Updated on 09/11/2010 and displayed until Current
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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 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 27-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The following changes have been made:
section 4.4 (Special warnings and precautions for use) of the SPC, added statement ; (for example, sleep driving), due to the risk to the patient and others.
section 4.6 (Pregnancy and lactation) of the SPC, added statement; 'Cases of severe neonatal respiratory depression have been reported when zolpidem tartrate was used with other CNS depressants at the end of pregnancy'.
section 4.8 (Undesirable effects) of the SPC, to replace the Psychiatric disorder, sleep walking with somnambulism, bringing it in line with the CCDS V6.
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Updated on 12/02/2009 and displayed until 09/11/2010
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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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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: 27-Jan-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Changes affect the 10mg only;
Change in marketing authorisation number, date of first renewal, date of revision of text
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Updated on 15/09/2008 and displayed until 12/02/2009
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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 4.3 - Contraindications
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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 4.4 - Special warnings and precautions for Use
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| Date of revision of text on the SPC: 01-Aug-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 - the information has been re-formatted, however, no existing information has been removed, nor new information added
Section 4.3 - the following contra-indication has been added;
A hypersensitivty to any of the inactive ingrediants
Section 4.4 - this section has been re-formatted, however, the following information has also been added;
Respiratory Insufficiency
As hypnotics have the capacity to depress respiratory drive, precautions should be observed if zolpidem is prescribed to patients with compromised respiratory function.
Paediatric Patients:
Safety and effectiveness of zolpidem have not been established in patients below the age of 18 years. In an 8-week study in paediatric patients (aged 6-17 years) with insomnia associated with attention-deficit/hyperactivity disorder (ADHD), psychiatric and nervous system disorders comprised the most frequent treatment emergent adverse events observed with zolpidem versus placebo and included dizziness (23.5% vs. 1.5%), headache (12.5% vs. 9.2%), and hallucinations (7.4% vs. 0%). (See Section 4.2 Posology and method of administration).
Pre-existing depression may be unmasked during use of zolpidem. Since insomnia may be a symptom of depression, the patient should be re-evaluated if insomnia persists.
Somnambulism and associated behaviours:
Sleep walking and other associated behaviours such as “sleep driving”, preparing and eating food, making phone calls or having sex, with amnesia for the event, have been reported in patients who had taken zolpidem and were not fully awake. The use of alcohol and other CNS-depressants with zolpidem appears to increase the risk of such behaviours, as does the use of zolpidem at doses exceeding the maximum recommended dose. Discontinuation of zolpidem should be strongly considered for patients who report such behaviours (See Section 4.5 Interactions with other medicinal products and other forms of interaction; and Section 4.8 Undesirable effects).
Section 4.5 - this section has been re-formatted to include the CIOMS frequency rating, however, the following information has also been added;
Immune system disorders
Not known: angioneurotic oedema
Psychiatric disorders
Not known: dependence (withdrawal symptoms, or rebound effects may occur after treatment discontinuation), libido disorder
Most of these psychiatric undesirable effects are related to paradoxical reactions
Nervous system disorders:
Common: exacerbated insomnia, amnestic effects may be associated with inappropriate behavrious
Not known: depressed level of consciousness
Gastro-intestinal disorders
Common: diarrhoea
Hepatobiliary disorders
Not known: liever enzymes elevated
Skin and subcutaneous tissues disorders
Not known: rash, pruritus, urticaria
General disorders and administration site conditions
Not known: drug tolerance, fall (predominantly in elderly patients and when zolpidem was not taken in accordance with prescribing recommendation)
Section 4.9 - this section has been re-formatted, however, the following information has also been edited;
Removed: Individuals have fully recovered from zolpidem tartrate overdoses up to 400mg
Added: The value of dialysis in the treatment of an overdose has not been determined. Dialysis in patients with renal failure receiving therapeutic doses of zolpidem have demonstrated no reduction in levels of zolpidem
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Updated on 20/09/2007 and displayed until 15/09/2008
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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: 10/2006 |
| 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 in MA Holder's details
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Updated on 19/09/2006 and displayed until 20/09/2007
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 07/2004 |
| 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 17/09/2004 and displayed until 19/09/2006
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Reasons for adding or updating:
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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. 5 - Nature and Contents of Container
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Change to section 10 (date of (partial) revision of the text
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Updated on 23/03/2004 and displayed until 17/09/2004
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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 10 (date of (partial) revision of the text
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Updated on 26/09/2003 and displayed until 23/03/2004
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Reasons for adding or updating:
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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 4.7 - 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 4.9 - Overdose
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Updated on 16/07/2002 and displayed until 26/09/2003
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 23/08/2001 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 20/08/2001 and displayed until 23/08/2001
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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