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.
Prochlorperazine maleate 3 mg Buccal Tablet (P)
⚠ 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 Prochlorperazine tablets are effective in treating nausea (feeling sick) and vomiting (being sick) associated with migraine. Prochlorperazine 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 Prochlorperazine tablets You should only use this medicine if migraine has previously been diagnosed by your doctor. Do not use Prochlorperazine 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 using Prochlorperazine tablet
if you are elderly 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 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.
Prochlorperazine tablet may cause you to be more sensitive to sunlight. When using Prochlorperazine tablet it is particularly important that you should avoid exposure to direct sunlight and use sunscreen. Other medicines and Prochlorperazine tablet Tell your doctor or pharmacist if you are using, have recently taken or might use any other medicines. In particular, tell your doctor or pharmacist if you are using:
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 Prochlorperazine 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)
Prochlorperazine tablets with food, drink and alcohol Prochlorperazine are best taken after food. Do not drink alcohol when using the tablets as it may interact with medicines like Prochlorperazine maleate. Pregnancy and breast-feeding If you are pregnant or thinking of becoming pregnant, you should not use Prochlorperazine Maleate 3 mg Buccal Tablets. Experience with prochlorperazine is limited. You should therefore not use the tablets if you are breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines
Prochlorperazine maleate can make you feel drowsy. Therefore, you should avoid driving or using dangerous machines until you know how the tablets affect you. Prochlorperazine tablet contains sucrose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicinal product.
How to take it
Prochlorperazine tablet Always use 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. Recommended dose is 1 or 2 tablets twice a day for a maximum of 2 days, for adults aged 18 year or over. Prochlorperazine maleate are not recommended for children under 18 years of age. INSTRUCTIONS FOR USE Please read carefully before using 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 use 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 use more Prochlorperazine tablet than you should If you accidentally use too many tablets you must seek medical attention immediately. Show any leftover medicines or the empty packet to the doctor. If you forget to use Prochlorperazine tablet Do not use a double dose to make up for a forgotten. Just carry on using the medicine as the doctor, pharmacist has told you.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects If you experience any of the following side effects, you should stop using Prochlorperazine tablets and contact your doctor immediately:
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 using medicines of the same type as Prochlorperazine maleate compared with those not using 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
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 Yellow Card Scheme at Website: 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
Prochlorperazine Buccal Tablet Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. This medicinal product medicine does not require any special storage conditions. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Prochlorperazine Buccal Tablet contains
- Each buccal tablet contains 3 mg of prochlorperazine maleate.
- The other ingredients are: compressible sugar (sucrose), xanthan gum, locust bean gum, riboflavin 5 – phosphate sodium, povidone K30, talc and magnesium stearate. What Prochlorperazine Buccal Tablet looks like and contents of the pack The buccal tablet is yellow colored, circular shaped biconvex uncoated tablet debossed with 'C77' on one side and plain on other side with approximately 5.5 mm in diameter. Pack size: Blister containing 2 or 8 buccal tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Brown & Burk UK Ltd 5 Marryat Close Hounslow West Middlesex
TW4 5DQ UK. This leaflet was last revised in 03/2024
Frequently asked questions about Prochlorperazine maleate 3 mg Buccal Tablet (P)
How do I take Prochlorperazine maleate 3 mg Buccal Tablet (P)?
Prochlorperazine maleate 3 mg Buccal Tablet (P) comes as tablet containing 3mg. 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 Prochlorperazine maleate 3 mg Buccal Tablet (P)?
The active substance in Prochlorperazine maleate 3 mg Buccal Tablet (P) is prochlorperazine maleate.
Are there equivalent medicines to Prochlorperazine maleate 3 mg Buccal Tablet (P)?
Medicines with the same active substance, strength and form include: Almus Migraine Relief 3mg Buccal Tablets, Prochlorperazine 3 mg Buccal Tablets, Prochlorperazine maleate 3 mg Buccal Tablets (POM). They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Prochlorperazine maleate 3 mg Buccal Tablet (P), 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 Prochlorperazine maleate 3 mg Buccal Tablet (P) 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
• Parkinsons 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.
Almus Migraine Relief/ Prochlorperazine maleate Buccal 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 Almus Migraine Relief Tablets/ Prochlorperazine maleate Buccal 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 Almus Migraine Relief Tablets/ Prochlorperazine maleate Buccal 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. Almus Migraine Relief / Prochlorperazine maleate Buccal 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 Almus Migraine Relief/ Prochlorperazine maleate Buccal 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.
Almus Migraine Relief Tablets/ Prochlorperazine maleate Buccal Tablets are not licensed for the treatment of dementia-related behavioural disturbances.
The tablet contains sucrose
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not use 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.
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).
Prochlorperazine opposes the effects of levodopa.
4.6. Fertility, pregnancy and lactation
Pregnancy
Almus Migraine Relief Tablets/ Prochlorperazine Maleate 3 mg Buccal Tablets is contraindicated during pregnancy (see section 4.3).
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.
Breast-feeding
Since data from animal studies shows that prochlorperazine may be found in breast milk, Almus Migraine Relief Tablets/ Prochlorperazine Maleate 3 mg Buccal Tablets should not be used during breastfeeding.
Fertility
There are no data on the effects of prochlorperazine on fertility.
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 Yellow Card Scheme at Website: 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.
💬 Ask about this leaflet
Ask anything about Prochlorperazine maleate 3 mg Buccal Tablet (P). 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.