Zestoretic 10 mg /12.5 mg Tablets & Zestoretic 20 mg /12.5 mg Tablets

  • Name:

    Zestoretic 10 mg /12.5 mg Tablets & Zestoretic 20 mg /12.5 mg Tablets

  • Company:
    info
  • Active Ingredients:

    Hydrochlorothiazide, Lisinopril dihydrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/11/19

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Summary of Product Characteristics last updated on medicines.ie: 1/11/2019

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AstraZeneca Pharmaceuticals (Ireland) DAC

AstraZeneca Pharmaceuticals (Ireland) DAC

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26 - 50 of 56 items.Total: 3 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 1 November 2019 SmPC

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)

Free text change information supplied by the pharmaceutical company

Information added relating to risk of non-melanoma skin cancer

Updated on 1 November 2019 PIL

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

Free text change information supplied by the pharmaceutical company

2. What you need to know before you take Zestoretic

Warnings and Precautions

Talk to your doctor or pharmacist before taking Zestoretic:

 if you have had skin cancer or if you develop an unexpected skin lesion during the treatment. Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Zestoretic.

4. Possible side effects

Possible side effects with hydrochlorothiazide (frequency not known)

 Skin and lip cancer (Non-melanoma skin cancer).

This leaflet was last revised in August October 2019.

Updated on 23 September 2019 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

3. Pharmaceutical form

Tablet.

Zestoretic 10 mg/12.5 mg Tablets

Round, biconvex, peach uncoated tablets, containing lisinopril dihydrate and hydrochlorothiazide. The tablets have ‘10 12.5’ on one side and a break line on the other side. ‘Zt’ and ‘10’ on one side.

The break line is not intended for breaking the tablet.

4.8 Undesirable effects

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via: 

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

email: medsafety@hpra.ie

6.5 Nature and contents of container

Unplasticised PVC/Aluminium foil coated with a heat sealable lacquer coating. 14 tablets/blister, 2 blisters per box

10. Date of revision of the text

25th January 2019 18th September 2019

 

Updated on 23 September 2019 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 - date of revision

Updated on 30 April 2019 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 29 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 5 June 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 5 June 2017 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic 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 10 - Date of revision of the text
  • Correction of spelling/typing errors
  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

Section 4.2-editorial updates to align with QRD template

Section 4.3-History of anaphylactic/anaphylactoid reactions added

Section 4.4-  information on concomitant use with ACE inhibitors and risk of angioedema added. minor editorial update- Angiotensin coverting enzyme abbreviated to ACE and alignment to QRD template.

Section 4.5-revised text on drugs that may increase the risk of angioedema added.

Section 4.8- anaphylactic /anaphylactoid reaction added as not known side effect in lisinopril table with editoral and formating changes made to table also.

Section 4.9- editorial updates to align with QRD template

Section 5.2 editorial updates to align with QRD template

Section 6.4 editorial updates to align with QRD template

Section 6.6 editorial updates to align with QRD template

Section 10 date of revision amended

Updated on 1 June 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 June 2017 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 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 6 November 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 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 4.2: removal of essential from essential hypertension

Section 4.5: information about hyperkalaemia

Section 4.5: information relating to hydrochlorothiazide interactions

Section 4.6: removal of essential from essential hypertension

Section 10: date of revision

Updated on 4 November 2015 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 3 November 2015 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to joint SPC covering all presentations

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

Free text change information supplied by the pharmaceutical company

Section 2 – QRD update to SmPC to combine 10mg and 20mg wording.

Section 3 – QRD update to SmPC to combine 10mg and 20mg wording.

Section 6.1 – QRD update to SmPC to combine 10mg and 20mg wording.

Section 6.4 – QRD update to SmPC to combine 10mg and 20mg wording.

Section 8 – QRD update to SmPC to combine 10mg and 20mg wording.

Section 9 – QRD update to SmPC to combine 10mg and 20mg wording.

Section 10 – Update to "Date of Revision"

 
Also there is a change to a joint SmPC covering 10 and 20mg presentations - as agreed with datapharm staff the individual 10mg SmPC will be modified to the joint SmPC and the 20mg SmPC will be retired.

Updated on 25 September 2015 SmPC

Reasons for updating

  • 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

Section 4.5 To include a consequence of an interaction between lisinopril and tissue plasminogen activators (tPA)

Section 10 – Update to "Date of Revision"

Updated on 24 September 2015 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision
  • Change to marketing authorisation holder
  • Addition of information on reporting a side effect.

Updated on 25 February 2015 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 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life
  • 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

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

Free text change information supplied by the pharmaceutical company

Section 2 – Editorial update in line with latest QRD template.

Section 4.2 – Editorial update in line with latest QRD template.

Section 4.3 – Clarification of contraindication regarding concomitant use of Zestoretic with aliskiren-containing products and editorial updates in line with latest QRD template.

Section 4.4 – Addition of warnings around concomitant use of Zestoretic with aliskiren-containing products

Section 4.5 – Clarification of interactions observed with combined use of Zestoretic with aliskiren-containing products.

Section 4.6 – Editorial update in line with latest QRD template.

Section 4.7 – Editorial update in line with latest QRD template.

Section 4.8 – Editorial update in line with latest QRD template.

Section 5.1 – Addition of clinical data for Renin-angiotensin system (RAS)-acting agents and editorial updates in line with latest QRD template.

Section 5.2 – Editorial update in line with latest QRD template.

Section 6.3 – Editorial update in line with latest QRD template.

Section 6.6 – Editorial update in line with latest QRD template.

Section 10 – Update to "Date of Revision"

Updated on 24 February 2015 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

Updated on 6 November 2013 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 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 4.3 – Additional information regarding concomitant administration with aliskiren-containing medicines in patients with moderate to severe renal impairment.

Section 4.4 – Addition of warning regarding dual blockade of the renin-angiotensin-aldosterone system (RAAS) by combining lisinopril with aliskiren-containing medicines.

Section 4.5 – Addition of information regarding interactions with aliskiren-containing medicines.

Section 4.8 – Addition of hallucinations and systemic lupus erythematosus to undesirable effects. Addition of “Reporting of suspected adverse reactions” wording.

Section 10 – Update to "Date of Revision"

Updated on 4 November 2013 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 29 August 2013 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 4.7 - Effects on ability to drive and use machines
  • 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 4.3 – addition of  concomitan administation with aliskiren.

- Section 4.4 – addition of Aortic and mitral valve stenosis/hypertrophic cardiomyopathy; addition of Hyperkalaemia; addition of Diabetic patients.

- Section 4.5 – addition of Dual blockade of the renin-angiotensin-aldosterone system. Include information on acetylsalicyclic acid.

- Section 4.6 – addition of Hydrochlorothiazide interation during lactation.

- Section 4.7 – addition of information about driving vechicles/operating machines.

- Section 4.8 – reformatting inline with MedDRA guidelines.  Addition of hypochloremic alkalosis and hypomagnesaemia to Hydrochlorothiazide side effects.

- Section 10 – Date of revision.

Updated on 23 August 2013 PIL

Reasons for updating

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

Updated on 15 March 2012 PIL

Reasons for updating

  • Change to date of revision
  • Change to appearance of the medicine

Updated on 24 August 2011 SmPC

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 23 August 2011 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to MA holder contact details

Updated on 12 May 2011 PIL

Reasons for updating

  • Change to side-effects
  • Joint PIL superseded by PILs for individual presentations

Updated on 8 October 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery

Updated on 26 June 2009 PIL

Reasons for updating

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

Updated on 13 May 2009 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change due to user-testing of patient information
  • Change of contraindications

Updated on 12 April 2007 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 10 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie