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Diovan 160 mg film-coated tablets

*
Pharmacy Only: Prescription

  • Company:

    Novartis Ireland Limited

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Valsartan

    *Additional information is available within the SPC or upon request to the company

Updated on 28 April 2023

File name

Diovan FCT_REG PIL_PF 21-0133_Clean_IPHA.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 29 October 2021

File name

Diovan FCT_REG PIL_PF 21-0233_Clean_IPHA.pdf

Reasons for updating

  • Change to other sources of information section

Updated on 25 June 2021

File name

Diovan FCT_REG PIL_PF 21-0085_Clean_IPHA.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 02 July 2020

File name

Diovan_40mg, 80mg, 160mg, 320mg_REG PIL_PF 20-0019_IPHA.pdf

Reasons for updating

  • Change to section 2 - driving and using machines

Updated on 02 July 2020

File name

Diovan_160mg FCT_REG SPC_PF 20-0019_June 2020_IPHA.pdf

Reasons for updating

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

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

Updated on 19 November 2019

File name

Diovan 40mg, 80mg, 160mg, 320mg_REG PIL_PF 18-0157_IPHA.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 13 November 2019

File name

Diovan160mgfilm-coatedtabletSPC_REG_PF 18-0157_IPHA.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Updated on 23 August 2018

File name

Diovan 40mg, 80mg, 160mg, 320mg REG PIL 1125159_A18_IE_p1_LFT_X-4-IPHA.pdf

Reasons for updating

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

Updated on 17 July 2018

File name

Diovan160mgfilm-coatedtabletSPC_REG_PF 18-0185_clean.pdf

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 11 May 2018

File name

Diovan160mgFCT.docx

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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)

Updated on 25 August 2015

File name

PIL_15598_326.pdf

Reasons for updating

  • New PIL for new product

Updated on 25 August 2015

Reasons for updating

  • New SPC for new product

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

Updated on 25 August 2015

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5 - Pharmacological properties

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

Free text change information supplied by the pharmaceutical company

Changes were made throughout the SmPC in line with that recommended by the PRAC committee, resulting from the Article 31 Referral on the combined use of Renin-angiotensin-system (RAS)-acting agents in patients with hypertension and heart failure.
A tracked changes version of the SmPC can be provided if necessary.

Updated on 25 August 2015

Reasons for updating

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

Updated on 12 May 2014

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

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

Free text change information supplied by the pharmaceutical company

updated section 4.5 of the SmPC with information regarding an interaction between valsartan and lithium.
updated section 4.8 of the SmPC with new adverse drug reaction (i.e. dermatitis bullous has been included).

Updated on 12 May 2014

Reasons for updating

  • Change to side-effects
  • Change to product name

Updated on 07 November 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications

Updated on 25 October 2013

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

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

Free text change information supplied by the pharmaceutical company

Section 4.2, added:
Renal impairment.....

“Concomitant use of Diovan with aliskiren is contraindicated in patients with renal impairment (GFR < 60 mL/min/1.73 m2) (see section 4.3).

Diabetes Mellitus

Concomitant use of Diovan with aliskiren is contraindicated in patients with diabetes mellitus (see section 4.3).”



Section 4.3, added:

“-Concomitant use of angiotensin receptor antagonists (ARBs) - including Diovan - or of angiotensin-converting-enzyme inhibitors (ACEIs) with aliskiren in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73m2) (see sections 4.4 and 4.5).”


Section 4.4 added:
Impaired renal function:
....... “The concomitant use of ARBs - including Diovan - or of ACEIs with aliskiren is contraindicated in patients with renal impairment (GFR < 60 mL/min/1.73m2) (see sections 4.3 and 4.5).

Dual Blockade of the Renin-Angiotensin-Aldosterone System (RAAS)

Hypotension, syncope, stroke, hyperkalaemia, and changes in renal function (including acute renal failure) have been reported in susceptible individuals, especially if combining medicinal products that affect this system. Dual blockade of the renin-angiotensin-aldosterone system by combining aliskiren with an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin II receptor blocker (ARB) is therefore not recommended.

The use of aliskiren in combination with Diovan is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3).”

 

Section 4.5, added:

“Dual blockade of the Renin-Angiotensin- System (RAS) with ARBs, ACEIs, or aliskiren

Caution is required while co-administering ARBs, including Diovan, with other agents blocking the RAAS such as ACEIs or aliskiren (see section 4.4).

 

Concomitant use of angiotensin receptor antagonists (ARBs) - including Diovan - or of angiotensin-converting-enzyme inhibitors (ACEIs) with aliskiren in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73m2) is contraindicated (see section 4.3).”

 

 

Updated on 25 July 2013

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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

Free text change information supplied by the pharmaceutical company

Section 3 - revised the text to explain that "The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses."

Updated on 19 July 2013

Reasons for updating

  • Change to separate SPCs covering individual presentations

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

Free text change information supplied by the pharmaceutical company

The 4 Diovan SPC's for the 40mg, 80mg, 160mg and 320mg tablet strengths have been separated out again for better version control. There have been no actual text updates as a result of this.

Updated on 19 July 2013

Reasons for updating

  • Change of manufacturer
  • Change to further information section

Updated on 18 January 2013

Reasons for updating

  • New PIL for medicines.ie

Updated on 14 March 2012

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Individual presentations superseded by joint SPC

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

Free text change information supplied by the pharmaceutical company

Section 4.4 Added in text:
"

History of angioedema

Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue has been reported in patients treated with valsartan; some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Diovan should be immediately discontinued in patients who develop angioedema, and Diovan should not be re-administered."

Updated on 12 April 2011

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients

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

Free text change information supplied by the pharmaceutical company

Section 4.8 Added "Hyponatraemia" with frequency unknown.
Section 6.1 Updated excipient name of crospovidone to crospovidone Type A

Updated on 09 June 2010

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 4.8 - Undesirable effects
  • 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 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

Sections 3, 6.4 and 6.5 were updated as a result of the Quality CMC harmonsiation procedure.
Section 4.1, 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2 and 5.3 were all updated as a result of the new paediatric indication, taking into account the new Diovan 3mg/ml oral solution which has been introduced.

Updated on 30 June 2009

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
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

All of the changes made to this SPC were as a result of the MRP Harmonisation procedure, i.e. bringing the SPC of countries who previously only had Diovan approved nationally inline with the SPC of all the current MRP countries, of which Ireland is one.  Therefore most of the changes were formatting and tidying up sections - the only main change for Ireland occured in section 4.3 and 4.6 relating to pregnancy which was previously contraindicated altogether, but now is only contraindicated for second and third trimesters.

Updated on 01 May 2007

Reasons for updating

  • 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

Date of last revision corrected

Updated on 17 April 2007

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to improve clarity and readability

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

Free text change information supplied by the pharmaceutical company

Changes following completion of renewal

Updated on 23 January 2007

Reasons for updating

  • 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

Correction of revision date

Updated on 24 October 2006

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.9 - Overdose
  • 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

Section 4.6: The phrase "There have been reports of spontaneous abortion, oligohydramnios and newborn renal dysfunction, when pregnant women have inadvertently taken valsartan." has been added.
 
 
Section 4.9: The phrase "Overdose with Diovan may result in marked hypotension, which could lead to depressed level of consciousness, circulatory collapse and/or shock." has been added.
 
 
In addition to the changes listed above, various sentences have been reworded throughout the SPC.

Updated on 24 February 2006

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.5 - Nature and contents of container

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

Updated on 15 August 2005

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

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

Updated on 29 March 2005

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Updated on 04 February 2005

Reasons for updating

  • New SPC for medicines.ie

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