Updated on 26/08/2009 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 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6.2 - Incompatibilities
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Change to section 6. 3 - Shelf Life
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 6 - Instructions for use, handling and disposal
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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: 10-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1
Change from Zimovane and Zimovane LS to Zimovane 7.5mg film-coated tablets, Zimovane LS 3.75mg film-coated tablets
Section 2
Following wording added;
For full list of excipients, see section 6.1.
Section 3
Following wording added;
Film-coated tablet (tablet) - for both strengths
The tablet can be divided into equal halves - for 7mg only
Section 4.2
Following wording added - For oral use only
Section 4.3
Following wording added - 'or to any of the excipients'
Section 5.1
ATC code added
Section 6.2
Changed from non stated to not applicable
Section 6.3
Following text removed - Clear PVC/aluminium foil blister
Section 6.4
Following text added - 'Keep the blister in the outer carton in order to'
Section 6.6
'No special instructions' replaced by 'no special requirments'
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Updated on 26/03/2009 and displayed until 26/08/2009
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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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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: 01-Jan-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Marketing authorisation numbers, date of first renewal and date of revision changed for both strengths.
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Updated on 06/01/2009 and displayed until 26/03/2009
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Reasons for adding or updating:
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Change to section 4.9 - Overdose
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| Date of revision of text on the SPC: 01-Jun-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.9 - following text removed;
'Overdose is usually manifested by varying degrees of central nervous system depression ranging from drowsiness to coma according to the quantity ingested. In mild cases, symptoms include drowsiness, confusion, and lethargy; in more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression and coma. Other risk factors, such as combining zopiclone with other CNS depressants (including alcohol), the presence of concomitant illness and the debilitated state of the patient, may contribute to the severity of the symptoms and very rarely can result in fatal outcome.
Symptomatic and supportive treatment in an adequate clinical environment is recommended. Attention should be paid to respiratory and cardiovascular functions. Gastric lavage is only useful when performed soon after ingestion. Haemodialysis is of no value due to the large volume of distribution of zopiclone. Flumazenil may be a useful antidote'
and replaced by the text below;
'Fatal dose not known.
Symptoms
In the cases of overdosage reported, the main effects are drowsiness, lethargy and ataxia.
Management
Consider activated charcoal if an adult has ingested more than 150 mg or a child more than 1.5 mg/kg within one hour. Alternatively, consider gastric lavage in adults within one hour of a potentially life-threatening overdose. If CNS depression is severe consider the use of flumazenil. It has a short half-life (about an hour). NOT TO BE USED IN MIXED OVERDOSE OR AS A “DIAGNOSTIC” TEST. Management should include general symptomatic and supportive measures including a clear airway and monitoring cardiac and vital signs until stable.'
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Updated on 23/07/2008 and displayed until 06/01/2009
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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: 05-Jun-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2: Posology: addition of the following:
Children and young adults less than 18 years: The safe and effective dose has not been established.
Section 4.4: Special warnings: addition of the following:
Other psychiatric and paradoxical reactions:
Other psychiatric and paradoxical reactions have been reported (see Section 4.8 Undesireable effects)
Somnambulism and associated behaviours:
Sleep walking and other associated behaviours such as “sleep driving”, preparing and eating food, or making phone calls, with amnesia for the event, have been reported in patients who have taken zopiclone and were not fully awake. The use of alcohol and other CNS-depressants with zopiclone appears to increase the risk of such behaviours, as does the use of zopiclone at doses exceeding the maximum recommended dose. Discontinuation of zopiclone should be strongly considered for patients who report such behaviours (see Section 4.5 Interactions with other medicinal products and other forms of interactions).
Excipients:
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Section 4.8: Undesirable effects: addition of sleep walking
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Updated on 12/06/2007 and displayed until 23/07/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 12/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to sanofi-aventis trading style
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Updated on 09/08/2005 and displayed until 12/06/2007
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Reasons for adding or updating:
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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 5.2 - Pharmacokinetic Properties
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Change to section 10 (date of (partial) revision of the text
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Updated on 28/02/2005 and displayed until 09/08/2005
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Change to section 4.8 - Undesirable Effects
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Updated on 29/09/2004 and displayed until 28/02/2005
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Change to section 6.1 - List of Excipients
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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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Change to section 6. 5 - Nature and Contents of Container
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Updated on 23/10/2003 and displayed until 29/09/2004
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Correction of spelling/typing errors
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Updated on 30/09/2003 and displayed until 23/10/2003
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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 10 (date of (partial) revision of the text
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Updated on 24/08/2001 and displayed until 30/09/2003
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Transferred from eMC version 1
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Updated on 31/10/2000 and displayed until 24/08/2001
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Updated on 06/09/1999 and displayed until 31/10/2000
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