
natural defence system)
•
if you have haemolytic uraemic syndrome (HUS - a disorder of blood
clotting causing failure of the kidneys)
•
if you have sickle cell anaemia (an inherited disease of the red blood
cells)
•
if you have elevated levels of fat in the blood
(hypertriglyceridaemia) or a
positive family history for this condition. Hypertriglyceridaemia has
been
associated with an increased risk of developing pancreatitis
(inflammation
of the pancreas)
•
if you need an operation, or you are off your feet for a long time
(see in
section 2 ‘Blood clots’)
•
if you have just given birth you are at an increased risk of blood
clots.
You should ask your doctor how soon after delivery you can start
taking
Logynon
•
if you have an inflammation in the veins under the skin (superficial
thrombophlebitis)
•
if you have varicose veins
•
if you have epilepsy (see “Logynon and using other medicines”)
•
if you have a disease that first appeared during pregnancy or with
earlier
use of sex hormones (for example, hearing loss, a blood disease called
porphyria, skin rash with blisters during pregnancy (gestational
herpes), or
a nerve disease causing sudden movements of the body (Sydenham’s
chorea)
•
if you have ever had golden brown pigment patches (chloasma), so
called
“pregnancy patches”, especially on t

Summary of Product characteristics

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: Each tablet also contains lactose and sucrose.
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
Magnesium stearate (E572)
Sucrose
Polyethylene glycol 6000
Calcium carbonate (E170)
Talc
Montan glycol wax
Glycerin (E422)
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Titanium dioxide (E171)
Ferric oxide pigment red (E172)
Ferric oxide pigment yellow (E172)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin