Microlite 100/20 microgram Tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Ethinylestradiol; Levonorgestrel

Saatavilla:

Bayer Limited

ATC-koodi:

G03AA; G03AA07

INN (Kansainvälinen yleisnimi):

Ethinylestradiol; Levonorgestrel

Annos:

100/20 microgram(s)

Lääkemuoto:

Tablet

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

Progestogens and estrogens, fixed combinations; levonorgestrel and ethinylestradiol

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

1998-04-03

Pakkausseloste

BP22055, REC30965
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MICROLITE
® 100/20 MICROGRAM 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 Microlite is and what it is used for
2.
What you need to know before you take Microlite
3.
How to take Microlite
4.
Possible side effects
5.
How to store Microlite
6.
Contents of the pack and other information
1.
WHAT MICROLITE IS AND WHAT IT IS USED FOR
•
Microlite contains a small amount of two different female hormones,
namely levonorgestrel, a
progestogen, and ethinylestradiol, an estrogen.
•
Microlite is a contraceptive pill and is used to prevent pregnancy.
•
Contraceptive pills that contain two hormones are called 'combination'
pills. Microlite is called a
‘low-dose’ contraceptive pill because it contains only a small
amount of hormones.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MICROLITE
GENERAL NOTES
Before you start using Microlite you should read the information on
blood clots in section 2. It is
partic

Valmisteyhteenveto

Health Products Regulatory Authority
21 November 2022
CRN00D8K3
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Microlite 100/20 microgram Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 micrograms Levonorgestrel and 20 micrograms
Ethinylestradiol.
Excipients with known effect
Each tablet contains lactose monohydrate 35.19 mg and sucrose 19.374
mg.
Please see section 4.4 for further information.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet (Tablet).
Pink coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Microlite should take into consideration the
individual woman’s current risk factors, particularly those
for venous thromboembolism (VTE), and how the risk of VTE with
Microlite 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 Microlite _
_ _
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.
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 after the last coated tablet and may not have
finished before the next pack is started.
_How to start Microlite_
_ _

_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). Starting on days
2-5 is allowed but during the first cycle a barrier method is
recommended in addition for the first 7 days of tablet-taking.

_Changing from a combined hormonal contraceptive (combined oral
contraceptive/CO