Plendil 2.5mg, 5mg & 10mg Tablets
- Name:
Plendil 2.5mg, 5mg & 10mg Tablets
- Company:
AstraZeneca Pharmaceuticals (Ireland) DAC
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/09/19
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AstraZeneca Pharmaceuticals (Ireland) DAC
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Company Products
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 18 September 2019 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 11 February 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 11 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)
Free text change information supplied by the pharmaceutical company
Change Reasons:
Change to section 7 - Marketing authorisation holder
Change to section 8 - Marketing authorisation number
Change to section 10 - Date of revision of the text
Updated on 4 November 2016 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 4 November 2016 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 - how to report a side effect
- Change to section 4.9 - Overdose
- 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 6.1 - List of excipients
- 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 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Change to section 1 - Name of medicinal product
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 1– Editorial changes to harmonise text
Section 2– Editorial changes to harmonise text
Section 3– Editorial changes to harmonise text
Section 4.4 – Editorial changes to harmonise text
Section 4.5 – Editorial changes to harmonise text, Saint John’s wort changed to St. John’s wort
Section 4.6 – Editorial changes to harmonise text
Section 4.8 – Editorial changes to harmonise text, spelling corrected for leukocytoclastic
Section 4.9 – Editorial changes to harmonise text
Section 5.1 – Editorial changes to harmonise text
Section 5.2 – Editorial changes to harmonise text
Section 5.3 – Editorial changes to harmonise text
Section 6.1 – Editorial changes to harmonise text
Section 6.3 – Editorial changes to harmonise text, all strengths added and months changed to years
Section 6.4 – Editorial changes to harmonise text (removal of storage temp)
Section 6.5 – Editorial changes to harmonise text – mention of all pack types (module 3 harmonisation)
Section 9– additional of correct dates of authorisation and renewal
Section 10– Update to Date of Revision
Updated on 3 November 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 3 November 2016 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 8 February 2016 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 4.1 - 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- 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 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
- 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– Editorial changes to harmonise text with Article 30 Referral and QRD update
Section 2– Editorial changes to harmonise text with Article 30 Referral, QRD update and change of name of excipient from Polyoxyl 40 hydrogenated castor oil to Macrogolglycerol hydroxystearate
Section 3– Editorial changes to harmonise text with Article 30 Referral and QRD update, extra detail added to tablet description as a result of this.
Section 4.1– Editorial changes to harmonise text with Article 30 Referral and QRD update
Section 4.2 – Editorial changes to harmonise text with Article 30 Referral and QRD update. Removal of text regarding beta blockers ACE inhibitors and diuretics as well as effects on blood pressure
Section 4.3 – Editorial changes to harmonise text with Article 30 Referral.
Section 4.4 – Editorial changes to harmonise text with Article 30 Referral and QRD update. Warning added about drugs that induce or inhibit CYP3 A4. Warning regarding castor oil added.
Section 4.5 – Editorial changes to harmonise text with Article 30 Referral and QRD update. Warnings about drugs that interfere with CYP3A4 added.
Section 4.6 – Editorial changes to harmonise text with Article 30 Referral and QRD update
Section 4.7 – Editorial changes to harmonise text with Article 30 Referral and QRD update
Section 4.8 – Editorial changes to harmonise text with Article 30 Referral and QRD update
Section 4.9 – Editorial changes to harmonise text with Article 30 Referral.
Section 5.1 – Editorial changes to harmonise text with Article 30 Referral and QRD update. Name of Pharmacotherapeutic group changed from Calcium antagonist to calcium channel blockers, dihydropyridine derivatives. Paragraph regarding felodipine being well tolerated in certain patients removed. Clinical efficacy studies added.
Section 5.2 – Editorial changes to harmonise text with Article 30 Referral and QRD update. Information on biotransformation and Linearity/non-linearity added.
Section 5.3 – Editorial changes to harmonise text with Article 30 Referral and QRD update. Information on reproduction toxicity studies added
Section 6.1 – Editorial changes to harmonise text with Article 30 Referral,QRD update and change of name of excipient from Polyoxyl 40 hydrogenated castor oil to Macrogolglycerol hydroxystearate
Section 6.3 – Editorial changes to harmonise text with Article 30 Referral and QRD update
Section 6.6 – Editorial changes to harmonise text with Article 30 Referral. Change in statement for disposal from non stated.
Section 8 – Editorial changes to harmonise text with Article 30 Referral and QRD update
Section 9 – QRD update
Section 10– Update to Date of Revision
Updated on 5 February 2016 PIL
Reasons for updating
- Change of inactive ingredient
- 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
- Change due to harmonisation of PIL
- Addition of information on reporting a side effect.
- Correction of spelling/typing errors
- Improved electronic presentation
Updated on 10 July 2013 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- 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 administrative changes.
- Section 4.4 addition of Mild gingival enlargement.
- Section 4.5 administartive changes
- Section 4.6 update to subheading and addition of male and female fertility
- Section 4.8 new side effects table following the MedDRA guidelines.
- Section 5.2 addition of cytochrome P450 3A4
- Section 10 date of revision
Updated on 9 July 2013 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 22 October 2012 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
- Change to section 4.9 - Overdose
- 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
Major update – (addition to administration information on hypertension, elderly population, hepatic and renal impairment and paediatric population).
Section 4.3
Addition of unstable angina pectoris, haemodynamically significant cardiac valvular obstruction, dynamic cardiac outflow obstruction, and acute myocardial infarction.
Section 4.4
Update to section 4.4 name. Major change.
Section 4.5
Major update to whole section.
Section 4.6
Addition of information on fertility and update to breast-feeding info.
Section 4.7
Section reworded.
Section 4.8
Major update to whole section. Side effects now listed by frequency and organ class.
Section 4.9
Wording updated.
Section 5.1
Addition of Pharmacotherapeutic group and ATC code.
Section 10
Date of revision updated to 12th October 2012.
Updated on 18 October 2012 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
- Change to date of revision
- Change to dosage and administration
Updated on 9 July 2012 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- 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
Section 2
Polyoxyl 40 hydrogenated castor oil replaced with macrogolglycerol hydroxystearate.
Section 4.4
New paragraph added “This product contains castor oil. This may cause stomach upset and diarrhoea.”
Section 6.1
Polyoxyl 40 hydrogenated castor oil replaced with macrogolglycerol hydroxystearate.
Section 10
Date of revision changed to 2nd July 2012
Updated on 3 July 2012 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to further information section
- Change to date of revision
Updated on 20 September 2011 SmPC
Reasons for updating
- 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
ISection 5.1
Text added
There is limited clinical trial experience of the use of felodipine in hypertensive paediatric patients. In a randomised, double-blind, 3‑week, parallel group study in children aged 6‑16 years with primary hypertension, the antihypertensive effects of once daily felodipine 2.5 mg (n=33), 5 mg (n=33) and 10 mg (n=31) were compared with placebo (n=35). The study failed to demonstrate the efficacy of felodipine in lowering blood pressure in children aged 6-16 years.
The long-term effects of felodipine on growth, puberty and general development have not been studied. The long-term efficacy of antihypertensive therapy as therapy in childhood to reduce cardiovascular morbidity and mortality in adulthood has also not been established.
Section 5.2
Text added
In a single dose (felodipine prolonged-release 5 mg) pharmacokinetic study with a limited number of children aged between 6 and 16 years (n=12) there was no apparent relationship betwee the age and AUC, Cmax or half-life of felodipine.
Section 10
Date of revision changed to 6th September 2011
Updated on 9 December 2009 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 6 November 2007 SmPC
Reasons for updating
- Change to section 6.3 - Shelf life
- 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 on 6 September 2007 PIL
Reasons for updating
- Change of trade or active ingredient name
- Change of inactive ingredient
- Change to storage instructions
Updated on 6 September 2007 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- 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
Plendil 2.5mg Prolonged Release Tablets 19th May 1997/18th May 2007
Plendil 5mg Prolonged Release Tablets 18th May 1993/18th May 2007
Plendil 10mg Prolonged Release Tablets 18th May 1993/18th May 2007Updated on 11 April 2007 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 2 April 2007 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Additional new text last paragraph-lactose warning
Updated on 6 February 2007 PIL
Reasons for updating
- Change in co-marketing arrangement
Updated on 25 July 2006 PIL
Reasons for updating
- Change to date of revision
- Change from the BAN of the active substance to the rINN
Updated on 14 June 2006 SmPC
Reasons for updating
- Change from the BAN of the active substance to the rINN
- 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 on 15 June 2005 PIL
Reasons for updating
- Change to date of revision
- Change to side-effects
Updated on 15 June 2005 PIL
Reasons for updating
- Change to date of revision
Updated on 25 May 2005 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 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- 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)
Updated on 9 August 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 20 October 2003 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)
Updated on 3 July 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)