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APO-PROCHLORPERAZINE

Contains the active ingredient, prochlorperazine (as maleate)


Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before taking your medicine.

Ask your doctor or pharmacist if you do not understand anything or are worried about taking your medicine. This leaflet answers some common questions about prochlorperazine.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the last page. More recent information on your medicine may be available. Speak to your pharmacist or doctor to obtain the most up-to-date information.

All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.

Keep this leaflet with your medicine. You may want to read it again.

What prochlorperazine is used for

The name of your medicine is APO-Prochlorperazine. It contains the active ingredient, prochlorperazine (as prochlorperazine maleate).

Prochlorperazine belongs to a group of medicines called phenothiazines. It helps to correct chemical imbalances in the brain, allowing it to function correctly. These chemicals may also affect the parts of the brain which control nausea (feeling sick) and vomiting.

It is used to treat nausea, vomiting and dizziness due to various causes, including migraine (severe headache).

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed this medicine for another reason.

This medicine is available only with a doctor's prescription.

Use in children

Prochlorperazine is not recommended for use in children (under the age of 2 years or children under 10 kg in weight).

Before you take prochlorperazine

When you must not take it

Do not take this medicine if you have in the past experienced jaundice (yellow skin and/or eyes) or problems with your blood cells, after taking prochlorperazine or similar medicines called phenothiazines. This is called a hypersensitivity reaction.

Do not take this medicine if you have had an allergic reaction to prochlorperazine, the group of medicines called phenothiazines or any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include: shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

You must not take prochlorperazine if you suffer from bone marrow depression, a disease of the blood with a low number of blood cells.

Prochlorperazine must not be given to anyone who is in shock, unconscious or in a coma.

Do not take this medicine after the expiry date (EXP) printed on the pack. If you take it after the expiry date has passed, it may not work as well.

Do not take this medicine if the packaging is torn, shows signs of tampering or if it does not look quite right. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor or pharmacist.

Before you start to take it

Before you start taking this medicine, tell your doctor or pharmacist if:

  1. You have allergies to:
  • any other medicines
  • any other substances, such as foods, preservatives or dyes.
  1. You have or have had any medical conditions, especially the following:
  • phaeochromocytoma, a rare tumour of the adrenal glands which sit near the kidneys
  • Parkinson's disease, a disease of the brain affecting movement which causes trembling, rigid posture, slow movement and a shuffling, unbalanced walk
  • myasthenia gravis, a disease of the muscles causing drooping eyelids, double vision, difficulty in speaking and swallowing and sometimes muscle weakness in the arms or legs
  • kidney problems or problems urinating
  • constipation
  • heart and blood vessel problems, low blood pressure, blood clots, stroke (sudden weakness or numbness of the face, arms, or legs, especially on one side, or instances of slurred speech)
  • liver disease
  • prostate problems
  • epilepsy, seizures or fits
  • low blood calcium levels associated with a condition called hypoparathyroidism
  • hypothyroidism (an underactive thyroid gland)
  • narrow-angle glaucoma, a condition in which there is a build-up of fluid in the eye
  • neuroleptic malignant syndrome, a reaction to some medicines with a sudden increase in body temperature, extremely high blood pressure and severe convulsions, muscle stiffness and excessive sweating
  • tardive dyskinesia, a reaction to some medicines with uncontrollable twitching or jerking movements of the face, tongue, mouth, jaw, arms and legs
  • dementia
  • diabetes, or risk factors for diabetes (e.g. overweight)
  • QT prolongation (change in the electrical activity of the heart) or conditions which put you at risk of getting QT prolongation (such as slow heartbeat, low potassium levels, family history of QT prolongation) or taking other medicines which prolong the QT interval
  • you have lost lots of fluid due to vomiting, diarrhoea or sweating (which increases the chance of having low potassium levels).
  1. You are currently pregnant or you plan to become pregnant.
    Prochlorperazine is not recommended for use during pregnancy. If there is a need to take prochlorperazine during your pregnancy, your doctor will discuss with you the benefits and risks of using it.
  2. You are currently breastfeeding or you plan to breast-feed.
    It is recommended that you do not breastfeed while taking prochlorperazine, as it is not known whether prochlorperazine passes into breast milk.
    If there is a need to take prochlorperazine whilst breast-feeding, your doctor will discuss with you the benefits and risks of using it.
  3. You are planning to have surgery which requires a spinal and/or general anaesthetic.

Make sure to tell your doctor all of your symptoms, in case taking this medicine covers up any undiagnosed problem.

Taking other medicines

Tell your doctor or pharmacist if you are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.

Some medicines may interact with prochlorperazine. These include:

  • medicines taken to reduce fever
  • some medicines used to control depression or mood swings or to calm you down or help you sleep
  • any other medicines which make you drowsy
  • alcohol
  • desferrioxamine, used to treat excess iron in your blood
  • procarbazine, an anticancer drug
  • some medicines used to control epilepsy, e.g. phenytoin
  • medicines used to treat Parkinson's disease, e.g. levodopa
  • anticholinergic medicines including those that can be used to relieve stomach cramps, spasms and travel sickness
  • atropine, a medicine which may be used in some eye drops or cough and cold preparations
  • some oral medicines, or some products available over the counter at pharmacies, used to prevent your blood from clotting, e.g. warfarin
  • medicines used to treat high blood pressure
  • medicines used to treat heart problems, such as bepridil , digoxin/digitalis, quinidine, disopyramide, amiodarone and sotalol
  • other medicines which can slow your heart rate down, such as diltiazem, verapamil, beta-blockers (e.g. propranolol), clonidine and guanfacine
  • diuretic (fluid) tablets, for treating excess fluid and high blood pressure
  • tetracosactide, used for diagnosing some illnesses
  • cisapride, used for treating some stomach problems
  • halofantrine, used for treating malaria
  • certain medicines for treating infections: erythromycin or amphotericin B (when given via injection or infusion); pentamidine and sparfloxacin
  • thioridazine, sultopride and other antipsychotics
  • stimulant laxatives containing, for example, bisacodyl or senna
  • methadone, a strong painkiller
  • some anti-inflammatory drugs such as steroid medicines (glucocorticoids)
  • other medications such as vincamine i.v. injection.

These medicines may be affected by prochlorperazine or may affect how well it works. You may need different amounts of your medicine or you may need to take different medicines.

Your doctor and pharmacist can tell you if you are taking any of these medicines. They may also have more information on medicines to be careful with or avoid while taking prochlorperazine.

Other interactions not listed above may also occur.

How to take this medicine

Follow all directions given to you by your doctor or pharmacist carefully.

They may be different to the information in this leaflet.

If you do not understand any written instructions, ask your doctor or pharmacist for help.

How much to take

Your doctor or pharmacist will tell you how many you will need to take. This depends on your condition and whether or not you are taking any other medicines.

The usual recommended dose for nausea and vomiting in adults is 1 or 2 tablets two to three times daily.

The usual recommended dose for dizziness in adults is 1 or 2 tablets three to four times daily. This may gradually be reduced to 1 or 2 tablets once a day.

Children are usually given lower doses which depend on their body weight.

If you have liver problems you may take a smaller dose.

Do not stop taking your medicine or change your dosage without first checking with your doctor.

How to take it

Swallow APO-Prochlorperazine tablets whole with a glass of water. Do not chew the tablets.

When to take it

Take it at about the same time each day.

Taking your medicine at the same time each day will have the best effect. It will also help you remember when to take it.

It does not matter if you take it before, with or after food.

How long to take it for

Continue taking your medicine for as long as your doctor tells you.

Make sure you have enough to last over weekends and holidays.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Do not try to vomit.

Immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 for Australia) for advice, or go to the Accident and Emergency Department at the nearest hospital, if you think that you or anyone else may have taken too much prochlorperazine.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too much prochlorperazine, you may get some or all of the following:

  • coma
  • restlessness, shaking, muscle twitching, muscle weakness, spasm
  • confusion
  • excitement or agitation
  • low blood pressure
  • fast heart beat
  • decrease in body temperature
  • small pupils in the eye
  • difficulty in swallowing or breathing
  • blue lips and/or skin

While you are taking prochlorperazine

Things you must do

Tell your doctor immediately if you notice any uncontrolled movements of the tongue, face, mouth or jaw, such as puffing of the cheeks, puckering of the mouth or chewing movements. These are symptoms of a very rare condition called Tardive Dyskinesia, which may develop in people taking phenothiazine medicines, including prochlorperazine.

The condition is more likely to occur during long term treatment with prochlorperazine, especially in elderly women. In very rare cases, this may be permanent.

Tell any other doctors, dentists, and pharmacists who are treating you that you are taking prochlorperazine.

Tell your doctor immediately if you become pregnant.

If you are about to have any blood tests, tell your doctor that you are taking this medicine.

Go to your doctor regularly for a check-up.

Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects.

Tell your doctor if you are planning to have surgery and you are taking this medicine.

If you have diabetes or are at risk of developing diabetes be sure to monitor your blood glucose levels carefully. This medicine may affect blood glucose levels.

Things you must not do

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Do not take your medicine to treat any other condition unless your doctor or pharmacist tells you to.

Do not stop taking your medicine, or change the dosage, without checking with your doctor.

Things to be careful of

Be careful while driving or operating machinery until you know how prochlorperazine affects you. Prochlorperazine may cause dizziness, light-headedness, tiredness, drowsiness in some people.

Make sure you know how you react to prochlorperazine before you drive a car, operate machinery, or do anything else that could be dangerous if you are tired, drowsy, dizzy or light-headed. If this occurs do not drive. If you drink alcohol, drowsiness, dizziness or light-headedness may be worse.

If prochlorperazine makes you feel light-headed, dizzy or faint, be careful when getting up from a sitting or lying position. Getting up slowly may help.

Be careful when drinking alcohol while taking prochlorperazine. Combining prochlorperazine and alcohol can make you more sleepy, dizzy or light-headed. Your doctor may suggest you avoid alcohol while you are being treated with prochlorperazine.

If outdoors, wear protective clothing and use at least a 15+ sunscreen. Prochlorperazine may cause your skin to be much more sensitive to sunlight than it is normally. Exposure to sunlight may cause a skin rash, itching, redness, or even severe sunburn. If your skin does appear to be burning, tell your doctor.

Make sure you keep cool in hot weather and keep warm in cool weather. Prochlorperazine may affect the way your body reacts to temperature changes. For example if you swim in cold water you body may not be able to adjust your body temperature to keep you warm and you may get hypothermia.

Side effects of prochlorperazine

All medicines may have some unwanted side effects. Sometimes they are serious, but most of the time, they are not. Your doctor has weighed the risks of using this medicine against the benefits they expect it will have for you.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking prochlorperazine.

Ask your doctor or pharmacist to answer any questions you may have.

Following is a list of possible side effects. Do not be alarmed by this list. You may not experience any of them.

Tell your doctor or pharmacist if you notice any of the following and they worry you.

  • Constipation, dry mouth
  • drowsiness
  • restlessness, twitching
  • trembling, rigid posture, mask-like face, slow movements and a shuffling unbalanced walk
  • blurred vision

The above list includes the more common side effects. Mostly, these are mild.

Tell your doctor as soon as possible if you notice any of the following.

  • tardive dyskinesia, a reaction to some medicines with uncontrollable twitching or jerking movements of the face, tongue, mouth, jaw, arms and legs
  • low blood pressure
  • swelling of the hands, ankles or feet
  • dermatitis, skin rash, hives, sunburn after only a small time in the sun, flaking skin, red, itchy spots, unusual skin pigmentation
  • sudden uncoordinated movements
  • signs of frequent infections such as fever, chills, sore throat or mouth ulcers
  • feeling tired due to lowered levels of blood cells
  • night blindness, worsening sight
  • unusual secretion of breast milk
  • breast enlargement
  • for females: changes in periods
  • for males: problems ejaculating
  • severe pain in the stomach with bloating, cramps and vomiting
  • difficulty passing urine
  • yellowing of the skin and/or eyes (jaundice)
  • headache
  • insomnia
  • high or low blood sugar levels
  • confusion, excitement or agitation
  • trance-like state
  • raised body temperature

These may be serious side effects. You may need medical attention. Most of these side effects are rare.

If any of the following happen, do not take any more of your medicine and either tell your doctor immediately or go to Accident and Emergency department at your nearest hospital:

  • unusual muscle tone or spasms causing distortion of the body in children
  • neuroleptic malignant syndrome, a reaction to some medicines with a sudden increase in body temperature, extremely high blood pressure and severe convulsions
  • blood clots - for example, red, painful swollen areas in the leg; or clots in the lung seen by sudden breathlessness, coughing up blood cough or pain when breathing
  • other problems breathing, blue lips and/or skin
  • changes in heart rate or rhythm
  • seizures
  • coma
  • an allergic reaction, which may have some or all of the following symptoms: cough, shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting, hayfever-like symptoms

These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are usually very rare.

Other side effects not listed above may occur in some patients.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

After taking this medicine

Storage

Keep your medicine in its original packaging until it is time to take it. If you take your medicine out of its original packaging it may not keep well.

Keep your medicine in a cool dry place where the temperature will stay below 25°C. Protect your medicine from light.

Do not store your medicine, or any other medicine, in the bathroom or near a sink.

Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

If your doctor or pharmacist tells you to stop taking this medicine or it has passed its expiry date, ask your pharmacist what to do with any medicine that is left over.

Where to go for further information

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.

Product description

What APO-PROCHLORPERAZINE looks like

APO-Prochlorperazine 5 mg tablets:
White, round and marked with "5".
Available in blister packs of 25 14, 25, 28, 56, 84, 100 and 250 tablets.

Ingredients

Each tablet contains 5 mg of prochlorperazine maleate as the active ingredient.

It also contains the following inactive ingredients:

  • Lactose
  • Maize starch
  • Colloidal anhydrous silica
  • Magnesium stearate

This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.

Australian Registration Numbers

  • APO-Prochlorperazine 5 mg tablets (blisters):
    AUST R 158416

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113

Apotex Pty Ltd is the licensee of the registered trade marks APO and APOTEX from the registered proprietor, Apotex Inc.

This leaflet was last updated in:
June 2012.

Published by MIMS April 2013

Consumers should be aware that the information provided by the Consumer Medicines Information (CMI) search (CMI Search) is for information purposes only and consumers should continue to obtain professional advice from a qualified healthcare professional regarding any condition for which they have searched for CMI. CMIs are provided by MIMS Australia. CMI is supplied by the relevant pharmaceutical company for each consumer medical product. All copyright and responsibility for CMI is that of the relevant pharmaceutical company. MIMS Australia uses its best endeavours to ensure that at the time of publishing, as indicated on the publishing date for each resource (e.g. Published by MIMS/myDr January 2007), the CMI provided was complete to the best of MIMS Australia's knowledge. The CMI and the CMI Search are not intended to be used by consumers to diagnose, treat, cure or prevent any disease or for any therapeutic purpose. Cirrus Media Pty Limited, its servants and agents shall not be responsible for the continued currency of the CMI, or for any errors, omissions or inaccuracies in the CMI and/or the CMI Search whether arising from negligence or otherwise or from any other consequence arising there from.

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