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Stiefel
Stockley Park West, , Uxbridge, Middlesex, UB11 1BT , UK
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.com

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: 23/08/2011
SPC Stiemycin 2.0% w/v

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 23/08/2011 and displayed until Current
Reasons for adding or updating:
  • 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 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   16-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.1    Updated information in-line with the GDS
4.2    Updated information in-line with the GDS
4.3    Updated information in-line with the GDS
4.4    Updated information in-line with the GDS
4.5    Updated information in-line with the GDS
4.6    Updated information on fertility, pregnancy & lactation
4.8    Updated information on common adverse reactions
4.9    Updated overdose information on signs and symptons plus treatment
6.1    Minor amendment to text
10.0    Updated with new date of revision of text
Updated on 30/03/2011 and displayed until 23/08/2011
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
Date of revision of text on the SPC:   21-Feb-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
6.4: Do Not Store above 25ºC
Updated on 23/02/2011 and displayed until 30/03/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   21-Feb-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


7.

GlaxoSmithKline UK Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS

Trading as Stiefel
Stockley Park West
Uxbridge
Middlesex
UB11 1BT

 

8.

PL 19494/0055

10.

21 February 2011
Updated on 11/08/2010 and displayed until 23/02/2011
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • 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:   10-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.3 - Changed from 36 months to 24 months
Section 6.4 - Deleted “store in a cool place” and replaced with “Do not store above 25C”
Section 10 - Replaced with approval date of this variation 10-August-2010
Updated on 06/04/2010 and displayed until 11/08/2010
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   26-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 - Change Stiemycin 2.0% w/w to Stiemycin 2.0% w/v.

Section 2 - Addition of For a full list of excipients, see section 6.1

Section 3 - Change from “Solution for topical use” to “Cutaneous solution”
 
Section 4.2 - Advice on duration of therapy has been added

Section 4.4 - Text added regarding risk of pseudomembranous colitis, a risk of broad spectrum antibiotics.
Propylene glycol warning added in line with excipient guideline

Section 4.7 - Pregnancy and lactation statement updated to state product should only be used if clearly needed and to avoid application to the chest if breastfeeding.

Section 4.8 - Side effects section updated to include skin reactions including dryness, itching, reddening, rash, urticaria, burning sensation, allergic reactions to erythromycin and diarrhea.

Section 4.9 - Advice added in case of accidental contact with eyes or mucous membranes to rinse with water and to seek medical advice in case of accidental ingestion

Section 5.1 - ATC code added.

Section 5.2 - Text added “Percutaneous absorption of erythromycin from Stiemycin solution is negligible”.

Section 5.3 - Text added “The preclinical and clinical safety of erythromycin is well established. Erythromycin has been in widespread use for many years”.

Section 6.4 - Additional storage statements added “Keep away from heat and flame.
Replace cap firmly after use to prevent evaporation.”

Section 6.5 - Addition of “Not all pack sizes may be marketed”.

Section 10 - Date Updated
Updated on 21/08/2009 and displayed until 06/04/2010
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:   17-Aug-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7: Update to the address of the MAH

Section 10: Date updated 
Updated on 27/09/2005 and displayed until 21/08/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 21/08/2001 and displayed until 27/09/2005
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 06/09/1999 and displayed until 21/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  erythromycin