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Shire Pharmaceuticals Ireland Limited
5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland,
Telephone: +353 1 429 7700
Fax: +353 1 429 7701
Medical Information Direct Line: 1 800 818 016
Medical Information e-mail: MedInfoIE@shire.com
Customer Care direct line: +44 (0)1256 894 107
Summary of Product Characteristics last updated on medicines.ie: 07/11/2011
SPC Equasym XL 10, 20 & 30mg Modified Release Capsules

When a pharmaceutical company changes an SPC or PIL, 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 07/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   25-Oct-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 4.8

To include; bruxism
Updated on 15/07/2011 and displayed until 07/11/2011
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   05-Jul-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
4.9 Overdose

Signs and symptoms - pyychosis has been added.
Updated on 31/05/2011 and displayed until 15/07/2011
Reasons for adding or 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   19-May-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


4.2     Posology and method of administration

Equasym XL should not be taken too late in the morning as it may cause disturbances in sleep. If the effect of the medicinal product wears off too early in the late afternoon or evening, disturbed behaviour and/or inability to go to sleep may recur. A small dose of an immediate-release methylphenidate hydrochloride tablet late in the day may help to solve this problem. In that case, it could be considered that adequate symptom control might be achieved with a twice daily immediate release methylphenidate regimen. The pros and cons of a small evening dose of immediate-release methylphenidate versus disturbances in falling asleep should be considered.


4.4     Special warnings and precautions for use

Aggressive or hostile behaviour

Physicians should evaluate the need for adjustment of the treatment regimen in patients experiencing behaviour changes bearing in mind that upwards or downwards titration may be appropriate. Treatment interruption can be considered.


4.8         Undesirable effects – updated in line with SPC Guideline

 
4.9     Overdose

When treating patients with overdose, allowances must be made for the delayed release of methylphenidate from formulations with extended durations of action.


10.     DATE OF REVISION OF THE TEXT

19 May 2011
Updated on 16/02/2011 and displayed until 31/05/2011
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • 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-Feb-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Section 3. Pharmaceutical Form
Change in capsule logo from 'UCB' to 'S544'

6.4     Special precautions for storage

Change in storage conditions from 'Store below 30°C' to 'Store below 25°C'.

10. Date of Revision of Text
05/2010 to 02/2011

Updated on 10/06/2010 and displayed until 16/02/2011
Reasons for adding or updating:
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Addition of legal category
  • Change to section 4.7 - Effects on ability to drive and use machines
Date of revision of text on the SPC:   01-May-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 4.1: Completely updated in lince with article 31 referral
Section 4.2: Completely updated in lince with article 31 referral
Section 4.3: Completely updated in lince with article 31 referral
Section 4.4: Completely updated in lince with article 31 referral
Section 4.5: Completely updated in lince with article 31 referral
Section 4.6: Completely updated in lince with article 31 referral
Section 4.7: Completely updated in lince with article 31 referral
Section 4.8: Completely updated in lince with article 31 referral
Section 4.9: Completely updated in lince with article 31 referral
Section 5.1: Table has been reformatted and replacement of noradrenaline for norepinephrine in the 2nd sentence of the last paragraph
Section 5.3: Completely updated in lince with article 31 referral
Section 6.3: 36 months replaced with 3 years in line with the QRD template
Section 6.5: Updated to list only the pack size available in Ireland
Section 7: MAH telephone number and e-mail address added
Section 9: Information corrected
Section 9: Information corrected
Legal category added
Updated on 12/08/2009 and displayed until 10/06/2010
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
Date of revision of text on the SPC:   12-Jun-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


7.      MARKETING AUTHORISATION HOLDER

 

Shire Pharmaceuticals Ireland Limited

5 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

 

 

8.      MARKETING AUTHORISATION NUMBER(S)

 

PA 1575/1/1, 2, 3



 

10.    DATE OF REVISION OF THE TEXT

 

12 June 2009
Updated on 14/11/2007 and displayed until 12/08/2009
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   10/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update shelf life to 36 months
Updated on 19/02/2007 and displayed until 14/11/2007
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Methylphenidate Hydrochloride