Implanon NXT

  • Name:

    Implanon NXT

  • Company:
    info
  • Active Ingredients:

    Etonogestrel

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/05/20

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Summary of Product Characteristics last updated on medicines.ie: 14/1/2020

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MSD Ireland (Human Health) Limited

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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 20 May 2020 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 6 - date of revision

Updated on 16 January 2020 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 14 January 2020 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
  • Change to information for healthcare professionals

Updated on 14 January 2020

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 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Inclusion of a video link to demonstrate insertion and removal procedures, updates to  the insertion and removal text, Patient Alert card [formerly user card] instructing the patient to  palpate the implant and an update to reported side effects that can be associated with an implant found in the pulmonary artery.

Updated on 23 April 2019 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 28 March 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 28 March 2019

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

A warning about hormonal contraception and suicidality

 

Updated on 18 December 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 24 November 2016 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

SPC Change Details:   Update on interactions with HIV/HCV protease inhibitors and non-nucleoside reverse transcriptase inhibitors

Updated on 24 November 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 24 November 2016

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 24 November 2016 PIL

Reasons for updating

  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 21 October 2016 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC Change Details:   correction of spellings/typing errors

Updated on 25 May 2016 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 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

SPC Change Details:   Risk of migration with Implanon NXT and updated recommendations on insertion, localisation and removal

Updated on 24 May 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 30 September 2015 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 18 November 2014 SPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Reason for submission:  correction of spelling/typing errors

Updated on 14 November 2014 PIL

Reasons for updating

  • Change of licence holder
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to drug interactions
  • Change to date of revision
  • Introduction of new pack/pack size
  • Addition of information on reporting a side effect.

Updated on 14 November 2014 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 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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

Change to Sections: 4.2, 4.4, 7,8 & 10

Updated on 25 August 2014 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • 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

Change to Sections: 4.4, 4.5, 4.8, 6.4, 6.5, 10


Reason for submission: Updates to section 4.4 special warnings and precautions for use, section 4.5, interaction with other medicinal products 4.8 Undesirable effects [HPRA AE statement] 6.4, Special precautions for storage, reworded, section 6.5, additional pack size, Section 10 Date of revision

Updated on 15 October 2013 PIL

Reasons for updating

  • Change to date of revision

Updated on 19 September 2013 SPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Reason for submission: Renewal: Section 9 - Date of renewal of authorisation,

Updated on 18 September 2012 PIL

Reasons for updating

  • Change to side-effects

Updated on 30 August 2012 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 4.8 Undesirable Effects - Addition of  Anaphylactic reactions,  angioedema

Updated on 26 July 2012 SPC

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 6.1 List of excipients

 

Updated on 24 July 2012 SPC

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 6.1 List of excipients

 

Updated on 2 February 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to further information section
  • Change to date of revision
  • Change to MA holder contact details

Updated on 1 February 2012 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

 

4.2    Posology and method of administration

[….]

Additional information and more detailed instructions concerning the insertion and removal of the implant will be sent on request free of charge (Schering-Plough, telephone 00 44 1707 363418Merck Sharp & Dohme Ireland (Human Health) Limited, telephone: +353 1 299 8700).

[….]

 

4.2.2 When to insert Implanon nxt

IMPORTANT: Rule our pregnancy before inserting the implant.

 

Timing of insertion depends on the woman’s recent contraceptive history, as follows:

 

No preceding hormonal contraceptive use in the past month:

The implant should be inserted between Day 1 (first day of menstrual bleeding) and Day 5 of the menstrual cycle, even if the woman is still bleeding.


If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.


Switching contraceptive method to Implanon NXT


Changing from a combined hormonal contraceptive method (combined oral contraceptive (COC), vaginal ring or transdermal patch).

The implant should be inserted preferably on the day after the last active tablet (the last tablet containing the active substances) of the previous COC, but at the latest on the day following the usual tablet-free or placebo tablet interval of the previous COC. In case a combined oral contraceptive or on the day of removal of the vaginal ring or transdermal patch. has been used,At the latest,  the implant should be inserted preferably on the day of removal, but at the latestfollowing the usual tablet free, ring-free, patch-free or placebo tablet interval of the previous combined hormonal contraceptive when the next application would have been due. Not all contraceptive methods (transdermal patch, vaginal ring) may be available in all countries.

If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.


[….]

·           Injectable contraceptives: Insert the implant on the day the next injection is due.

·           Progestagen-only pill: A woman may switch from the progestagen-only pill to Implanon nxt on any day of the monthfrom the progestagen-only pill. The implant should be inserted on the day after stopping the progestagen-only pillwithin 24 hours after taking the last tablet.

·           Implant/Intrauterine system (IUS): Insert the implant on the same day the previous implant or IUS is removed.

If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.


Following abortion or miscarriage

·         First trimester: The implant may should be inserted immediately following a complete first trimester abortion or miscarriage. If the implant is not inserted within five days following a first trimester abortion or miscarriage., follow the instructions under “No preceding hormonal contraceptive use in the past month”.

·         Second trimester: Insert the implant between 21 to 28 days following second trimester abortion or miscarriage.

If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.


Postpartum

§Breast-feeding: The implant should be inserted after the fourth postpartum week (see Section 4.6 “Pregnancy and Lactation”).

§         Not breast-feeding: The implant should be inserted between 21 to 28 days postpartum. If inserted as recommended, back-up contraception is not necessary. If the implant is inserted later than 28 days postpartum, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.

§         Breast-feeding: The implant should be inserted after the fourth postpartum week (see Section 4.6 “Pregnancy and Lactation”). The woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.

 

Note:
It is important to follow the directions above regarding the proper timing of the insertion of the Implanon nxt implant. If deviating from the above directions, pregnancy should be first ruled out and the woman should be instructed to also use a non-hormonal contraceptive method, such as condoms, until 7 days after insertion of the implant.

4.2.3 How to insert Implanon nxt

[….]

It is recommended that the HCP is in a seated position during the entire insertion procedure so that the insertion site and the movement of the needle just under the skin can be clearly seen from the side.

 

·          Hold the applicator just above the needle at the textured surface area. R and remove the transparent protection cap by sliding it horizontally in the direction f the arrow away from the needle which contains the implant (Figure 3). If the cap does not come off easily the applicator should not be used. You may can see the white colored implant by looking into the tip of the needle. Do not touch the purple slider until you have fully inserted the needle subdermally, as it will retract the needle and release the implant from the applicator.

 Figure 3

·[….]

 

·          While keepingKeep the applicator in the same position and the needle inserted to its full length. If needed, you may use your free hand to keep the applicator in the same position during the following procedure. , uUnlock the purple slider by pushing it slightly down. Move the slider fully back until it stops (Figure 7)., leaving t The implant is now in its final subdermal position, and locking the needle is locked inside the body of the applicator (Figure 7).  The applicator can now be Ifremoved. If  the the applicator is not kept in the same position during this procedure or if the purple slider is not completely moved to the back, the needle will not be fully retracted and the implant will not be inserted properly. The applicator can now be removed.

Figure 7

 

[….]

 

·          If the tip of the implant does not become visible in the incision, gently insert a forceps into the incision (Figure 15). Grasp the implant. Flip the forceps over into your other hand (Figure 16). With a second pair of forceps carefully dissect the tissue around the implant and grasp the implant (Figure 17). The implant can then be removed.

 

[….]

 

·          Confirm that the entire rod, which is 4 cm long, has been removed by measuring its length. If a partial implant (less than 4cm) is removed, the remaining piece should be removed by following the instructions in Section 4.2.4. “How to remove Implanon nxt.

[….]

 

 

4.3       Contraindications

·         Active venous thromboembolic disorder.

·         Known or suspected sex steroid sensitive malignancies.

·         Presence or history of liver tumours (benign or malignant)

·         Presence or history of severe hepatic disease as long as liver function values have not returned to normal.

·         Undiagnosed vaginal bleeding.

·         Hypersensitivity to the active substance or to any of the excipients of Implanon nxt.

 

 

4.5       Interaction with other medicinal products and other forms of interaction

 

[….]

Hepatic metabolism

Interactions can occur with medicinal products that induce hepatic enzymes, specifically cytochrome P450 enzymes, which can result in increased clearance of sex hormones (e.g., phenytoin, phenobarbital, primidone, carbamazepine, rifampicin, and HIV-medicartion (e.g. ritonavir, nelfinavir, nevirapine, efavirenz) and possibly also oxcarbazepine, topiramate, felbamate, , griseofulvin and the herbal remedy St. John’s wort). 

 

Management

Women on treatment with any of the above mentioned drugs should use a non-hormonal contraceptive method in addition to Implanon nxt. With hepatic enzyme-inducing drugs, the non-hormonal contraceptive method should be used during the time of concomitant drug administration and for 28 days after their discontinuation.

In women on long-term treatment with hepatic enzyme-inducing drugs, it is recommended to remove the implant and to advise prescribe a contraceptive non-hormonal method that is unaffected by the interacting drug.

 

Increase in plasma hormone levels associated with co-administered drugs

[….]

 

4.8       Undesirable effects

 

[….]

Paresthesia or paresthesia-like events may occur. Expulsion or migration of the implant may be possible (see also section 4.4.1 ‘Warnings’). If instructions are not followed (see section 4.2 "Posology and method of administration"), incorrect insertions, difficult localizations and difficult removals of the implant may occur. Surgical intervention might be necessary when removing the implant.

 

10        DATE OF REVISION OF THE TEXT

April 2010December 2011

 

Updated on 15 February 2011 SPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Improved Electronic presentation

Updated on 1 October 2010 SPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 1 October 2010 PIL

Reasons for updating

  • New PIL for medicines.ie