Jaydess 13.5mg Intrauterine delivery system

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LEVONORGESTREL

Available from:

Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland

ATC code:

G02BA03

INN (International Name):

LEVONORGESTREL 13.5 mg

Pharmaceutical form:

INTRAUTERINE DELIVERY SYSTEM

Composition:

LEVONORGESTREL 13.5 mg

Prescription type:

POM

Therapeutic area:

OTHER GYNECOLOGICALS

Authorization status:

Authorised

Authorization date:

2013-03-30

Patient Information leaflet

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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
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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 hormonal contraceptives, does not pro

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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 section 4.4
under Medical
examination/consultation).
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Table 1: When to insert Jaydess in women of fertile age
Starting Jaydess
-
Jaydess should be inserted into the uterine cavity
within 7 days of the onset of menstruation. In this case
Jaydess provides contraceptive protection upon
insertion and no