Selincro Tablets *

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 01 April 2019

File name

PL UK-IE Selincro 18 mg FCT clean_1553976915.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to date of revision

Updated on 30 March 2019

File name

IE SPC Selincro clean_1553976798.pdf

Reasons for updating

  • Change to section 8 - Marketing authorisation number(s)
  • 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

Amendment is due to delection of two pack sizes in Section 8.

Updated on 22 January 2019

File name

IE Selincro Nov18 pil clean_1548107969.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to date of revision

Updated on 21 January 2019

File name

IE Selincro Nov18 SPC clean_1548107869.pdf

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

Addition of the following undesirable effects in Section 4.8:  

Skin and subcutaneous tissue disorders (frequency, unknown): Angiodema, Urticaria, Pruritus, Rash, Erythema.  

Reproductive system disorders (frequency unknown), Priapism.  

Updated on 20 February 2018

Reasons for updating

  • 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
  • Removal of black triangle

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

Free text change information supplied by the pharmaceutical company

The changes are as follows:

Removal of black triangle symbol.

Section 4.4
Addition of the following text in patients with psychiatric disorders:

The increased suicidal risk in alcohol and substances abusers, with or without accompanying depression, is not reduced by the intake of nalmefene.

Section 4.8
The addition of myalgia to the table of undesirable effects, frequency unknown

Date of renewal of authorisation added:

Updated on 20 February 2018

Reasons for updating

  • New SPC for new product

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

Updated on 20 February 2018

File name

PIL_16199_495.pdf

Reasons for updating

  • New PIL for new product

Updated on 20 February 2018

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 6 - date of revision
  • Removal of black triangle

Updated on 12 July 2017

Reasons for updating

  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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

The changes affects Section 4.7 and 4.8

 

Section 4.7 Effects on ability to drive and use machines

 

Updated text as follows: 

 

The effects of nalmefene on the ability to drive and use machines have not been studied.

Adverse reactions such as disturbance in attention, feeling abnormal, nausea, dizziness, somnolence, insomnia, and headache may occur following administration of nalmefene (see section 4.8). The majority of these reactions were mild or moderate, associated with treatment initiation, and of short duration.

 

Consequently, Selincro may have minor to modrate influence on the ability to drive and use machines and patients should exercise caution particular when starting treatment with Selincro

 

Section 4.8 Undesirable effects. 

 

Addition of ‘diarrhoea’ in the table of adverse reactions, with a frequency of, ‘common’.

  

Updated on 11 July 2017

Reasons for updating

  • Change to section 2 - driving and using machines
  • Change to section 4 - possible side effects

Updated on 13 March 2017

Reasons for updating

  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

Changes due to just template changes

Updated on 06 March 2017

Reasons for updating

  • Change to section 6 - date of revision

Updated on 15 June 2015

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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

Update to section 4.3: 

 Patients taking opioid analgesics agonists (such as opioid analgesics, opioids for substitution therapy with opioid agonists (e.g. methadone) or partial agonists (e.g. buprenorphine)) (see section 4.4).

Updated on 09 February 2015

Reasons for updating

  • 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

Updated date to November 2014, when it was last revised. No other changes have been made.

Updated on 20 January 2015

Reasons for updating

  • Change to date of revision
  • Introduction of new pack/pack size

Updated on 30 December 2014

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

None provided

Updated on 22 December 2014

Reasons for updating

  • New PIL for new product