Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Buccastem M Buccal Tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Prochlorperazine maleate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Buccastem M Tablets are effective in treating nausea (feeling sick) and vomiting (being sick) associated with migraine. Buccastem M Tablets contain prochlorperazine maleate. Prochlorperazine belongs to a large group of drugs known as phenothiazines, which have a variety of effects.
What you need to know before you take it
e Buccastem M Tablets You should only use this medicine if migraine has previously been diagnosed by your doctor. Do not take Buccastem M Tablets:
- if you are allergic to prochlorperazine maleate or any of the other ingredients of this medicine (listed in section 6)
- if you are pregnant, or you think you might be pregnant, or breast feeding
- if you have problems with your liver
- if you have blood problems
- if you suffer from epilepsy, Parkinson's Disease or glaucoma
- if you have problems with your prostate gland
- if you are under 18 years of age Warnings and precautions Talk to your doctor or pharmacist before taking Buccastem M Tablets:
- if you are elderly
Buccastem M PIL UK 012
• • • • • • •
if you were born with or have a family history of prolonged QT interval, or if you have acquired QT prolongation (seen on ECG, electrical recording of the heart) if you have heart disorders or have a history of heart attack (myocardial infarction) if you have salt imbalance in the blood (especially low level of potassium or magnesium) if you have risk factors for a blood clot or stroke such as high blood pressure, high cholesterol levels, diabetes or smoking if you or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots if you have a condition called myasthenia gravis, which causes muscle weakness if you have AIDS.
Buccastem M Tablets may cause you to be more sensitive to sunlight. When taking Buccastem M Tablets it is particularly important that you should avoid exposure to direct sunlight and use sunscreen. Other medicines and Buccastem M Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor or pharmacist if you are taking:
- medicines known to affect the rhythm of your heart. This includes medicines used for abnormal heart rhythm (antiarrhythmics), for depression (tricyclic antidepressants) and for psychiatric disorders (antipsychotics)
- azithromycin, clarithromycin, or erythromycin (antibiotics used for treating infections). Taking these medicines at the same time as Buccastem M Tablets may increase the chance of you getting side effects that affect your heart
- sedatives or tranquilisers, used to help you sleep (such as diazepam and temazepam)
- antihypertensive medicines, used to treat high blood pressure (such as atenolol, propranolol or clonidine)
- anticholinergic medicines, used for conditions such as depression (such as amitriptyline and imipramine)
- anticonvulsant medicines, used to prevent or treat fits (such as carbamazepine and lamotrigine)
- lithium, (used to treat mania and depression)
- desferrioxamine, (used to treat high levels of iron in your body)
- oral anticoagulants, to help prevent blood clots (such as warfarin)
- levodopa (used to treat Parkinson's disease). Buccastem M Tablets with food and drink Buccastem M Tablets are best taken after food. Do not drink alcohol when taking the tablets as it may interact with medicines like Buccastem M. Pregnancy and breast feeding If you are pregnant or thinking of becoming pregnant, you should not take Buccastem M Tablets. Experience with Buccastem M Tablets is limited. You should therefore not take the tablets if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Buccastem M Tablets can make you feel drowsy. Therefore you should avoid driving or using dangerous machines until you know how the tablets affect you. Buccastem M Tablets contain sucrose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
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How to take it
Buccastem M Tablets Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is one or two tablets twice a day for a maximum of 2 days, for adults aged 18 years or over. Buccastem M Tablets are not recommended for children under 18 years of age. INSTRUCTIONS FOR USE Please read carefully before taking the tablet(s).
• • • •
Place the tablet high up along your top gum, under the upper lip either side of your mouth as indicated above. The tablet must not be swallowed whole or chewed. The tablet will soften and adhere to the gum. Allow it to dissolve slowly and completely – this may take between 1 and 2 hours. Most people find that after a few minutes they no longer notice the tablet. The tablet should not be moved about the mouth with the tongue as this will cause it to dissolve too quickly. If you wear dentures, the tablet may be placed in any comfortable position between your lip and gum.
The tablet(s) is best taken after meals. If you take more Buccastem M Tablets than you should If you accidentally take too many tablets you must seek medical attention immediately. Show any left-over medicines or the empty packet to the doctor. If you forget to take Buccastem M Tablets If you forget to take a dose do not double the dose next time. Just carry on taking the medicine as the doctor, pharmacist or nurse has told you.
Possible side effects
Like all medicines, Buccastem M Tablets can cause side effects, although not everybody gets them. Serious side effects If you experience any of the following side effects, you should stop taking Buccastem M Tablets and contact your doctor immediately:
Buccastem M PIL UK 012
• • • • • • •
Symptoms of an allergic reaction such as rash and swelling of the face, tongue or throat A high temperature, pale complexion, muscle stiffness and changes in levels of alertness, you may have developed a serious condition called neuroleptic malignant syndrome. Convulsions (fits). Signs of infection such as shivering, headache, sweating, high temperature, flushing, a sore throat or mouth and swollen glands. Very fast, uneven or forceful heartbeats (palpitations) and breathing problems such as wheezing, shortness of breath, tightness in the chest and chest pain. Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. Symptoms of decreased sodium concentration in the blood, such as nausea and vomiting, headache, confusion, loss of energy, restlessness, muscle weakness, spasms or cramps, seizures and coma.
In elderly people with dementia, a small increase in the number of deaths has been reported for patients taking medicines of the same type as Buccastem M Tablets compared with those not taking these medicines. Other side effects include: Rare: may affect up to 1 in 1,000 people
- jaundice
- blood problems. Very rare: may affect up to 1 in 10,000 people
- breast swelling (in men as well as in women)
- milk secretion from the breasts which is not due to breast-feeding
- absence of menstrual periods Unknown: frequency cannot be estimated from the available data
- drowsiness
- dizziness
- dry mouth
- inability to sleep (insomnia)
- agitation
- a feeling of restlessness or anxiety that can range from mild to severe
- skin reactions
- increased sensitivity to sunlight
- low blood pressure (this makes you feel dizzy or faint, particularly when you stand up), particularly in elderly or volume depleted patients (those who have lost both water and salts from the body)
- high blood sugar level, which can cause increased thirst, a dry mouth, needing to urinate frequently, tiredness and recurrent infections such as thrush
- a condition known as cholestasis where bile cannot flow properly in the body, and can cause itchiness, jaundice (yellowing of the skin and/or the whites of the eyes), pale stools and dark urine
- abnormal movements, tremors and muscle rigidity, and unusual movements of the face and tongue
- impotence, ejaculation problems and persistent/ painful erections
- local irritation to the gum and mouth.
- numbness of mouth
- tingling, pricking or burning of mouth
- altered or decreased ability to taste
Buccastem M PIL UK 012
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Buccastem M Tablets Keep this medicine out of the sight and reach of children. Keep the blisters in the outer carton in order to protect from light. This medicinal product does not require any special temperature storage condition. Do not use after the expiry date (EXP month/year) shown on the outer carton and blister. The expiry date refers to the last day of that month.
Contents of the pack and other information
What Buccastem M Tablets contain Each tablet contains 3 mg of the active ingredient prochlorperazine maleate. The other ingredients are: compressible sugar (sucrose), povidone K30, xanthan gum, locust bean gum, talc, magnesium stearate and riboflavin sodium phosphate. What Buccastem M Tablets look like and contents of the pack The buccal tablet is pale yellow and has JI on one side and is plain on the other. This product is available from pharmacists in packs of 8 tablets. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, UK. Manufacturer: Piramal Healthcare UK Limited, Whalton Road, Morpeth, NE61 3YA, United Kingdom. This leaflet was last revised in March 2023. Buccastem and Buccastem M are registered trademarks of Alliance Pharmaceuticals Limited. Alliance and associated devices are registered trademarks of Alliance Pharmaceuticals Limited. © Alliance Pharmaceuticals Limited 2023 XXXXXX
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Frequently asked questions about Buccastem M Buccal Tablets
How do I take Buccastem M Buccal Tablets?
Buccastem M Buccal Tablets comes as tablet. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Buccastem M Buccal Tablets?
The active substance in Buccastem M Buccal Tablets is prochlorperazine maleate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Buccastem M Buccal Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Buccastem M Buccal Tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: prochlorperazine maleate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
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.
4.3. Contraindications
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
• Impaired liver function
• Existing blood dyscrasias
• Epilepsy
• Parkinson's Disease
• Prostatic hypertrophy
• Narrow angle glaucoma
• Pregnancy.
4.4. Special warnings and precautions for use
Only use when migraine has previously been diagnosed by a doctor.
Buccastem M tablets should be avoided in patients with stroke risk factors and myasthenia gravis.
Agranulocytosis has been reported with phenothiazines. The occurrence of unexplained infections or fever may be evidence of blood dyscrasia (see section 4.8), and requires immediate haematological investigation.
It has been reported that patients with AIDS may be particularly susceptible to antipsychotic-induced extrapyramidal effects.
Because of the risk of photosensitisation, patients should be advised to avoid exposure to direct sunlight and use sunscreen (see section 4.8).
Hypotension, usually postural, may occur, particularly in elderly or volume depleted patients.
Nausea and vomiting as a sign of organic disease may be masked by the anti-emetic action of Buccastem M tablets.
Neuroleptic malignant syndrome (NMS) is a potentially fatal symptom complex associated with antipsychotic medicinal products. Alteration in mental status and other neurological signs often precede systemic signs of NMS. It is imperative that treatment be discontinued in the event of NMS (characterised by unexplained fever, hyperthermia, autonomic dysfunction, altered consciousness, muscle rigidity) (see section 4.8).
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 (see section 4.8).
QT prolongation
Neuroleptic phenothiazines may potentiate QT interval prolongation which increases the risk of onset of serious ventricular arrhythmias of the torsade de pointes type, which is potentially fatal. Buccastem M tablets should be used with caution in patients with congenital or documented acquired QT prolongation and/or known risk factors for prolongation of the QT interval such as:
• cardiac disease e.g. heart failure, myocardial infarction
• proarrhythmic conditions e.g bradycardia (< 50 bpm)
• a history of ventricular dysrhythmias
• uncorrected hypokalemia and/or hypomagnesemia
• and during concomitant administration with QT interval prolonging drugs (see section 4.5).
If signs of cardiac arrhythmia occur during treatment with Buccastem M tablets, treatment should be stopped and an ECG should be performed.
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 M tablets are not licensed for the treatment of dementia-related behavioural disturbances.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-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 due to the possible additive CNS depressant effect.
The mild anticholinergic effect of neuroleptics may be enhanced by other anticholinergic drugs.
Oral anticoagulants – may have diminished effect.
Anticonvulsants – efficacy may be diminished necessitating dosage adjustment, as prochlorperazine may lower the seizure threshold.
The hypotensive effect of antihypertensive drugs may be exaggerated.
The concomitant use of lithium may result in severe extrapyramidal side effects or severe neurotoxicity.
The concurrent use of desferrioxamine and prochlorperazine should be avoided.
Prochlorperazine opposes the effects of levadopa.
There is an increased risk of arrhythmias when neuroleptics are used with concomitant QT prolonging drugs (including certain anti-arrhythmics, antidepressants, macrolide antibiotics and other antipsychotics) and drugs causing electrolyte imbalance (see section 4.4).
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
Undesirable effects are listed by MedDRA System Organ Classes.
Assessment of undesirable effects is based on the following frequency groupings:
Very common: ≥ 1/10
Common: ≥ 1/100 to <1/10
Uncommon: ≥ 1/1,000 to <1/100
Rare: ≥ 1/10,000 to <1/1,000
Very rare: <1/10,000
Not known: cannot be estimated from the available data
Tabulated list of adverse reactions
System organ class
Undesirable effect and frequency
Blood and lymphatic system disorders
Rare:
Blood dyscrasia
Immune system disorders
Not known:
Hypersensitivity reactions such as rash and angioedema
Endocrine disorders
Very rare:
Hyperprolactinaemia which may result in gynaecomastia, galactorrhoea and amenorrhoea
Metabolism and nutrition disorders
Not known:
Hyponatraemia
Syndrome of inappropriate antidiuretic hormone secretion
Hyperglycaemia
Glucose tolerance impaired
Psychiatric disorders
Not known:
Insomnia
Agitation
Nervous system disorders
Not known:
Convulsion
Drowsiness
Dizziness
Extrapyramidal reactions including acute dystonia, akathisia, parkinsonism and tardive dyskinesia
Cardiac disorders
Not known:
Arrythmia*
QT prolongation*
Vascular disorders
Not known:
Hypotension (usually orthostatic)
Gastrointestinal disorders
Not known:
Dry mouth
Irritation gum
Mouth irritation
Hypoaesthesia oral
Paraesthesia oral
Taste disorders
Hepatobiliary disorders
Rare:
Jaundice
Not known:
Cholestasis
Skin and subcutaneous tissue disorders
Not known:
Skin reaction
Photosensitivity (see section 4.4)
Pregnancy, puerperium and perinatal conditions
Not known:
Drug withdrawal syndrome neonatal (see Section 4.6)
* See 'Description of selected adverse reactions'
Description of selected adverse reactions
Impotence, ejaculation disorder, priapism, and agranulocytosis (see section 4.4) are class effects associated with phenothiazines.
Neuroleptic malignant syndrome may occur with any neuroleptic (see section 4.4).
Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs- Frequency unknown (see section 4.4).
QT prolongation, cardiac arrhythmias, including ventricular arrhythmias which may result in ventricular fibrillation or cardiac arrest have been reported during neuroleptic phenothiazine therapy. Pre-existing cardiac disease, proarrhythmic conditions, hypokalaemia, hypomagnesemia, or concomitant administration with QT interval prolonging drugs may predispose.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
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. 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 or orphenadrine 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.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- EMETIRAL® 5 mg (vezi N05AB04) prescriptionPROCHLORPERAZINUM · taken by mouth
- EMETIRAL® 5 mg (vezi A04ADN1) prescriptionPROCHLORPERAZINUM · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Prochlorperazine maleate. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
- Chloropernazinum partial — not the same combinationProchlorperazini dimaleas · taken by mouth
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Buccastem M Buccal Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.