Updated on 29/09/2011 and displayed until Current
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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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| Date of revision of text on the SPC: 01-Sep-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Update to sections 4.5 of the SPC.
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Updated on 30/06/2010 and displayed until 29/09/2011
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8 of the SPC has been updated to include post-marketing adverse event Raynaud’s phenomenon. In addition, in section 4.8, the adverse event "cold extremities" has been replaced with "peripheral coldness".
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Updated on 19/11/2009 and displayed until 30/06/2010
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8 – additional spontaneous reports of adverse events hyponatremia and testicular pain.
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Updated on 25/09/2008 and displayed until 19/11/2009
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Reasons for adding or updating:
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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 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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| Date of revision of text on the SPC: 01-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.3: contraindication in pregnancy and lactation removed
Section 4.6 wording on use in pregnancy and lactation updated
Additional wording agreed by the Pharmacovigilance Working Party in section 4.4 and 4.8 of the SPC
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Updated on 29/07/2008 and displayed until 25/09/2008
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.3 - Contraindications
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| 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
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Section 4.3: contraindication in pregnancy and lactation removed
Section 4.6 wording on use in pregnancy and lactation updated
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Updated on 31/03/2008 and displayed until 29/07/2008
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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 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 02/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Additional of wording agreed by the Pharmacovigilance Working Party
Addition of wording in section 4.4:
Suicide/suicidal thoughts or clinical worsening:
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide‑related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Patients with a history of suicide‑related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta‑analysis of placebo‑controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Addition of text in section 4.8 of the SPC:
Cases of suicidal ideation and suicidal behaviours have been reported during reboxetine therapy or early after treatment discontinuation (see section 4.4).
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Updated on 09/11/2007 and displayed until 31/03/2008
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Reasons for adding or updating:
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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 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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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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| Date of revision of text on the SPC: 04/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.2 – Clarification on use in adolescents and children
4.4 – Placing the information on the use in children and adolescents under 18 years of age and the risk of suicidal thoughts at the beginning of the section and include a further suicide/suicidal thoughts warning
4.6 – Update the information to be consistent with section 4.3 of the SPC
4.7 – Update the wording of the section
4.8 – Addition of agitation, anxiety, irritability and hallucination and information on discontinuation of the product
Minor changes to sections 2, 3 and 6
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Updated on 14/09/2007 and displayed until 09/11/2007
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 05/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.8 - Typing error
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Updated on 14/11/2006 and displayed until 14/09/2007
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 05/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8 of the SmPC is updated to include paraesthesia and hypertension as adverse events,
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Updated on 18/04/2006 and displayed until 14/11/2006
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Reasons for adding or updating:
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Change to section 5.3 - Preclinical Safety Data
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Updated on 01/02/2006 and displayed until 18/04/2006
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Reasons for adding or updating:
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Change to section 1 - trade name
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Change to section 2 - qualitative and quantitative composition
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Change to section 4.4 - Special Warnings and Precautions for Use
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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 27/09/2004 and displayed until 01/02/2006
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Updated on 17/04/2003 and displayed until 27/09/2004
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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 10 (date of (partial) revision of the text
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Updated on 16/07/2002 and displayed until 17/04/2003
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 10 (date of (partial) revision of the text
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Updated on 04/03/2002 and displayed until 16/07/2002
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 27/02/2002 and displayed until 04/03/2002
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Reasons for adding or updating:
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Change to section 1 - trade name
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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 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 6. 3 - Shelf Life
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Change to section 10 (date of (partial) revision of the text
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