Prochlorperazine Tablets Bp 5mg
Patient Information Leaflet Prochlorperazine Tablets BP 5mg
Please read this leaflet carefully before you start to take your tablets.
It contains important information.
If you are not sure about anything, or you want to know more, ask your doctor or a pharmacist.
Keep this leaflet safe, as you may want to read it again.
About your tablets
Your tablets are called Prochlorperazine Tablets.
They are part of a group of drugs known as phenothiazines.
Prochlorperazine is used to treat Menieres disease (characterised by vertigo, ringing in the ears and deafness) as well as giddiness, nausea (feeling sick) and vomiting (being sick) from different causes.
Prochlorperazine may also be used with other treatment to treat anxiety, or in the treatment of schizophrenia and related mental illnesses.
What is in your tablets
Each tablet contains:
• Prochlorperazine Maleate BP 5 milligrams (mg) (active ingredient);
• excipients: lactose, maize starch, microcrystalline cellulose, povidone, sodium starch glycolate and magnesium stearate.
Prochlorperazine Tablets BP are white compressed tablets, FBE coded PCP 5 and breakline on one side, twin triangle logo on reverse.
(Diagram of tablet showing markings)
They come in packs of 7, 14, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120 and 1000.
Not all packs may be marketed.
Who makes your tablets
Your tablets are made by IVAX Pharmaceuticals Ireland, Waterford, Ireland.
The product licence holder is IVAX Pharmaceuticals UK, Royal Docks, London E16 2QJ, UK.
What your tablets do
Prochlorperazine Tablets are used mainly to treat sickness (both feeling and being sick) from different causes and Menieres disease (see also ‘About your tablets’).
Before you take your tablets
DO not take Prochlorperazine and talk to your doctor if you:
• are allergic (hypersensitive) to prochlorperazine or any of the other ingredients of this medicine
• Pregnancy and breast-feeding
are pregnant, may become pregnant or are breast-feeding. The following symptoms may occur in newborn babies, of mothers that have used Prochlorperazine 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.
Take special care with Prochlorperazine
Tell your doctor before you start to take this medicine if you:
• have ever had any problems with your liver, kidneys or heart, or have a family history of heart problems;
• have previously had a stroke, transient ischaemic attack (TIA) or heart attack, or have a family history of strokes;
• suffer from epilepsy, Parkinson’s disease, glaucoma or myasthenia gravis (a disease in which your muscles are weak and tire easily);
• have or have ever had a growth in your adrenal gland (phaeochromocytoma) which causes high blood pressure, an under-active thyroid gland (for which you need to take thyroxine tablets) or (in men) have an enlarged prostate gland;
• Diabetes; your blood glucose levels may be altered due to Prochlorperazine and your diabetes medicines may need to be adjusted.
• Have depression and/or dementia
• Have a low number of white blood cells (agranulocytosis). This would lead you to get infections more easily than usual.
• Are a child. This is because children may develop unusual face and body movements (dystonic reactions).
• Are elderly and particularly during very hot or cold weather as you may make you prone to high or low body temperature.
• 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
• have a history of narrow angle glaucoma (increase pressure in the eye).
Exposure to sunlight
Prochlorperazine Tablets can cause your skin to be more sensitive to sunlight. You should 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.
Taking other medicines
Talk to your doctor if you are taking any of the following:
• are taking medicines which affect the central nervous system such as sleeping tablets (sedatives) or amphetamines;
• are taking antidepressant (for example amitriptyline, imipramine, maprotiline) for the treatment of depression;
• are taking medicines to lower your blood pressure for example guanethidine, clonidine, prazosin, doxazosin, terazosin, indoramin and beta blockers (for example propranolol),
• medicines to treat diabetes (for example chlorpropamide and glibenclamide);
• medicines to reduce the amount of saliva, sweat or digestive juices your body produces (for example atropine, hyoscine, propantheline);
• ipratropium (for asthma, bronchitis); oxybutinin (for bladder disorders);
• are taking any drugs which can affect the chemicals in your blood stream known as electrolytes, such as diuretics e.g. furosemide; antibiotics, e.g. amphotericin B; corticosteroids e.g. hydrocortisone and chemotherapy drugs e.g. cisplatin
• are taking certain medicines which affect the heart e.g. halofantrine, pimozide, quinidine, disopyramide, procainamide, amiodarone, sotalol, dofetiline
• are taking certain antibiotics e.g. moxifloxacin, sparfloxacin, erythromycin
• are taking levodopa or other medicines for Parkinson’s disease, or lithium (for mental illness);
• are taking barbiturates for epilepsy or as sleeping tablets;
• any antihistamine, for an allergy or hay-fever
• quinine and mefloquine, for malaria
• are taking any drug similar to prochlorperazine, known as a neuroleptic, e.g. promazine, amisulpiride, pimozide, sertindole, haloperidol;
• use adrenaline for the emergency treatment of anaphylactic reactions (unusual reactions to foreign bodies or drugs) or need injections of desferriosamine because you have too much iron in your blood; or
• are taking other medicines, including antacids that you have bought for yourself without a prescription.
If you see another doctor or visit a hospital, remember to tell them what medicines you are already taking.
Taking Prochlorperazine with food and drink
Do not drink alcohol while you are taking your tablets.
Driving and using machines
Your tablets may make you feel drowsy during the day, especially when you first start to take them. Do not drive or use machinery as it may be dangerous.
Prochlorperazine reduces the body’s ability to respond to temperature changes. Tell your doctor if you are planning to travel abroad.
Important information about some of the ingredients of lactose
Patients who are intolerant to lactose should note that Prochlorperazine tablets contain a small amount of lactose. If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicine.
How to take your tablets
If your doctor has prescribed this medicine, always take Prochlorperazine exactly as your doctor has told you.
You must take your tablets as your doctor has told you to. The label will tell you how many to take and how often to take them.
The number of tablets you take is called the ‘dose’. The dose you will have to take will depend on what you are taking the tablets for.
To stop you from feeling and being sick, the most common adult dose is 5mg to 10mg (1 or 2 tablets) two or three times a day. If you are being sick, you will be given 20mg (4 tablets) as a single dose, followed by 10mg (2 tablets) two hours later to stop the sickness.
To treat vertigo or Menieres disease the most common adult dose is 5mg (1 tablet) three times a day. Your doctor may increase this to 30mg (6 tablets) a day if necessary. After several weeks, your doctor may reduce your dose to 5mg to 10mg (1 or 2 tablets) a day.
The most common adult dose is part of your treatment for anxiety is 15mg to 20mg (3 or 4 tablets and occasionally up to 40mg -8 tablets) a day taken as several smaller doses during the day.
For other mental disorders (for example schizophrenia), your doctor will start your treatment at 12.5mg (2.5 tablets) twice a day for 7 days. He or she will then increase this dose every four to seven days until they find the dose that works best for you. This is usually 75mg to 100mg (15 to 20 tablets) a day. After a few weeks, your doctor may gradually reduce your treatment.
Children can take Prochlorperazine Tablets for sickness. The dose your child should take will be worked out depending on their weight. The usual dose is 250 micrograms for each kilogram of your child’s body weight two or three times a day. Children weighing less than 10 kilograms should not take Prochlorperazine Tablets.
You are more likely to develop side effects from your tablets if you are elderly, so your treatment will be started at a lower dose than the usual adult dose.
Swallow your tablets whole with water.
If you forget to take Prochlorperazine
If you forget to take a dose at the right time, take it as soon as you remember, unless it is nearly time to take the next one.
Do not take two doses together to make up for a forgotten dose.
If it is almost time to take the next dose, wait until then and then carry on as before.
What to do if you take too many tablets
If you (or someone else) swallow too many tablets or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or a doctor immediately.
An overdose is likely to cause drowsiness, low blood pressure, low body temperature, fast heart beat and loss of consciousness.
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you stop taking Prochlorperazine
DO NOT stop taking your medicine without talking to your doctor first even if you feel better.
Possible side effects
Like all medicines, Prochlorperazine can cause side effects, although not everybody gets them.
Stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest
hospital if the following happens:
• an allergic reaction causing swelling of the lips, face or neck leading to severe difficulty in breathing, severe skin rash or hives. This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.
• 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 call ‘neuroleptic malignant syndrome’.
• 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.
Tell your doctor if you suffer from any of the following for more than a few days.
• A dry mouth, a blocked up nose, difficulty sleeping, feeling agitated, and feeling dizzy and lightheaded when you stand up.
• Uncontrolled movements especially in your limbs and face, tremor, muscle rigidity/spasm in your shoulders, neck, body and arms, and feeling restless.
• 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)
Occasionally Prochlorperazine Tablets can cause the following:
• Changes to your normal heart rhythm, skin rashes and your skin may become sensitive to the sun. Do not sunbathe or you may find you burn more easily.
• Women may find that their periods stop and their breasts may become bigger and produce milk. Men may notice breast swelling and have problems having sex.
• Problems with your eye sight after taking Prochlorperazine for a long time.
• Jaundice (your skin and the whites of your eyes may become yellow) and blood abnormalities which can cause fever or chills, a sore throat and ulcers in your mouth and throat. Tell your doctor as soon as possible if you develop a fever.
• Difficulty breathing.
• 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.
• Blood test showing a decrease in the number of white blood cells
• 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.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Looking after your tablets
Keep out of the reach and sight of children.
You should keep your tablets in a cool, dry place, away from light Keep them in the pack they came in. Do not put them into another container.
You should take any tablets that are out of date or which you no longer need back to your pharmacist.
Do not use Prochlorperazine after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that 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 to protect the environment..
PL number 00530/5067R
This leaflet was rewritten in November 2011