Mirena 52 mg Intrauterine Delivery System

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Levonorgestrel

Dostupné s:

PCO Manufacturing Ltd.

ATC kód:

G02BA03

INN (Mezinárodní Name):

Levonorgestrel

Dávkování:

52 milligram(s)

Léková forma:

Intrauterine delivery system

Druh předpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

plastic IUD with progestogen

Stav Autorizace:

Authorised

Datum autorizace:

2012-08-24

Informace pro uživatele

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PACKAGE LEAFLET: INFORMATION FOR THE USER
MIRENA
® 52 MG INTRAUTERINE
DELIVERY SYSTEM
levonorgestrel
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 nurse.
•
This medicine has been prescribed for you only. Do not
pass it on to others.
•
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1.
What Mirena is and what it is used for
2.
What you need to know before you use Mirena
3.
How to use Mirena
4.
Possible side effects
5.
How to store Mirena
6.
Contents of the pack and other information
1.
WHAT MIRENA IS AND WHAT IT IS USED FOR
Mirena is an intrauterine delivery system (IUS) placed inside the
womb (uterus) where it slowly releases the hormone
levonorgestrel. It can be used in the following three ways:
1.
As an effective long-term and reversible method of
CONTRACEPTION.
It is used for prevention of pregnancy (contraception) for a
maximum of 8 years.
2.
For REDUCING MENSTRUAL BLOOD FLOW, so it can be used if
you suffer from heavy periods (heavy menstrual bleeding).
This is called menorrhagia.
It is used for heavy menstrual bleeding (idiopathic
menorrhagia) for up to 5 years. If symptoms have not
returned after 5 years of use, continued use may be
considered. Your Mirena should be removed or replaced
after a maximum of 8 years.
3.
If you are going through the MENOPAUSE, a gradual process
which usually takes place between the ages of about 45
and 55. It is used for protection from excessive growth of
the lining of the womb (_endometrial hyperplasia_) during
oestrogen replacement therapy for a maximum of 5 years.
If you like, you may have a new Mirena inserted when the old
one is removed.
Oestrogens can be taken to relieve menopausal symptoms.
However, taking oestrogens alone increases the risk of abn

Charakteristika produktu

Health Products Regulatory Authority
03 March 2023
CRN00DC12
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mirena 52 mg Intrauterine Delivery System
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance:
Levonorgestrel 52 mg.
The in-vivo dissolution rate is about 20 microgram/24 hours initially
and is reduced to about 10 microgram/24 hours after five
years.
The mean dissolution rate of levonorgestrel is about 15 micogram/24
hours over the time up to five years.
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Intrauterine delivery system.
_ _
_Product imported from Greece, France and Spain_
The levonorgestrel intrauterine delivery system consists of a white or
almost white drug core covered with an opaque
membrane, which is mounted on the vertical stem of a T-body. The
T-body has a loop at one end of the vertical stem and two
horizontal arms at the other end. Removal threads are attached to the
loop. The vertical stem of the intrauterine delivery
system is loaded in the insertion tube at the tip of the inserter.
4 CLINICAL PARTICULARS
As per PA1410/008/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1410/008/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Product imported from Greece and France:_
Polydimethylsiloxane elastomer
Polydimethylsiloxane tubing
Polyethylene
Barium sulphate
Iron oxide
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_Product imported from Spain:_
Polydimethylsiloxane elastomer
Colloidal silica anhydrous
Polyethylene
Barium sulphate
Iron oxide
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
03 March 2023
CRN00DC12
Page 2 of 2
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the inner and outer package of the product on the market
in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
_Product imported from Greece:_
Do not store above 30°C. Store in the original package to protect
from moisture and direct sunlight.
_Product imported from France and Spain:_
Store in the original package to protect fro