Skip to content
SPC Logo

Sominex Tablets

Last Updated on eMC 20-Mar-2017 View document  | Actavis UK Ltd Contact details

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 20-Mar-2017 and displayed until Current

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 4.3 - 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 - Fertility, pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 13-Mar-2017

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Sominex (Promethazine hydrochloride), PL 30306/0080

 

Variation approval date: 13.03.2017

 

Single Variation

Variation Type: IB, C.I.z

 

Variation Description: To update the SPC fragments 2, 4.2, 4.3, 4.4, 4.5, 4.6, 5.1 and 9 in line with the latest QRD template version 10, 02/2016. Consequential changes have been made to PIL and Label.

 

SmPC sections updated: 2, 4.2, 4.3, 4.4, 4.5, 4.6, 5.1, 9 and 10.

PIL sections updated: 1, 2, 3, 4, 5 and 6.

Updated on 09-Sep-2015 and displayed until 20-Mar-2017

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 10-Jul-2015

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

(1) To implement the ADR reporting statement into section 4.8 (undesirable effects) of the SmPC in line with the MHRA recommendations.
(2) To update section 5.2 (pharmacokinetics) of the SmPC to change the name of ’Sulphoxide’ to Sulfoxide as per the WHO recommendations.

Updated on 06-Oct-2010 and displayed until 09-Sep-2015

Reasons for adding or updating:

  • 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 4.8 - 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: 16-Sep-2010

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

SPC sections 4.4, 4.5, 4.8, 4.9 and 10 have been updated following revision of Core Company Safety Information.

Updated on 15-Sep-2008 and displayed until 06-Oct-2010

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Legal Category:P

Black Triangle (CHM): NO

Company contact details

Company image
Address

Actavis UK Ltd, a subsidiary of Accord Healthcare Ltd, Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK

Fax

+44 (0)1271 346 106

Medical Information e-mail
Telephone

+44 (0)1271 385 200

Medical Information Direct Line

+44 (0)1271 385 257

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?

Active ingredients

promethazine hydrochloride

Legal categories

P - Pharmacy

This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Continue