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APO-Prochlorperazine Nausea Relief

Contains the active ingredient, prochlorperazine (as maleate)
Consumer Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about APO-Prochlorperazine Nausea Relief. It does not contain all the information that is known about APO-Prochlorperazine Nausea Relief. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What this medicine is used for

The name of your medicine is APO-Prochlorperazine Nausea Relief. It contains the active ingredient, prochlorperazine (as prochlorperazine maleate).
It is used to treat nausea associated with migraine (throbbing headache, usually affecting one side of the head, and often accompanied by nausea, vomiting and sensitivity to light).
Ask your doctor or pharmacist if you have any questions about why this medicine has been selected for you.

How it works

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.

Use in children

APO-Prochlorperazine Nausea Relief tablets should not be given to adolescents or children under 18 years of age.

Before you take this medicine

When you must not take it

Do not take this medicine if:
You are under 18 years of age.
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.
The expiry date (EXP) printed on the pack has passed.
The packaging is torn, shows signs of tampering or it does not look quite right.
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.

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.

2. 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) or a family history of these problems
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.

3. You have lost lots of fluid due to vomiting, diarrhoea or sweating (which increases the chance of having low potassium levels).

4. You are currently pregnant or you plan to become pregnant.

Prochlorperazine can affect your baby and 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.

5. You are currently breastfeeding or you plan to breastfeed.

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 breastfeeding, your doctor or pharmacist will discuss with you the benefits and risks of using it.

6. You are planning to have surgery which requires a spinal and/or general anaesthetic.

7. 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.

Make sure to tell your doctor or pharmacist all of your symptoms, in case taking this medicine covers up any undiagnosed problem.
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
antipsychotics (medicines used to treat certain mental or emotional conditions)
stimulant laxatives containing, for example, bisacodyl or senna
methadone, a strong painkiller
some anti-inflammatory drugs such as steroid medicines (glucocorticoids).
If you are taking any of these you may need a different dose or you may need to take different medicines.
Other medicines not listed above may also interact with prochlorperazine.

How to take this medicine

Follow all directions given to you by your doctor or pharmacist carefully. Their instructions may be different to the information in this leaflet.

How much to take

Adults 18 years and over
For the treatment of nausea associated with migraine, take one or two tablets, two or three times a day if necessary.
Do not use in adolescents or children under 18 years of age.

How to take it

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

If you take too much (overdose)

Do not try to vomit.
If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively, go to the Accident and Emergency department at your nearest hospital.
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 this medicine

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 some 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 your doctor or pharmacist that you are taking this medicine if:
You become pregnant
You are breastfeeding
You are about to have any blood tests
You are planning to have surgery, dental work or an anaesthetic and you are taking this medicine.
Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you experience the following symptoms, which may be due to a serious reaction called neuroleptic malignant syndrome.
Sudden increase in body temperature
Stiff muscles
Fast heart beat
Altered mental state
Excessive sweating
Difficulty in breathing
Tell any other doctors, dentists, and pharmacists who are treating you that you are taking prochlorperazine.
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.
Take your medicine to treat any other condition unless your doctor or pharmacist tells you to.

Things to be careful of

Do not drive or operate machinery until you know how prochlorperazine affects you.
Prochlorperazine may cause dizziness, light-headedness, tiredness, drowsiness in some people.
Be careful when drinking alcohol while taking prochlorperazine. Combining prochlorperazine and alcohol can make you more sleepy, dizzy or light-headed.
Your doctor or pharmacist may suggest you avoid alcohol while you are being treated with prochlorperazine.
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.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 or pharmacist.
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 your body may not be able to adjust your body temperature to keep you warm and you may get hypothermia.

Possible side effects

Tell your doctor as soon as possible if you do not feel well while you are taking prochlorperazine.
Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Tell your doctor or pharmacist if you notice any of the following:
constipation, dry mouth
drowsiness
headache
restlessness, twitching
trembling, rigid posture, mask-like face, slow movements and a shuffling unbalanced walk
blurred vision
Tell your doctor as soon as possible if you notice any of the following.
These may be serious side effects and you may need medical attention:
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)insomnia
high or low blood sugar levels
confusion, excitement or agitation
trance-like state
raised body temperature
If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
These are very serious side effects and you may need urgent medical attention or hospitalisation:
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.
Other side effects not listed above may occur in some patients.

Allergic reactions

If you think you are having an allergic reaction to prochlorperazine, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
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
hay fever-like symptoms.

Storage and disposal

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 the medicine 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, your pharmacist can dispose of the remaining medicine safely.

Product description

What APO-PROCHLORPERAZINE NAUSEA RELIEF looks like

APO-Prochlorperazine Nausea Relief 5 mg tablets:
White to off-white, circular, uncoated tablets with '5' embossed on one side.
Available in blister packs of 5 and 10 tablets.
* Not all strengths, pack types and/or pack sizes may be available.

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 Nausea Relief 5 mg tablets (blisters):
AUST R 186540.

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
APO and APOTEX are registered trade marks of Apotex Inc.
This leaflet was last updated in:
May 2015.