Updated on 05/10/2010 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and method of administration
-
Change to section 4.3 - Contraindications
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
-
Change to section 4.8 - Undesirable Effects
|
| Date of revision of text on the SPC: 13-Jan-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
In section 4.2 (Posology and Method of Administration) the sentence which read ‘This may be increased to 15 - 30ml (30 - 40mg Temazepam) in patients who do not respond to the lower dose' has been corrected to 15 - 20ml .
In section 4.3 (Contra-indications) added: Phobic/obsessional state, chronic psychosis, mild anxiety states, acute narrow angle glaucoma, use as monotherapy in patients with depression
In section 4.4 (Special Warnings and Special Precautions for Use) added further withdrawal symptoms. Caution in patients with personality disorders and in cases of loss or bereavement has been added. The sentence regarding benzodiazapines use alone in depression or anxiety associated depression has been removed.
In section 4.5 (Interaction with other Medicinal Products and other forms of Interaction)
added: antipsychotics, hypnotics, lofexidine, nabilone, anti-epileptics, antihypertensives, antivirals, clozapine, disulfiram, dopaminergics and muscle relaxants.
In section 4.8 (Undesirable Effects) added: fatigue, respiratory depression, slurred speech. The following sentence has been added 'These reactions are more likely to occur in the elderly'. Other adverse effects added are dry mouth, restless sleep, nightmares, dysarthria, tremor, hypersalivation, hypersensitivity and incontinence.
|
|
Updated on 24/03/2010 and displayed until 05/10/2010
|
Reasons for adding or updating:
|
-
Change to section 6.1 - List of Excipients
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 13-Jan-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
In section 6.1: The list if excipients has been edited to read Trometamol rather than Tris (hydroxymethyl) Methylamine USP.
In Section 10: The date of revision of the text has been updated from November 2007 to 13-Jan-2010
|
|
Updated on 09/01/2008 and displayed until 24/03/2010
|
Reasons for adding or updating:
|
-
Change to section 4.3 - Contraindications
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
-
Change to section 4.8 - Undesirable Effects
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 12/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 4.3: Added: Phobic/obsessional state, chronic psychosis, mild anxiety states, acute narrow angle glaucoma, use as monotherapy in patients with depression
Section 4.4: added further withdrawal symptoms. Caution in patients with personality disorders and cases if loss or bereavement.
Section 4.5: Added antipsychotics, hypnotics, lofexidine, nabilone, anti-epileptics, antihypertensives, antivirals, clozapine, disulfiram, dopaminergics, muscle relaxants.
Section 4.8: Added: fatigue, respiratory dpression, slurred speech, reactions are more likely ot occur in elderly, dry mouth, restless sleep, nightmares, dysarthria, tremor, hypersalivation, hypersensitivity, incontinence
|
|
Updated on 23/11/2007 and displayed until 09/01/2008
|
Reasons for adding or updating:
|
-
Change to section 1 -Name of the Medicinal product
-
Change to section 10 date of revision of the text
|
| 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
|
| Section 1 - Re-arrangement of product name to: Temazepam 10mg/5ml Oral Solution
|
|
Updated on 11/04/2007 and displayed until 23/11/2007
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and method of administration
-
Change to section 4.3 - Contraindications
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
-
Change to section 4.8 - Undesirable Effects
-
Change to section 4.9 - Overdose
|
| Date of revision of text on the SPC: 02/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 4.2: Updated: Adults:Insomnia: Each 5ml dose of Temazepam Elixir is equivalent to 10mg Temazepam. The usual dose is 5 - 15ml orally on retiring; a dose of 10ml will be found to be satisfactory for most patients and is equivalent to 20mg Temazepam in capsule form. This may be increased to 20 - 30ml (30 - 60mg Temazepam) This may be increased to 15-20ml (30-40mg temazepam) in patients who do not respond to the lower dose. Lower doses may be adequate for some patients, as for the elderly.
Section 4.3. Added: Sleep apnoea syndrome, Severe hepatic insufficiency.
Section 4.4. Paragraph on tolerance, paragraph on psychiatric and paradoxical reactions, added extra withdrawal symptoms, excipient warnings updated, added paragraph about use in depression or anxiety secondary to depression.
Section 4.5. Updated as per: " The concurrent use of other CNS depressants such as alcohol, general anaesthetics, narcotic analgesics, monoamine oxidase inhibitors, anxiolytics/sedatives, antiepileptic drugs, sedative antihistamines and anti-depressants should be avoided as it will result in accentuation of their effects an enhancement of the central depressive effect. In the case of narcotic analgesics enhancement of the euphoria may also occur leading to an increase in psychotic dependence."
Section 4.8. More specific detail in paragraph about amnesia, adverse effects added, detail on dependence.
Section 4.9. Updated, more detail
|
|
Updated on 10/04/2007 and displayed until 11/04/2007
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and method of administration
-
Change to section 4.3 - Contraindications
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
-
Change to section 4.8 - Undesirable Effects
-
Change to section 4.9 - Overdose
|
| Date of revision of text on the SPC: 02/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 4.2: Dosage of product corrected udner the dose for insomnia in adults. Reference to capsules is removed.
Section 4.3: Sleep apnoea and severe hepatic insufficiency is added
Section 4.4: Statements added on 'tolerance', 'Psychiatric and paradoxical reactions', 'not reccommended for the primary teatment of psychotic illness', 'should not be used alone to treat depression or anxiety secondary to depression', Syptoms of abrupt withdrawal added, symptoms pf qbrupt witdrawal of excessive doses.
Section 4.5: Added anxiolytics, sedatives, antiepileptic drugs, sedative antihistamines.
Section 4.8: Amnesia paragprah specified, behavioural adverse effecst added. Adverse effects described as 'occasional' as opposed to 'rare'.Statement on dependence added.
Section 4.9: Updated
|
|
Updated on 25/08/2004 and displayed until 10/04/2007
|
Reasons for adding or updating:
|
-
Improved Electronic Presentation
|
|
Updated on 20/08/2004 and displayed until 25/08/2004
|
Reasons for adding or updating:
|
-
Change to section 4.9 - Overdose
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 27/09/2002 and displayed until 20/08/2004
|
Reasons for adding or updating:
|
|
|
|
