Jaydess 13.5 mg intrauterine delivery system
- Name:
Jaydess 13.5 mg intrauterine delivery system
- Company:
Bayer Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/11/20

Click on this link to Download PDF directly
Bayer Limited

Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 2 November 2020 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
- Change to other sources of information section
- Change to information for healthcare professionals
Free text change information supplied by the pharmaceutical company
‘Patient’s/ Doctor’s Details’ at the top of the Leaflet have been deleted.
The revision date of the PIL has been updated to September 2020.
The following information has been added:
"Other sources of information
Detailed and updated information on this medicine is available by scanning the QR Code included in the package leaflet, outer carton and patient reminder card with a smartphone. The same information is also available on the following URL: www.pi.bayer.com/jaydess/ie-mt and on the HPRA website: www.hpra.ie."
A QR Code has been added to the bottom of the Leaflet.
A QR Code has been added to the bottom of the Insertion Instructions.
The following has been added to the bottom of the Insertion Instructions:
“Summary of Product Characteristics for Jaydess online at www.pi.bayer.com/jaydess/ie-mt”
Updated on 8 October 2020 Ed-Ptnt
Reasons for updating
- Add New Doc
Updated on 21 August 2020 Ed-HCP
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
New document combining information from previous HCP educational materials
Updated on 22 July 2020 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Reason for update:
Implement the outcome of the finished PSUSA procedure of all levonorgestrel-containing products (PSUSA/00001856/201905).
Reporting of suspected adverse reactions details updated for Ireland.
Section 4.8: Undesirable effects:
[.....]
Tabulated summary of adverse events
'Deceased libido' added as a common side effect under System Organ Class: Psychiatric disorders.
'Dizziness' added as an uncommon side effect under added System organ Class: Vascular disorders.
'Increased weight' added as a common side effect under added System Organ Class: Investigations
[.....]
Section 4.8: Reporting of suspected adverse reactions
[.....]
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. website: www.hpra.ie.; e-mail: medsafety@hpra.ie.
[.....]
Section 10 Date of revision of the text:
12th June 2019 July 2020
Updated on 16 July 2020 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Reason for update:
Implement the outcome of the finished PSUSA procedure of all levonorgestrel-containing products (PSUSA/00001856/201905), addition of the adverse reactions: dizziness, libido decrease and weight increase and adding information on the use of menstrual cups.
Section 2: Warnings and Precautions
[.....]
Use of sanitary pads is recommended. If tampons or menstrual cups are used, you should change them with care so as not to pull the threads of Jaydess.
[.....]
Section 4: Possible side effects
[.....]
Common side effects: may affect up to 1 in 10 people
[.....]
<Common side effects added:>
'decreased libido'
'increased weight'
<'hair loss' re-located to maintain the same order of the adverse events as in the SmPC.>
[.....]
Uncommon side effects: may affect up to 1 in 100 people
[.....]
<Uncommon side effects added:>
'Dizziness'
[.....]
Section 4: Reporting of side effects:
[.....]
<Reporting of Side Effects details updated for Ireland and added for Malta>:
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
Ireland
HPRA Pharmacovigilance
Website: www.hpra.ie
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
[.....]
Section 6: Revision date
[.....]
This leaflet was last revised in June 2019 July 2020
Updated on 9 September 2019 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 9 September 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 10 June 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 10 June 2019 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 12 March 2019 PIL
Reasons for updating
- Removal/change of distributor
Updated on 9 May 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 9 May 2017 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 16 March 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 16 March 2017 SPC
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Added Deleted
3. PHARMACEUTICAL FORM
[…]
The white T-body has a loop at one end of the vertical stem and two horizontal arms at the other end. Removal Brown coloured removal threads are attached to the loop.
4.2 Posology and method of administration
[…]
Physical examination alone may not be sufficient to exclude partial perforation, which may have occurred even if the threads are still visible.
Jaydess can be distinguished from other IUSs by the combination of the visibility of the silver ring on ultrasound and the brown colour of the removal threads.
[…]
Patients with hepatic impairment
Jaydess has not been studied in women with hepatic impairment. Jaydess is contraindicated in women with acute liver disease or liver tumor tumour (see section 4.3).
4.4. Special warnings and precautions for use
[…]
· marked increase of in blood pressure
[…]
Pelvic infection
While Jaydess and the inserter as such are sterile they may, due to bacterial contamination during insertion, become a vehicle for microbial transport in the upper genital tract.
[…]
Perforation
[…]
|
Breastfeeding |
Not breastfeeding |
Insertion ≤ 36 weeks after delivery |
5.6 |
1.7 |
4.8 Undesirable effects
[…]
Reproductive system and breast disorders |
Bleeding changes including increased and decreased menstrual bleeding, spotting, infrequent Ovarian cyst* Vulvovaginitis |
Upper genital tract infection Dysmenorrhea Breast pain/discomfort Device expulsion (complete and partial) Genital discharge |
|
Uterine perforation** |
5.1 Pharmacodynamic properties
[…]
Pharmacodynamic effects
[…]
Evidence of ovulation was seen in 34 out of 35 women in the first year, in 26 out of 27 women in the second year, and in all 27 26 women in the third year.
5.2 Pharmacokinetic properties
[…]
Distribution
Within one The concentration of SHBG declined on average by about 15% during the first month after insertion of Jaydess, the concentration of SHBG declines by about 30%. Thereafter, plateau-like SBHG concentrations are observed with a tendency to increase towards baseline values and remained stable over time the 3 year period of use.
[…]
Linearity/ non-linearity
[…]
During the first month of use of Jaydess, a mean SBHG A decrease of about 30% is observed which SHBG concentration leads to a decrease of total levonorgestrel concentration in serum indicating non-linear pharmacokinetics of levonorgestrel with regard to time.
[…]
Paediatric population
In a one-year phase III study in post-menarcheal female adolescents (mean age 16.2, range 12 to 18 years) pharmacokinetic analysis of 283 subjects adolescents showed estimated LNG serum concentrations slightly higher (approximately 10%) in adolescents compared to adults.
[…]
No differences in the pharmacokinetics of LNG are expected between adolescents and adults following insertion of Jaydess.
Ethnic differences
A three-year phase III study in the Asian-Pacific region (93% Asian women, 7% other ethnicities) using Jaydess has been performed. A comparison of pharmacokinetic characteristics of LNG of the Asian population in this study with that of the Caucasian population from another phase III study showed no clinically relevant difference in systemic exposure and other pharmacokinetic parameters. In addition, the daily release rate of Jaydess was the same in both populations.
No differences in the pharmacokinetics of LNG are expected between Caucasian and Asian women following insertion of Jaydess.
10. DATE OF REVISION OF THE TEXT
July 2016 February 2017
Updated on 8 March 2017 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 22 August 2016 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Jaydess - Irregular bleeding*
First 90 days - 39%
Second 90 days - 25%
End of year 1 - 18%
End of year 3 - 15%
Updated on 9 June 2015 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Jaydess – PA 1410/68/1
14101
BEC 7153 + 6960
www.medicines.ie
(Inserted Text; Deleted Text)
4.2 Posology and method of administration
…
Paediatric population
Safety and efficacy has not been studied in women aged below 18. Use of this product before menarche is not indicated. For data on safety and efficacy in adolescents, see section 5.1.
4.8 Undesirable effects
Summary of the safety profile
…
Table 1 2: Bleeding patterns reported with Jaydess in clinical trials
…
Paediatric population
The safety profile of Jaydess observed in a study of 304 adolescents was consistent with that in the adult population.
5.1 Pharmacodynamic properties
Clinical efficacy and safety
…
The safety profile of Jaydess observed in a study of 304 adolescents was consistent with that in the adult population. Efficacy is expected to be the same for adolescents under the age of 18 as for users 18 years and older.
5.2 Pharmacokinetic properties
…. Estimated in vivo delivery rates for different time points are provided in Table 2 3.
Table 2 3: Estimated in vivo release rates based on observed ex vivo residual content data
…
Paediatric population
In a one-year phase III study in post-menarcheal female adolescents (mean age 16.2, range 12 to 18 years) pharmacokinetic analysis of 283 subjects showed estimated LNG serum concentrations slightly higher (10%) in adolescents compared to adults. This correlates to the generally lower body weight in adolescents. The ranges estimated for adolescents lie, however, completely within the ranges estimated for adults, showing high similarity.
10 Date of revision of the text
Updated on 29 April 2015 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Jaydess 13.5 mg intrauterine delivery system (PA 1410/68/1);
BP14043
Changes for www.medicines.ie
(Inserted text; Deleted text)
4.2 Posology and method of administration
Insertion and removal/ replacement
In case of a difficult insertion and/ or exceptional pain or bleeding during or after insertion, appropriate steps should be taken immediately to exclude perforation, such as physical examination and ultrasound.
Physical examination may not be sufficient to exclude partial perforation.
4.4 Special Warning and Precautions for Use
Medical examination/ consultation
Before insertion, a woman must be informed of the benefits and risks of Jaydess, including the signs and symptoms of perforation and the risk of ectopic pregnancy, see below.
Perforation
Perforation or penetration of the uterine corpus or cervix by an intrauterine contraceptive may occur rarely, most often during insertion, although it may not be detected until sometime later, and may decrease the effectiveness of Jaydess. In case of a difficult insertion and/ or exceptional pain or bleeding during or after insertion, appropriate steps should be taken immediately to exclude perforation, such as physical examination and ultrasound. Such a system must be removed; surgery may be required. The risk of perforations is increased in breast feeding women and may be increased in post partum insertions (see section 4.2) and in women with a fixed retroverted uterus.
In a large prospective comparative non-interventional cohort study in users of other IUDs (N=61,448 women), the incidence of perforation was 1.3 (95% CI: 1.1 - 1.6) per 1000 insertions in the entire study cohort; 1.4 (95% CI: 1.1 - 1.8) per 1000 insertions in the cohort of another LNG- IUS and 1.1 (95% CI: 0.7 - 1.6) per 1000 insertions in the copper IUD cohort.
The study showed that both breastfeeding at the time of insertion and insertion up to 36 weeks after giving birth were associated with an increased risk of perforation (see Table 1). These risk factors were independent of the type of IUD inserted.
Table 1: Incidence of perforation per 1000 insertions for the entire study cohort, stratified by breastfeeding and time since delivery at insertion (parous women)
|
Breastfeeding |
Not breastfeeding |
Insertion ≤ 36 weeks after delivery |
5.6 |
1.7 |
Insertion > 36 weeks after delivery |
1.6 |
0.7 |
The risk of perforations may be increased in women with fixed retroverted uterus.
Re-examination after insertion should follow the guidance given under the heading "Medical examination/consultation" which may be adapted as clinically indicated in women with risk factors for perforation.
Lost threads
If the removal threads are not visible at the cervix on follow-up examinations, unnoticed expulsion and pregnancy must be excluded. The threads may have been drawn up into the uterus or cervical canal and may reappear during the next menstrual period. If pregnancy has been excluded, the threads may usually be located by gently probing the cervical canal with a suitable instrument. If they cannot be found, the possibility of expulsion or perforation should be considered the system may have been expelled. Ultrasound exam may be used to ascertain the position of the system. If ultrasound is not available or is not successful, X-ray may be used to locate Jaydess.
4.8 Undesirable effects
Summary of the safety profile
The majority of women experience changes in menstrual bleeding pattern after insertion of Jaydess. Over time, the frequency of amenorrhoea and infrequent bleeding increases, and the frequency of both prolonged and frequent bleeding decreases. The following bleeding patterns were observed in clinical trials:
Table 1 2: Bleeding patterns reported with Jaydess in clinical trials…..
….
System Organ Class |
Very Common |
Common |
Uncommon |
Rare |
Psychiatric disorders |
|
Depressed mood/ Depression |
|
|
Nervous system disorders |
Headache |
Migraine |
|
|
Gastrointestinal disorders |
Abdominal/pelvic pain |
Nausea |
|
|
Skin and subcutaneous tissue disorders |
Acne/ Seborrhoea |
Alopecia |
Hirsutism |
|
Reproductive system and breast disorders |
Bleeding changes including increased and decreased menstrual bleeding, spotting, infrequent bleeding and amenorrhoea Ovarian cyst* Vulvovaginitis |
Upper genital tract infection Dysmenorrhea Breast pain/discomfort Device expulsion (complete and partial) Genital discharge |
|
Uterine perforation** |
* In clinical trials ovarian cysts had to be reported as AEs if they were abnormal, non-functional cysts and/or had a diameter > 3 cm on ultrasound examination.
** This frequency is based on clinical trials that excluded breastfeeding women. In a large prospective comparative non-interventional cohort study with women using another LNG-IUS and copper IUDs, the frequency of perforation in women who were breastfeeding or had an insertion up to 36 weeks after delivery was “uncommon” (see section 4.4 under Perforation).
Description of selected adverse events
With the use of another LNG-IUS, cases of hypersensitivity including rash, urticaria and angioedema have been reported.
If a woman becomes pregnant while using Jaydess, the relative likelihood of this pregnancy being ectopic is increased (see section 4.4 under Ectopic Pregnancy).
The removal threads may be felt by the partner during intercourse.
Clinical trials with Jaydess excluded breast feeding women. A large post authorization safety study with other IUDs/IUSs shows an increased risk of perforation in breast feeding women (see section 4.4. under Perforation).
5.2 Pharmocokinetic properties
Levonorgestrel is released locally into the uterine cavity. The in vivo release curve is characterized by an initial steep decline that slows down progressively resulting in little change after 1 year until the end of the intended 3-year period of use. Estimated in vivo delivery rates for different time points are provided in Table 23.
Table 23: Estimated in vivo release rates based on observed ex vivo residual content data
10. Date of Revision of the Text
April 2014 April 2015
Updated on 29 April 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Change to dosage and administration
- Change to name of manufacturer
Updated on 15 April 2014 SPC
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
6.3 Shelf life
32
years.
In Section 6.3, the shelf-life has been changed from 2 to 3 years.
Date of revision has been changed from February 2014 to April 2014
10. DATE OF REVISION OF THE TEXT
February 2014 April 2014
Updated on 1 April 2014 SPC
Reasons for updating
- Addition of black triangle
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SUMMARY OF PRODUCT CHARACTERISTICS
4.8 Undesirable effects
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via IMB Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.imb.ie; e-mail: imbpharmacovigilance@imb.ie.
the national reporting system listed in Appendix V.
10. DATE OF REVISION OF THE TEXT
February 2014
Updated on 1 April 2014 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
- Addition of black triangle
Updated on 3 January 2014 PIL
Reasons for updating
- New PIL for new product
Updated on 2 January 2014 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
HCP brochure - diferentiation IUS+ectopic pregnancyRisk Minimisation Materials
(Click to Download)
Educational Materials for Medicines
Educational Materials for Medicines
Patient Reminder CardRisk Minimisation Materials
(Click to Download)
Educational Materials for Medicines
Educational Materials for Medicines