Procalm

Procalm

Active ingredient(s): prochlorperazine maleate

---

Consumer Medicine Information (CMI)

This leaflet provides important information about using Procalm. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Procalm.

Where to find information in this leaflet:

1. Why am I using Procalm?
2. What should I know before I use Procalm?
3. What if I am taking other medicines?
4. How do I use Procalm?
5. What should I know while using Procalm?
6. Are there any side effects?
7. Product details

1. Why am I using Procalm?

Procalm contains the active ingredient prochlorperazine. Procalm belongs to a group of medicines called phenothiazines.

It helps to correct chemical imbalances in the brain, allowing 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 Procalm for another reason. Ask your doctor if you have any questions about why Procalm has been prescribed for you.

2. What should I know before I use Procalm?

Warnings

Do not use Procalm if:

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

Check with your doctor if you:

• you have allergies to any other medicines or any other
• substances, such as foods, preservatives or dyes.
• have any other 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 usually 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
  – symptoms of Reye’s syndrome in children such as diarrhoea, rapid breathing vomiting and severe fatigue
  – chicken pox or measles in children
  – dehydration in children

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

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. See additional information under Section 6. Are there any side effects?

Use in children

Do not use in children less than 2 years of age or weighing less than 10 kg.

Do not use Procalm intramuscular injection in children.

Pregnancy and breastfeeding

Use of Procalm is not recommended during pregnancy.

Check with your doctor if you are a woman of childbearing age and not using effective contraception, or if you are pregnant, might become pregnant or think you may be pregnant. If there is a need to take Procalm during your pregnancy, your doctor will discuss with you the benefits and risks of using it.

Use of Procalm is not recommended during breastfeeding. If you are breastfeeding or planning to breastfeed, talk to your doctor about using Procalm.

It is recommended that you do not breastfeed while taking Procalm, as it is not known whether Procalm passes into breast milk.

3. What if I am taking other medicines?

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

Some medicines may interfere with Procalm and affect how 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
• medicines used for cancer such as procarbazine
• 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 build-up in your body
• medicines used to treat a fast or irregular heart beat e.g. amiodarone, quinidine, disopyramide.
• medicines that can slow your heart beat 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

These medicines may be affected by Procalm 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 will advise you.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Procalm.

4. How do I use Procalm?

How much to use

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.

Adults’ dose:

• 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.
• Follow the instructions provided and use Procalm until tor tells you to stop.

Children’s dose:

• The recommended dose for nausea, vomiting and dizziness is 1 tablet two to three times a day.
• Follow the instructions provided and use Procalm until your doctor tells you to stop.

When to use Procalm

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

How to use Procalm

Tablets:

• Swallow Procalm tablets whole with a full glass of water.
• Do not chew the tablets.

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

If you use too much Procalm

If you think that you have used too much Procalm, you may need urgent medical attention.

Do not try to vomit.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning. Your doctor or pharmacist has information on how to recognise and treat an overdose. Ask your doctor or pharmacist if you have any concerns.

5. What should I know while using Procalm?

Things you should do

• 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 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.

Call your doctor straight away 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 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.
• become pregnant while taking Procalm.

Things you should not do

• Do not give Procalm to anyone else, even if they have the same condition as you.
• Do not take Procalm to treat any other complaints unless your doctor or pharmacist tells you to.
• Do not stop taking Procalm, or lower the dosage, even if you are feeling better, without checking with your doctor.
• Do not stop taking Procalm suddenly. If you do, 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.
• Do not take any medicines that cause drowsiness while you are taking Procalm.

Sun exposure

• Procalm may cause your skin to be much more sensitive to sunlight than it is normally. It is advised to avoid exposure to direct sunlight during treatment.
• If outdoors, wear protective clothing and use at least a 15+ sunscreen.
• Exposure to sunlight may cause a skin rash, itching, redness, or 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.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Procalm affects you.

Procalm may cause drowsiness, dizziness and blurred vision. If this occurs do not drive.

Drinking alcohol

Tell your doctor if you drink alcohol.

Be careful when drinking alcohol while taking Procalm. If you drink alcohol, dizziness, drowsiness or light-headedness may be worse.
Your doctor may suggest you avoid alcohol while you are being treated with Procalm.

Looking after your medicine

• Keep Procalm tablets in a cool dry place where the temperature stays below 30°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 well.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. Procalm helps most people with nausea, vomiting and dizziness, but it may have unwanted side effects in a few people. If you are over 65 years of age, you may have an increased chance of getting side effects.

If you do experience any side effects, do not stop taking Procalm without first talking to your doctor or pharmacist. Most side effects are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects

What to do

Gastrointestinal or gut related: constipation dry mouth Central nervous system related: drowsiness restlessness trembling, rigid posture, mask-like face, slow movements and a shuffling unbalanced walk uncontrollable twitching, jerking or writhing movements Vision or eye related: blurred vision Cardiovascular or heart related: 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

Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

Allergic reaction related (that can occur either immediately or within several days of drug administration) that may be life-threatening): shortness of breath, wheezing or difficulty in breathing or swallowing swelling of the face, lips, throat, tongue or other parts of the body cold, clammy skin, palpitations, dizziness, weakness or fainting rash, itching or hives on the skin Musculoskeletal related: unusual muscle tone or spasms causing distortion of the body in children General: sudden increase in body temperature, extremely high blood pressure and severe convulsions. hypersensitivity, fever, rash, facial swelling, swollen lymph nodes (which could be symptoms relating to raised levels of infection fighting cells (relating to eosinophilia) Nervous system related: high fever, muscle cramps or stiffness, dizziness, severe headache, fast heartbeat, confusion, agitation, hallucinations, or are sweating a lot (symptoms relating to Neuroleptic malignant syndrome). Liver related: yellowing of the skin and/or eyes (jaundice) and urine becomes darker in color Blood related: bleeding and bruising (thrombocytopenic purpura)

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

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

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/reporting-problems. 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 stop taking any of your medicines.

7. Product details

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

What Procalm tablets contains

Active ingredient (main ingredient)	prochlorperazine maleate 5 mg
Other ingredients (inactive ingredients)	lactose monohydrate maize starch colloidal anhydrous silica magnesium stearate

This medicine contains sugars as lactose.

Do not take this medicine if you are allergic to any of these ingredients.

What Procalm looks like

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

Each pack contains 25 tablets (AUST R 158415).

Who distributes Procalm

Procalm is supplied in Australia by:
Arrow Pharma Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121

This leaflet was prepared in November 2023.