Updated on 22/12/2011 and displayed until Current
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 06-Dec-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To update section 4.6 and 4.8 of the SPC and leaflet with information on the use of conventional and atypical antipsychotics during pregnancy and the risk of abnormal muscle movements and withdrawal symptoms in newborns.
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Updated on 01/12/2011 and displayed until 22/12/2011
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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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| Date of revision of text on the SPC: 05-Apr-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| section 4.4 - text regarding "Increased Mortality in Elderly people with Dementia" duplicated in previous update
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Updated on 21/04/2011 and displayed until 01/12/2011
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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 4.1 - Therapeutic indications
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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 4.5 - 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 5.1 - Pharmacodynamic Properties
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Change to section 6.1 - List of Excipients
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Change to section 6.2 - Incompatibilities
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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 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: 05-Apr-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Spc has been changed as described below;
section 2: following text has been added: Also contains 23.4mg of sucrose, 5.0mg sodium sulphite anhydrous (E221) and 5.0 mg of sodium metabisulphite (E222).
Section 4.1, 4.4, 4.6 have been re-formmatted only.
Section 4.3- text changed from pleasee see special warnings and precautions for use to see section 4.4.
Section 5.1: following text added- Psycholeptics; phenothiazines with piperazine structure
6.1- excipients for banana flavour now specifed: ethyl acetate, ethanol, ethyl butrate, isomyle acetate, limonene, amyle butyrate, propylene glycol, eugenol, vaniline.
Section 6.4: wording now states- strore in the original carton in order to ptotect from light. This is more specific than previous wording.
section 6.5: bottle type now specified as type III bottles.
section 9: dates ammended to read- date of first authourisation: 28 february 1973 and date of latest renewal : 16th september 2002
section 10: date changed to 05 april 2011
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Updated on 27/04/2010 and displayed until 21/04/2011
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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: 17-Feb-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Addition of warnings re risk of VTE
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Updated on 14/05/2008 and displayed until 27/04/2010
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 04-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.1 (List of excipients) - name changes of excipients from those of the British Pharmacopoeia to those of the European Pharmacopoeia:
Sucrose, Polysorbate 80 (E433), banana flavour, caramel (E150a), anhydrous citric acid (E330), sodium citrate (E331), sodium benzoate (E211), sodium sulphite anhydrous (E221), sodium metabisulphite (E223), ascorbic acid L(+) (E300) and purified water.
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Updated on 18/09/2007 and displayed until 14/05/2008
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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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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 06/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 (Special warnings and precautions for use): QT prolongation section updated, and further information regarding use with other neroleptics concomitantly, and use in elderly also added:
'Neuroleptic phenothiazines may potentiate QT interval prolongation which increases the risk of onset of serious ventricular arrhythmias of the torsade de pointes type, which is potentially fatal (sudden death). QT prolongation is exacerbated, in particular, in the presence of bradycardia, hypokalaemia, and congenital or acquired (i.e. drug induced) QT prolongation. The risk-benefit should be fully assessed before Stemetil treatment is commenced. If the clinical situation permits, medical and laboratory evaluations (e.g. biochemical status and ECG) should be performed to rule out possible risk factors (e.g. cardiac disease; family history of QT prolongation; metabolic abnormalities such as hypokalaemia, hypocalcaemia or hypomagnesaemia; starvation; alcohol abuse; concomitant therapy with other drugs known to prolong the QT interval) before initiating treatment with Stemetil and during the initial phase of treatment, or as deemed necessary during the treatment (see also sections 4.5 and 4.8).
Avoid concomitant treatment with other neuroleptics (see section 4.5).
In randomised clinical trials versus placebo performed in a population with elderly patients with dementia and treated with certain atypical antipsychotic drugs, a 3-fold increase of the risk of cerebrovascular events has been observed. The mechanism of such risk increase is not known. An increase in the risk with other antipsychotic drugs or other populations of patients cannot be excluded. Stemetil should be used with caution with stroke risk factors.'
Section4.8 (Undesirable effects): Cardiac disorders section updated:
'Cardiac disorders: ECG changes include QT prolongation (as with other neuroleptics), ST depression, U-Wave and T-Wave changes. Cardiac arrhythmias, including ventricular arrhythmias and atrial arrhythmias, a-v block, ventricular tachycardia, which may result in ventricular fibrillation or cardiac arrest have been reported during neuroleptic phenothiazine therapy, possibly related to dosage. Pre-existing cardiac disease, old age, hypokalaemia and concurrent tricyclic antidepressants may predispose.
There have been isolated reports of sudden death, with possible causes of cardiac origin (see section 4.4, above), as well as cases of unexplained sudden death, in patients receiving neuroleptic phenothiazines.'
Section 7 (Marketing Authorisation Holder): Change in MA Holder's detail
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Updated on 19/09/2006 and displayed until 18/09/2007
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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: 08/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change of licence holder from Castlemead to Aventis Pharma.
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Updated on 30/08/2005 and displayed until 19/09/2006
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Reasons for adding or updating:
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Addition of separate SPCs covering individual presentations
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