Logynon Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
28-02-2023
Summary of Product characteristics
(SPC)
21-11-2022
Active ingredient:
Levonorgestrel micronized; Levonorgestrel micronized; Levonorgestrel micronized; Ethinylestradiol micronized; Ethinylestradiol micronized
Available from:
Bayer Limited
ATC code:
G03AB; G03AB03
INN (International Name):
Levonorgestrel micronized; Levonorgestrel micronized; Levonorgestrel micronized; Ethinylestradiol micronized; Ethinylestradiol micronized
Dosage:
percent volume/volume
Pharmaceutical form:
Coated tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Progestogens and estrogens, sequential preparations; levonorgestrel and ethinylestradiol
Authorization status:
Marketed
Authorization date:
1981-08-26
Patient Information leaflet
BP22046_REC30885
PACKAGE LEAFLET: INFORMATION FOR THE USER
LOGYNON
® TABLETS
levonorgestrel and ethinylestradiol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
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 only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
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.
Contents of the pack and other information
1.
WHAT LOGYNON IS AND WHAT IT IS USED FOR
•
Logynon contains a small amount of two different female hormones,
namely levonorgestrel, a
progestogen, and ethinylestradiol, an estrogen.
•
Logynon is a contraceptive pill and is used to prevent pregnancy.
•
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
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
21 November 2022
CRN00D8K3
Page 1 of 16
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 with known effect:
Each tablet contains 33 mg lactose monohydrate.
Each tablet contains 19 mg sucrose.
Please see section 4.4 for further information.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet.
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
4.1 THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Logynon should take into consideration the
individual woman's current risk factors, particularly those
for venous thromboembolism (VTE), and how the risk of VTE with Logynon
compares with other combined hormonal
contraceptives (CHCs) (see sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_How to take Logynon_
Combined oral contraceptives, when taken correctly, have a failure
rate of approximately 1% per year. The failure rate may
increase when pills are missed or taken incorrectly.
The memo-pack contains 21 tablets. Tablet-taking is always started
from the section marked “Start” and then continued daily
inthe direction of the arrows.
Health Products Regulatory Authority
21 November 2022
CRN00D8K3
Page 2 of 16
Tablets must be taken in the order directed on the package every day
at about the same time with some liquid as needed. One
tablet is to be taken daily for 21 consecutive days. Each subsequent
pack is started after a 7‑day tablet-free interval, during
which time a withdrawal bleed usually occurs. This usually starts on
day 2‑3
Read the complete document
