Kyleena 19.5 mg intrauterine delivery system *

Pharmacy Only: Prescription

BP22036, REC30610

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BP22036, REC30610

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6. Contents of the pack and other information

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Marketing Authorisation Holder

Bayer Limited

1st Floor

The Grange Offices

The Grange

Brewery Road

Stillorgan

Co. Dublin

A94 H2K7

The Atrium

Blackthorn road

Dublin 18

Ireland

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This leaflet was last revised in June September 2022.

[….]

BP22036, REC30610

Note:

Text in blue = added text

Text in red with strikethrough = deleted text

7. Marketing Authorisation holder

Bayer Limited

1st Floor

The Grange Offices

The Grange

Brewery Road

Stillorgan

Co. Dublin

A94 H2K7

The Atrium

Blackthorn road

Dublin 18

Ireland

10. Date of revision of text

June September 2022

(REC30360+30040, BP22032)

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Text in red with strikethrough = deleted text

4.4 Special warnings and precautions for use

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Expulsion

In clinical trials with Kyleena, the incidence of expulsion was low (<4% of insertions) and in the same range as that reported for other IUDs and IUSs. Symptoms ofthe partial or complete expulsion of Kyleena may include bleeding or pain. However, the system can be expelled from the uterine cavity partial or complete expulsion can occurwithout the woman noticing it, leading todecrease or loss of contraceptive protection. As Kyleena typically decreases menstrual flowbleeding over time, anincrease of menstrual flowbleeding may be indicative of an expulsion.

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Partial expulsion may decrease the effectiveness of Kyleena.

A partially expelled Kyleena should be removed. A new system can be inserted at the time of removal, provided pregnancy has been excluded.

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4.6 Fertility, pregnancy and lactation

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Pregnancy

The insertion of Kyleena in pregnant women is contraindicated (see section 4.3).

The use of Kyleena during an existing or suspected pregnancy is contraindicated, see section 4.3 Contraindications. If the a woman becomes pregnant while using Kyleenaectopic pregnancy should be excluded and the system should be removed as soon as possible, since any intrauterine contraceptive left in situ may increase the risk of abortion and preterm labour. Removal of Kyleena or probing of the uterus may also result in spontaneous abortion. Ectopic pregnancy should be excluded.

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There have been isolated cases of masculiniszation of the external genitalia of the female foetus following local exposure to levonorgestrel during pregnancy with an LNG-IUS in place.

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10. DATE OF REVISION OF THE TEXT

September 2021 June 2022

(REC30360+30040, BP22032)

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Text in red with strikethrough = deleted text

2. What you need to know before you use Kyleena

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Pregnancy, breast-feeding and fertility

Pregnancy

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However, if Kyleena is left in place during pregnancy, not only is the risk of having a miscarriage higher, but also the risk of havingpreterm labour. If Kyleena cannot be removed, talk with your healthcare professional about the benefits and risks of continuing the pregnancyand possible effects of the hormone on the developing baby. If the pregnancy is continued, you will be closely monitored during your pregnancy and you should contact your healthcare professional right away if you experience stomach cramps, pain in your stomach or fever.

Kyleena contains a hormone, called levonorgestrel, and there have been isolated reports of effects on the genitalia of female babies if exposed to levonorgestrel intra-uterine devices while in the womb.

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4. Possible side effects

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Expulsion

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As Kyleenatypically decreases menstrual flowovertime, increase of menstrual flow may be indicative of an expulsiona sign that Kyleena has been expelled.

It is recommended that you check for the threads with your finger, for example while having a shower. See also section 2 “Warnings and precautions” for how to check if Kyleena is in placeand what to do if you suspect that Kyleena is no longer in place. If you have signs indicative of an expulsion or you cannot feel the threads, you should use another contraceptive (such as condoms), and consult your healthcare professional.

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6. Contents of the pack and other information

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This medicineal product is authorised in the Member States of the European Economic Area under the following names:

·        Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Iceland, Ireland, Italy, Latvia, Lithuania, The Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden, United Kingdom: Kyleena

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This leaflet was last revised in September 2021June 2022.

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"Ireland" has been added to the Marketing Authorisation Holder address. 

BEC 18535

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Text in red with strikethrough = deleted text

4.4 Special warnings and precautions for use

[….]

Expulsion

In clinical trials with Kyleena, the incidence of expulsion was low (<4% of insertions) and in the same range as that reported for other IUDs and IUSs. Symptoms of the partial or complete expulsion of Kyleena may include bleeding or pain. However, partial or complete expulsion can occur without the woman noticing it, leading to decrease or loss of contraceptive protection. As Kyleena typically decreases menstrual bleeding over time, an increase of menstrual bleeding may be indicative of an expulsion.

Risk of expulsion is increased in

- Women with history of heavy menstrual bleeding

- Women with greater than normal BMI at the time of insertion; this risk increases gradually with increasing BMI

Women should be counselled on possible signs of expulsion and how to check the threads of Kyleena and advised to contact a healthcare professional if the threads cannot be felt. A barrier contraceptive (such as a condom) should be used until the location of Kyleena has been confirmed.

A partially expelled Kyleena should be removed. A new system can be inserted at that the time of removal, provided pregnancy has been excluded.

A woman should be advised how to check the threads of Kyleena and to contact her healthcare professional if the threads cannot be felt

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10. Date of revision of the text

July 2021September 2021

BEC 18535

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Text in red with strikethrough = deleted text

2. What you need to know before you use Kyleena

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Warnings and precautions

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Contact your healthcare professional promptly if any of the following occur (see also section 4):

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• you no longer feel the threads in your vagina. This may be a sign of expulsion or perforation. You can check by gently putting a finger into your vagina and feeling for the threads at the end of your vagina near the opening of your womb (cervix). Do not pull the threads because you may accidentally pull out Kyleena. Avoid intercourse or uUse a barrier contraceptive (such as condoms) until your healthcare professional has checked that the IUS is still in position.

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4. Possible side effects

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Expulsion

The muscular contractions of the womb during menstruation may sometimes push the IUS out of place or expel it. This is more likely to occur if you are overweight at the time of IUS insertion or have a history of heavy periods. If the IUS is out of place, it may not work as intended and therefore, the risk of pregnancy is increased. If the IUS is expelled, you are not protected against pregnancy anymore.It is rare but possible for Kyleena to come out during your menstural period without you noticing.

Possible symptoms of an expulsion are pain and abnormal bleeding but Kyleena may also come out without you noticing. As Kyleena typically decreases menstrual flow over time, increase of menstrual flow may be a sign that Kyleena has been expelled. See section 2 “Warnings and precautions” for how to check if Kyleena is in place and what to do if you suspect that Kyleena is no longer in place.

It is also possible for your Kyleena to partially expel from your womb, meaning that it is displaced but not completely expelled (you and your partner may notice this during sexual intercourse). If Kyleena is completely or partially expelled ,you will not be protected from pregnancy.

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Section 6 Content of the pack and other information

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This medicinal product is authorised in the Member States of the EEA under the following names:

• Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Latvia, Lithuania, The Netherlands, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden, United Kingdom: Kyleena

 This leaflet was last revised in July 2021September 2021.

(BP20061_BEC17809)

2. What you need to know before you use Kyleena

Warnings and precautions

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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 Kyleena. If you think you may have pulled Kyleena out of place (see list above for possible signs), avoid intercourse or use a barrier contraceptive (such as condoms), and contact your healthcare professional.

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Pregnancy, breastfeeding and fertility

Pregnancy

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If you become pregnant with Kyleena in place, you should see your healthcare professional immediately to have Kyleena removed. There isThe removal may cause a risk of spontaneousmiscarriage. However, if Kyleena is removed during pregnancy.

If you leave Kyleena left in place during pregnancy, not only is the risk of having a miscarriage, infection or higher, but also the risk having preterm labour. will If Kyleena cannot be increased. Talkremoved, talk with your healthcare professional about the benefits and risks of continuing the pregnancy,. and possible effects of the hormone on the developing baby.

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3. How to use Kyleena

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Follow-up examination:

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Bring the patient reminder card you have received from your doctor to every scheduled appointment. If you received a patient reminder card from your doctor bring this with you to every scheduled appointment.

6. Contents of the pack and other information

Marketing Authorisation Holder

Bayer Limited,

The Atrium,

Blackthorn Road,

Dublin 18,

Ireland.

[…]

This leaflet was last revised in July 2021September 2020.

(BP20061_BEC17809)

4.6 Fertility, pregnancy and lactation

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Pregnancy

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If a woman becomes pregnant while using Kyleena ectopic pregnancy should be excluded and the system should be removed as soon as possible, timely removal of the system is recommended since any intrauterine contraceptive left in situ may increase the risk of abortion and preterm labour.

[…]

In addition, an increased risk of virilising effects in a female foetus because of the intrauterine exposure to levonorgestrel cannot be excluded. There have been isolated cases of masculinization of the external genitalia of the female foetus following local exposure to levonorgestrel during pregnancy with an LNG-IUS in place.

Because of the intrauterine administration and the local exposure to levonorgestrel, the possible occurrence of virilizing effects in a female fetus should be taken into consideration. Clinical experience of the outcomes of pregnancies under Kyleena treatment is limited due to the high contraceptive efficacy. Women should be informed that, to date, there is no evidence of birth defects caused by a levonorgestrel-releasing intrauterine system use in cases where pregnancy has continued to term with the levonorgestrel-IUS in place.

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10. DATE OF REVISION OF THE TEXT

April 2021July 2021

Educational materials - HCP:

(BP21013+BP21031)

• Content updates were made to extend the duration of use of Mirena to 6 years, for the indication contraception.
• Additional information has been included on the pearl index and ectopic pregnancy rates, as observed in clinical trials and included in the respective SmPCs for Mirena, Jaydess and Kyleena.
• 2D and 3D ultrasound pictures were updated.

BEC: Renewal

Reason for change: Renewal of Marketing Authorisation

Sections updated:

7.          MARKETING AUTHORISATION HOLDER

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

Ireland

9.          DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 16^th December 2016

Date of last renewal: 3^rd October 2021

10.        DATE OF REVISION OF THE TEXT

April 2021 June 2020

The start of the PIL

Deletion of Patient's name, Doctor's name, Doctor's phone number, Date of insertion, Latest date of removal, First check up visit and Next visits: 1, 2, 3, 4, 5.

Section 6

Deletion of Croatia from the list of member states of the EEA.

Section 6 - date of revision

This leaflet was last revised in July 2020September 2020.

Change to information for healthcare professionals

Summary of Product Characteristics for Kyleena online at www.pi.bayer.com/kyleena/ie

(Addition of website address).

HCP brochure containing information re differentiation between Bayer's LNG-IUDs and ectopic pregnancy

To implement the outcome of the finished PSUSA procedure of all levonorgestrel-containing products (PSUSA/00001856/ 201905). For Kyleena additional wording for SmPC section 4.8 and PL section 3 and 4 has to be introduced.

The HPRA details for the reporting of side effects have also been updated.

PIL Section 2 Warnings and Precautions

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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 Kyleena.

PIL Section 4 Possible side effects

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Common side effects: may affect up to 1 in 10 people

Common side effects added:

'decreased libido'

'dizziness'

'increased weight'

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<'hair loss' re-located to maintain the same order of the adverse events as in the SmPC.>

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<Update of Reporting of Side Effects details updated for Ireland in line with Appendix V>:

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. W website: www.hpra.ie.; E-mail: medsafety@hpra.ie.

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PIL Section 6:

This leaflet was last revised in April 2019 July 2020

To implement the outcome of the finished PSUSA procedure of all levonorgestrel-containing products (PSUSA/00001856/ 201905). For Kyleena additional wording for SmPC section 4.8 and PL section 3 and 4 has to be introduced.

The HPRA details for the reporting of side effects have also been updated.

SmPC Section 4.8

Tabulated summary of adverse events

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'Deceased libido' added as a common side effect under System Organ Class: Psychiatric disorders.

'Dizziness' added as a common side effect under System organ Class: Vascular disorders

'Increased weight' added as a common side effect under System Organ Class: Investigations

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<Update of Reporting of Side Effects details updated for Ireland in line with Appendix V>:

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. W  website: www.hpra.ie.; E-mail: medsafety@hpra.ie.

[.....]

SmPC section 10, Date of revision of the text:

April 2019 June 2020

To implement the outcome of the finished PSUSA procedure of all levonorgestrel-containing products (PSUSA/00001856/ 201905). For Kyleena additional wording for SmPC section 4.8 and PL section 3 and 4 has to be introduced.

The HPRA details for the reporting of side effects have also been updated.

PIL Section 2 Warnings and Precautions

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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 Kyleena.

[.....]

PIL Section 4 Possible side effects

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Common side effects: may affect up to 1 in 10 people

Common side effects added:

'decreased libido'

'dizziness'

'increased weight'

[.....]

[.....]

<'hair loss' re-located to maintain the same order of the adverse events as in the SmPC.>

[.....]

<Update of Reporting of Side Effects details updated for Ireland in line with Appendix V>:

HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. W website: www.hpra.ie.; E-mail: medsafety@hpra.ie.

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PIL Section 6:

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This leaflet was last revised in April 2019 July 2020

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Update to warnings and prcautions due to PRAC reccommendation

The SmPC has updated as a result of the final study report for the subgroup of EURAS-IUD. The perforation text under subsection ‘Insertion and removal/ replacement’ was adapted to current medical practice, the average estimated in vivo release rate over the 1st year was added to section 5.2 and text under 4.8 regarding sepsis was adjusted to reflect the class effect. Editorial spelling changes also made.