LIOFORA 3.0/0.020 Milligram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
27-04-2024
Summary of Product characteristics
(SPC)
27-04-2024
Active ingredient:
DROSPIRENONE ETHINYLESTRADIOL
Available from:
Bayer Limited
INN (International Name):
DROSPIRENONE ETHINYLESTRADIOL
Dosage:
3.0/0.020 Milligram
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization date:
0000-00-00
Patient Information leaflet
Liofora PIL
Page:
1 of
19
Liofora PL, clean version, July 2014.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Liofora 0.02 mg / 3 mg film-coated tablets
Ethinylestradiol / Drospirenone
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. _
_ _
_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”). _
IN THIS LEAFLET
1.
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WHAT LIOFORA IS AND WHAT IT IS USED FOR ................................................... 3
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2.
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WHAT YOU NEED TO KNOW BEFORE
YOU TAKE LIOFORA ............................. 3
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When you should
not use Liofora ...................................................................................
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Liofora 0.02 mg/3 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.020 mg ethinylestradiol (as betadex clathrate) and 3 mg drospirenone.
Excipient: lactose 46 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Light pink, round tablet with convex faces, one side embossed with the letters "DS" in a regular hexagon.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Liofora should take into consideration the individual woman’s current risk factors,
particularly those for venous thromboembolism (VTE), and how the risk of VTE with Liofora compares with other
combined hormonal contraceptives (CHCs), see sections 4.3 and 4.4.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: oral use
HOW TO TAKE LIOFORA
The tablets must be taken every day at about the same time, if necessary with a little liquid, in the order shown on the
blister pack. 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 after the last
tablet and may not have finished before the next pack is started.
HOW TO START LIOFORA
•
No preceding hormonal contraceptive use (in the past month)
Tablet-taking has to start on day 1 of the woman’s natural cycle (i.e. the first day of her menstrual bleeding).
•
Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or
transdermal patch)
The woman should start with Liofora preferably on the day after the last active tablet (the last tablet containing the
active sub
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