ABILIFY 1 mg/ml oral solution
- Name:
ABILIFY 1 mg/ml oral solution
- 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
ABILIFY 1 mg/mL oral solution
ABILIFY 1 mg/mL oral solution
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 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
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
Updated on 21 October 2019 SPC
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
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 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.
Updated on 10 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 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
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 12 March 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
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 4 May 2018 PIL
Reasons for updating
- New PIL for new product