ABILIFY 5 mg, 10 mg, 15 mg and 30 mg tablets
- Name:
ABILIFY 5 mg, 10 mg, 15 mg and 30 mg tablets
- Company:
Otsuka Pharmaceutical UK Ltd.
- Active Ingredients:
- 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
(Click to Download)XPIL
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
What is in this leaflet
1. What ABILIFY is and what it is used for
1. What ABILIFY is and what it is used for
2. What you need to know before you take ABILIFY
2. What you need to know before you take ABILIFY
3. How to take ABILIFY
3. How to take ABILIFY
4. Possible side effects
4. Possible side effects
5. How to store ABILIFY
5. How to store ABILIFY
6. Contents of the pack and other information
6. Contents of the pack and other information
Click on this link to Download PDF directly
Otsuka Pharmaceutical UK Ltd.
Company Products
| Medicine Name | Active 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 |
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 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
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 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
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 SPC
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
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 SPC
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
Legal category: Product subject to medical prescription which may be renewed (B)
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 SPC
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 be renewed (B)
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 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category: Product subject to medical prescription which may be renewed (B)
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 SPC
Reasons for updating
- New SPC 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