ABILIFY 1 mg/ml oral solution

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.

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.

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.

Package Leaflet Section 3 How to take ABILIFY for Abilify oral solution: 

Change from “30 mg (i.e., 30 mL) once a day” to “30 mL (i.e., 30 mg) once a day”

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of oral aripiprazole but the frequency for them to occur is not known: the wording ‘sensitivity to light’ has been replaced by ‘skin sensitivity to light’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

Section 2: minor editorial changes

Additional statement on the content of fructose and sucrose

Additional statement on the content of parahydroxybenzoate

Additional statement on the content of sodium

Section 4.4: addition of statement regarding the medicine containing fructose and sucrose.

addition of section on parahydroxybenzoate

addition of statement on sodium

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

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

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

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