Abilify Orodispersable Tablets 10 mg, 15 mg and 30 mg *

  • Company:

    Otsuka Pharmaceutical UK Ltd.
  • Status:

    No Recent Update
  • Legal 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

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 October 2020

File name

Abilify Orodispersible Tablets PIL-Ireland_1603186257.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Update of Common side effects: akathisia (an uncomfortable feeling of inner restlessness and a compelling need to move constantly),

Uncommon side effects: restless legs,

Frequency not known side effects:

• serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia).

Updated on 20 October 2020

File name

Abilify Orodispersible Tablets SPC-Ireland_1603186125.pdf

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

Update of “Restless legs syndrome” under the frequency “Uncommon”

Update of “Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)” under the frequency “Not known”

Updated on 05 May 2020

File name

Abilify orodispersable tablets PIL- Ireland_1588698612.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Section 4 Possible side effects:
-          Uncommon side effects (may affect up to 1 in 100 people): the wording ‘eye sensitivity to light’ has been added

-          The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known: the wording ‘sensitivity to light’ has been replaced by ‘skin sensitivity to light’

 

Updated on 05 May 2020

File name

Abilify orodispersable tablets SPC- Ireland_1588698392.pdf

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

Section 4.8 Undesirable effects: Eye disorders- Uncommon section
‘Photophobia’ has been added

Updated on 21 October 2019

File name

Abilify orodisp Sodium update - PIL IE_1571671488.pdf

Reasons for updating

  • Change to section 2 - excipient warnings

Free text change information supplied by the pharmaceutical company

Section 2: addition of statement on Abilify containing aspartame and sodium.

Updated on 21 October 2019

File name

Abilify orodisp tabs Sodium update - SPC Ireland_1571649099.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • 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

Section 4.4: admendments to the statement of aspartame

addition of statement of sodium containment

Section 4.6: added 'metabolites' to section on breastfeeding

Section 4.8: reclassification of a number of adverse events under 'Investigations'. Editorial changes.

Updated on 13 May 2019

File name

Abilify Orodispersible Tablets PIL Ireland_1557503473.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 09 May 2019

File name

Abilify Orodispersible Tablets SmPC Ireland_1557422184.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

The SmPC has been updated as follows:

Update to Section 4.4 Special warnings and precautions for use

Falls

Aripiprazole may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls. Caution should be taken when treating patients at higher risk, and a lower starting dose should be considered (e.g., elderly or debilitated patients; see section 4.2). 

 

Update to Section 4.8 Undesirable effects:

Oculogyric crisis is listed under Not known

Updated on 11 December 2018

File name

Abilify MAH change Orodispersable tablets - PIL IE_1544537472.pdf

Reasons for updating

  • New PIL for new product

Updated on 11 December 2018

File name

Abilify orodispersable tablets MAH Change - SPC IE_1544536835.pdf

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

Initial upload of SPC