Prochlorperazine Maleate 3mg Buccal Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prochlorperazine maleate 3mg Buccal Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each buccal tablet contains prochlorperazine maleate 3mg.
Each tablet also contains 53.090mg of sucrose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Buccal tablet.
Pale yellow, round, biconvex, uncoated tablet debossed with PC on one side and plain on the other.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Symptomatic treatment of vertigo due to Meniere's Disease, Labyrinthitis and other causes. For nausea and vomiting from whatever cause. In the treatment of migraine.
4.2 Posology and method of administration
To be placed in the buccal cavity, high up along the top gum under the upper lip, until dissolved. Do not chew or swallow the tablet.
Adults and children aged 12 years and over: One or two tablets twice a day. Children under 12 years: Not recommended.
Elderly patients: There is no evidence that dosage need be modified for the elderly
4.3 Contraindications
Contraindicated in patients with impaired liver function, existing blood dyscrasias, epilepsy, Parkinsons Disease, prostatic hypertrophy, narrow angle glaucoma and known hypersensitivity to the active ingredient or any of the ingredients of this product.
4.4 Special warnings and precautions for use
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 prochlorperazine buccal tablets. Nausea and vomiting as a sign of organic disease may be masked by the anti-emetic action of prochlorperazine buccal tablets.
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 Prochlorperazine buccal tablets and preventative 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.
Prochlorperazine buccal tablets are not licensed for the treatment of dementia-related behavioural disturbances.
4.5 Interaction with other medicinal products and other forms of interaction
Alcohol and CNS depressants should be used with caution as should a-adrenoreceptor blocking antihypertensives.
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, prochlorperazine 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.
4.7 Effects on ability to drive and use machines
Patients who drive or operate machinery should be warned of the possibility of drowsiness.
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
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
The signs and symptoms will be predominately extrapyramidal and may be accompanied either by restlessness and agitation or central nervous depression. Hypotension may also occur. Treatment is essentially symptomatic and supportive. There is no specific antidote. Gastric lavage is helpful, particularly when carried out within 6 hours of ingestion. Do not induce vomiting. Particular attention must be directed to maintaining a clear airway since this may be threatened by extrapyramidal muscle dystonias. Severe dystonic reactions usually respond to procyclidine (5-10mg) or orphenadrine (20-40mg) given i.m. or i.v. If convulsions occur they should be treated using i.v. diazepam. If hypotension is present, strict attention to ventilation and posturing of the patient will often secure the desired effect, but failing this, consideration should be given to volume expansion by i.v. fluids. If this is insufficient, positive inotropic agents such as dopamine may be tried, but peripheral vasoconstrictor agents are not generally recommended. Adrenaline should NOT be used.
5.1 Pharmacodynamic properties
ATC code: N05AB04
Pharmacotherapeutic group: Phenothiazines with piperazine structure Prochlorperazine is a member of the phenothiazine group of neuroleptics which, in doses lower than those used in psychiatry, is usually employed for its anti-emetic properties. The site of action is thought to be the chemoreceptor trigger zone.
5.2 Pharmacokinetic properties
Prochlorperazine buccal tablets are placed in the buccal cavity where they form a gel from which the prochlorperazine is released and absorbed. The plasma levels achieved at steady-state on a dosage regimen of one 3mg buccal tablet twice daily are similar to those observed with the standard oral dosage of one 5mg tablet taken three times daily. The elimination half-life of prochlorperazine in this formulation is 9.0 hours, similar to that observed with the oral formulation.
5.3 Preclinical safety data
No preclinical findings of relevance have been reported
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose
Locust bean gum Xanthan gum Hypromellose 2910 Riboflavin sodium phosphate Magnesium stearate Talc
6.2 Incompatibilities
None known
6.3 Shelf life
30 Months
6.4 Special precautions for storage
No special storage conditions required.
6.5 Nature and contents of container
Tablets are packed in PVC/PVDC or OPA/A1/PV//A1 blister packs containing 30 or 50 tablets. Not all packs are marketed.
6.6 Special precautions for disposal
No special requirements
7 MARKETING AUTHORISATION HOLDER
Primegen Limited Unit 15, Moorcroft Harlington Road Uxbridge UB8 3HD UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 43659/0024
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
02/02/2016
10 DATE OF REVISION OF THE TEXT
02/02/2016