ABILIFY 7.5 mg/ml solution for injection

  • Name:

    ABILIFY 7.5 mg/ml solution for injection

  • 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 22 October 2019 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

Minor editorial changes to the PIL made.

In section 2, additional statement on the product containing sodium.

Updated on 21 October 2019

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

Free text change information supplied by the pharmaceutical company

Section 4.4: addition of statement on sodium content

Section 4.6: added word 'metabolites' to section on breastfeeding

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

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 9 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

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 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 13 May 2018 PIL

Reasons for updating

  • New PIL for new product

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)