Mylite 100 micrograms / 20 micrograms coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levonorgestrel; Ethinylestradiol

Available from:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC code:

G03AA; G03AA07

INN (International Name):

Levonorgestrel; Ethinylestradiol

Dosage:

100/20 microgram(s)

Pharmaceutical form:

Coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Progestogens and estrogens, fixed combinations; levonorgestrel and ethinylestradiol

Authorization status:

Not marketed

Authorization date:

2012-02-24

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MYLITE 100 MICROGRAMS / 20 MICROGRAMS COATED 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 symptoms 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 Mylite is and what it is used for
2.
What you need to know before you take Mylite
3.
How to take Mylite
4.
Possible side effects
5.
How to store Mylite
6.
Contents of the pack and other information
1. WHAT MYLITE IS AND WHAT IT IS USED FOR

Mylite is a contraceptive pill 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
“combination” pills.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYLITE
GENERAL NOTES
Before you start using Mylite 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 Mylite, your doctor will ask you some
questions about your pe

Summary of Product characteristics

Health Products Regulatory Authority
20 November 2020
CRN009WV7
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mylite 100 micrograms / 20 micrograms coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 100 micrograms of levonorgestrel and 20
micrograms of ethinylestradiol.
Excipients with known effect:
Each coated tablet contains 48.23 mg of lactose monohydrate and 14.38
mg of sucrose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet.
Pink, round (5.60 mm diameter), coated, biconvex tablets, plain on
both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Mylite should take into consideration the
individual woman’s current risk factors, particularly those
for venous thromboembolism (VTE), and how the risk of VTE with Mylite
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 MYLITE
Tablets must be taken orally in the order directed on the blister
package at about the same time every day, with some liquid if
necessary. 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.
The bleeding usually starts within 2 to 3 days after the last tablet
and may not end before the next pack is started.
HOW TO START TAKING OF MYLITE
- No preceding hormonal contraceptive use (in the past month)
Tablet-taking is started 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 in that case an additional barrier method is
recommended for the first 7 days of the first cycle.
- Changing from another combined hormonal contraceptive (combined oral
contraceptive(COC), vaginal ring, transdermal
patch)
The women should start with levonorgestrel/ethinylestradiol preferably
on the day after the last ho