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Essential Generics

7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB, UK
Telephone: +44 (0)1784 477 167
Fax: +44 (0)1784 471 776
E-mail: info@chemidex.co.uk

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 05/02/2014
SPC Ethosuximide 250mg Capsules

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 05/02/2014 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 - Name of the medicinal product
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   23-Jan-2014
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

In section 1, the name has been updated to include the company name. Ethosuximide Essential Generics 250 mg Capsules.
In section 10, the revision date has been updated to 23.01.2014
Updated on 21/07/2011 and displayed until 05/02/2014
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   20-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



4.2 Posology and method of administration

Adults, the Elderly and Children over 6 Years: Start with a small dose - 500mg daily with increments of 250mg every five to seven days until control is achieved with 1000 - 1500 mg daily.  Occasionally 2000 mg in divided doses may be necessary.

Children aged 0-6 years old and those who are unable to swallow capsules should be given ethosuximide oral liquid. Currently available clinical trial data regarding the use of ethosuximide in the paediatric population are described in section 5.1.

Effective plasma levels of ethosuximide normally lie between 40 and 100 mcg per ml, but the clinical response should be the criteria for the regulation of the dosage.  The half-life of ethosuximide in the plasma is more than 24 hours but the daily dose if large is more comfortably divided between morning and evening.

5.1       Pharmacodynamic properties

Ethosuximide gives selective control of absence seizures (petit mal) even when complicated by grand mal.  It is also indicated for myoclonic seizures. Compared to other anti-convulsants, ethosuximide is more specific for pure petit mal.

The reduction of seizure frequency is thought to be achieved by depression of the motor cortex and elevation of the threshold to convulsive stimuli as seen by the suppression of the characteristic spike and wave EEG pattern.

In a double-blind randomized trial of 20 weeks duration in 453 children aged 2.5 to 13 years old with newly diagnosed childhood absence epilepsy, the efficacy, tolerability, and neuropsychlogical effects of ethosuximide, valproic acid and lamotrigine as monotherapy in childhood absence epilepsy were investigated. Those treated with either ethosuximide or valproic acid had higher freedom-from-failure rates (53% and 58%, respectively) than those given lamotrigine (29%; odds ratio with ethosuximide vs. lamotigine, 2.66; 95% confidence interval [CI], 1.65 to 4.28; odds ratio with valproic acid vs. lamotrigine, 3.34; 95% CI, 2.06 to 5.42; P<0.001 for both comparisons). In both prespecified and post hoc analyses, ethosuximide resulted in fewer attentional effects as compared with valproic acid (at week 16 and week 20, the percentage of subjects with a Confidence Index score of 0.60 or higher in the Conners’ Continuous Performance Test was greater in the valproic acid group than in the ethosuximide group (49% vs. 33%; odds ratio, 1.95; 95% CI, 1.12 to 3.41; P=0.03) and the lamotigine group (49% vs. 24%; odds ratio, 3.04; 95% CI, 1.69 to 5.49; P<0.001).

Updated on 05/02/2010 and displayed until 21/07/2011
Reasons for adding or updating:
  • Change to section 6.2 - Incompatibilities
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   20-Jan-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 6.2 (Incompatibilities): 'Carbamazepine, phenytoin, sodium valproate or isoniazid' have been removed, Section 6.2 now reads: 'None stated'
Section 10 now reads: 22/01/2010
Updated on 24/12/2009 and displayed until 05/02/2010
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   25-Sep-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Capsules are now supplied in Grey polypropylene container with a white low density polyethylene cap

 

Updated on 16/10/2008 and displayed until 24/12/2009
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Correction of spelling/typing errors
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   17-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


  • In section 4.4, MHRA suicide warnings added as 2 paragraphs:

Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for ethosuximide.

Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.

  • In section 9, Date of authorisation/renewal corrected to: 

                        01/11/1990 
                        14/12/1995

  • In section 10, Date of revision of text changed to 17/09/2008
  • Hyphen inserted in Stevens-Johnson
Updated on 12/11/2007 and displayed until 16/10/2008
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics