Tenoret 50

  • Name:

    Tenoret 50

  • Company:
    info
  • Active Ingredients:

    Atenolol, Chlortalidone

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 31/01/20

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Summary of Product Characteristics last updated on medicines.ie: 30/1/2019

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AstraZeneca Pharmaceuticals (Ireland) DAC

AstraZeneca Pharmaceuticals (Ireland) DAC

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1 - 0 of 52 items.Total: Infinity pages

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 31 January 2020 PIL

Reasons for updating

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

Updated on 30 January 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 30 January 2019 SmPC

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

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

Updated on 14 September 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 September 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 14 September 2015 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - 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 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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–        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 4.6 –    Changes relating to QRD update

Section 4.7 –    Changes relating to QRD update

Section 4.8 –    Changes relating to QRD update including ADR reporting and addition of side effect ‘lupus-like syndrome’

Section 5.1 –    Changes relating to QRD update

Section 6.1 –    Changes relating to inclusion of sub-headings

Section 6.6 –    Changes relating to QRD update

Section 9 –       Changes relating to QRD update

Section 10 –     Update to Date of Revision

Updated on 14 September 2015 PIL

Reasons for updating

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

Updated on 4 February 2014 SmPC

Reasons for updating

  • 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 4.8 – Undesirable effects - how to report a side effect
  • 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 4.1: Indication wording revised

-                      Section 4.2: Update on use in patients with renal, hepatic impairment and adolescents (<18 years). Wording updated to improve readability. 

-              Section 4.3: Contra-indications added: Severe renal impairment added. Minor update to wording known hypersensitivity to atenolol and chlortalidone.

-              Section 4.4: Update to warning and precautions including: patients with phaeochromocytoma, use with anaesthetic agents and ophthalmic beta-blockers, patients with bronchospastic disease, patients with diabetes and additional plasma electrolyte monitoring. Minor editorial changes.

-              Section 4.5: Update to include caution with anaesthetic agents and concomitant use of prostaglandin synthetase-inhibiting drugs, dihydropyridines and baclofen. Minor editorial changes.

-              Section 4.6: Changed the subject heading to Fertility, Pregnancy and Lactation.

-              Section 4.8: Reporting of suspect adverse reaction wording added.

-              Section 10: Amendment to revision date

Updated on 30 January 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to date of revision
  • Addition of information on reporting a side effect.
  • Correction of spelling/typing errors

Updated on 20 September 2010 SmPC

Reasons for 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

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

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: 7 September 2010

Updated on 16 September 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 14 September 2009 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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 4.6

Deletion of text under heading Pregnancy:

Atenolol/chlortalidone is suspected to cause birth defects when administered during pregnancy. Tenoret 50 mg/12.5 mg Film-coated Tablets is contraindicated in pregnancy (see section 4.3)

Deletion of text under heading Lactation:

Atenolol is excreted in breast milk to such an extend that effects on the suckling child are likely if therapeutic doses of Tenoret 50 mg/12.5 mg Film-coated Tablets are administered to breast feeding women.

Section 4.7

Deletion of last sentence:

The medicinal product has no or negligible influence on these abilities.

Section 9

Change of renewal date to:

9th September 2007

Section 10

Change of date to:

19th August 2009


Updated on 10 September 2009 PIL

Reasons for updating

  • Change to storage instructions
  • Change to drug interactions

Updated on 4 January 2008 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change due to user-testing of patient information

Updated on 3 January 2008 SmPC

Reasons for 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

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

Free text change information supplied by the pharmaceutical company

Section 4.5

Following text deleted:

Caution must be exercised when prescribing a beta-blocker with Class 1 antiarrhythmic agents such as disopyramide.

And replaced by following new text:

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

 

 

Section 4.8

Undesirable effects now listed by body system with frequencies.

New text added:

The following undesirable effects, listed by body system, have been reported with the following frequencies: Very common (¡Ý10%), common (1-9.9%), uncommon (0.1-0.9%), rare (0.01-0-09%), very rare (<0.01%):

 

Undesirable effects now listed as shown below:

 

Blood and lymphatic system disorders:

Rare:             Purpura, thrombocytopenia, leucopenia (related to chlortalidone).

Psychiatric disorders:

Uncommon: Sleep disturbances of the type noted with other beta blockers.

Rare:    Mood changes, nightmares, confusion, psychoses and hallucinations.

Nervous system disorders:

Rare:             Dizziness, headache, paraesthesia.

Eye disorders:

Rare:    Dry eyes, visual disturbances.

Cardiac disorders:

Common:             Bradycardia

Rare:    Heart failure deterioration, precipitation of heart block.

Vascular disorders:

Common:             Cold extremities.

Rare:             Postural hypotension which may be associated with syncope, intermittent claudication may be increased if already present, in susceptible patients Raynaud¡¯s phenomenon.

Respiratory, thoracic and mediastinal disorders:

Rare:             Bronchospasm may occur in patients with bronchial asthma or a history of asthmatic complaints.

Gastrointestinal disorders:

Common:             Gastrointestinal disturbances (including nausea related to chlortalidone).

Rare:    Dry mouth.

Hepatobiliary disorders:

Rare:    Hepatic toxicity including intrahepatic cholestasis, pancreatitis (related to chlortalidone).

Skin and subcutaneous tissue disorders:

Rare:             Alopecia, psoriasiform skin reaction, exacerbation of psoriasis, skin rashes.

Reproductive system and breast disorders:

Rare:             Impotence.

General disorders and administration site conditions:

Common:             Fatigue.

Investigations:

Common:             Related to chlortalidone: Hyperuricaemia, hyponatraemia, hypokalaemia, impaired glucose tolerance.

Uncommon: Elevations of transaminase levels.

Very rare:             An increase in ANA (Antinuclear Antibodies) has been observed, however the clinical relevance of this is not clear.

 

 

Section 10

Date changed to 27th November 2007

Updated on 14 August 2006 PIL

Reasons for updating

  • Change of active ingredient
  • Change to storage instructions
  • Change to date of revision
  • Change from the BAN of the active substance to the rINN

Updated on 6 July 2006 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • 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 1

  • The name is now expressed as Tenoret 50 mg/12.5 mg Film‑coated Tablets.

Section 3

·        ‘White, biconvex, film-coated tablet imprinted with the name Tenoret 50 on one face.’ has been added.

Section 5.1

·        ‘Beta-blocking agents, selective and other diuretics. C07C B03.’ has been added.

·        Atenolol and Chlortalidone Pharmacodynamic properties are now listed separately.

 

Section 6.4

·        ‘Store in the original package’ and ‘Keep the blister in the outer carton’ have been added.

Section 6.6

·        ‘Use as directed by the prescriber’ has been replaced by ‘No special requirements’.

 

Section 9

  • The date of Renewal has been updated.

Updated on 10 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 6 June 2003 SmPC

Reasons for updating

  • New SPC for new product

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