Logynon Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levonorgestrel; Ethinylestradiol; Ethinylestradiol; Levonorgestrel; Levonorgestrel

Available from:

IMED Healthcare Ltd.

ATC code:

G03AB; G03AB03

INN (International Name):

Levonorgestrel; Ethinylestradiol; Ethinylestradiol; Levonorgestrel; Levonorgestrel

Dosage:

*** AWAITING VALUE ***

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:

2012-10-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LOGYNON® TABLETS
LEVONORGESTREL/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 your blood pressure, and de

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
Excipient(s) with known effect
Lactose and sucrose.
For the 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
Macrogol 6000
Calcium carbonate (E170)
Talc
Montan glycol wax
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_2_
_7_
_/_
_0_
_6_
_/_
_2_
_0_
_1_
_8_
_C_
_R_
_N_
_ _
_2_
_2_
_0_
_8_
_7_
_3_
_4_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
Glycerin (E422)
Titanium dioxide (E171)
Ferric oxide pigment yellow (E172)
Ferric oxide pigment red (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 on the
market in the country of origin.
6.4 SPECIAL PRECA