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Plendil 2.5mg, 5mg & 10mg Tablets

  • Name:

    Plendil 2.5mg, 5mg & 10mg Tablets

  • Company:
    info
  • Active Ingredients:

    Felodipine

  • 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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Summary of Product Characteristics last updated on medicines.ie: 11/2/2019

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AstraZeneca Pharmaceuticals (Ireland) DAC

AstraZeneca Pharmaceuticals (Ireland) DAC

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1 - 0 of 51 items.Total: Infinity 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 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 SPC

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 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 4 November 2016 SPC

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 SPC

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 SPC

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 SPC

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 SPC

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 SPC

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 SPC

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

Section 6.3 
Following text deleted: '3 years' and replaced with following new text :
36 months for the 5 and 10 mg tablets.
 
24 months for the 2.5mg tablets.
 
 
Section 10
Date changed to 1st November 2007

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 SPC

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

Section 1
The words film-coated added (in bold)
Plendil 2.5mg Prolonged-release, Film-coated tablets
Plendil 5mg Prolonged-release, Film-coated tablets
Plendil 10mg Prolonged-release, Film-coated tablets
 
 
Section 2
Folowing text in bold added:
Each tablet contains Felodipine 2.5mg and anhydrous lactose 28mg and polyoxyl 40 hydrogenated caster oil 2.5mg
Each tablet contains Felodipine 5mg and anhydrous lactose 28mg and polyoxyl 40 hydrogenated caster oil 5mg
Each tablet contains Felodipine 10mg and anhydrous lactose 28mg and polyoxyl 40 hydrogenated caster oil 10mg
 
For full list of excipients, see section 6.1
 
 
Section 9
new date added 18th May 2007 as shown below:

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 2007
 
Section 10
Date changed to 24th August 2007
 
 

Updated 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 SPC

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

 

This product contains lactose.  Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
 
Section 10
New date of revision-22nd February 2007

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 SPC

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

 
Section 4.5 - Phenobarbitone has been changed to Phenobarbital
 
Section 5.1 - Indomethacin has been changed to Indometacin

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 SPC

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 SPC

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 SPC

Reasons for updating

  • New SPC for medicines.ie

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