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Co-Diovan 320mg/12.5mg 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):

    HydrochlorothiazideValsartan

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

Updated on 25 March 2022

File name

Co-Diovan_REG PIL_PF 22-0017_March 2022_Clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 25 March 2022

File name

Co-Diovan 320-12.5mg_REG SPC_PF 22-0017_March 2022_IPHA.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Addition to Section 4.4

Acute respiratory toxicity
Very rare severe cases of acute respiratory toxicity, including acute respiratory distress syndrome
(ARDS), have been reported after taking hydrochlorothiazide. Pulmonary oedema typically develops
within minutes to hours after hydrochlorothiazide intake. At the onset, symptoms include dyspnoea,
fever, pulmonary deterioration and hypotension. If diagnosis of ARDS is suspected, Co-Diovan should
be withdrawn, and appropriate treatment given. Hydrochlorothiazide should not be administered to
patients who previously experienced ARDS following hydrochlorothiazide intake.

Addition to Section 4.8

Respiratory, thoracic and mediastinal disorders

Very rare

Acute respiratory distress syndrome (ARDS) (see
section 4.4), respiratory distress including
pneumonitis and pulmonary oedema

Updated on 08 October 2021

File name

Co-Diovan_REG PIL_PF 21-0132_October 2021_Clean.pdf

Reasons for updating

  • Change to other sources of information section

Updated on 30 September 2020

File name

f3ced688-70db-4b18-b4d8-055bfbfd8cb4.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 30 September 2020

File name

Co-Diovan 320-12.5_REG SPC_PF 20-0100_September 2020_IPHA.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Updated on 26 March 2020

File name

Co-Diovan_REG PIL_1233990-1233991_PF 19-0276_Clean_IPHA.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 11 December 2019

File name

Co-Diovan REG PIL_1231638_1231639_IE_TA_TBI by 19.07.19_IPHA.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 25 April 2019

File name

Co-Diovan REG PIL_1231638_1231639_IE_TA_TBI by 19.07.19_IPHA.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 05 February 2019

File name

Co-Diovan 320mg-12.5mg REG SmPC_PF 18-0272_clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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)

Updated on 23 August 2018

File name

Co-Diovan REG_ PIL_1230462_1230463_IE_TA_p1_LFT_X-4_IPHA.pdf

Reasons for updating

  • Addition of manufacturer
  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 18 July 2018

File name

Co-Diovan 320mg-12.5mg REG SmPC.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 27 August 2015

Reasons for updating

  • New SPC for new product

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

Updated on 27 August 2015

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 4.5 - 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

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

File name

PIL_15578_488.pdf

Reasons for updating

  • New PIL for new product

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 February 2015

Reasons for updating

  • Change of manufacturer

Updated on 28 November 2014

Reasons for updating

  • Change of manufacturer

Updated on 14 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 with information regarding an interaction between valsartan and lithium.

· updated section 4.8 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 17 January 2014

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 following text under "Renal impairment" heading:

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

Section 4.3, added following contraindication:

 

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

Section 4.4, added following text under "Renal impairment" heading:
"The concomitant use of ARBs - including valsartan- or of ACEIs with aliskiren is contraindicated in patients with renal impairment (GFR < 60 mL/min/1.73 m2) (see sections 4.3 and 4.5)."

and also added new heading and following text:
"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 Comp 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 following paragraph under "Interactions related to valsartan":
"Dual blockade of the Renin-Angiotensin-System (RAS) with ARBs, ACEIs, or aliskiren

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

Concomitant use of angiotensin receptor antagonists (ARBs) - including valsartan – 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 14 January 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
  • Addition of manufacturer

Updated on 08 April 2013

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

Section 10 - Corrected date of revision to that of national IMB approval date rather than the RMS (MRP) approval date.

Updated on 17 December 2012

Reasons for updating

  • New PIL for medicines.ie

Updated on 30 November 2012

Reasons for updating

  • Change to product name

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

Free text change information supplied by the pharmaceutical company

Diovan Comp removed (name in RMS) Co-Diovan added(Product name in Ireland)

Updated on 23 November 2012

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

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

Free text change information supplied by the pharmaceutical company

In Section 4.4, Special warnings and precautions for use the following information has been added Evaluation of patients with heart failure or post-myocardial infarction should always include assessment of renal function. and information on History of angioedema.

In Section 4.5 Interaction with other medicinal products and other forms of interaction information on Transporters has been added.

In Section 4.6, Pregnancy and lactation information on lactation has been modified.

 

Updated on 06 July 2012

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 4.8 - 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

Section 4.2 Update to posology in patients with Hepatic impairment.

Section 4.4 Update to special warnings and precaution for use in patients with Hepatic impairment and Acute Angle-Closure Glaucoma.

Section 4.5 Update to concominant use requiring caution.

Section 4.8 Update to Table 3:  Frequency of adverse reactions with hydrochlorothiazide

Section 5.2 Update of Pharmacokinetic properties with regard to Hydrochlorothiazide

Updated on 29 March 2012

Reasons for updating

  • 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

Section 4.6 - added text re lactation:

Thiazides in high doses causing intense dieresis can inhibit the milk production.

 

If Co-Diovan is used during breast feeding, doses should be kept as low as possible.

 

Updated on 06 May 2011

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

In section 4.8 Hyponatraemia was added as a side effect with not known frequency, as a result of RMS comments from the PRAR.

Updated on 05 November 2009

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

The SPC was harmonised under an Artilcle 30 referral procedure in order to standardise the SPC's of all MRP Member States.

The changes in most of the outlined sections were minor re-formatting and re-wording for clarity and harmonisation purposes.  The main change of signficance was in section 4.6 Pregnancy and Lactation, where Co-Diovan has gone from being totally contraindicated in pregnancy to now being not recommended in the first trimester of pregnancy and contraindicated in the second and third trimesters of pregnancy.

Updated on 25 August 2009

Reasons for updating

  • 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

In section 6.3, the shelf-life has been changed from 2 to 3 years.

Updated on 01 September 2008

Reasons for updating

  • New SPC for new product

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