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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: 30/04/2010
SPC Tenoret 50 mg/12.5 mg film coated tablets

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 30/04/2010 and displayed until Current
Reasons for adding or updating:
  • 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:   12-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.5

New additional text 3rd paragraph:

Concomitant use of baclofen may increase the antihypertensive effect making dose adjustments necessary.

 

Section 4.8

Additional undesirable effect in section of Gastrointestinal disorders:

Not known: Constipation.

 

Section 10

Date of revision of text: 12 April 2010
Updated on 18/02/2010 and displayed until 30/04/2010
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   08-Feb-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1

Change of name to:

Tenoret 50 mg/12.5 mg film coated tablets

(Name also changed throughout document)

Section 10

Change of date to:

8th February 2010
Updated on 06/01/2009 and displayed until 18/02/2010
Reasons for adding or updating:
  • 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:   28-Apr-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.5

Text in 5th paragraph - include information on the potential additive pharmacodynamic effects of atenolol and amiodarone

 

Section 4.8

The frequency descriptors for the current adverse drug reactions have been added to section 4.8 and the system organ classes have been updated according to MedDRA terminology.

 

Section 10

Date of revision of text: 28 April 2008
Updated on 18/01/2006 and displayed until 06/01/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 16/03/2005 and displayed until 18/01/2006
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 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments 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 5 - Pharmacological Properties
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 5.2 - Pharmacokinetic 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 7 - Marketing Authorisation Holder
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 14/03/2005 and displayed until 16/03/2005
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 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments 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 5 - Pharmacological Properties
  • 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 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 05/12/2001 and displayed until 14/03/2005
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 02/07/2001 and displayed until 05/12/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 16/10/2000 and displayed until 02/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 16/10/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  atenolol
  chlortalidone