PROCALM

prochlorperazine maleate

---

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about PROCALM. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.

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

If you have any concerns about taking this medicine, talk to your doctor or pharmacist.

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

What PROCALM is used for

PROCALM 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.

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

Your doctor may have prescribed this medicine for another reason.

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

PROCALM is available only with a doctor’s prescription.

This medicine is not recommended for use in children (under the age of 2 years or children under 10 kg in weight) because children may develop unusual face and body movements

Before you take it

When you must not take it

Do not take PROCALM if you have an allergy to:

• prochlorperazine
• the group of medicines called phenothiazines
• any of the ingredients listed at the end of this leaflet.
  Always check the ingredients to make sure you can use this medicine

Symptoms of an allergic reaction to PROCALM may include:

• shortness of breath, wheezing or difficulty in breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin.

You should not take PROCALM if you have any of the following medical conditions:

• shock
• disease of the blood with a low number of blood cells
• yellowing of the skin and/or eye, also called jaundice.

PROCALM must not be given to anyone who is unconscious or in a coma.

Do not take any medicines that cause drowsiness while you are taking PROCALM.

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

Do not take it if the packaging is torn or shows signs of tampering.

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

Before you start to take it

Tell your doctor or pharmacist if you have allergies to:

• any other medicines
• any other substances, such as foods, preservatives or dyes.

Tell your doctor if you are pregnant or intend to become pregnant. Like most phenothiazine medicines, PROCALM is not recommended for use during pregnancy. If there is a need to take PROCALM during your pregnancy, your doctor will discuss with you the benefits and risks of using it.

Tell your doctor or pharmacist if you are breastfeeding or plan to breastfeed. It is recommended that you do not breastfeed while taking PROCALM, as it is not known whether this medicine passes into breast milk.

Tell your doctor or pharmacist if you have or have had any medical conditions, especially the following:

• phaechromocytoma, 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
• heart and blood vessel problems, low blood pressure
• blood clots
• liver disease
• prostate problems
• bowel problems
• epilepsy, seizures or fits
• low blood calcium levels
• decreased thyroid activity
• 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
• a reaction to some medicines with uncontrollable twitching or jerking movements of the arms and legs
• dementia
• diabetes
• a low number of white blood cells.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them.

Tell your doctor if you are about to have any surgery which requires a general anaesthetic.

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking PROCALM.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may be affected by PROCALM or may affect how well it works. These include:

• some medicines used to control depression or mood swings or mental illness such as lithium
• medicines metabolised by CYP2D6 enzymes such as amitriptyline
• alcohol
• desferrioxamine, a drug used in iron overdose
• procarbazine, an anticancer drug
• some medicines used to control epilepsy such as phenobarbital and carbamazepine
• antibiotics used to treat infections
• medicines used to treat Parkinson’s disease such as levodopa
• medicines used for the treatment of diabetes
• anticholinergic medicines which are 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 used to prevent your blood from clotting
• medicines used to treat high blood pressure or heart problems such as clonidine, guanethidine and propranolol
• medicines used to treat fluid buildup in your body
• medicines used to treat a fast or irregular heart beat e.g. amiodarone, quinidine, disopyramide
• medicines that can slow your heartbeat e.g. diltiazem, verapamil
• medicines that can reduce potassium levels in the blood e.g. diuretics, laxatives
• other medicines that can affect your heart rate e.g. methadone, pentamidine
• antacids containing magnesium, aluminium and calcium salts, oxides and hydroxides
• adrenaline used for severe allergic reactions
• amfetamine.

Your doctor can tell you what to do if you are taking any of these medicines.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking PROCALM.

How to take it

Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.

How much to take

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

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

How to take it

Swallow PROCALM tablets whole with a glass of water. Do not chew the tablets.

When to take it

It does not matter if you take PROCALM before or after food.

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.

How long to take it for

Continue taking PROCALM for as long as your doctor recommends.

If you take too much (overdose)

Do not try to vomit.

Immediately telephone your doctor or pharmacist or the Poisons Information Centre (13 11 26) or go to Accident and Emergency at your nearest hospital if you think that you, or anyone else, has taken too much PROCALM. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Symptoms of overdose may include 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 skin.

You should do this even if there are no signs of discomfort or poisoning. Your doctor or pharmacist has information on how to recognize and treat an overdose.

Ask your doctor or pharmacist if you have any concerns.

While you are taking it

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 medicine, including PROCALM.

The condition is more likely to occur during long term treatment with PROCALM, 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 PROCALM.

If you are about to be started on any new medicines, tell your doctor, dentist or pharmacist that you are taking PROCALM.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking PROCALM.

If you become pregnant while taking PROCALM, tell your doctor immediately.

Things you must not do

Do not give PROCALM to anyone else, even if they have the same condition as you.

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

Do not stop taking it, or lower the dosage, even if you are feeling better, without checking with your doctor. If you stop taking PROCALM suddenly, your condition may worsen or your chance of getting an unwanted side effect may increase. To prevent this, your doctor may gradually reduce the amount of PROCALM you take each day before stopping completely.

Things to be careful of

Be careful driving or operating machinery until you know how PROCALM affects you.

As with other medicines, PROCALM may cause dizziness, light-headedness, tiredness, drowsiness in some people.

Make sure you know how you react to PROCALM before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed. If this occurs do not drive.

If you drink alcohol, dizziness or light-headedness may be worse.

If PROCALM 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 PROCALM. Combining it with alcohol can make you more sleepy, dizzy or light-headed. Your doctor may suggest you avoid alcohol while you are being treated with PROCALM.

It is advised to avoid exposure to direct sunlight during treatment. If outdoors, wear protective clothing and use at least a 15+ sunscreen. PROCALM 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. PROCALM may affect the way your body reacts to temperature changes.

Side effects

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

This medicine helps most people with nausea, vomiting and dizziness, but it may have unwanted side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. If you are over 65 years of age you may have an increased chance of getting side effects.

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

If you get any side effects, do not stop taking PROCALM without first talking to your doctor or pharmacist. However, some side effects may need medical attention.

Tell your doctor or pharmacist if you notice any of these less serious side effects and they worry you:

• constipation
• dry mouth
• drowsiness
• restlessness
• trembling, rigid posture, mask-like face, slow movements and a shuffling unbalanced walk
• uncontrollable twitching, jerking or writhing movements
• blurred vision
• low blood pressure.

The following side effects are less common:

• changes in heart beats
• swelling of the hands, ankles or feet
• skin rash
• for females: unusual secretion of breast milk, irregular or stopping of periods
• for males: breast enlargement, difficulty in ejaculating, getting or maintaining an erection, or persistent painful erection
• severe pain in the stomach with bloating, cramps and vomiting
• difficulty passing urine
• yellowing of the skin and/or eyes
• headache
• insomnia
• seizures
• agitation
• dizziness
• difficulty in breathing
• brownish deposits in the eyes
• stuffy nose.

If any of the following happen, tell your doctor or pharmacist immediately or go to Accident and Emergency at your nearest hospital:

• unusual muscle tone or spasms causing distortion of the body in children
• shortness of breath, wheezing or difficulty in breathing or swallowing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin
• sudden increase in body temperature, extremely high blood pressure and severe convulsions.

These are very serious side effects. You may need urgent medical attention or hospitalization.

All these side effects are 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.

Other side effects not listed here may occur in some people.

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

Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reportingproblems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to sop taking any of your medicines.

After using it

Storage

Keep PROCALM tablets in a cool dry place where the temperature stays below 25°C. Protect from light.

Keep your PROCALM in the pack until it is time to take them. If you take the tablets out of the pack, they may not keep as well.

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

Do not leave it in the car on hot days or on window sills. 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.

Disposal

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

Product description

What it looks like

PROCALM is a white, round tablet marked with “5”.

Each pack contains 25 tablets.

Ingredients

The active ingredient in PROCALM is prochlorperazine maleate

Each PROCALM tablet contains 5 mg of prochlorperazone maleate.

The tablets also contain:

• lactose monohydrate
• maize starch
• colloidal anhydrous silica
• magnesium stearate.

The medicine contains sugars as lactose.

Supplier

Arrow Pharma Pty Ltd
15 – 17 Chapel Street
Cremorne VIC 3121
Australia

Australian registration numbers:
PROCALM – AUST R 158415

Date of preparation: November 2021.

Published by MIMS January 2022