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Ebixa Oral Solution

  • Name:

    Ebixa Oral Solution

  • Company:
    info
  • Active Ingredients:

    Memantine hydrochloride

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 23/02/21

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Summary of Product Characteristics last updated on medicines.ie: 23/2/2021

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Lundbeck (Ireland) Limited

Lundbeck (Ireland) Limited

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Medicine Name Depixol Conc. 100 mg/ml Injection Active Ingredients Flupentixol Decanoate
Medicine Name Ebixa Oral Solution Active Ingredients Memantine hydrochloride
Medicine Name Ebixa Tablets Active Ingredients Memantine hydrochloride
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1 - 0 of 25 items.Total: Infinity pages

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 23 February 2021 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

Revisions in SmPC according to EMA request of supplementary information (procedure no. EMEA/H/C/000463/IB/0091): 
•    Sodium wording is added in the SmPC of film coated tablets according to the EMA request
•    Sorbitol and Potassium wording in the SmPC for oral solution was revised according to EMA request

Updated on 23 February 2021 PIL

Reasons for updating

  • Change to section 2 - excipient warnings

Free text change information supplied by the pharmaceutical company

Excipients information update in PIL based on EC guideline

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

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

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

Change to template formatting - no text change

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

Update due to QRD 9.0. Spelling errors and admin changes.
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

The variation covers including of Hepatitis and Elevated liver function test in section 4.8
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

Section 1
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

Excipients Section 4.4 - Changed oral drops to oral solution

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

Section 1
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

Removed gaps in Table in Section 4.8

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

Addition of Drug hypersensitivity AE (Common) to Immune System Disorders in Section 4.8

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

Section 6.5

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

All sections - typographical changes
Section 4.8 - addition of undesirable effect

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

Change in Section 4.8 Table:
 
Cardiac Disorders    Uncommon    Cardiac failure

Updated on 22 December 2008 PIL

Reasons for updating

  • Change to side-effects

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

Section 4.2
 
Change to once daily administration

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

Section 4.2 sections amended to:
 

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.

 

 

Hepatic impairment:  In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B) no dosage adjustment is needed. No data on the use of memantine in patients with severe hepatic impairment are available.
 
Section 4.4
Sentence removed:
As no data are available for patients with severe renal impairment (creatinine clearance less than 9 ml/min/1.73 m²) therapy is not recommended (see section 4.2).
 
Section 4.5
Sentences added:

In single dose PK studies in young healthy subjects no relevant drug-drug interaction of memantine with glyburide/metformin or donepezil was observed.

 

In a clinical study in young healthy volunteers no relevant effect of memantine on the pharmacokinetics of galantamine was observed.
 
Secrion 4.9
Relative changed to relatively
 
Section 5.2
Paragraphs removed:

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).

 

The effect of liver disease on the pharmacokinetics of memantine has not been studied. As memantine is metabolised to a minor extent only, and into metabolites with no NMDA-antagonistic activity, clinically relevant changes in the pharmacokinetics are not expected in mild to moderate liver impairment.
 
Section 10
27th August 2007

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

Section 4.2 sections amended to:
 

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.

 

 

Hepatic impairment:  In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B) no dosage adjustment is needed. No data on the use of memantine in patients with severe hepatic impairment are available.
 
Section 4.4
Sentence removed:
As no data are available for patients with severe renal impairment (creatinine clearance less than 9 ml/min/1.73 m²) therapy is not recommended (see section 4.2).
 
Section 4.5
Sentences added:

In single dose PK studies in young healthy subjects no relevant drug-drug interaction of memantine with glyburide/metformin or donepezil was observed.

 

In a clinical study in young healthy volunteers no relevant effect of memantine on the pharmacokinetics of galantamine was observed.
 
Secrion 4.9
Relative changed to relatively
 
Section 5.2
Paragraphs removed:

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).

 

The effect of liver disease on the pharmacokinetics of memantine has not been studied. As memantine is metabolised to a minor extent only, and into metabolites with no NMDA-antagonistic activity, clinically relevant changes in the pharmacokinetics are not expected in mild to moderate liver impairment.
 
Section 10
27th August 2007

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 3 August 2007 PIL

Reasons for updating

  • Change to date of revision

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 2 now contains:
Excipients: 1 g of solution contains 100 mg of Sorbitol E420 and 0.5 mg Potassium, see section 4.4.
 
3rd line now reads:
For a full list of excipients, see section 6.1.

Section 4.2 Children and adolescents now reads:
Ebixa is not recommended for use in children below 18 years due to lack of data on safety and efficacy.
 
mL changed to ml
memantine changed to Ebixa
 
Section 4.4:
mL changed to ml
 
Now added:
Excipients: The oral drops contain sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
 
Section 4.6
levels, which
 
Section 4.7
memantine changed to Ebixa
 
Section 4.8
memantine changed to Ebixa
 
Now added:
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
 
New table of AEs:

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
 
 Less than or equals sign changed to <
 
Section 4.9 now reads:

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.

 
Section 5.2:
mL changed to ml
 
Sentence moved:
Linearity: Studies in volunteers have demonstrated linear pharmacokinetics in the dose range of 10 to 40 mg.
 
Section 5.3
levels, which
 
Section 6.1
E420 added to sorbitol
 
Section 6.4 now reads:
This medicinal product does not require any special storage conditions.
 
Section 6.6 heading now reads:
Special precautions for disposal
 
Section 9:

Date of first authorisation: 15/05/2002

Date of last renewal:  March 2007
 
Section 10:
April 2007

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

Change to table in Section 4.8:
 

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)