Zofenil

  • Name:

    Zofenil

  • Company:
    info
  • Active Ingredients:

    zofenopril calcium

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/10/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 22/10/2019

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A. Menarini Pharmaceuticals Ireland Ltd

A

Company Products

Medicine NameActive Ingredients
Medicine Name Trinomia 20 mg hard capsules Active Ingredients Acetylsalicylic Acid, Atorvastatin calcium trihydrate, Ramipril
Medicine Name Trinomia 40 mg hard capsules Active Ingredients Acetylsalicylic Acid, Atorvastatin calcium trihydrate, Ramipril
Medicine Name Vaborem 1 g/1 g powder for concentrate for solution for infusion Active Ingredients Meropenem Trihydrate, Vaborbactam
Medicine Name Zofenil Active Ingredients zofenopril calcium
26 - 29 of 29 items.Total: 2 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 22 October 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 22 October 2019 SmPC

Reasons for updating

  • 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 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

The SmPC is updated to implement the outcome of the PSUSA procedure on cilazapril and cilazapril/hydrochlorothiazide, applicable to the whole class of medicinal products containing ACE inhibitors. 

Main changes to the SmPC safety sections:

4.3-Contraindications: Concomitant use with sacubitril/valsartan therapy. Zofenil must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan (see also sections 4.4 and 4.5).

4.4-Special warnings and precautions for use: Concomitant use of ACE inhibitors with sacubitril/valsartan is contraindicated due to the increased risk of angioedema. Treatment with sacubitril/valsartan must not be initiated earlier than 36 hours after the last dose of Zofenil. Treatment with Zofenil must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan (see sections 4.3 and 4.5).

Concomitant use of ACE inhibitors with racecadotril, mTOR inhibitors (e.g. sirolimus, everolimus, temsirolimus) and vildagliptin: caution should be used when starting racecadotril, mTOR inhibitors (e.g. sirolimus, everolimus, temsirolimus) and vildagliptin in a patient already taking any ACE inhibitor. This may lead to an increased risk for angioedema.  Warning on serum potassium updated.

4.5-Interactions: Medicines increasing the risk of angioedema have been added.  Co-administration with other agents that increase serum potassium. Cyclosporin interaction updated. Heparin has been added

 

Updated on 25 July 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink

Updated on 3 August 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose

Updated on 3 August 2018 SmPC

Reasons for updating

  • 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
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

The SmPC was updated to implement the outcome of PSUSA on Captopril / Hydrochlorothiazide, applicable to the whole class of medicinal products containing ACE inhibitors.

 The following amendments were made:

-          update in line with the latest QRD template;

-          addition of the standard statement on sodium content in the PL in accordance with the Annex to the EC guideline on excipients;

-          addition of ‘Endocrine effects’ in section 4.8 of the SmPC as  text alignment of a known class effect.

Updated on 12 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 16 December 2014 SmPC

Reasons for updating

  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • 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 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

Administrative amendments (to align to the current QRD template)

Sections 2, 3, 4.2, 4.4, 4.6, 4.8, 5.2, 6.6.

 

Section 4.3 Contraindications

New contra-indication added on the concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment.

 

Section 4.4 Special warnings and precautions

New warning added regarding the dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is not recommended,

 

Section 4.5 Interactions with other medicinal products and other forms of interaction

New interaction added under ‘Concomitant use not recommended’:

ACE-inhibitors, angiotensin II receptor blockers or aliskiren:

 

Section 4.8 Undesirable effects

Reporting of side-effects details added.

 

Section 5.1 Pharmacodynamic properties

Details of two studies added with details about the use of combination of an ACE-inhibitor with an angiotensin II receptor blocker.

Information added on a further study to test the benefit of adding aliskiren to a standard therapy of an ACE-inhibitor or an angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both.

 

Section 10 Date of revision of the text

Updated to November 2014

Updated on 16 December 2014 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 December 2014 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 16 December 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 10 July 2013 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change to date of revision

Updated on 9 July 2013 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Section 6.5 Nature and contents of container:
New packaging material for the blister added - Aclar/Aluminium

Updated on 30 March 2010 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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
  • 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



Main changes:

 

  • Section 2 Qualitative and Quantative composition: reference added on excipients including lactose.
  • Section 3 Pharmaceutical form: Zofenil 15 mg tablets – the tablet can be divided into equal halves.
  • Section 4.3 Contraindications: Specify second and third trimester of pregnancy.  Remove lactation period.
  • Section 4.4 Special warnings and precautions for use: Further information added on hypotension and heart failure, anaphylactic reactions during desensitisation or after insect bites, angioedema, cough, hyperkalaemia, surgery/anaesthesia, aortic and mitral valve stenosis/hypertrophic cardiomyopathy,  neutropenia/agranulocytosis, proteinuria. New information included on hepatic failure, diabetic patients, lithium, race, pregnancy and lactose.
  • Section 4.5 Interactions:  Further information added on potassium sparing diuretics or potassium supplements, diuretics (thiazide or loop diuretics),other antihypertensive agents,  lithium, NSAIDs, sympathomimetics. New information added on gold, tricyclic antidepressants, barbiturates, procainamide, cytostatic or immunosuppressive agents, antidiabetics.
  • Section 4.6 Pregnancy and lactation: Information updated.  Use in first trimester of pregnancy not recommended, contraindicated during the second and third trimester.  Not recommended during breastfeeding.
  • Section 4.8 Undesirable effects: Section rewritten to add adverse reactions associated with ACE inhibitors therapy.
  • Section 9 Date of first authorisation/renewal – updated.
  • Section 10 Date of the revision of the text – updated.

Updated on 12 March 2010 PIL

Reasons for updating

  • Change due to harmonisation of patient information leaflet
  • Change due to user-testing of patient information

Updated on 22 December 2005 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Updated on 27 June 2005 PIL

Reasons for updating

  • Change of active ingredient

Updated on 23 September 2004 SmPC

Reasons for updating

  • New SPC for new product

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

Updated on 5 August 2004 PIL

Reasons for updating

  • New PIL for new product