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AstraZeneca UK Limited
Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU
Telephone: +44 (0)1582 836 000
Fax: +44 (0)1582 838 000
Medical Information Direct Line: +44 (0)1582 836 836
Medical Information e-mail: medical.informationuk@astrazeneca.com
Customer Care direct line: +44 (0)1582 837 837
Medical Information Fax: +44 (0)1582 838 003

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 16/04/2012
SPC Plendil 2.5mg, Plendil 5mg and Plendil 10mg

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 16/04/2012 and displayed until Current
Reasons for adding or 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 10 date of revision of the text
Date of revision of text on the SPC:   05-Apr-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2

 

Update to information on how and when to take the tablets, update to posology in Hypertension and Angina Pectoris. New information added and updated for special patient populations (i.e. hepatic, renal).

 

Section 4.3

 

Update to existing statement relating to hypersensitivity and information about clinically significant conditions when Plendil cannot be used.

 

Section 4.4

 

Update to information about precautions to be taken with Plendil and certain heart conditions (i.e tachycardia) and addition of information of reduced liver function and galactose intolerance.

 

Section 4.5

 

Separation of existing information under two sub-headings – ‘Enzyme interactions’ and ‘Additional interactions’. Revision of information under both sub-headings.

 

Section 4.6

 

Update to title of SmPC section and separation of exiting information under three sub-headings ‘Pregnancy’, ‘Breast-feeding’ and ‘Fertility’.

 

Section 4.7

 

Update to section, Plendil may cause dizziness and fatigue and necessary precautions should be taken before driving or using machines.

 

Section 4.8

 

Update to existing information and revision of ADRs to the MEDdra Class system.

 

Section 4.9

 

Update to existing information to improve readability.   

 

Section 10

 

Date of revision amended to 5th April 2012
Updated on 11/03/2010 and displayed until 16/04/2012
Reasons for adding or 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
Date of revision of text on the SPC:   22-Feb-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 5.1

Deletion of text:

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 felodipine as therapy in childhood to reduce cardiovascular morbidity and mortality in adulthood has also not been established.

 

Additional new text at end of section:

 

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

Change of text last paragraph of section:

 

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 between the age and AUC, Cmax or half-life of felodipine.

 

Section 10

Revision date of text: 22 February 2010
Updated on 12/11/2007 and displayed until 11/03/2010
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.3
Plendil 2.5mg – 30 months has now changed to Plendil 2.5mg – 24 months
 
Section 10
Date changed to 27th September 2007
 
Updated on 12/04/2006 and displayed until 12/11/2007
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 (date of (partial) revision of the text
  • Change from BAN to rINN
Updated on 24/09/2003 and displayed until 12/04/2006
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 03/09/2002 and displayed until 24/09/2003
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 27/08/2002 and displayed until 03/09/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 19/07/2002 and displayed until 27/08/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 16/07/2002 and displayed until 19/07/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number
  • Change to section 10 (date of (partial) revision of the text
Updated on 13/03/2002 and displayed until 16/07/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 21/08/2001 and displayed until 13/03/2002
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Updated on 30/05/2001 and displayed until 21/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 30/05/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  felodipine