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

This type IB variation is to add “blood prolactin decreased” as an ADR to section 4. Possible side effects of the Package Leaflet.

The product information was also updated according QRD standard statement and excipients guideline.

Some typographical errors in Abilify tablets detected during the annual QC were also corrected.

This type IB variation was to add “blood prolactin decreased” as an ADR to section 4.8 of the SmPC.

The product information was also updated according QRD standard statement and excipients guideline.

Some typographical errors in Abilify tablets detected during the annual QC were also corrected.

Package Leaflet Section 6. Contents of the pack and other information (all formulations): 

Change of Local Representative from Otsuka Pharmaceuticals (UK) Ltd. to Otsuka Pharmaceutical Netherlands B.V.

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).

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

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

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marketing of oral aripiprazole but the frequency for them to occur is not known: the wording ‘sensitivity to light’ has been replaced by ‘skin sensitivity to light’

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

Update of the XPIL

Minor editorial changes made to section 2 and section 6.

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

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

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

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

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

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