Adalat 5
Last Updated on eMC 30-Sep-2016 View document | Bayer plc Contact details
Versions
- 30-Sep-2016 to Current
- 24-Aug-2016 to 30-Sep-2016
- 04-Aug-2015 to 24-Aug-2016
- 03-Feb-2014 to 04-Aug-2015
- 08-Mar-2012 to 03-Feb-2014
- 08-Feb-2012 to 08-Mar-2012
- 20-Dec-2011 to 08-Feb-2012
- 22-Sep-2011 to 20-Dec-2011
- 01-Jul-2010 to 22-Sep-2011
- 23-Jan-2009 to 01-Jul-2010
- 04-Nov-2008 to 23-Jan-2009
- 05-Jun-2008 to 04-Nov-2008
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 30-Sep-2016 and displayed until Current
Reasons for adding or 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 4.6 - Fertility, 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
Date of revision of text on the SPC: 19-Sep-2016
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
The key changes are:To implement nifedipine CCDS changes and therefore update information related to patients with hepatic impairment in the SmPC; add changes resulting from a new pharmacokinetic study.
Updated on 24-Aug-2016 and displayed until 30-Sep-2016
Reasons for adding or updating:
- Change to section 4.6 - Fertility, pregnancy and lactation
- 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: 10-Aug-2016
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
The key changes are:
Implementation of Adalat PSUSA EMA/394060/2016 outcome. Inclusion of information on tocolytic use in pregnant women, SmPC sections 4.6 and 4.8 updated and PIL section 4.
Updated on 04-Aug-2015 and displayed until 24-Aug-2016
Reasons for adding or updating:
- Change to section 2 - Qualitative and quantitative composition
- 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 - Fertility, 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 4.8 - Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
Date of revision of text on the SPC: 24-Jul-2015
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
The update includes changes to sections 2, 4.2, 4.3, 4.4, 4.6, 4.7, 4.8, 5.1 and 6.3. For changes in line with QRD template.
Updated on 03-Feb-2014 and displayed until 04-Aug-2015
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 - Fertility, pregnancy and lactation
- 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: 22-Jan-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Changes to sections 4.2 (Posology and method of administration), 4.3 (Contraindications), 4.4 (Special warnings and precautions for use), 4.6 (Pregnancy and Lactation) and 4.8 (Undesirable effects), in line with the agreed CSP resulting from the Nifedipine PSUR Workshare.
Updated on 08-Mar-2012 and displayed until 03-Feb-2014
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-Feb-2012 and displayed until 08-Mar-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
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-Dec-2011 and displayed until 08-Feb-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:
Updated on 22-Sep-2011 and displayed until 20-Dec-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:
Updated on 01-Jul-2010 and displayed until 22-Sep-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-Jan-2009 and displayed until 01-Jul-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-Nov-2008 and displayed until 23-Jan-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-Jun-2008 and displayed until 04-Nov-2008
Reasons for adding or updating:
- New individual SPC (was previously included in combined SPC)
Legal Category:POM
Black Triangle (CHM): NO
Bayer plc
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
+44 (0)1635 563 393
+44 (0)1635 563 000
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