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Bayer plc
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
Telephone: +44 (0)1635 563 000
Fax: +44 (0)1635 563 393
WWW: http://www.bayer.co.uk

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Summary of Product Characteristics last updated on the eMC: 08/03/2012
SPC Adalat 5

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 08/03/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The key changes to the SmPCs are:

·        Section 6.4, change to the storage instructions of the finished product from "Do not store above 25°C" to "Do not store above 30°C" for all primary packaging materials.  
Updated on 08/02/2012 and displayed until 08/03/2012
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The key changes to the SmPC are:

 4.2 Posology and method of administration
Paediatric population
The safety and efficacy of nifedipine in children below 18 years have not been established. Currently available data for the use of nifedipine in hypertension are described in section 5.1

5.1 Pharmacodynamic properties
Paediatric population:
Limited information on comparison of nifedipine with other antihypertensives is available for both acute hypertension and long-term hypertension with different formulations in different dosages. Antihypertensive effects of nifedipine have been demonstrated but dose recommendations, long term safety and effect on cardiovascular outcome remain unestablished. Pediatric dosing forms are lacking.
Updated on 20/12/2011 and displayed until 08/02/2012
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   10-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The key changes are:

  • The statement 'Trading as Bayer plc, Bayer Schering Pharma' has been removed from Section 7 'MARKETING AUTHORISATION HOLDER' of the SmPC
Updated on 22/09/2011 and displayed until 20/12/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The key changes to the SmPC are:

  • To amend section 4.8 adding additional side effects of unknown frequency
Updated on 01/07/2010 and displayed until 22/09/2011
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 10 date of revision of the text
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   04-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 - (Product Name) - this has been updated to add the strength and pharmaceutical form to the product name, in line with the current SPC guideline.
 
Section 3 ( Pharmaceutical form) - this section  has been amended to bring the description of the capsules in line with the description given in Module 3 of the product dossiers and in line with the CCDS

Section 10 (Revision date) - now 4 June 2010
Updated on 23/01/2009 and displayed until 01/07/2010
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   16-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The key changes are to Section 4.1 of the SmPC:

  • restriction of the indication from "hypertension" to "essential hypertension"
  • restriction of use in patients with essential hypertension or chronic stable angina pectoris to use only when no other treatment is appropriate (due to demonstrable dose-dependant increase in cardiovascular complications and mortality in this population, when treated with fast-release forms of nifedipine)
Updated on 04/11/2008 and displayed until 23/01/2009
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 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   30-Apr-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The key changes to the SmPC are:

Section 4.2: statement regarding the potential effect of CYP3A4 inducers on the recommended starting dose of nifedipine

Section 4.3/4.6: the "pregnancy" contraindication has changed such that nifedipine use is now only contraindicated in pregnancy before week 20

 

 

Section 4.4: addition/re-wording of existing warnings and precautions (severe hypotension, risk of myocardial/cerebrovascular ischaemia, angina pectoris, myocardial infarction, use with iv magnesium sulphate)

Section 4.8: conversion to MedDRA terminology and inclusion of ACTION study data

Sections 5.1-5/3: addition of new pharmacodynamic/pharmacokinetic and preclinical data

 
Updated on 05/06/2008 and displayed until 04/11/2008
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  nifedipine