Updated on 28/03/2012 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
|
| Date of revision of text on the SPC: 19-Mar-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.8 - Addition of hallucination as an Uncommon Adverse Reaction
|
|
Updated on 28/02/2012 and displayed until 28/03/2012
|
Reasons for adding or updating:
|
-
Change to section 1 -Name of the Medicinal product
-
Change to section 2 - Qualitative and quantitative composition
-
Change to section 3 - Pharmaceutical form
-
Change to section 4.1 - Therapeutic indications
-
Change to section 4.2 - Posology and method of administration
-
Change to section 4.3 - Contraindications
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.6 - Pregnancy and Lactation
-
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 6.2 - Incompatibilities
-
Change to section 6. 3 - Shelf Life
-
Change to section 6. 4 - Special Precautions for Storage
-
Change to section 6. 5 - Nature and Contents of Container
-
Change to section 6. 6 - Instructions for use, handling and disposal
-
Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 21-Feb-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
Section 1, 2 and 3 - Addition of 10 mg/ml syrup.
Section 4.1 - Clarification of the age range of the indication
Section 4.2 - Added method of administration for 10 mg/ml syrup
Section 4.3 - Administrative change to add 10 mg/ml syrup data
Section 4.4 - Addition of precautions for use for the 10 mg/ml syrup
Section 4.6 - Addition of non-clinical fertility data
Section 5.2 - Administrative change to add 10 mg/ml syrup data
Section 5.3 - Addition of Environmental Risk Assessment data
Section 6.1 - Addition of excipients data for 10 mg/ml syrup
Section 6.2 - Administrative change to add 10 mg/ml syrup data
Section 6.3 - Addition of shelf life data for 10 mg/ml syrup
Section 6.4 - Addition of storage instructions for 10 mg/ml syrup
Section 6.5 - Addition of nature and contents of container for 10 mg/ml syrup
Section 6.6 - Addition of special precautions for disposal for 10 mg/ml syrup
Section 8 - Addition of 2 new licence numbers for 10 mg/ml syrup
Section 10 - Update of the date of revision of text.
|
|
Updated on 02/12/2011 and displayed until 28/02/2012
|
Reasons for adding or updating:
|
-
Change to section 1 -Name of the Medicinal product
-
Change to section 2 - Qualitative and quantitative composition
-
Change to section 3 - Pharmaceutical form
-
Change to section 4.2 - Posology and method of administration
-
Change to section 4.3 - Contraindications
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 5.2 - Pharmacokinetic Properties
-
Change to section 6.1 - List of Excipients
-
Change to section 6.2 - Incompatibilities
-
Change to section 6. 3 - Shelf Life
-
Change to section 6. 4 - Special Precautions for Storage
-
Change to section 6. 5 - Nature and Contents of Container
-
Change to section 6. 6 - Instructions for use, handling and disposal
-
Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 24-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
Sections 1,2,3 - Deleted reference to 15 mg/ml syrup (no longer licenced).
Section 4.3 - Deleted reference to 15 mg/ml syrup measuring cup.
Section 4.4 - Deleted warning about 15 mg/ml syrup ingredients.
Sections 5.2, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 8 - Deleted reference to 15 mg/ml syrup (no longer licenced).
Section 10 - Updated date of revision of text.
|
|
Updated on 18/05/2011 and displayed until 02/12/2011
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.8 - Undesirable Effects
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 06-May-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
In Section 4.4 (Special warnings and precautions for use) - Addition of the statement that second degree or higher AV block has been reported in post-marketing experience. Atrial fibrillation or flutter have been reported in open-label clinical trials and post-marketing experience. Patients should be made aware of the symptoms of second degree or higher AV block.and of the symptoms of atrial fibrillation and flutter.
In Section 4.8 (Undesirable effects)
The following symptoms were added to the tabulated list of adverse events.:
Common- Insomnia
Uncommon - Aggression, Agitation, Psychotic disorder, Suicide attempt, Suicidal ideation, Atrial Fibrillation, Atrial Flutter, Angioedema, Urticaria.
The following statement has been added:
Atrial fibrillation or flutter were not reported in short term clinical trials however both have been reported in open-label epilepsy trials and in post-marketing experience.
Other minor amendments have been made to the SmPC e.g. formatting/update of headings.
|
|
Updated on 11/05/2011 and displayed until 18/05/2011
|
Reasons for adding or updating:
|
-
Change to section 2 - Qualitative and quantitative composition
-
Change to section 4.3 - Contraindications
-
Change to section 6.1 - List of Excipients
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 10-Jan-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
In Section 2, Qualitative and Quantitative Composition, removal of the excipient soya-lecithin.
In Section 4.3, Contraindication, removal of hypersensitivity to peanuts or soya warning.
In Section 6.1, List of excipients, removal of soya-lecithin as an ingredient in the tablet coat.
In Section 10, Date of Revsion of the text changed to JAN/2011 in line with EMA approval date for all text.
|
|
Updated on 09/05/2011 and displayed until 11/05/2011
|
Reasons for adding or updating:
|
-
Change to section 2 - Qualitative and quantitative composition
-
Change to section 4.3 - Contraindications
-
Change to section 6.1 - List of Excipients
-
SPC Submitted in error
|
| Date of revision of text on the SPC: 01-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
In Section 2, Qualitative and Quantitative Composition, removal of the excipient soya-lecithin.
In Section 4.3, Contraindication, removal of hypersensitivity to peanuts or soya warning.
In Section 6.1, List of excipients, removal of soya-lecithin as an ingredient in the tablet coat.
|
|
Updated on 11/03/2011 and displayed until 09/05/2011
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 07-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
- Section 6.3, the shelf-life of Vimpat film-coated tablets has changed from 3 to 4 years.
|
|
Updated on 04/11/2010 and displayed until 11/03/2011
|
Reasons for adding or updating:
|
-
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 5.1 - Pharmacodynamic Properties
-
Change to section 5.2 - Pharmacokinetic Properties
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 29-Oct-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.5 - Addition of in vitro data. Caution is recommended in concomitant treatment with strong inhibitors of CYP2C9 (e.g.
fluconazole) and CYP3A4 (e.g. itraconazole, ketoconazole, ritonavir, clarithromycin), which may lead to increased systemic exposure of lacosamide. Such interactions have not been established in vivo but are possible based on in vitro data.
Section 4.8 - Addition of uncommon side effects; drug sensitivity, euphoric mood, abnormal liver function test.
Section 5.1 - Deletion of CRMP-2 data.
Section 5.2 - Clarification of in vitro data.
|
|
Updated on 28/07/2010 and displayed until 04/11/2010
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
|
| Date of revision of text on the SPC: 01-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
In section 4.8 ( undesirable effects) a number of additions have been made in the frequency table
1. A new sentence has been added - (with an incidence rate ³1% in the lacosamide group and which are >1% more than placebo) and
post-marketing experience.
2. New column added - "uncommon"
3. The words "Confusional state(1)" has been added to the common column under psychiatric disorders
4. Hypoesthesia(1) , Dysarthria(1), Disturbance in attention(1) have been added in the common column under nervous system disorders
5. Tinnitus(1) has been added in the common column under Ear and labyrinth disorders
6. New system class added - Cardiac disorders along with Atrioventricular block(2)Bradycardia(2 under the uncommon column has
been added.
7. Dyspepsia(1)Dry mouth(1) have been added to the common column under gastrointestinal disorders
8. The word Rash(2) has been added under the common column for skinand subcutaneous tissue disorders
9. New system class added - " Musculoskeletal and connective tissue disorders" along with Muscle spasms(1) added under the
common column.
10. In the common column under General disorders and administration site conditions - Irritability(1)injection site pain or discomfort (3)
irritation(3) have been added. In the uncommon column the following has been added "Erythema(3)"
11. The following footnotes have also been added to the table :
(1) potentially important adverse drug reactions identified as being reported in pooled clinical trials with an incidence rate not meeting the criteria used above.
(2) adverse reactions reported in post marketing experience.
(3) local adverse events associated with intravenous administration
12. The following words have been added in the 2nd paragraph below the frequency table -
In clinical trials in epilepsy patients the incidence rate of reported first degree AV Block is uncommon, 0.7%, 0%, 0.5% and 0% for lacosamide 200 mg, 400 mg, 600 mg or placebo, respectively. No second or higher degree AV Block was seen in lacosamide treated epilepsy patients.
|
|
Updated on 25/05/2010 and displayed until 28/07/2010
|
Reasons for adding or updating:
|
-
Change to section 2 - Qualitative and quantitative composition
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 6.1 - List of Excipients
-
Change to section 6. 3 - Shelf Life
-
Change to section 6. 4 - Special Precautions for Storage
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 01-Apr-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
The following changes relate to the syrup formulation only:
Section 2: updated to reflect removal of excipient (E217) and subsequent adjustment of quantities of E219 and sodium
Section 4.4: updated to reflect removal of excipient (E217) and subsequent adjustment of sodium quantity
Section 6.1: updated to reflect removal of excipient (E217)
Section 6.3: increased shelf-life
Section 6.4: removal of special storage conditions
Section 10: updated to refelct approval of the above changes
|
|
Updated on 21/04/2010 and displayed until 25/05/2010
|
Reasons for adding or updating:
|
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
-
Change to section 4.6 - Pregnancy and Lactation
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 01-Apr-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.5: updated in-vivo interaction data, removal of paragraph relating to omeprazole under “other” sub heading”
Section 4.6: correction of typographical error
Section 10: updated to reflect the approval of the above changes
|
|
Updated on 04/11/2009 and displayed until 21/04/2010
|
Reasons for adding or updating:
|
-
Change to section 6. 5 - Nature and Contents of Container
|
| Date of revision of text on the SPC: 01-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
Section 6.5: Additional pack size added for solution and standard statement that not all pack sizes may be marketed.
Section 10: Updated to reflect inclusion of above in annex issued by EC.
|
|
Updated on 05/03/2009 and displayed until 04/11/2009
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 02-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
Section 4.4, addition of class wording regarding the monitoing of suicidal ideation and behaviours.
Section 10, updated to reflect approval of variation to include new wording in section 4.4.
|
|
Updated on 12/09/2008 and displayed until 05/03/2009
|
Reasons for adding or updating:
|
|
|
| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
| None provided |
|
