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4.6 Fertility, pregnancy and lactation
Contraindicated in pregnancy.
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.
Since data from animal studies shows that prochlorperazine may be found in breast milk, Buccastem M tablets should not be used during lactation.
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 Buccastem M 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.
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System Organ Class:
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Pregnancy, puerperium and perinatal conditions
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Adverse Drug Reaction / Frequency:
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Drug withdrawal syndrome neonatal (see Section 4.6) / not known
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