Prochlorperazine Maleate 5 mg tablets – patient leaflet, side effects, dosage

1. WHAT PROCHLORPERAZINE TABLETS ARE AND WHAT THEY ARE USED FOR

Prochlorperazine maleate belongs to a group of medicines called ‘phenothiazine antipsychotics.

It works by blocking the effects of a chemical in the brain.

Prochlorperazine can be used to:

• treat balance problems or dizziness (vertigo). This includes problems of the inner ear such as ‘Meniere’s Syndrome’ or ‘labyrinthitis’
• stop you feeling sick (nausea) or being sick (vomiting). This can be from any cause including migraines
• treat anxiety in the short-term, when used in addition to other medicines
• treat schizophrenia
• treat over-active behaviour or thoughts (mania)

2. BEFORE YOU TAKE PROCHLORPERAZINE TABLETS

Do not take this medicine and tell your doctor if:

You are allergic (hypersensitive) to prochlorperazine maleate or any of the other ingredients of Prochlorperazine Tablets (listed in Section 6 below)

Signs of an allergic reaction include; a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

Take special care with Prochlorperazine Tablets Check with your doctor or pharmacist before taking your medicine if:

• You have heart problems or a family history of heart problems
• You have ever had a stroke
• You have an enlarged prostate gland. This means you may have problems when passing water (urine)
• 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
• You have Parkinson’s disease
• You have epilepsy or have ever had fits (seizures)
• You have a tumour on your adrenal gland called ‘phaeochromocytoma’
• You have a type of muscle weakness called ‘myasthenia gravis’
• You have or have ever had glaucoma (signs include painful eyes with blurred vision)
• You have or have ever had a low number of white blood cells (agranulocytosis). This would lead you to get infections more easily than usual
• You have low blood levels of potassium, calcium and magnesium. Your doctor may perform blood tests to check on these
• You are not eating properly or are very under-weight
• You have a history of alcohol problems
• You are diabetic or have high levels of sugar in your blood (hyperglycaemia). Your doctor may want to monitor you more closely.
• You have liver or kidney problems or have ever had jaundice (yellowing or the skin or whites of the eyes)
• You have an underactive thyroid gland
• You suffer with dementia
• You suffer from depression
• The person is a child. This is because children may develop unusual face and body movements (dystonic reactions)
• You are elderly (65 years of age or older). Prochlorperazine tablets should be used with caution during very hot or very cold weather to reduce the risk of an extreme rise or fall in body temperature

If any of these points apply to you, do not take this medicine until you have talked to your doctor.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Prochlorperazine Tablets can affect the way some other medicines work.

POM Marketing Authorisation Holder:

Rudipharm Limited

Unit 6, Salbrook Road Industrial Estate

Salbrook Road, Redhill, Surrey,

RH1 5GJ, United Kingdom

Manufacturer:

Rudipharm Limited

Oak House, Reeds Crescent,

Watford, WD24 4QP, UK.

This leaflet was last revised in March 2026.

To listen to or request a copy of this leaflet in Braille, large print or audio please call, 01293 827819 (UK only) Please be ready to give the following information: Product name Reference number Prochlorperazine Maleate 5mg Tablets PL 49565/0074

Also, some medicines can affect the way Prochlorperazine Tablets works. In particular, tell your doctor if you are taking any of the following:

• antibiotics (medicines used to treat infections)
• cytotoxic (medicines used to treat cancer)
• antacids (medicines used for indigestion and heartburn)
• medicines to treat depression including amitriptyline
• medicines to treat diabetes

• medicines to treat high blood pressure (e.g. clonidine, doxazosin, guanethidine and

  terazosin)

• medicines to treat Parkinson’s disease such as levodopa

• anticholinergics (includes some medicines used for irritable bowel syndrome, asthma

  or incontinence)

• sotalol (to prevent and treat some heart conditions)
• desferrioxamine (to treat iron poisoning in the blood)
• sibutramine (used for weight loss)
• adrenaline e.g. epinephrine (used for life threating allergic reactions)
• amphetamine (treatment for Attention Deficit Hyperactivity Disorder (ADHD)
• antipsychotics (e.g. chlorpromazine, trifluoperazine)
• medicines to treat epilepsy such as carbamazepine

• medicines to treat irregular heartbeat (e.g. amiodarone, disopyramide, propranolol or

  quinidine)

• if you are about to undergo surgery or dentistry where an anaesthetic will be used
• ritonavir (for HIV infection)
• cimetidine (to treat stomach ulcers)
• strong pain killers (e.g. morphine, codeine phosphate)
• antihistamines, medicines used to treat allergies (e.g. terfenadine)
• Medicines to help you sleep (sedatives, barbiturates)
• Other medicines used to calm emotional and mental conditions
• Lithium - used for some types of mental illness

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Prochlorperazine Tablets.

Taking Prochlorperazine Tablets with food and drink

Do not drink alcohol while you are taking Prochlorperazine Tablets. This is because alcohol can add to the effects of Prochlorperazine Tablets and can cause serious breathing difficulties.

Pregnancy and breast-feeding

This medicine is not recommended for women who are pregnant or breast-feeding. If you are pregnant, planning to become pregnant or are breastfeeding ask your doctor or pharmacist for advice before taking any medicine.

The following symptoms may occur in newborn babies, of mothers that have used prochlorperazine tablets in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor

Driving and using machines

Prochlorperazine tablets may cause drowsiness. Make sure you are not affected before you drive or operate machinery.

Important information about some of the ingredients of Prochlorperazine Tablets

• Lactose: This medicine contains lactose, a type of sugar. If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking Prochlorperazine Tablets

3. HOW TO TAKE PROCHLORPERAZINE TABLETS

Always take Prochlorperazine tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

• Swallow the tablets with water.
• Do not give to children under 1 year of age or who weigh less than 10 kg

• You should not let the tablets touch your skin for very long, as you may get skin

  redness, swelling and itching (contact skin sensitisation)

• If you feel the effect of your medicine is too weak or too strong, do not change the

  dose yourself, but ask your doctor

Doses

Adults:

Treatment of balance problems or dizziness (Vertigo):

• 5mg three times a day, up to a maximum of 30mg a day.
• Your doctor may gradually reduce to 5-10mg a day after several weeks.

Nausea and vomiting:

• Prevention: 5-10mg two or three times a day.
• Treatment: 20mg immediately, followed, if necessary, by 10mg two hours later.

To help with the short-term treatment of anxiety:

• 15-20mg a day (divided throughout the day). Up to a maximum of 40mg a day

  (divided throughout the day).

  Treatment of schizophrenia and overactive behaviour or thoughts (mania):

  • The starting dose is usually 12.5mg twice each day for seven days.
  • Your doctor may increase your dose up to a total daily dose of 75-100mg per day
  • After several weeks of treatment, your doctor may then lower your dose to a total daily dose of 25-50mg each day.

Elderly: Your doctor may prescribe a lower dose. You should be careful during very hot or very cold weather to make sure that you do not get too hot or too cold.

Children (over 1 year of age and weighing more than 10kg)

Stopping your child feeling sick or being sick:

• Your doctor will decide the dose according to your child’s weight.
• A dose of 0.25mg for each kilogram of your child’s weight is usually given.
• This dose may be given two or three times a day.

If you take more Prochlorperazine tablets than you should

If you take too many tablets or a child swallows some, see your doctor immediately or contact the accident and emergency department of the nearest hospital. Take the medicine pack with you. This is so the doctor knows what you have taken. Taking too much Prochlorperazine may cause symptoms such as feeling sleepy or dizzy, increased or rapid heartbeat, feeling very cold and confused, writhing movements, feeling restless, stiffness or shaking. You may lose consciousness.

If you forget to take Prochlorperazine Tablets

If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Prochlorperazine Tablets

Keep taking Prochlorperazine Tablets until your doctor tells you to stop. Do not stop taking the tablets just because you feel better. If you stop, your illness may come back and you may have other effects such as feeling or being sick or difficulty sleeping. Your doctor will gradually stop your medicine to prevent these effects happening.

Exposure to sunlight

Prochlorperazine Tablets can cause your skin to be more sensitive to sunlight. Avoid exposure to direct sunlight while taking this medicine.

Tests

Your doctor may do regular tests while you are taking this medicine. These might include blood tests and an ECG to check your heart is working properly. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Prochlorperazine maleate Tablets can cause side effects, although not everybody gets them.

Stop taking Prochlorperazine maleate Tablets and see a doctor or go to a hospital straight away if:

• You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• You have an unusually pale complexion, sweating, high temperature, fast heartbeat, stiff muscles, fast breathing and feel confused, drowsy or agitated. These could be signs of a serious side effect called neuroleptic malignant syndrome’
• You have frequent infections such as fever, sore throat or mouth ulcers. These could be signs of a blood problem called leucopenia
• You may get infections more easily than usual. This could be because of a blood disorder (agranulocytosis)
• You have yellowing of your skin or eyes (jaundice). These could be signs of liver problems.
• You have very fast, uneven or forceful heartbeats (palpitations) and experience breathing problems such as wheezing, shortness of breath, tightness in the chest and chest pain
• You have 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. If you notice any of these symptoms seek medical advice immediately

• You have rigid or stiff muscles, trembling or shaking, unusual eye movements

  (including rolling of the eyes), difficulty moving, or loss of muscle power.

Tell your doctor as soon as possible if you have any of the flowing side effects:

• Breathing problems
• Changes in your skin or eye colour after taking Prochlorperazine Tablets for a long period of time
• Problems with your eyesight after taking Prochlorperazine Tablets for a long period of time
• Feeling dizzy, lightheaded or faint when you stand or sit up quickly (due to low blood pressure)
• You have fits (convulsions).
• Feeling tired, weak, confused and have muscles that ache, are stiff or do not work

Normal Text: 8.5pt (Roman)

• Feeling unwell, confused and/or weak, feeling sick (nausea), loss of appetite, feeling

  irritable. This could be something called a syndrome of inappropriate anti-diuretic hormone secretion (SIADH)

• Passing large amounts of urine, excessive thirst and having a dry mouth or skin. You

  may be more likely to get infections, such as thrush. This could be due to too much sugar in your blood (hyperglycaemia)

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days

• Abnormal production of breast milk in men and women
• Breast enlargement in men
• Loss of menstrual periods
• Difficulty in getting or maintaining an erection (impotence)
• Difficulty sleeping (insomnia)
• Feeling restless or agitated
• Dry mouth
• Your skin being more sensitive to the sun than usual
• Stuffy nose
• Skin rashes
• Skin redness, swelling and itching from touching the medicine

Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days or if you notice any side effects not listed in this leaflet. As with other phenothiazine medicines, there have been very rare reports of sudden death with Prochlorperazine tablets. These are possibly caused by heart problems. In elderly people with dementia, a small increase in the number of deaths has been reported for patients taking antipsychotics compared with those not receiving antipsychotics.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

5. HOW TO STORE PROCHLORPERAZINE TABLETS

Keep out of the reach and sight of children.

Do not store above 25 ºC. Store in the original package.

Do not remove the medicine form the blister until you are ready to take the medicine. Do not use Prochlorperazine Tablets after the expiry date stated on the blister and carton, after EXP. The expiry refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect environment.

6. FURTHER INFORMATION

What Prochlorperazine Tablets contains

Each tablet contains 5 mg of the active substance, Prochlorperazine Maleate. The other ingredients are Lactose Monohydrate, Maize Starch, Colloidal Anhydrous Silica, Magnesium Stearate.

What Prochlorperazine Tablets look like and contents of the pack

Prochlorperazine Maleate 5mg Tablets are white to off white coloured, circular shaped rounded tablets, with monogram P5 on one side and plain on the other side. Prochlorperazine Maleate 5mg Tablets are available in blister packs containing 28 and 84 tablets.

Not all pack sizes may be marketed.