Mirena 52 mg intrauterine delivery system
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
23-06-2023
Summary of Product characteristics
(SPC)
28-04-2023
Active ingredient:
Levonorgestrel
Available from:
Bayer Limited
ATC code:
G02BA; G02BA03
INN (International Name):
Levonorgestrel
Dosage:
52 milligram(s)
Pharmaceutical form:
Intrauterine delivery system
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Intrauterine contraceptives; plastic IUD with progestogen
Authorization status:
Marketed
Authorization date:
1998-08-28
Patient Information leaflet
Page 1 of 18
BP23021_REC31616
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
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
28 April 2023
CRN00DJJ6
Page 1 of 14
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.
For the full list of excipients, see section 6.1.
For details on release rates, see section 5.2.
3 PHARMACEUTICAL FORM
Intrauterine delivery system.
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 white
T-body has a loop at one end of the vertical stem
and two horizontal arms at the other end. Brown removal threads are
attached to the loop. The T-frame of Mirena contains
barium sulphate, which makes it visible in X-ray examination. The
vertical stem of the intrauterine delivery system is loaded in
the insertion tube at the tip of the inserter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Contraception.
Idiopathic menorrhagia.
Protection from endometrial hyperplasia during oestrogen replacement
therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Mirena is inserted into the uterine cavity. It is effective for 8
years in the indication contraception and 5 years in the indications
idiopathic menorrhagia and protection from endometrial hyperplasia
during oestrogen replacement therapy. For timing
regarding removal/replacement, see section "Removal/Replacement".
_Insertion_
It is strongly recommended that Mirena should only be inserted by
healthcare professionals who are experienced in Mirena
insertions and/or have undergone sufficient training for Mirena
insertion. Mirena must be inserted using aseptic technique.
Before insertion, the patient should have been carefully examined in
order to detect any contraindication to IUS insertion.
Exclude pregnancy before insertion. Consider the possibility of
ovulation and conception before using this product. Mirena is
not suitable for use as a post-coital c
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