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Allen & Hanburys Ltd
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
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: 16/07/2009
SPC Ventolin Respirator Solution

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 16/07/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   02-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.9 - The preferred antidote for overdosage with salbutamol is a cardioselective -blocking agent, but -blocking drugs should be used with caution in patients with a history of bronchospasm.

The most common signs and symptoms of overdose with salbutamol are transient beta agonist pharmacologically mediated events, including tachycardia, tremor, hyperactivity and metabolic effects including hypokalaemia (see sections 4.4 and 4.8). (see section 4.8)

Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be monitored.

Consideration should be given to discontinuation of treatment and appropriate symptomatic therapy such as cardio-selective beta-blocking agents in patients presenting with cardiac symptoms (e.g. tachycardia, palpitations). Beta-blocking drugs should be used with caution in patients with a history of bronchospasm.
Updated on 09/03/2009 and displayed until 16/07/2009
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   15-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   NO

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

The preferred antidote to overdosage with salbutamol is a cardioselective -blocking agent, but -blocking drugs should be used with caution in patients with a history of bronchospasm.

Hypokalaemia may occur following overdose with salbutamol. Serum potassium levels should be monitored.
Updated on 24/09/2008 and displayed until 09/03/2009
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 4.9 - Overdose
  • Change to section 10 date of revision of the text
  • Change to section 4.8 - Undesirable Effects
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   15-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 - Whole section

Section 4.4 - whole section

Section 4.8 - whole section

Section 4.9 - whole section

Section 7 - trading as Allen & Hanburys

section 10 - 15 august 2008
Updated on 11/07/2007 and displayed until 24/09/2008
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3, 4.4 and 4.8: Updates for presentations with obstetric and respiratory indications
Section 4.4 and 4.8: Updates for presentations with respiratory only indications to include additional wording regarding myocardial ischaemia.
Section 10: Now 05/06/2007
Updated on 24/04/2006 and displayed until 11/07/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 21/04/2006 and displayed until 24/04/2006
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 10 (date of (partial) revision of the text
Updated on 19/04/2006 and displayed until 21/04/2006
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 10 (date of (partial) revision of the text
  • Pending awaiting re-submission
  • Pending awaiting re-submission
  • Pending awaiting re-submission
  • Pending awaiting re-submission
Updated on 27/09/2005 and displayed until 19/04/2006
Reasons for adding or updating:
  • No reasons supplied
Updated on 26/09/2005 and displayed until 27/09/2005
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
  • Pending awaiting re-submission
Updated on 11/08/2001 and displayed until 26/09/2005
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 06/09/1999 and displayed until 11/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  salbutamol sulphate