Ebixa Oral Solution
- Name:
Ebixa Oral Solution
- Company:
Lundbeck (Ireland) Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 13/03/19

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Lundbeck (Ireland) Limited
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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 10 April 2019 SPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
correction of date of revision text: 01/2019 instead of 10/2016
Updated on 13 March 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 13 March 2019 SPC
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of information concerning types of glass bottles in Section 6.5 as per below:
50 ml (and 10 x 50 ml) in brown glass bottles (Hydrolytic Class II) and 100 ml in brown glass bottles (Hydrolytic Class III)"
Not all pack sizes may be marketed.
Updated on 10 May 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 20 March 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 20 March 2017 PIL
Reasons for updating
- Change to section 6 - date of revision
Updated on 7 March 2017 SPC
Reasons for updating
- Improved presentation of SPC
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 7 March 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 30 December 2014 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 change in lay-out (admin change)
Section 4.6 Fertility information added: No adverse effects of memantine were noted on male and female fertility.
Sectio 4.8: New reporting contact details information.
Updated on 23 December 2014 PIL
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
- Change to improve clarity and readability
Updated on 21 July 2014 PIL
Reasons for updating
- Change to date of revision
- Addition of marketing authorisation holder
Updated on 8 June 2012 PIL
Reasons for updating
- Change to side-effects
Updated on 8 June 2012 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Further it covers including of Balance disorder in section 4.8
Updated on 8 November 2011 SPC
Reasons for updating
- Change to product name
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Ebixa 5mg/pump oral solution changes to Ebixa 5mg/pump actuation oral solution
Section 2
Addition of actuation
Section 4.2
Following text added:
The tolerance and dosing of memantine should be reassessed on a regular basis, preferably within three months after start of treatment. Thereafter, the clinical benefit of memantine and the patient’s tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines. Maintenance treatment can be continued for as long as a therapeutic benefit is favourable and the patient tolerates treatment with memantine. Discontinuation of should be considered when evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment.
Addition of pump actuation in dose titration and renal impairment sections
Section 6.6
Pump actuation added to Diagram 5.
Updated on 4 November 2011 PIL
Reasons for updating
- Change to MA holder contact details
- Change to product name
Updated on 12 July 2011 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 10 January 2011 PIL
Reasons for updating
- Change of trade or active ingredient name
Updated on 6 January 2011 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change name to Ebixa 5 mg/pump oral solution
Section 2
Change gram to millilitre
Section 4.2
Change stroke to pump
Section 6.5
Change g to ml
Section 6.6
Change stroke to pump
Updated on 13 August 2010 SPC
Reasons for updating
- Change to improve clarity and readability
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 17 June 2010 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 17 June 2010 PIL
Reasons for updating
- Change to side-effects
Updated on 28 April 2010 SPC
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
New instruction section for use of new pump device
Updated on 23 April 2010 PIL
Reasons for updating
- Change to dosage and administration
- Correction of spelling/typing errors
Updated on 23 August 2009 SPC
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Deletion of 20g bottle
Updated on 20 August 2009 PIL
Reasons for updating
- Deletion of a pack size
Updated on 31 July 2009 PIL
Reasons for updating
- Change to side-effects
Updated on 26 July 2009 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.9 - Overdose
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8 - addition of undesirable effect
Updated on 22 December 2008 PIL
Reasons for updating
- Change to side-effects
Updated on 22 December 2008 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 12 August 2008 SPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 9 June 2008 PIL
Reasons for updating
- Change to dosage and administration
- Change to marketing authorisation holder address
Updated on 30 May 2008 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 12 October 2007 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Children and adolescents under the age of 18 years: Ebixa is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Renal impairment: In patients with mildly impaired renal function (creatinine clearance 50-80ml/min) no dosage adjustment is required. In patients with moderate renal impairment (creatinine clearance 30 ‑ 49 ml/min) daily dose should be 10 mg per day. If tolerated well after at least 7 days of treatment, the dose could be increased up to 20 mg/day according to standard titration scheme. In patients with severe renal impairment (creatinine clearance 5 – 29 ml/min) daily dose should be 10 mg per day.
In single dose PK studies in young healthy subjects no relevant drug-drug interaction of memantine with glyburide/metformin or donepezil was observed.
Specific patient population: In elderly volunteers with normal and reduced renal function (creatinine clearance of 50 ‑ 100 mL/min/1.73 m²), a significant correlation was observed between creatinine clearance and total renal clearance of memantine (see section 4.2).
Updated on 24 September 2007 PIL
Reasons for updating
- Improved electronic presentation
Updated on 12 September 2007 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Children and adolescents under the age of 18 years: Ebixa is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Renal impairment: In patients with mildly impaired renal function (creatinine clearance 50-80ml/min) no dosage adjustment is required. In patients with moderate renal impairment (creatinine clearance 30 ‑ 49 ml/min) daily dose should be 10 mg per day. If tolerated well after at least 7 days of treatment, the dose could be increased up to 20 mg/day according to standard titration scheme. In patients with severe renal impairment (creatinine clearance 5 – 29 ml/min) daily dose should be 10 mg per day.
In single dose PK studies in young healthy subjects no relevant drug-drug interaction of memantine with glyburide/metformin or donepezil was observed.
Specific patient population: In elderly volunteers with normal and reduced renal function (creatinine clearance of 50 ‑ 100 mL/min/1.73 m²), a significant correlation was observed between creatinine clearance and total renal clearance of memantine (see section 4.2).
Updated on 3 August 2007 PIL
Reasons for updating
- Change to date of revision
Updated on 3 August 2007 SPC
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Date of last renewal - replaced March 2007 with 15/05/07
Date of revision of the text - changed to May 2007
Updated on 5 April 2007 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 3 April 2007 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 Children and adolescents now reads:
Nervous system disorders |
Common |
Dizziness |
|
Uncommon |
Gait abnormal |
|
Very rare |
Seizures |
Gastrointestinal disorders |
Common |
Constipation |
|
Uncommon |
Vomiting |
|
Not known |
Pancreatitis2 |
Infections and infestations |
Uncommon. |
Fungal infections |
Vascular disorders |
Common |
Hypertension |
|
Uncommon |
Venous thrombosis/thromboembolism |
General disorders and administration site conditions |
Common |
Headache |
|
Uncommon |
Fatigue |
Psychiatric disorders |
Common |
Somnolence |
|
Uncommon Uncommon |
Confusion Hallucinations1 |
|
Not known |
Psychotic reactions2 |
Only limited experience with overdose is available from clinical studies and post-marketing experience.
Symptoms: Relative large overdoses (200mg and 105mg/day for 3 days, respectively) have been associated with either only symptoms of tiredness, weakness and/or diarrhoea or no symptoms. In the overdose cases below 140mg or unknown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination, and gait disturbance) and/or of gastrointestinal origin (vomiting and diarrhoea)
In the most extreme case of overdosage, the patient survived the oral intake of a total of 2000 mg memantine with effects on the central nervous system (coma for 10 days, and later diplopia and agitation). The patient received symptomatic treatment and plasmapheresis. The patient recovered without permanent sequelae.
In another case of a large overdose, the patient also survived and recovered. The patient had received 400 mg memantine orally. The patient experienced central nervous system symptoms such as restlessness, psychosis, visual hallucinations, proconvulsiveness, somnolence, stupor, and unconsciousness.
Treatment: In the event of overdosage, treatment should be symptomatic. No specific antidote for intoxication or overdose is available. Standard clinical procedures to remove drug material, e.g. gastric lavage, carbo medicinalis (interruption of potential entero-hepatic recirculation), acidification of urine, forced diuresis should be used as appropriate.
In case of signs and symptoms of general CNS overstimulation, careful symptomatic clinical treatment should be considered.
Date of first authorisation: 15/05/2002
Updated on 20 December 2006 PIL
Reasons for updating
- Change to side-effects
Updated on 7 December 2006 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Body as a whole – general disorders |
Common |
Headache |
|
Uncommon |
Fatigue |
Infections and infestations |
Uncommon |
Fungal Infections |
Psychiatric disorders |
Common |
Somnolence |
|
Uncommon Uncommon Not known |
Confusion Hallucinations1 Psychotic reactions² |
Vascular disorders |
Common Uncommon |
Hypertension Venous thrombosis/thromboembolism |
Gastro-intestinal system disorders |
Common |
Constipation |
|
Uncommon |
Vomiting |
|
Not known |
Pancreatitis2 |
Central & Peripheral nervous system disorders |
Common |
Dizziness |
|
Uncommon |
Gait abnormal |
|
Very rare |
Seizures |
Updated on 24 May 2006 PIL
Reasons for updating
- Change to side-effects
Updated on 11 May 2006 SPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 13 April 2006 PIL
Reasons for updating
- Change to, or new use for medicine
Updated on 25 January 2006 SPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 15 August 2005 PIL
Reasons for updating
- Improved electronic presentation
Updated on 14 September 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 8 August 2004 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 not be renewed (A)
Updated on 28 January 2004 SPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 18 December 2003 SPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 6.5 - Nature and contents of container
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 16 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)