Zestril Tablets

  • Name:

    Zestril Tablets

  • Company:
    info
  • Active Ingredients:

    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: 11/11/19

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Summary of Product Characteristics last updated on medicines.ie: 18/2/2019

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AstraZeneca Pharmaceuticals (Ireland) DAC

AstraZeneca Pharmaceuticals (Ireland) DAC

Company Products

Medicine NameActive Ingredients
Medicine Name VIMOVO 500 mg/20 mg modified-release tablets Active Ingredients Esomeprazole magnesium trihydrate, Naproxen
Medicine Name Xigduo 5 mg/850 mg and 5 mg/1,000 mg film coated tablets Active Ingredients Dapagliflozin propanediol monohydrate, Metformin Hydrochloride
Medicine Name Zestoretic 10 mg /12.5 mg Tablets & Zestoretic 20 mg /12.5 mg Tablets Active Ingredients Hydrochlorothiazide, Lisinopril dihydrate
Medicine Name Zestril Tablets Active Ingredients Lisinopril dihydrate
Medicine Name Zoladex 3.6mg Active Ingredients Goserelin Acetate
Medicine Name Zoladex LA 10.8mg Active Ingredients Goserelin Acetate
51 - 56 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 11 November 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

Free text change information supplied by the pharmaceutical company

2. What you need to know before you take Zestril

Do not take Zestril:

  • ….
  • If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased.
  • if a member of your family has had severe allergic reactions (angioedema) to an ACE inhibitor or you have had severe allergic reactions (angioedema) without a known cause.
  • if you are more than 3 months pregnant. (It is also better to avoid Zestril in early pregnancy - see Ppregnancy section).
     

Warnings and precautions

Talk to your doctor or pharmacist before taking Zestril:

  • ….
  • if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in area such as the throat) is increased:
  • temsirolimus, sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors (used to avoid rejection of transplanted organs and for cancer).
  • Racecadotril, a medicine used to treat diarrhoea;
  • Vildagliptin, a medicine used to treat diabetes.
  • ….
  • you must tell your doctor if you think you are (or might become) pregnant. Zestril is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see Ppregnancy section).

 

Other medicines and Zestril

….

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

  • …..
  • Potassium supplements, salt substitutes that have potassium in them or other drugs that may increase serum potassium in your body (such as heparin, and co‑trimoxazole also known as trimethoprim/sulfamethoxazole).
  • Potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that can increase the amount of potassium in your blood (e.g. trimethoprim and co-trimoxazole for infections caused by bacteria; ciclosporin, an immunosuppressant medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin blood to prevent clots).
  • ….

The following medicines may increase the risk of angioedema (signs of angioedema include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing):

  • ….
  • Medicines which are most often used to avoid rejection of transplanted organs (temsirolimus, sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors). See section 2 “Warnings and precautions”.
  • Racecadotril used to treat diarrhoea.
  • Vildagliptin, a medicine used to treat diabetes.
     
    This leaflet was last revised in February 2019 May 2019.
    © AstraZeneca 20189

Updated on 24 April 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 18 February 2019 PIL

Reasons for updating

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

Updated on 18 February 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 18 June 2018 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 9 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 9 November 2017 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
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 3 November 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 3 November 2017 SmPC

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 5.1 - 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)

Free text change information supplied by the pharmaceutical company

Section 4.2 editorial update to align with QRD template. Older people changed to Elderly

Section 4.4 wording on Angioedema updated to state that patients taking concomitant mTOR inhibitors therapy may be at increased risk of angioedema and minor editorial changes.

Section 4.5 information on ‘drugs that may increase the risk of angioedema’ added and minor editorial updates. Deletion of sub-heading and text on Tissue plasminogen activators, this is now included in the ‘drug that may increase the risk of angioedema’ section. Information on Co-trimoxazole and risk of hyperkalaemia added.

Section 4.8 anaphylactic/anaphylactoid reaction added.

Section 5.1 minor editorial changes with no changes to content.

Section 5.2 editorial update to align with QRD template. Older people changed to Elderly

Section 10 revision date amended

Updated on 26 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

Section 4.4 update to Hyperkalaemia section

Section 4.5 information on interactions with potassium levels updated.

Section 10 revision date updated

Updated on 24 May 2016 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 9 June 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 10 March 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 4.8 – Undesirable effects - how to report a side effect
  • 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

Section 4.2 – Addition of cross reference to Hypertension section.

Section 4.3 – Clarification of contraindication regarding concomitant use of Zestoretic with aliskiren-containing products.

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 4.8 – Update to Adverse Reaction reporting address in line with latest QRD template.

Section 5.1 – Addition of clinical data for Renin-angiotensin system (RAS)-acting agents.

Section 10 – Update to "Date of Revision"

Updated on 9 March 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

Updated on 15 July 2014 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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
  • 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

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

Free text change information supplied by the pharmaceutical company

Section 1 – Remove reference to 2.5mg strength

Section 2 – Remove reference to 2.5mg strength

Section 3 – Remove details of 2.5mg strength

Section 4.2 – Editorial amendment to heading.

Section 4.4 – Correction to “patent airway” wording.

Section 4.8 – Amend reporting address for Reporting of suspected adverse reactions.

Section 6.1 – Reference to 2.5mg strength removed.

Section 6.4 – Remove details of 2.5mg strength

Section 6.5 – Remove reference to 2.5mg strength and Al/Al blister packs deleted for 5mg and 20mg strengths.

Section 8 – Remove reference to 2.5mg strength

Section 9 – Remove reference to 2.5mg strength

Section 10 – Update to "Date of Revision"

Updated on 14 July 2014 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 4 February 2014 SmPC

Reasons for updating

  • 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
  • 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 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 2 – Minor editorial change.

Section 3 – Clarification of tablet division.

Section 4.2 – Editorial change to headings of Paediatric population and Older people.

Section 4.3 – Addition of new contraindication in combination with aliskiren-containing medicines in patients with diabetes mellitus or with moderate to severe renal impairment. Editorial change.

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

Section 4.5 – Addition of information regarding interaction between lisinopril and other antihypertensive agents.

Section 4.6 – Editorial change to Breastfeeding title.

Section 4.8 – Addition of Hallucination side effect. Addition of Adverse Event Reporting wording.

Section 5.1 – Addition of titles to make the section clearer.

Section 5.2 – Editorial change to headings of Paediatric population and Older people.

Section 10 – Update to "Date of Revision"

Updated on 29 January 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration
  • Addition of information on reporting a side effect.
  • Correction of spelling/typing errors

Updated on 6 September 2013 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Discontinuation of one or more strengths

Updated on 18 February 2013 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 19 March 2012 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 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 4.4

Hypersensitivity/Angioedema

Paragraph 1
Word changed from uncommonly to rarely.


Section 4.6

Word Fertility added to section heading


Section 4.8

Skin and subcutaneous tissue disorders

Undesirable effects amended to:

uncommon:      rash, pruritus

rare:                 urticaria, alopecia, psoriasis, hypersensitivity/angioneurotic oedema: angioneurotic oedema of the face, extremities, lips, tongue, glottis, and/or larynx (see section 4.4)

very rare:          sweating, pemphigus, toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme, cutaneous pseudolymphoma.


Endocrine disorders

Undesirable effects amended to:

rare:                 syndrome of inappropriate antidiuretic hormone secretion (SIADH).


Section 10

Date of revision changed to: 2nd March 2012

Updated on 15 March 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 25 July 2011 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 23 February 2011 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

SPC Changes, Zestril range Renewal

 

Section 4.4

Paragraph on Pregnancy changed, now reads as,

 

“Pregnancy

ACE inhibitors should not be initiated during pregnancy. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).”

 

Section 4.5

Paragraph on Non Steroidal anti-inflammatory drugs (NSAIDs) ioncluding acetylsalicylic acid changed, now reads as,

 

“Non steroidal anti-inflammatory medicinal products (NSAIDs) including acetylsalicylic acid ≥ 3g/day

When ACE-inhibitors are administered simultaneously with non-steroidal anti-inflammatory drugs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and non-selective NSAIDs), attenuation of the antihypertensive effect may occur. Concomitant use of ACE-inhibitors and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function. These effects are usually reversible. The combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.”

 

Section 10

4th February 2011

 

Updated on 18 February 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions

Updated on 24 August 2010 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

cSPC Changes, Zestril

 

Section 6.5

Additional text to all strengths throughout section, now reads,

 

“2.5 mg Tablets: Aluminium/PVC-PVDC or Aluminium/PVC foil blister packs of

14, 20, 28, 30, 50, 84, 100 and 400 tablets.

Aluminium/PVC-PVDC or Aluminium/PVC foil blister calendar packs of

14, 28 and 84 tablets.

HDPE bottle packs of 20, 30, 50, 100 and 400 tablets.

 

5 mg Tablets: Aluminium/PVC-PVDC, Aluminium/PVC or

Aluminium/Aluminium foil blister packs of 14, 20, 28, 28x1, 30, 42, 50, 56, 60, 84, 98, 100, 400 and 500 tablets.

Aluminium/PVC-PVDC, Aluminium/PVC or

Aluminium/Aluminium foil blister calendar packs of 14, 28, 42, 56, 84 and 98 tablets.

HDPE bottle packs of 20, 30, 50, 100 and 400 tablets.

 

10 mg Tablets: Aluminium/PVC-PVDC or Aluminium/PVC foil blister packs of

14, 20, 28, 30, 50, 56, 84, 98, 100 and 400 tablets.

Aluminium/PVC-PVDC or Aluminium/PVC foil blister calendar packs of

14, 28, 56, 84 and 98 tablets.

HDPE bottle packs of 20, 30, 50, 100 and 400 tablets.

 

20 mg Tablets: Aluminium/PVC-PVDC, Aluminium/PVC or Aluminium/Aluminium foil blister packs of 14, 20, 28, 30, 42, 50, 56, 56x1 60, 84, 98, 100, 400 and 500 tablets.

Aluminium/PVC-PVDC, Aluminium/PVC or Aluminium/Aluminium foil blister calendar packs of 14, 28, 42, 56, 84 and 98 tablets.

HDPE bottle packs of 20, 30, 50, 100 and 400 tablets.

Not all pack sizes may be marketed.”

 

 

Section 10

12 August 2010

Updated on 24 August 2010 PIL

Reasons for updating

  • Addition of manufacturer

Updated on 9 April 2010 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • 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

cSPC changes – Zestril

 

Section 4.2

Additional 2 paragraphs of text before ‘Heart Failure’ heading,

Use in Hypertensive Paediatric Patients aged 6-16 years

The recommended initial dose is 2.5 mg once daily in patients 20 to <50 kg, and 5 mg once daily in patients ≥50 kg. The dosage should be individually adjusted to a maximum of 20 mg daily in patients weighing 20 to <50 kg, and 40 mg in patients ≥50 kg. Doses above 0.61 mg/kg (or in excess of 40 mg) have not been studied in paediatric patients (see section 5.1).

 

In children with decreased renal function, a lower starting dose or increased dosing interval should be considered.”

Additional paragraph titled ‘Paediatric Use’ after Renal Complications of Diabetes Mellitus,

“Paediatric Use

There is limited efficacy and safety experience in hypertensive children >6 years old, but no experience in other indications (see section 5.1). Zestril is not recommended in children in other indications than hypertension.

 

Zestril is not recommended in children below the age of 6, or in children with severe renal impairment (GFR <30 ml/min/1.73m2)(see section 5.2).”

Section 4.8

Under heading, “Nervous system and psychiatric disorders”, “rare”, the words, “olfactory disturbance” is added after mental confusion.

 

Additional heading, “Endocrine disorders” added after heading “Renal and urinary disorders”,

Endocrine disorders:

frequency

not known:        inappropriate antidiuretic hormone secretion.”

 

Additional text at end of section,

“Safety data from clinical studies suggest that lisinopril is generally well tolerated in hypertensive paediatric patients, and that the safety profile in this age group is comparable to that seen in adults.”

Section 5.1
Addition of two paragraphs at end of section,

“In a clinical study involving 115 paediatric patients with hypertension, aged 6-16 years, patients who weighed less than 50 kg received either 0.625 mg, 2.5 mg or 20 mg of Zestril once a day, and patients who weighed 50 kg or more received either 1.25 mg, 5 mg or 40 mg of Zestril once a day. At the end of 2 weeks, Zestril administered once daily lowered trough blood pressure in a dose-dependent manner with a consistent antihypertensive efficacy demonstrated at doses greater than 1.25 mg.

 

This effect was confirmed in a withdrawal phase, where the diastolic pressure rose by about 9 mm Hg more in patients randomized to placebo than it did in patients who were randomized to remain on the middle and high doses of Zestril. The dose-dependent antihypertensive effect of Zestril was consistent across several demographic subgroups: age, Tanner stage, gender, and race.”

Section 5.2

Addition of two paragraphs after Heart failure heading,

Paediatrics

The pharmacokinetic profile of lisinopril was studied in 29 paediatric hypertensive patients, aged between 6 and 16 years, with a GFR above 30 ml/min/1.73m2. After doses of 0.1 to 0.2 mg/kg, steady state peak plasma concentrations of lisinopril occurred within 6 hours, and the extent of absorption based on urinary recovery was about 28%. These values are similar to those obtained previously in adults.

 

AUC and Cmax values in children in this study were consistent with those observed in adults.”

Section 6.1
In list of excipients, the addition of the word “strengths” after “Red Iron Oxide, in all strengths .........”

 

Section 10

27th November 2009

 

 

 

 

Updated on 30 March 2010 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects

Updated on 25 November 2009 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 3

Changed text: 
2.5 mg tablets: round, white, uncoated, biconvex tablet with “♥ 2.5” on one side and plain on the other side. Diameter 6 mm.

5 mg tablets: round, pink, uncoated, biconvex tablet with “♥ 5” on one side and bisected on the other side. Diameter 6 mm.

The tablet can be divided into equal halves.

10 mg tablets: round, pink, uncoated, biconvex tablet with “♥ 10” on one side and plain on the other side. Diameter 8 mm.

20 mg tablets: round, brownish-red, uncoated, biconvex tablet with “♥ 20” on one side and plain on the other side. Diameter 8 mm.”

 

Section 4.4
Additional wording at the end of last subheading, Pregnancy & Lactation, "(See Section 4.6)."

Section 4.6

Final sub heading, Lactation, has new wording, "Because no information is available regarding the use of Zestril during breast-feeding, Zestril is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant."

 

Section 10

29 September 2009

Updated on 20 October 2009 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 16 January 2009 PIL

Reasons for updating

  • Change to side-effects

Updated on 16 January 2009 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 4.8 - 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 4.4

 

Paragraph 15

 

Addition of text:

Anaphylactoid reactions have been reported in patients dialysed with high flux membranes (e.g. AN 69) and treated concomitantly with an ACE inhibitor. In these patients consideration should be given to using a different type of dialysis membrane or different class of antihypertensive agent.

 

Section 4.5

 

Paragraph Gold has moved to be underneath the paragraph Non steroidal anti-inflammatory drugs (NSAIDs) including acetylsalicylic acid ≥ 3g/day

 

Section 4.8

 

Paragraph 1

 

Change of text to:

The following undesirable effects have been observed and reported during treatment with Zestril and other ACE inhibitors with the following frequencies: Very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

 

Changes to table on side effects:

 

Addition of text in-

 

Nervous system and psychiatric disorders:

Frequency not known:       depressive symptoms, syncope.

 

Change of text in-

 

Skin and subcutaneous tissue disorders:

hypersensitivity/angioneurotic oedema: angioneurotic oedema of the face, extremities, lips, tongue, glottis, and/or larynx (see section 4.4) moved from rare to uncommon side effects.

 

Section 10:

 

Change of date:

16th December 2008

 

Updated on 29 May 2008 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 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 4.4

Addition of following text for Pregnancy
: ACE inhibitors should not be initiated during pregnancy. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).

 

Deletion of following text: Lisinopril should not be used during the first trimester of pregnancy. Zestril is contraindicated in the second and third trimesters of pregnancy (see section 4.3). When pregnancy is detected, lisinopril treatment should discontinue as soon as possible (see section 4.6)

 

Section 4.5
 
Addition of following:
Gold
 
Nitritoid reactions (symptoms of vasodilatation including flushing, nausea, dizziness and hypotension, which can be very severe) following injectable gold (for example, sodium aurothiomalate) have been reported more frequently in patients receiving ACE inhibitor therapy.
 
Section 4.6

Addition of the following for Pregnancy:

 

The use of ACE inhibitors  is not recommended during the first trimester of pregnancy (see section 4.4).The use of ACE inhibitors is contra-indicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).

 
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Unless continued ACE inhibitors therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.
 
    Deletion of following for pregnancy:
Zestril should not be used during the first trimester of pregnancy. When pregnancy is planned or confirmed the switch to an alternative treatment should be initiated as soon as possible. Controlled studies with ACE inhibitors have not been done in humans, but a limited number of cases with first trimester toxicity exposure have not appeared to manifest malformations consistent with human foetotoxicity as described below.

Zestril is contraindicated during the second and third trimester of pregnancy.

Prolonged ACE inhibitor exposure during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia (see also  section 5.3).

Should exposure to Zestril have occurred from the second trimester of pregnancy, an ultrasound check of renal function and the skull is recommended.

Infants whose mothers have taken Zestril should be closely observed for hypotension, oliguria and hyperkalaemia.  Zestril, which crosses the placenta, has been removed from the neonatal circulation by peritoneal dialysis with some clinical benefit, and theoretically may be removed by exchange transfusion.

 

Section 4.8

Addition of cutaneous pseudolymphoma as a very rare disorder


Section 10

New revision date of text: 19th  May 2008

Updated on 29 May 2008 PIL

Reasons for updating

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

Updated on 3 March 2008 PIL

Reasons for updating

  • Change to storage instructions
  • Change to MA holder contact details

Updated on 3 March 2008 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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

6.3 Shelf Life - From 2 years to 4 years
6.4 Special precautions for storage -Change to storage conditions
6.5 Nature and contents of container  - New information regarding packs
10 -New revision date of text 15 January 2008

Updated on 5 August 2005 PIL

Reasons for updating

  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 15 July 2005 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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)

Updated on 10 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 20 August 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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)