Last Updated on eMC 15-05-2018 View medicine  | Teva UK Limited 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.

Reasons for adding or updating:

  • Change to section 4.6 - Fertility, pregnancy and lactation

Date of revision of text on the SPC:01-03-2018

Legal Category:P

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



 

4.6 Fertility, pregnancy and lactation

The advice of a doctor should be sought before use.

Pregnancy

Sominex should not be used in pregnancy unless the physician considers it essential. The use of Sominex is not recommended in the 2 weeks prior to delivery in view of the risk of irritability and excitement in the neonate.

Breast-feeding

Available evidence suggests that the amount excreted in milk is insignificant. However, there are risks of neonatal irritability and excitement.

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:13-03-2017

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.

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:10-07-2015

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.

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:16-09-2010

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.

Reasons for adding or updating:

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

Date of revision of text on the SPC:01-01-0001

Legal Category:P

Black Triangle (CHM): NO