Summary of Product Characteristics
last updated on the eMC:
28/03/2011
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 28/03/2011 and displayed until Current
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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 - MARKETING AUTHORISATION NUMBER(S)
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| Date of revision of text on the SPC: 21-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change of Ownership from Cephalon to Winthrop
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Updated on 15/04/2010 and displayed until 28/03/2011
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Reasons for adding or updating:
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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 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 19-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.2 has been updated to add:
Treatment should not exceed 3 months due to the presence of metoclopramide. (see also SPC 4.4 Special warnings and precautions for use and SPC 4.8 Undesirable effects)
The following warning has been added to section 4.4
Due to the risk of tardive dyskinesia with metoclopramide, treatment should not exceed 3 months. (see also SPC 4.2 Posology and method of administration and SPC 4.8 Undesirable effects)
Cross references to sections 4.2 and 4.4 (as above) have been added to section 4.8
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Updated on 22/09/2009 and displayed until 15/04/2010
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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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| Date of revision of text on the SPC: 24-Jun-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The name of the product has been changed from Migramax to Migramax 900mg/10mg Powder for oral solution.
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Updated on 18/03/2009 and displayed until 22/09/2009
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Reasons for adding or updating:
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Change to section 4.9 - Overdose
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 01-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.9 has been updated to include the following:
Metoclopramide overdose may cause extrapyramidal disorders and drowsiness, decreased level of consciousness, confusion, hallucinations and convulsions.
Treatment for extrapyramidal disorders caused by metoclopramide overdose is symptomatic (benzodiazepines in children and/or anticholinergic anti-parkinsonian drugs in adults).
In section 6.3, the shelf life has also been reduced from 24 months to 1 year
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Updated on 24/12/2008 and displayed until 18/03/2009
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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 4.6 - 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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Change to section 6.2 - Incompatibilities
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 01-Nov-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4: “Extrapyramidal disorders, drowsiness, decreased level of consciousness, confusion and hallucination occur more frequently when high doses of metoclopramide are used (see adverse reactions).”And, “care should be exercised when using MIGAMAX SACHETS in patients with a history of atopy (including asthma) or porphyria.”
Section 4.5, the following sentence has been added: “Due to the promotion of gastric emptying and normal peristalsis (see section 5.1) caused by metoclopramide, the absorption of certain drugs may be modified:”
Section 4.6 (Pregnancy and lactation). Two paragraph have been added “data on pregnant patients (> 1000) indicate no malformative nor foeto/ neonatal toxicity during 1rst trimester of pregnancy. A limited amount of data on pregnant patients (> 300) indicate no neonatal toxicity in other trimesters. Animal studies do not indicate reproductive toxicity.” And regarding lactation”- and adverse reactions in the breast-fed baby cannot be excluded. A decision should be made whether to discontinue breast-feeding or to abstain from Migramax treatment.”
The wording for use in the 1st and 2nd trimester has been altered slightly.
Section 4.8 (Undesirable effects): There is a new warning for extrapyramidal symptoms in young adults and the elderly and the side effects of decreased level of consciousness, hallucination, sulfhaemoglobinaemia, anaphylaxis and asthenia have been added.
New headings for section 5.3, 6.2 and 6.6 have been included as has the legal classification.
In addition full details of the trading styles are contained in section 7 which were not on the version present on the eMC.
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Updated on 27/09/2005 and displayed until 24/12/2008
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Reasons for adding or updating:
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Change to section 4.9 - Overdose
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Change to section 10 (date of (partial) revision of the text
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Updated on 28/05/2004 and displayed until 27/09/2005
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Reasons for adding or updating:
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Company name change or merger
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Updated on 20/07/2001 and displayed until 28/05/2004
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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 9 - Date of Renewal of Authorisation
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Updated on 17/05/2000 and displayed until 20/07/2001
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Reasons for adding or updating:
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