APO-Prochlorperazine Nausea Relief

APO-PROCHLORPERAZINE NAUSEA RELIEF TABLETS

Contains the active ingredient, prochlorperazine (as maleate)

Consumer Medicine Information

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 or pharmacist 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.

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.

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.

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

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 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.

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

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.

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

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

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.

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.

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.

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.

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.

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.

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.

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.

APO-Prochlorperazine Nausea Relief 5 mg tablets (blisters):

AUST R 186540.

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.