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AstraZeneca UK Limited
Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU
Telephone: +44 (0)1582 836 000
Fax: +44 (0)1582 838 000
Medical Information Direct Line: +44 (0)1582 836 836
Medical Information e-mail: medical.informationuk@astrazeneca.com
Customer Care direct line: +44 (0)1582 837 837
Medical Information Fax: +44 (0)1582 838 003

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: 16/03/2012
SPC Inderal LA 160mg

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 16/03/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   20-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Error found in date of revision.

Revised to 20th January 2011.
Updated on 26/01/2011 and displayed until 16/03/2012
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   20-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


SPC Changes
Inderal LA capsules 160mg

 

Section 4.2

Additional text in first paragraph, now reads as,

 

“For oral administration. The capsule must not be chewed, but swallowed whole to ensure a prolonged release action.”

 

Section 4.5

Additional second paragraph, reads as,

 

“Simultaneous administration of rizatriptan and propranolol can cause an increased rizatriptan AUC and Cmax by approximately 70-80%. The increased rizatriptan exposure is presumed to be caused by inhibition of first-passage metabolism of rizatriptan through inhibition of monoamine oxidase-A. If both drugs are to be used, a rizatriptan dose of 5 mg has been recommended.”

 

Section 10

20th January 2011
Updated on 18/08/2009 and displayed until 26/01/2011
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • 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 10 date of revision of the text
Date of revision of text on the SPC:   19-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 3

Change of text:

Pink/lavender or white opaque capsules containing propranolol hydrochloride in a controlled release formulation.

 

Section 4.5

Change of text 2nd paragraph to include amiodarone:

Class I anti-arrhythmic drugs (e.g. disopyramide) and amiodarone may have potentiating effect on atrial-conduction time and induce negative inotropic effect.

 

Section 4.8

Revised table.

 

Section 10

Change of revision date to 19 May 2009
Updated on 18/07/2007 and displayed until 18/08/2009
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:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
6.3 Shelf Life
 
Old Text 5 years
New Text 3 years.

6.4 Special Precautions for storage
 
Old text Store below 30°C, protected from light and moisture.
New text Store below 25°C, protected from light and moisture.
 
Section 10
New revision date of text: 21 June 2007
Updated on 29/06/2007 and displayed until 18/07/2007
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
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
6.3
 
Before the shelf life was 4 years
Changed to 3 years
 
6.4
 
storage temperature was 30oC
Now reads 25oC
Updated on 29/06/2007 and displayed until 29/06/2007
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
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
6.3  Shelf Life was 4 years
now reads 3 years
 
6.4
 
Before Store below 30oC
 
Now reads Store below 25oC
Updated on 03/12/2004 and displayed until 29/06/2007
Reasons for adding or updating:
  • Change to section 1 - trade name
  • 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 4.3 - Contra-indications
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instruction for Use/Handling
Updated on 13/12/2002 and displayed until 03/12/2004
Reasons for adding or updating:
  • Improved Electronic Presentation

Active Ingredients/Generics

 
  propranolol hydrochloride