Updated on 24/05/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 16-May-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In Section 4.8 (undesirable effects) addition of balance disorders and elevated liver function tests as frequency common and hepatitis as frequency unknown
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Updated on 07/11/2011 and displayed until 24/05/2012
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.2 - Posology and method of administration
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 24-Oct-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 1 the name of the oral solution has changed to include actuation - is now Ebixa 5mg/pump actuation oral solution
Section 2 - Each pump actuation replaces each pump activation (one downward pump)
Section 4.2 addition of the following text -
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 memantine should be considered when evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment.
Also in the titration details and under elderly and renal impairment the text has changed from downward pump(s) to pump actuation(s)
Section 6.6 - diagram 5 the text (equivalent to one pump actuation) has been added and diagram 8 pump actuation has replaced downward pump
Section 10 - date has been changed to 24/10/11
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Updated on 18/02/2011 and displayed until 07/11/2011
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 25-Oct-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The 10mg tablets are now lactose-free and have changed from white to pale yellow/yellow (excipient is Iron oxide yellow - E 172) and tablets are now marked with M M on one side and 1 0 on the other. The shape of the tablets has also changed from oblong to oval have changed colour from white to pale-yellow.
Section 2 has removed - Excipient: The 10 mg film-coated tablet contains 166 mg lactose, see section 4.4.
Section 3 10 mg tablets has changed to - The 10 mg film-coated tablets are pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings “1 0” on one side and “M M” on the other side. The tablet can be divided into equal halves.
Section 4.2 - Treatment Initiation pack - the colour of the 10mg tablets has been changed from to pale yellow to yellow oval shaped from white to off-white, centrally tapered oblong, biconvex, with a single breakline on both sides
Section 4.4 lactose warning has been removed
Section 6.1 the excipients have been changed to remove lactose and include Iron oxide yellow (E 172) for the 10mg tablets. Excipients are now:
Tablet cores for 5/10/15/20 mg film-coated tablets:
Microcrystalline cellulose
Croscarmellose sodium
Colloidal anhydrous silica
Magnesium stearate
Tablet coat for 5/10/15/20 mg film-coated tablets:
Hypromellose
Macrogol 400
Titanium dioxide (E 171)
Additional for 10 mg film-coated tablets:
Iron oxide yellow (E 172)
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Updated on 02/12/2010 and displayed until 18/02/2011
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 25-Oct-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1. - Name change from Ebixa 10mg/g oral drops, solution to Ebixa 5mg/pump oral solution
In the text of the SPC all mention of oral drops solution now says oral solution.
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Updated on 19/07/2010 and displayed until 02/12/2010
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 4.8 (undesirable effects), addition of Drug Hypersensitivity as common (≥1/100 to < 1/10)
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Updated on 21/09/2009 and displayed until 19/07/2010
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 30-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8 of the SPC has been revised.
Dyspnoea has been added to the table of undesirable effects: frequency, common.
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Updated on 12/01/2009 and displayed until 21/09/2009
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 02-Dec-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Addition of cardiac failure as an uncommon undesirable effect (≥1/1000, <1/100)
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Updated on 23/09/2008 and displayed until 12/01/2009
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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Addition of joint SPC covering all presentations
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Change to section 6.1 - List of Excipients
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Introduction of new strength
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Introduction of new pack/pack size
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.2 - Posology and method of administration
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 08-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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- Ebixa is now licensed for once-daily administration.
- A new treatment initiation pack is available to aid titration – this consists of 5mg, 10mg, 15mg and 20mg tablets each to be taken for 7 days to reach the maximum daily dose of 20mg.
- A 20mg tablet pack is also now available for once-daily administration.
- The 10mg tablet packs will continue to be available.
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Updated on 20/09/2007 and displayed until 23/09/2008
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 08/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 Revision of paragraphs on dosing in renal and hepatic impairment (new text below).
Renal impairment: In patients with mildly impaired renal function (creatinine clearance 50 – 80 ml/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 4.5 Addition of:
"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."
Section 4.4 Removal of the following text:
“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”.
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Updated on 29/08/2007 and displayed until 20/09/2007
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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Change to section 4.9 - Overdose
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Change to section 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.2 - Posology and method of administration
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| Date of revision of text on the SPC: 05/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Specific changes are as follows:
Section 2. Qualitiative and quantitative composition
Addition of:
Excipients-oral drops: 1 g of solution contains 100 mg of Sorbitol E420 and 0.5 mg of potassium.
Excipient-tablets: Each film-coated tablet contains 166mg lactose.
Section 3. Pharmaceutical form
10mg film-coated tablet- Addition of:
The tablet can be divided into equal halves
Section 4.2 Posology and administration
Rewords paragraph as follows:
Children and adolescents under the age of 18 years: Ebixa is not recommended for use in children below 18 years due to lack of data on safety and efficacy.
Section 4.4 Special warnings and precautions for use
Addition of:
Excipients – oral drops: The oral drops contain sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Excipients – tablets: The tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.\
Section 4.8 Undesirable Effects
The Adverse Drug Reaction Table has been re-ordered so that: within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.\
Section 4.9 Overdose
This section has been expanded as follows: 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.”
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Updated on 21/12/2006 and displayed until 29/08/2007
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 10 date of revision of the text
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 11/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8 Undesirable effects
Addition of hypertension (4.1% vs 2.8%) to the list of most frequently occurring adverse events with higher incidence in the memantine group than in the placebo group.
The following Adverse Drug Reactions have been also been included:
Infections and infestations: fungal infections (uncommon)
Vascular disorders: hypertension (common) and Venous thrombosis/thromboembolism (uncommon)
Section 6.5 Nature and contents of container
Addition of '56 x 1' and '98 x 1' pack sizes
Section 8 MARKETING AUTHORISATION NUMBER(S)
Addition of EU/1/02/219/014-015
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Updated on 29/09/2006 and displayed until 21/12/2006
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Reasons for adding or updating:
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Addition of joint SPC covering all presentations
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| Date of revision of text on the SPC: 04/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Addition of SPC for both Eiba 10mg tablets and Ebixa oral drops, solution
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Updated on 15/05/2006 and displayed until 29/09/2006
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Reasons for adding or updating:
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 27/04/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Sections 4.5 - addition of
“In post marketing experience isolated cases with INR increases have been reported in patients concomitantly treated with warfarin. Although no causal relationship has been established, close monitoring of prothrombin time or INR is advisable for patients concomitantly treated with oral anticoagulants.”
Section 4.8 - addition of
Psychotic reactions and pancreatitis have been added to the table of ADRs both with the frequency stated as ‘not known’ (cannot be estimated from the available data) with a note “isolated cases reported in post-marketing experience.”
“Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. In post-marketing experience these events have been reported in patients treated with memantine.”
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Updated on 22/02/2006 and displayed until 15/05/2006
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Reasons for adding or updating:
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Removal of Black Triangle
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Updated on 12/12/2005 and displayed until 22/02/2006
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic Properties
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Updated on 24/09/2004 and displayed until 12/12/2005
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.8 - Undesirable Effects
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Updated on 03/06/2003 and displayed until 24/09/2004
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6. 5 - Nature and Contents of Container
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Updated on 30/05/2003 and displayed until 03/06/2003
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Reasons for adding or updating:
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Change to section 5 - Pharmacological Properties
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Change to section 6. 5 - Nature and Contents of Container
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Updated on 09/09/2002 and displayed until 30/05/2003
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Reasons for adding or updating:
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