SSL International plc

Freepost, RSBU-TEBT-GSTU, Reckitt Benckiser, Kingston Upon Thames, KT2 6LZ, UK
Telephone: +44 (0)500 455 456
Fax: +44 (0)1753 506 771
WWW: http://www.reckittbenckiser.com
Medical Information Direct Line: +44 (0)500 455 456
Medical Information e-mail: info.miu@reckittbenckiser.com
Customer Care direct line: +44 (0)500 455 456

Summary of Product Characteristics last updated on the eMC: 03/02/2012
SPC Medinol Paediatric Paracetamol Oral Suspension BP 120mg/5ml, Medinol For Children 120mg/5ml Oral Suspension

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 03/02/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 6.1 - List of Excipients
Date of revision of text on the SPC:   25-Jan-2012
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The SPC was updated in sections 4.3, 4.5, 4.6, 4.8 and 4.9 in line with minimum SPC requirements for paracetamol containing products licencesed as 'P'.

The SPC was updated in sections 2, 4.4 and 6.1 with information relating to excipients with a known effect.
Updated on 25/09/2009 and displayed until 03/02/2012
Reasons for adding or 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 4.9 - Overdose
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
  • SPC Retired pending re-submission
Date of revision of text on the SPC:   01-Jul-2006
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Section 2 –

Remove BP

 

Section 4.2

Formatting paragraphs

 

Section 4.4 –

Formatting paragraphs

 

Section 4.9

Formatting paragraphs

 

Section – 6.5

Additional sizes and container info

 

Section – 9

Amendments to authorisation date

 

Section – 10

Amendments to date

Updated on 28/09/2006 and displayed until 25/09/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 27/09/2006 and displayed until 28/09/2006
Reasons for adding or updating:
  • 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:   03/2006
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 7 - Change to address of MA holder
Section 10 - Change to text as above
Updated on 21/09/2005 and displayed until 27/09/2006
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
Updated on 24/09/2003 and displayed until 21/09/2005
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 03/07/2001 and displayed until 24/09/2003
Reasons for adding or updating:
  • No reasons supplied
Updated on 02/04/2001 and displayed until 03/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 02/04/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
   paracetamol