- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
1. Name of the medicinal product
Buccastem M Buccal Tablets
2. Qualitative and quantitative composition
Each buccal tablet contains 3.0 mg prochlorperazine maleate Ph Eur.
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
For nausea and vomiting in previously diagnosed migraine, in adults aged 18 years and over.
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.Duration of treatment: Two days maximum.Adults aged 18 years and over: One or two tablets twice a day.Children and young adults under 18 years: Not recommended.Elderly patients: There is no evidence that dosage need be modified for the elderly.
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. In pregnancy.
4.4 Special warnings and precautions for use
Only use when migraine has previously been diagnosed by a doctor. 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 M tablets. Nausea and vomiting as a sign of organic disease may be masked by the anti-emetic action of Buccastem M 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 Buccastem M tablets and preventive measures undertaken
Increased Mortality in Elderly people with DementiaData 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 M 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 possible additive effect. Tricyclic antidepressants and antimuscarinic agents possible enhanced antimuscarinic effect in the elderly although the risk is small. Oral anticoagulants may have diminished effect. Thiazide diuretics possible enhanced hypotensive effect. Propoanolol levels of both drugs may increase. Anticonvulsants efficacy may be diminished necessitating dosage adjustment. Alpha-adrenoreceptor blocking antihypertensives levels of both drugs may change. The concomitant use of lithium may result in severe extrapyrimidal side effects or severe neurotoxicity. The concurrent use of desferrioxamine and prochlorperazine should be avoided. Prochlorperazine opposes the effects of levadopa.
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.
4.7 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 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.
Reporting of suspected adverse reactionsReporting 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.
|System Organ Class:||Pregnancy, puerperium and perinatal conditions|
|Adverse Drug Reaction / Frequency:||Drug withdrawal syndrome neonatal (see Section 4.6) / not known|
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
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
Buccastem 3 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 3 mg buccal tablet twice daily are similar to those observed with the standard oral dosage of one 5 mg 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
Compressible sugar, povidone K30, xanthan gum, locust bean gum, talc, magnesium stearate and riboflavin sodium phosphate.
6.3 Shelf life
6.4 Special precautions for storage
Protect from light.
6.5 Nature and contents of container
250 micron PVC aluminium foil blister packs.Pack size: Blister packs of eight tablets.
6.6 Special precautions for disposal and other handling
To be placed in the buccal cavity, high up along the top gum under the upper up, until dissolved. Do not chew or swallow the tablet.
7. Marketing authorisation holder
Alliance Pharmaceuticals LtdAvonbridge HouseBath RoadChippenhamWiltshireSN15 2BB
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
16th February 2010
10. Date of revision of the text
09 April 2015
Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB
+44 (0)1249 466 977
+44 (0)1249 466 966
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