Summary of Product Characteristics
last updated on the eMC:
05/01/2012
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 05/01/2012 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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| Date of revision of text on the SPC: 01-Dec-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Additions/changes highlighted in red text below:
4.6 Fertility, pregnancy and lactation
There is inadequate evidence of the safety in human pregnancy, although prochlorperazine has been used for many years without apparent ill-effect. However, Buccastem/Prochlorperazine 3 mg Buccal Tablets should be avoided unless absolutely necessary during the first trimester of pregnancy. Since data from animal studies show that prochlorperazine may be found in breast milk it should not be used during lactation.
Neonates exposed to antipsychotics (including prochlorperazine) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.
4.8 Undesirable effects
Drowsiness, dizziness, dry mouth, insomnia, agitation and mild skin reactions may occur. Extrapyramidal reactions are very unlikely at the recommended dosage. Other effects which have occurred rarely with prochlorperazine and other phenothiazine neuroleptics include jaundice, blood dyscrasias and, very rarely, hyperprolactinaemic effects such as gynaecomastia. Neuroleptic malignant syndrome (hyperthermia, rigidity, autonomic dysfunction and altered consciousness) may occur with any neuroleptic. Use of the buccal tablets may occasionally result in local irritation to the gum and mouth.
Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs- Frequency unknown.
System Organ Class: Pregnancy, puerperium and perinatal conditions
Adverse Drug Reaction / Frequency: Drug withdrawal syndrome neonatal (see Section 4.6) / not known
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Updated on 28/03/2011 and displayed until 05/01/2012
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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: 22-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Addition of "Prochlorperazine 3mg Buccal Tablets" as a product name.
Consequential updates were made to sections 4.2, 4.3, 4.4, 4.6, 4.8, 5.2 and 8
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Updated on 18/05/2010 and displayed until 28/03/2011
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Reasons for adding or updating:
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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: 20-Apr-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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10. Now reads
20th April 2010
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Updated on 10/05/2010 and displayed until 18/05/2010
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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| Date of revision of text on the SPC: 02-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 4.1 Special warnings and precautions for use - now includes the following red text.
Hypotension, usually postural, may occur, particularly in elderly or volume depleted patients. Tardive dyskinesia may occur occasionally, although this is normally associated with higher doses than are recommended for Buccastem 3 mg. Nausea and vomiting as a sign of organic disease may be masked by the anti-emetic action of Buccastem 3 mg.
Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Buccastem 3mg and preventive measures undertaken
Increased Mortality in Elderly people with Dementia
Data from two large observational studies showed that elderly people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated. There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known.
Buccastem 3mg is not licensed for the treatment of dementia-related behavioural disturbances.
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Updated on 25/02/2010 and displayed until 10/05/2010
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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