ABILIFY 5 mg, 10 mg, 15 mg and 30 mg tablets

  • Name:

    ABILIFY 5 mg, 10 mg, 15 mg and 30 mg tablets

  • Company:
    info
  • Active Ingredients:

    aripiprazole

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/10/20

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 20/10/2020

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Otsuka Pharmaceutical UK Ltd.

Company Products

Medicine NameActive Ingredients
Medicine Name ABILIFY 1 mg/ml oral solution Active Ingredients aripiprazole
Medicine Name ABILIFY 5 mg, 10 mg, 15 mg and 30 mg tablets Active Ingredients aripiprazole
Medicine Name ABILIFY 7.5 mg/ml solution for injection Active Ingredients aripiprazole
Medicine Name Abilify Orodispersable Tablets 10 mg, 15 mg and 30 mg Active Ingredients aripiprazole
Medicine Name Jinarc 15mg, 30mg, 15mg + 45mg, 30mg + 60mg, 30mg + 90mg tablets Active Ingredients tolvaptan
Medicine Name Samsca 7.5 mg, 15mg and 30mg Tablets Active Ingredients tolvaptan
1 - 0 of 6 items.Total: Infinity pages

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 PIL

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

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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 5 May 2020 PIL

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 5 May 2020

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

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

Updated on 28 October 2019 PIL

Reasons for updating

  • XPIL Updated

Free text change information supplied by the pharmaceutical company

Update of the XPIL

Updated on 21 October 2019 PIL

Reasons for updating

  • Improved presentation of PIL

Free text change information supplied by the pharmaceutical company

Minor editorial changes made to section 2 and section 6.

Updated on 21 October 2019

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Section 4.6: wording added 'aripiprazole metabolites' on breastfeeding.

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

 

Updated on 13 May 2019 PIL

Reasons for updating

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

Updated on 13 May 2019

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Section 2: addition of 'as monohydrate' to tablet lactose composition

Section 4.4: addition of precaution for 'falls'

Section 4.8: oculogyric crisis listed as not known

Updated on 13 May 2019

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Section 4.4: addition of 'falls' as a warning and precaution

Section 4.8: addition of oculogyric crisis is listed under not known

Updated on 11 December 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 11 December 2018

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Section 7. Change of Marketing Authorisation Holder (MAH) from Otsuka Pharmaceutical Europe Ltd. to Otsuka Pharmaceutical Netherlands B.V.

Updated on 9 May 2018

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 8 May 2018 PIL

Reasons for updating

  • New PIL for new product