Jaydess 13.5 mg intrauterine delivery system
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
21-04-2023
Summary of Product characteristics
(SPC)
28-04-2023
Active ingredient:
Levonorgestrel, micronized
Available from:
Bayer Limited
ATC code:
G02BA; G02BA03
INN (International Name):
Levonorgestrel, micronized
Dosage:
13.5 milligram(s)
Pharmaceutical form:
Intrauterine delivery system
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Intrauterine contraceptives; plastic IUD with progestogen
Authorization status:
Marketed
Authorization date:
2013-02-08
Patient Information leaflet
Page 1 of 15
BP22015_REC30367
PACKAGE LEAFLET: INFORMATION FOR THE USER
JAYDESS 13.5 MG INTRAUTERINE DELIVERY SYSTEM
levonorgestrel
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects, you
may get. See the end of section 4
for how to report side effects.
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.
WHAT IS IN THIS LEAFLET:
1.
What Jaydess is and what it is used for
2.
What you need to know before you use Jaydess
3.
How to use Jaydess
4.
Possible side effects
5.
How to store Jaydess
6.
Contents of the pack and other information
Page 2 of 15
BP22015_REC30367
1.
WHAT JAYDESS IS AND WHAT IT IS USED FOR
Jaydess is used for the prevention of pregnancy (contraception) for up
to three years.
Jaydess is a T-shaped intrauterine delivery system (IUS) which after
placement inside the womb
slowly releases a small amount of the hormone levonorgestrel.
Jaydess works by reducing the monthly growth of the lining of the womb
and thickening the cervical
mucus. These actions prevent the sperm and egg from coming into
contact and so prevent fertilization
of an egg by sperm.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE JAYDESS
GENERAL NOTES
Before you can begin using Jaydess, your healthcare professional will
ask you some questions about
your personal health history.
In this leaflet, several situations are described where Jaydess should
be removed, or where the
reliability of Jaydess may be decreased. In such situations you should
either not have intercourse or
you should use a condom or another barrier method.
Jaydess, like other hor
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
28 April 2023
CRN00DJJ6
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
▼ This medicinal product is subject to additional monitoring. This
will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse
reactions. See section 4.8 for how to report adverse
reactions.
1 NAME OF THE MEDICINAL PRODUCT
Jaydess 13.5 mg intrauterine delivery system
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The intrauterine delivery system contains 13.5 mg levonorgestrel.
For the full list of excipients, see section 6.1.
For details of release rates, see section 5.2.
3 PHARMACEUTICAL FORM
Intrauterine delivery system (IUS).
The product consists of a whitish or pale yellow drug core covered
with a semi-opaque membrane, which is mounted on the
vertical stem of a T-body. In addition, the vertical stem contains a
silver ring located close to the horizontal arms. The white
T-body has a loop at one end of the vertical stem and two horizontal
arms at the other end. Brown coloured removal threads
are attached to the loop. The vertical stem of the IUS is loaded in
the insertion tube at the tip of the inserter. The IUS and
inserter are essentially free of visible impurities.
Dimensions of Jaydess: 28 x 30 x 1.55 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Contraception for up to 3 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Jaydess is inserted into the uterine cavity and is effective for up to
three years.
_Insertion_
It is recommended that Jaydess should only be inserted by healthcare
professionals who are experienced in IUS insertions and/
or have undergone training on the Jaydess insertion procedure.
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. Jaydess is
not suitable for use as a post-coital contraceptive (see section 4.3
and se
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