Updated on 28/04/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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Change to section 4.1 - Therapeutic indications
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 13-Apr-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 1 – Changed name to ‘Tildiem LA 200/300mg Prolonged-Release Capsules
Sections 2, 4.1, 5.2 – changed ‘sustained release’ to ‘prolonged release’
Section 3 – Changed ‘Sustained-release oral capsule’ to ‘Prolonged-release capsule’
Section 4.5 – Amended formatting
Section 4.6 – Altered title to include ‘fertility’
Section 5.1 – minor change to wording
Sections 9 & 10 – New dates
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Updated on 09/11/2010 and displayed until 28/04/2011
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 09-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.5: following text added
Diltiazem is metabolised by CYP3A4. A moderate (less than 2-fold) increase of diltiazem plasma concentration in cases of co-administration with a stronger CYP3A4 inhibitor has been documented. Diltiazem is also a CYP3A4 isoform inhibitor. Co-administration with other CYP3A4 substrates may result in an increase in plasma concentration of either co-administered drug. Co-administration of diltiazem with a CYP3A4 inducer may result in a decrease of diltiazem plasma concentrations.
Section 4.7: text changed to:
On the basis of reported adverse drug reactions, i.e. dizziness (common), malaise (common), the ability to drive and use machines could be altered. However, no studies have been performed.
Section 4.8 changed to the following
4.8 Undesirable effects
The following CIOMS frequency rating is used, when applicable: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000); not known (cannot be estimated from the available data).
Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
Each adverse event previously listed on the SPC has now been included in a concise table.
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Updated on 25/03/2010 and displayed until 09/11/2010
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 03-Feb-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4
The following text has been added:
Treatment with diltiazem may be associated with mood changes, including depression. Early recognition of relevant symptoms is important, especially in predisposed patients. In such cases, drug discontinuation should be considered.
Diltiazem has an inhibitory effect on intestinal motility. Therefore it should be used with caution in patients at risk of developing an intestinal obstruction
Section 10: New date of revision of text
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Updated on 22/01/2010 and displayed until 25/03/2010
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 02-Dec-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.5 - added information regarding interactions with statins, benzodiazepines (midazolam, triazolam) and methylprednisolone.
In section 4.8 - Further safety information regarding lichenoid keratosis, mood changes (depression) and thrombocytopenia due to diltiazem treatment has been added
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Updated on 25/02/2009 and displayed until 22/01/2010
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Reasons for adding or updating:
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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| Date of revision of text on the SPC: 27-Jan-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change in MA number to reflect change in ownership
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Updated on 09/02/2009 and displayed until 25/02/2009
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 5.3 - Preclinical Safety Data
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| Date of revision of text on the SPC: 01-Jan-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8; addition of vomiting, diarrhoea, angioneurotic oedema, nervousness, insomnia and leukocytoclastic vasculitis.
Sections 4.3 and 4.6 of the SPC to revise the advice about the use of diltiazem in pregnancy and section 5.3 was updated to include information on reproduction animal studies with diltiazem.
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Updated on 19/09/2007 and displayed until 09/02/2009
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 03/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.5 (Interactions with other medicinal products and other forms of interactions): Information regarding interaction with drugs exclusively metabolised by CYP3A4 has been updated:
'Oral administration of diltiazem can raise the plasma concentration of drugs exclusively metabolised by CYP3A4. The concomitant therapy of diltiazem and such drugs may increase the risk of adverse reactions (e.g. muscular disorders with statins such as simvastatin (refer to manufacturer’s prescribing information for simvastatin)).'
Section 7 (Marketing Authorisation Holder): Change in MA Holder's details
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Updated on 19/09/2006 and displayed until 19/09/2007
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 08/2003 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 7 (Marketing Authorisation Holder): Change to MA Holder's address
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Updated on 29/09/2003 and displayed until 19/09/2006
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Improved Electronic Presentation
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Updated on 26/09/2003 and displayed until 29/09/2003
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Change to section 4.2 - Posology and Method of Administration
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6. 4 - Special Precautions for Storage
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Updated on 27/09/2002 and displayed until 26/09/2003
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Change to section 4.8 - Undesirable Effects
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Updated on 21/08/2001 and displayed until 27/09/2002
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Change to section 7 - Marketing Authorisation Holder
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