Selincro Tablets
*Company:
Lundbeck (Ireland) LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 23 May 2022
File name
IE-XI PIL REG_00076036 version 14.0.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 23 May 2022
File name
IE SPC REG_00076037 version 9.0.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 December 2021
File name
IE Selincro 18mg Film-coated tablets SPC_REG_00076037.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 December 2021
File name
IE-XI Selincro 18mg Film-coated tablets PIL_REG_00076036.pdf
Reasons for updating
- Change to section 2 - driving and using machines
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 01 April 2019
File name
PL UK-IE Selincro 18 mg FCT clean.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.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.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.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
File name
PIL_16199_495.pdf
Reasons for updating
- New PIL for new product
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
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
- 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 ādiarrhoeaā in the table of adverse reactions, with a frequency of, ācommonā.
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
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
Patients taking opioid
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 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
Updated on 22 December 2014
Reasons for updating
- New PIL for new product