Prochlorperazine Maleate 3mg Buccal Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prochlorperazine Maleate 3 mg Buccal Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each buccal tablet contains Prochlorperazine Maleate Ph Eur 3 mg.
It also contains 48.09mg Sucrose.
For list of excipients refer 6.1
3 PHARMACEUTICAL FORM
Buccal tablet
Pale yellow to yellow, circular, biconvex uncoated tablets debossed with “P3” on one side and plain on the other side.
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.
Adults and children aged 12 years and over: One or two Prochlorperazine Maleate 3 mg Buccal 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
Prochlorperazine Maleate 3mg Buccal Tablet is 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
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 Maleate 3mg Buccal Tablets. Nausea and vomiting as a sign of organic disease may be masked by the anti-emetic action of Prochlorperazine Maleate 3mg 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 Maleate 3mg Buccal Tablets 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.
Prochlorperazine Maleate 3mg Buccal Tablet is not licensed for the treatment of dementia-related behavioural disturbances.
Prochlorperazine Maleate 3mg buccal Tablets contain Sucrose. Hyperglycaemia or intolerance to glucose has been reported in patients treated with antipsychotic phenothiazines. Patients with an established diagnosis of diabetes mellitus or with risk factors for the development of diabetes, who are started on Prochlorperazine Maleate, should get appropriate glycaemic monitoring during treatment (see section 4.8).
Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
Alcohol and CNS depressants should be used with caution as should alpha-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 Maleate 3mg 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, Prochlorperazine Maleate 3mg Buccal Tablets 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 Prochlorperazine Maleate 3mg 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 Pregnancy, puerperium and perinatal conditions
Class:
Adverse Drug Drug withdrawal syndrome neonatal (see Section 4.6) /
Reaction / not known
Frequency:
4.9 Overdose
The signs and symptoms will be predominantly 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 (5-10 mg) or orphenadrine (20-40 mg) 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 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antipsychotics, ATC code: N05AB04
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 Maleate 3mg 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 Prochlorperazine Maleate 3mg Buccal Tablets twice daily are similar to those observed with the standard oral dosage of one 5 mg tablet taken three times daily. The elimination halflife 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
Povidone (K-30)
Riboflavin Sodium Phosphate Xanthan Gum (FF)
Talc
Magnesium Stearate
6.2 Incompatibilities
None
6.3 Shelf life
2 years
6.4 Special precautions for storage
Store below 25°C, Store in Original Package
6.5 Nature and contents of container
Tablets are packed in an Alu/PVC/PVdC blisters Pack Size: 14, 15, 30, 50 and 60 tablet packs
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
Medreich Plc Warwick House Plane Tree Crescent Feltham TW13 7HF
8 MARKETING AUTHORISATION NUMBER(S)
PL 21880/0122
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
09/01/2014
10
DATE OF REVISION OF THE TEXT
14/03/2014