Updated on 27/01/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
|
| Date of revision of text on the SPC: 24-Jan-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Section
4.5 (Interactions with other medicinal products and other forms of interactions): New information has been added under the heading "Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Including Selective Cyclooxygenase-2 (COX-2) Inhibitors" as follows:
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Including Selective Cyclooxygenase-2 (COX-2) Inhibitors
Non-steroidal anti-inflammatory drugs Chronic administration of (NSAIDs) including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors) may reduce the effect of diuretics and other antihypertensive drugs. Therefore, the antihypertensive effect of angiotensin II receptor antagonists or an ACE inhibitors may be attenuated by NSAIDs including selective COX-2 inhibitors.
The co-administration of NSAIDs
(including COX-2 inhibitors) and angiotensin II receptor antagonists or ACE inhibitors exert an additive effect on the increase in serum potassium, and may result in a deterioration of renal function. These effects are usually reversible. Rarely, acute renal failure may occur, especially in patients with compromised renal function (such as the elderly or patients who are volume-depleted, including those on diuretic therapy). Therefore, the combination should be administered with caution in patients with compromised renal function. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy and periodically thereafter.
|
|
Updated on 25/05/2010 and displayed until 27/01/2011
|
Reasons for adding or updating:
|
-
Change to section 6. 5 - Nature and Contents of Container
|
| Date of revision of text on the SPC: 12-May-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Section 6.5 (Nature and contents of container): The details concerning registered pack sizes have been harmonised. No actual changes though to packs available in the UK.
|
|
Updated on 18/02/2010 and displayed until 25/05/2010
|
Reasons for adding or updating:
|
-
Change to section 2 - Qualitative and quantitative composition
-
Change to section 3 - Pharmaceutical form
-
Change to section 4.8 - Undesirable Effects
-
Change to section 6.1 - List of Excipients
-
Change to section 6. 4 - Special Precautions for Storage
|
| Date of revision of text on the SPC: 10-Feb-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
The changes made to the SmPC are as follows:
Section 2: Re-worded and quantity of lactose monohydrate included in each tablet is now stated.
Section 3: Added a footnote to the table stating that the scoreline mentioned in the tablet description is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Section 4.8: Frequency bands corrected; deleted references to section titles (only SmPC section numbers are now referenced)
Section 6.1: Excipient details have been reorganised
Section 6.4: Storage conditions now include "Store in the original package in order to protect from moisture."
|
|
Updated on 15/09/2009 and displayed until 18/02/2010
|
Reasons for adding or updating:
|
-
Change to section 3 - Pharmaceutical form
-
Change to section 6.1 - List of Excipients
-
Change to section 6.2 - Incompatibilities
-
Change to section 6. 3 - Shelf Life
|
| Date of revision of text on the SPC: 28-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Section 3: A new Table is included which details the appearance of each strength and which countries have each strength registered. This replaces the paragraph stating the tablet descriptions included on previous versions of the SmPC.
Section 6.1: The section on excipients (and quantities) has been re-worded.
The section on excipients (and quantities) has been re-worded.
Section 6.3: Shelf life of 2.5 mg, 5 mg and 10 mg strengths of Innovace has been reduced to 2 years. Shelf life of 20 mg strength remains as 2 years.
: Shelf life of 2.5 mg, 5 mg and 10 mg strengths of Innovace has been reduced to 2 years. Shelf life of 20 mg strength remains as 2 years.
Section 6.4: Product name has been included in storage instruction, and 'store in the original package' has been removed.
Product name has been included in storage instruction, and 'store in the original package' has been removed.
|
|
Updated on 05/03/2009 and displayed until 15/09/2009
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.6 - Pregnancy and Lactation
-
Change to section 5.2 - Pharmacokinetic Properties
|
| Date of revision of text on the SPC: 16-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Section 4.4: In the sub-section 'Pregnancy and lactation', a grammatical correction has been made and also a reference to section 4.6 and 5.2 has been included.
Section 4.4: In the sub-section 'Hyperkalaemia', the word 'cardiac' has been included ('…,acute cardiac decompensation,….') as this had been omitted in the previous version in error.
In the sub-section '', the word 'cardiac' has been included ('…,acute cardiac decompensation,….') as this had been omitted in the previous version in error.
Section 4.6: Information within the sub-category 'Lactation' has been changed in line with new class labelling wording requested by the regulatory agencies following recommendations from the Pharmacovigilance Working Party. The previous recommendation not to use Innovace if breast-feeding has been revised as the new wording now permits consideration of the use of Innovace in mothers who are breast feeding older infants if the treatment is necessary for the mother and the child is observed for any adverse effects. Note that Innovace in breastfeeding is not recommended for preterm infants and for the first few weeks after delivery.
Information within the sub-category '' has been changed in line with new class labelling wording requested by the regulatory agencies following recommendations from the Pharmacovigilance Working Party. The previous recommendation not to use Innovace if breast-feeding has been revised as the new wording now permits consideration of the use of Innovace in mothers who are breast feeding older infants if the treatment is necessary for the mother and the child is observed for any adverse effects. Note that Innovace in breastfeeding is not recommended for preterm infants and for the first few weeks after delivery.
Section 5.2: A new sub-category entitled 'Lactation' has been included. This is class labelling information which has been included at the request of the regulatory agencies following recommendations from the Pharmacovigilance Working Party.
A new sub-category entitled '' has been included. This is class labelling information which has been included at the request of the regulatory agencies following recommendations from the Pharmacovigilance Working Party.
|
|
Updated on 09/02/2009 and displayed until 05/03/2009
|
Reasons for adding or updating:
|
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
-
Change to section 4.8 - Undesirable Effects
|
| Date of revision of text on the SPC: 07-Jan-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
1) In section 4.5" Interaction with other Medicinal Products and other forms of Interaction", the sub-section "Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)" has been amended as follows:
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Chronic administration of NSAIDs may reduce the antihypertensive effect of an ACE inhibitor.
NSAIDs
(including COX-2 inhibitors) and ACE inhibitors exert an additive effect on the increase in serum potassium, and may result in a deterioration of renal function. These effects are usually reversible. Rarely, acute renal failure may occur, especially in patients with compromised renal function (such as the elderly or dehydrated patients who are volume-depleted, including those on diuretic therapy).
2) In section 4.8 "Undesirable Effects" and in the second paragraph where we reference frequency terms, the term "not known" has been added and defined.
3) Also in section 4.8 a new sub-section has been added as follows:
Endocrine disorders
:
not known
: syndrome of inappropriate antidiuretic hormone secretion (SIADH)
|
|
Updated on 16/05/2008 and displayed until 09/02/2009
|
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 4.6 - Pregnancy and Lactation
|
| Date of revision of text on the SPC: 01-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Update to section 4.3, 4.4 and 4.6 of the SPC in order to strengthen the wording relating to the use of ACE inhibitors during pregnancy in line with standard wording for this across the class.
|
|
Updated on 23/10/2007 and displayed until 16/05/2008
|
Reasons for adding or updating:
|
-
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 4.8 - Undesirable Effects
|
| Date of revision of text on the SPC: 10/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Section 4.4 - Update to section headed 'Hypoglycaemia' to include further information on the concomitant use of enalapril with antidiabetic drugs
Update to section headed 'Hyperkalemia' to add information on concomitant use with potassium-sparing diuretics, potassium supplements, or potassium - containing salt substitutes.
Section 4.5 - addition of eplerenone to list of potassium sparing diuretics.
Addition of information on gold products
Update to information on antidiabetics
Section 4.8 Cardiac and vascular disorders - moved MI and cerebrovascular accident from common to uncommon.
|
|
Updated on 27/03/2006 and displayed until 23/10/2007
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 27/03/2006 and displayed until 27/03/2006
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 16/01/2006 and displayed until 27/03/2006
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 25/11/2005 and displayed until 16/01/2006
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special Warnings and Precautions for Use
|
|
Updated on 16/11/2004 and displayed until 25/11/2005
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
|
|
Updated on 21/02/2004 and displayed until 16/11/2004
|
Reasons for adding or updating:
|
-
Change to joint SPC covering all presentations
|
|
Updated on 25/07/2002 and displayed until 21/02/2004
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
|
|
Updated on 11/06/2002 and displayed until 25/07/2002
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
|
|
Updated on 10/06/2002 and displayed until 11/06/2002
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
|
|
Updated on 15/08/2001 and displayed until 10/06/2002
|
Reasons for adding or updating:
|
-
Transferred from eMC version 1
|
|
Updated on 03/04/2001 and displayed until 15/08/2001
|
Reasons for adding or updating:
|
|
|
|
Updated on 06/09/1999 and displayed until 03/04/2001
|
Reasons for adding or updating:
|
|
|
|
