INNOVACE TABLETS | Medicines.ie

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INNOVACE TABLETS

Summary of Product Characteristics last updated on medicines.ie: 19/6/2019

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Company Products

Medicine Name	Active Ingredients
Medicine Name Adempas Film Coated Tablets	Active Ingredients Riociguat
Medicine Name Arcoxia 30 60 90 120 film-coated tablets	Active Ingredients Etoricoxib
Medicine Name Atozet 10mg/10mg, 10mg/20mg, 10mg/40mg and 10mg/80mg film-coated tablets	Active Ingredients Atorvastatin calcium trihydrate, ezetimibe
Medicine Name Bridion	Active Ingredients Sugammadex sodium
Medicine Name Cancidas 50mg Powder for concentrate for solution for infusion	Active Ingredients caspofungin acetate
Medicine Name Cancidas 70mg Powder for concentrate for solution for infusion	Active Ingredients caspofungin acetate
Medicine Name Cerazette 75 microgram film-coated tablet	Active Ingredients Desogestrel
Medicine Name Cozaar 12.5mg, 50mg & 100mg Film-coated Tablets	Active Ingredients Losartan potassium
Medicine Name Cozaar 2.5mg/ml Powder and Solvent for Oral Suspension	Active Ingredients Losartan potassium
Medicine Name Cozaar COMP 50 mg/12.5 mg, 100 mg/12.5 mg, 100 mg/25 mg film-coated tablets	Active Ingredients Hydrochlorothiazide, Losartan potassium
Medicine Name Cubicin 350mg Powder for Solution for injection or infusion	Active Ingredients Daptomycin
Medicine Name Cubicin 500mg powder for solution for injection or infusion	Active Ingredients Daptomycin
Medicine Name Delstrigo 100 mg/300 mg/245 mg film-coated tablets	Active Ingredients Lamivudine, Tenofovir disoproxil fumarate, Doravirine
Medicine Name Diprosalic Scalp Application	Active Ingredients Betamethasone dipropionate, Salicylic Acid
Medicine Name Elocon Cream	Active Ingredients Mometasone Furoate
Medicine Name Elocon Ointment	Active Ingredients Mometasone Furoate
Medicine Name Elocon Scalp Lotion	Active Ingredients Mometasone Furoate
Medicine Name EMEND 125 mg hard capsules	Active Ingredients Aprepitant
Medicine Name EMEND 80 mg hard capsules	Active Ingredients Aprepitant
Medicine Name EMEND 80mg, 125mg hard Capsules	Active Ingredients Aprepitant
Medicine Name Esmeron	Active Ingredients Rocuronium Bromide
Medicine Name EZETROL 10 mg Tablets	Active Ingredients ezetimibe
Medicine Name FOSAMAX Once Weekly 70 mg Tablets	Active Ingredients Alendronate Sodium Trihydrate
Medicine Name FOSAVANCE	Active Ingredients Alendronate Sodium Trihydrate, Colecalciferol (Vitamin D3)
Medicine Name GARDASIL	Active Ingredients human papillomavirus vaccine

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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 20 June 2019 PIL

Reasons for updating

Change to section 6 - date of revision
Change to warnings or special precautions for use
Change to drug interactions

Updated on 19 June 2019 SmPC

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 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

New text regarding concomitant use of other drugs that may increase serum potassium levels (e.g. trimethoprim/sulfamethoxazole)

Updated on 28 March 2019 PIL

Reasons for updating

Change to section 6 - date of revision
Change to warnings or special precautions for use
Change of contraindications
Change to drug interactions

Updated on 28 March 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

Updated regarding drug interaction between ACE-inhibitor and neprilysin (NEP) inhibitor resulting in an increased risk of angioedema

Updated on 29 August 2018 SmPC

Reasons for updating

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

Change to section 6.5 Nature and contents of container e.g. Innovace 5 mg tablet has a new pack size of 56 tablets

Updated on 15 August 2018 PIL

Reasons for updating

Change to section 4 - how to report a side effect
Change to section 6 - what the product looks like and pack contents
Change to section 6 - marketing authorisation holder
Change to section 6 - date of revision

Updated on 15 March 2018 PIL

Reasons for updating

New PIL for new product

Updated on 15 March 2018 PIL

Reasons for updating

Change to section 3 - how to take/use
Change to section 6 - date of revision

Updated on 13 May 2016 PIL

Reasons for updating

Change to warnings or special precautions for use
Change to drug interactions
Change to date of revision

Updated on 10 May 2016 SmPC

Reasons for updating

New SmPC for new product

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

Updated on 10 May 2016 SmPC

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 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

Change to Section 4.4 - Special warnings and precautions for use

Change to Section 4.5 - Interactions with other medicinal products and other forms of interaction

Change to Section 10 - Date of revision of the text
Reasons for submission: Type II036; Angiodema and ACE inhibitor and mTOR update

Updated on 10 February 2015 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 4.8 - Undesirable effects
Change to section 5.1 - Pharmacodynamic properties
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

Reasons for submission: SE/H/404/001-004/IB/030-Article 31 Dual RAS Blockade

Change to Section 4.3 - Contraindications
Change to Section 4.4 - Special warnings and precautions for use

Change to Section 4.5 - Interactions with other medicinal products and other forms of interaction
Change to Section 4.8 - Undesirable effects
Change to Section 5.1 - Pharmacodynamic properties
Change to Section 10 - Date of revision of the text

Updated on 9 February 2015 PIL

Reasons for updating

Change to warnings or special precautions for use
Change of contraindications
Change to side-effects
Change to drug interactions
Change to date of revision

Updated on 26 June 2014 SmPC

Reasons for updating

Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

Change to Section 9 - Date of renewal of authorisation

Updated on 21 May 2014 PIL

Reasons for updating

Change to MA holder contact details

Updated on 25 April 2014 SmPC

Reasons for updating

Change to section 8 - MA number
Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Which SPC sections have changed: Sections 7 & 8 Change information: Change to the MAH name and address and new PA numbers.

Updated on 13 March 2014 PIL

Reasons for updating

Change of contraindications
Change to information about pregnancy or lactation

Updated on 29 January 2014 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 4.6 - Pregnancy and lactation
Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Section 4.3, 4.4, 4.5, 4.6, 4.8
Detailed SPC change information: Added a warning that the combination of aliskiren-containing medicines and ACE inhibitors.

Updated on 24 September 2012 PIL

Reasons for updating

Change to information about pregnancy or lactation

Updated on 12 June 2012 SmPC

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 4.6 - Pregnancy and lactation
Change to section 5.2 - Pharmacokinetic properties
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, 4.5, 4.6, 5.2, 10 - Added warnings on drug interactions; updated text on pregnancy and lactation

Updated on 11 February 2011 PIL

Reasons for updating

Change to warnings or special precautions for use

Updated on 9 February 2011 SmPC

Reasons for updating

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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

Free text change information supplied by the pharmaceutical company

Update to section 4.5 - drug interactions (completion of II19) - Warnings on drug interactions

Updated on 8 June 2010 SmPC

Reasons for updating

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

Update to section 6.5 and 10 - Harmonised pack sizes

Updated on 7 June 2010 PIL

Reasons for updating

Change to further information section

Updated on 6 April 2010 SmPC

Reasons for updating

Change to section 2 - Qualitative and quantitative composition
Change to section 3 - Pharmaceutical form
Change to section 4.8 - Undesirable effects
Change to section 6.1 - List of excipients
Change to section 6.4 - Special precautions for storage
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

Renewal completion - Sections 2, 3, 4.8, 6.1, 6.4, 6.5
Detailed SPC change information: Composition, Storage conditions

Updated on 29 March 2010 PIL

Reasons for updating

Correction of spelling/typing errors

Updated on 17 November 2009 SmPC

Reasons for updating

Change to section 3 - Pharmaceutical form
Change to section 6.1 - List of excipients
Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Updated on completion of variation to reduce shelf-life II/16
Sections: 3, 6.1, 6.3:
Shelf-life reduced to 2 years.
Pharmaceutical form description - minor editorial changes.
Excipients names amended.

Updated on 3 September 2009 SmPC

Reasons for updating

Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

No change to any sections. (Section 4.6 duplicated and incorrectly placed before Sec. 4.5)
Deletion of Section 4.6 inserted incorrectly before Section 4.5

Deletion of Section 4.6 inserted incorrectly before Section 4.5

Updated on 10 March 2009 SmPC

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use
Change to section 4.6 - Pregnancy and lactation
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 changes are as a result of a variation to amend the following sections of the SmPC; 4.4 (Special warnings and special precautions for use), 4.6 (Pregnancy and lactation) and 5.2 (Pharmacokinetic properties) in response to the recommendation by the Pharmacovigilance Working Party regarding ACE inhibitors and lactation.

Updated on 6 February 2009 SmPC

Reasons for updating

Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

The variation to include the term "syndrome of inappropriate antidiuretic hormone secretion" (SIADH) has been added to section 4.8 of the SmPC.

Updated on 3 September 2008 PIL

Reasons for updating

Change to information about pregnancy or lactation

Updated on 27 August 2008 SmPC

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use
Change to section 4.6 - Pregnancy and lactation

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

Free text change information supplied by the pharmaceutical company

changed due to a variation to update pregnancy warning, sections 4.4 and 4.6 updated

Updated on 7 February 2008 PIL

Reasons for updating

Change to information about pregnancy or lactation
Change to drug interactions
Change to side-effects

Updated on 23 August 2007 SmPC

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

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

Free text change information supplied by the pharmaceutical company

This update is due to changes in sections 4.4 and 4.5

Updated on 12 May 2006 PIL

Reasons for updating

Change to warnings or special precautions for use

Updated on 27 March 2006 SmPC

Reasons for updating

Correction of spelling/typing errors

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

Updated on 16 January 2006 SmPC

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use

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

Updated on 16 November 2004 PIL

Reasons for updating

New PIL for medicines.ie

Updated on 16 November 2004 SmPC

Reasons for updating

Change to section 4.8 - Undesirable effects

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

Updated on 9 August 2004 SmPC

Reasons for updating

Correction of spelling/typing errors

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

Updated on 21 February 2004 SmPC

Reasons for updating

Change to joint SPC covering all presentations

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

Updated on 19 June 2003 SmPC

Reasons for updating

New SPC for medicines.ie

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