Reasons for adding or updating:

• Change to section 10 - Date of revision of the text
• Change to section 4.8 - Undesirable effects
• Change to section 4.6 - Fertility, pregnancy and lactation

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.

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 4.8 - Undesirable effects
• Change to section 5.1 - Pharmacodynamic properties
• 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: 05-Aug-2015

Legal Category:POM

Black Triangle (CHM): NO

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The key changes are:

·        To update sections 2., 4.2, 4.3, 4.4, 4.6, 4.8, 5.1 and 6.3 of the SmPC in line with QRD template. 

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;

Reasons for adding or updating:

• Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Oct-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The key changes are:

Section 10 (Date of revision of the text): Correction of date. 

 

 

Reasons for adding or updating:

• Change to section 10 date of revision of the text
• Improved Electronic Presentation

Date of revision of text on the SPC: 28-Jun-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Minor editorial changes have been made in the document.
Revision date is now 28 June 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: 12-Apr-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The key changes to the SmPCs are:

·        The statement 'Trading as Bayer plc, Bayer Schering Pharma' has been removed from Section 7 of the SmPC. 

Reasons for adding or updating:

• Change to section 4.2 - Posology and method of administration
• Change to section 5.1 - Pharmacodynamic Properties

Date of revision of text on the SPC: 16-Jan-2012

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.

 

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 10 date of revision of the text

Date of revision of text on the SPC: 10-Sep-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

 The key changes are:

• Section 4.2 (Posology and method of administration) and consequentially section 4.4 (Special warnings and precautions for use)  (Special warnings and precautions for use)to add revised dosage data in the elderly.
• Subheadings have also been added to align wording to the Company Core Data Sheet.
• Section 10 (Date of revision of the text) updated to date of approval, 10th September 2010. 

Reasons for adding or updating:

• Change to section 4.3 - Contraindications
• Change to section 4.4 - Special warnings and precautions for Use
• 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: 21-Jul-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

 The key changes are: 

• Change to section 4.8 (Undesirable effects) to add several ADRs following a reassessment of the spontaneous case reports database. A description of the frequency grouping has also been added. Consequentially, the PIL has been updated.. 
• Change to section 4.3 (Contraindications)to add the warning on the use in patients with a Koch pouch. This warning has been removed from section 4.4 (Special warnings and precautions for use). 
• Change to section 5.2 (Pharmacokinetic properties) to correct a typographical error from below 1.0% to below 0.1% relating to the traces on non-metabolised nifedipine detected in the urine. Subsectional headings have been included to improve readability of the section.
• Change to Section 10 (Date of Revision), updated to 21st July 2010. 

Reasons for adding or updating:

• Change to section 1 -Name of the Medicinal product
• Change to section 3 - Pharmaceutical form
• Change to section 10 date of revision of the text

Date of revision of text on the SPC: 20-Apr-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The key changes to the SmPC are:

• Section 1 to add the strength and pharmaceutical form (consequential changes are made to the leaflet and carton/blister).
• Section 3 to update the description of the tablets in line with current approved Quality information (consequential changes are made to the leaflet).

Reasons for adding or updating:

• Change to section 10 date of revision of the text
• Change to section 7 - Marketing Authorisation Holder

Date of revision of text on the SPC: 02-May-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 (MA Holder) has been updated with the 'Bayer Schering Pharma' trading sytle.
Section 10 (Date of Revision of the Text) has been updated with the date of approval of the above. 

Reasons for adding or updating:

• New individual SPC (was previously included in combined SPC)

Date of revision of text on the SPC: 01-Sep-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company: