Summary of Product Characteristics
last updated on the eMC:
20/12/2011
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 20/12/2011 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 6.1 - List of Excipients
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| Date of revision of text on the SPC: 01-Dec-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1 "capsules" has been added
Section 6.1 "DAB 10" has been deleted
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Updated on 24/05/2011 and displayed until 20/12/2011
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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 4.5 - Interaction with other medicinal products and other forms of interaction
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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: 01-May-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4
Concomitant use of alcohol and MXL capsules may increase the undesirable effects of MXL capsules; concomitant use should be avoided.
Morphine should be used with caution in patients who are concurrently receiving other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, other tranquilizers, muscle relaxants and antihypertensives . “alcohol” has been removed from this sentence.
Section 4.5
Alcohol may enhance the pharmacodynamic effects of MXL capsules; concomitant use should be avoided.
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Updated on 24/09/2009 and displayed until 24/05/2011
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 6.1 - List of Excipients
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Change to section 6. 3 - Shelf Life
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Change to section 6. 6 - Instructions for use, handling and disposal
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| Date of revision of text on the SPC: 01-Sep-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.8 Common (incidence of ≥ 1% and Uncommon (incidence of ≤ 1%) adverse drug reactions are listed in the table below: (greater than and less than symbols have been added.
6. List of Excipients
Hydrogenated vegetable Oil BP
Macrogol 6000 Ph Eur.
Talc Ph Eur.
Magnesium stearate Ph Eur.
BP and PH Eur have been added.
6.3 Shelf life now 2 years
6.6 Updated to no special requirements
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Updated on 03/12/2007 and displayed until 24/09/2009
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 11/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to section 4.1 Pharmacodynamic properties
Endocrine System now reads:
Opioids may influence the hypothalamic-pituitary-adrenal or -gonadal axes. Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol, oestrogen and testosterone in association with inappropriately low or normal ACTH, LH or FSH levels. Clinical symptoms may be manifest from these hormonal changes.
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Updated on 01/10/2007 and displayed until 03/12/2007
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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 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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Change to section 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6.1 - List of Excipients
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Change to section 6. 5 - Nature and Contents of Container
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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: 08/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The following sections have been re-written4.4, 4.5, 4.8, 4.9, 5.1,6.5, 10
Section 6.1 Propylene Glycol has been added
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Updated on 10/01/2007 and displayed until 01/10/2007
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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 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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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: 03/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1 prolonged release added to trade name
Section 4.4 impaired respiratory function, acute alcoholism and delerium tremens added
Section 4.8 Elevated hepatic enzymes added (Uncommon)
Section 5.1 Pharmacodynamic properties included
Section 10 date of revion (MRP renewal date) added
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Updated on 24/09/2002 and displayed until 10/01/2007
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MA number
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Change to section 10 (date of (partial) revision of the text
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Updated on 28/02/2002 and displayed until 24/09/2002
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Reasons for adding or updating:
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Change to section 3 - pharmaceutical form
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Change to section 4.3 - Contra-indications
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Change to section 4.8 - Undesirable Effects
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Updated on 16/08/2001 and displayed until 28/02/2002
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 13/10/2000 and displayed until 16/08/2001
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 13/10/2000
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Reasons for adding or updating:
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