Mymin 0.03 mg/3 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Drospirenone; Ethinylestradiol

Available from:

McDermott Laboratories Ltd t/a Gerard Laboratories

ATC code:

G03AA12

INN (International Name):

Drospirenone; Ethinylestradiol

Dosage:

0.03mg/3 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

drospirenone and ethinylestradiol

Authorization status:

Not marketed

Authorization date:

2019-03-22

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MYMIN 0.03 MG / 3 MG TABLETS
(ethinylestradiol/drospirenone)
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”)
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.
-
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.
WHAT IS IN THIS LEAFLET?
1.
What Mymin is and what it is used for
2.
What you need to know before you take Mymin
3.
How to take Mymin
4.
Possible side effects
5.
How to store Mymin
6.
Contents of the pack and other information
1.
WHAT MYMIN IS AND WHAT IT IS USED FOR
• Mymin is a contraceptive pill and is used to prevent pregnancy.
• Each tablet contains a small amount of two different female
hormones, namely
drospirenone and ethinylestradiol.
• Contraceptive pills that contain two hormones are called
"combination" pills.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYMIN
GENERAL NOTES
Before you start using Mymin 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 start taking Mymin, your doctor will ask you about your
personal health history and
the health history of your close relatives. The doctor will also
measure yo

Summary of Product characteristics

Health Products Regulatory Authority
23 May 2019
CRN0091SC
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mymin 0.03 mg/3 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.03 mg of ethinylestradiol and 3 mg of
drospirenone.
Excipients with known effect:
Each tablet contains 72 mg of lactose monohydrate, 0.12 mg of
Tartrazine (E102) and 0.032 mg of Sunset Yellow (E110).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
Round, yellow, uncoated biconvex tablets 6 mm in diameter, thickness
2.70 mm, with '143' debossed on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Mymin should take into consideration the
individual woman's current risk factors, particularly those
for venous thromboembolism (VTE), and how the risk of VTE with Mymin
compares with other CHCs (see sections 4.3 and 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY_
_ _
HOW TO TAKE MYMIN
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 MYMIN
_No preceding hormonal contraceptive use (in the previous month)._
Start taking Mymin on the first day 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 Mymin preferably on the day after the last
active tablet (the last tablet containing the active
substances) of her previous COC, but at the latest on the day
following the usual tablet-free or placebo tablet interval of her
previous COC. In case a vaginal ri