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Tenormin Tablets 25mg, 50mg & 100mg

  • Name:

    Tenormin Tablets 25mg, 50mg & 100mg

  • Company:
    info
  • Active Ingredients:

    Atenolol

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/01/20

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Summary of Product Characteristics last updated on medicines.ie: 5/2/2019

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AstraZeneca Pharmaceuticals (Ireland) DAC

AstraZeneca Pharmaceuticals (Ireland) DAC

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 15 January 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 5 February 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 5 February 2019

Reasons for 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

Free text change information supplied by the pharmaceutical company

Change Reasons:

Change to section 7 - Marketing authorisation holder

Change to section 8 - Marketing authorisation number

Change to section 10 - Date of revision of the text

Updated on 19 May 2017

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 19 May 2017 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2-            Removal of the excipient, glycerol

Section 3-            Update to description of tablets

Section 6.1-         Update to list of excipients

Section  6.2-       Removal of PVDC from the blister pack

Section 10-          Revision date updated

Updated on 18 May 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 18 May 2017 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 18 December 2015 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2-     Editorial changes relating to latest QRD template

Section 4.6-     Editorial changes relating to latest QRD template

Section 4.8-     Addition of lupus-like syndrome to musculoskeletal and connective tissue disorders and editorial changes relating to latest QRD template

Section 10 -     Update to Date of Revision

Updated on 18 December 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to MA holder contact details
  • Change to improve clarity and readability

Updated on 24 July 2015 SPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 1 – Changes relating to QRD update

Section 2– Changes relating to QRD update

Section 3– Changes relating to QRD update

Section 4.1– Changes relating to QRD update

Section 4.2 – Changes relating to QRD update

Section 4.3 – Changes relating to QRD update

Section 4.4 – Changes relating to QRD update

Section 4.5– Changes relating to QRD update

Section 4.6 – Changes relating to QRD update

Section 4.7 – Changes relating to QRD update

Section 4.8 – Changes relating to QRD update including ADR wording

Section 5.1 – Changes relating to QRD update

Section 5.2 – Changes relating to QRD update

Section 5.3 – Changes relating to QRD update

Section 6.1 – Changes relating to QRD update

Section 6.3 – Changes relating to QRD update

Section 6.4 – Changes relating to QRD update

Section 6.5 – Changes relating to QRD update

Section 6.6 – Changes relating to QRD update

Section 7 – Changes relating to QRD update

Section 8 – Changes relating to QRD update

Section 9 – Changes relating to QRD update

Section 10 – Update to Date of Revision

 

Updated on 22 July 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 7 September 2011 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 7 August 2008 PIL

Reasons for updating

  • Change due to user-testing of patient information
  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to side-effects

Updated on 5 August 2008 SPC

Reasons for 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 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4
New sentence added:
May cause a hypersensitivity reaction including angioedema and urticaria.
 
Section 4.5
following new text added and deleted:
Class I anti-arrhythmic drugs (e.g. disopyramide) and amiodarone may have a potentiating effect on atrial-conduction time and induce negative inotropic effect.Caution must be exercised when prescribing a beta-blocker with Class 1 antiarrhythmic agents such as disopyramide.
 
Section 4.8
New text added is in red:
The following undesired events, listed by body system, have been reported with the following frequencies: very common (³10%), common (1–9.9%), uncommon
 (0.1–0.9%), rare (0.01–0.09%), very rare (<0.01%) including isolated reports, not known (cannot be estimated from the available data).
 
Skin and subcutaneous tissue disorders:
 Rare:            Alopecia, psoriasiform skin reactions, exacerbation of psoriasis, skin rashes.
Not known:            Hypersensitivity reactions, including angioedema and urticaria.
 
Section 10
Date updated to 15th July 2008

Updated on 10 December 2007 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2

New text added in bold:

25 mg Tablets

Each tablet contains 25 mg Atenolol.

           

50 mg Tablets

Each tablet contains 50 mg Atenolol.

           

100 mg Tablets

Each tablet contains 100 mg Atenolol.

Each 100 mg tablet contains 0.8 mg Sunset Yellow Lake (E110).

 

For a full list of excipients, see section 6.1.

 

Section 3

New sentence added to end of section 3:

The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

           

 

Section 9

Date changed to 13 August 2007:

Tenormin 25 mg Film-coated Tablets

14 August 1992/13 August 2007  

 

Tenormin 50 mg Film-coated Tablets

04 February 1976/13 August 2007

 

Tenormin 100 mg Film-coated Tablets

17 May 1978/13 August 2007

 

 

Section 10

Date changed to 30th November 2007   

Updated on 10 December 2007 PIL

Reasons for updating

  • Change to storage instructions

Updated on 29 January 2007 PIL

Reasons for updating

  • Change in co-marketing arrangement

Updated on 28 September 2006 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 20 September 2006 SPC

Reasons for 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 4.5 - 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 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text
  • Change from the BAN of the active substance to the rINN

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2

-         Reference to intravenous Tenormin has been removed.

-         The paragraphs on ‘Early’ and ‘Late’ Intervention after Myocardial Infarction have been merged into one paragraph.

 

Section 4.4

-         Paragraphs on the withdrawal and discontinuation of therapy before surgery have been added.

The following warnings have been added:

-         Tenormin ‘may mask the symptoms of hypoglycaemia, in particular, tachycardia’.

-         Tenormin ‘should only be given to patients with psoriasis after careful consideration, as psoriasis may be aggravated’.

-         ‘Since Tenormin is excreted via the kidneys, dosage should be reduced in patients with a creatinine clearance of below 35 ml/min/1.73  m2’.

-         ‘As with other beta-blockers, in patients with a phaeochromocytoma, an alpha-blocker should be given concomitantly’.

 

Section 4.5

-         Drug class headings have been added to each paragraph.

 

Section 4.6

-         Neonatal bradycardia has been added.

 

Section 4.8

-         Frequencies have been added to the undesired events table.

 

Section 5.2

      -    Reference to intravenous administration has been removed.

Updated on 10 February 2005 SPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 8 February 2005 PIL

Reasons for updating

  • Change of active ingredient
  • Change of active ingredient
  • Change of inactive ingredient
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to date of revision

Updated on 10 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 18 June 2003 SPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)