Consumer medicine information

Chlorpromazine Mixture & Chlorpromazine Mixture Forte

Chlorpromazine 25mg/5mL, 100mg/10mL


Consumer Medicine Information

What is in this leaflet?

Please read this leaflet carefully before you take Chlorpromazine Mixture.

This leaflet answers some common questions about Chlorpromazine Mixture. It does not contain all the available information.

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

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

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

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

What is Chlorpromazine Mixture used for?

The brand name of your medicine is Chlorpromazine Mixture. The active ingredient in Chlorpromazine Mixture is called chlorpromazine hydrochloride.

Chlorpromazine Mixture belongs to a group of medicines called antipsychotics. It helps to correct chemical imbalances in the brain, which may cause mental illness or behavioral disturbances.

Chlorpromazine Mixture is used to treat a number of conditions and may be used either for a short time or for a long time. It is used to treat schizophrenia, mania or psychotic depression; agitation or behavioral disturbances in patients with delirium or dementia; agitation and severe depression; and in the management of terminal illness to enhance the effect of other drugs and to control nausea and vomiting. It is also used to control hiccoughs that do not respond to other treatments.

Your doctor may have prescribed Chlorpromazine Mixture for another use. Ask your doctor if you have any questions about why Chlorpromazine Mixture has been prescribed for you.

There is no evidence that Chlorpromazine Mixture is addictive.

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

Chlorpromazine Mixture is not recommended for children under 1 year of age as there is not enough information on its use in that age group.

Before you take Chlorpromazine Mixture

Do not take if:

You must not take Chlorpromazine Mixture if you have an allergy to:

  • Chlorpromazine hydrochloride or other phenothiazines (medicines related to chlorpromazine)
  • Any of the ingredients listed at the end of this leaflet (See “Ingredients”)

Symptoms of an allergic reaction to Chlorpromazine Mixture may include:

  • Shortness of breath, wheezing or difficulty breathing
  • Swelling of the face, lips, tongue or other parts of the body
  • Skin rash, itching or hives

You must not take Chlorpromazine Mixture if you have had any of the following medical conditions:

  • A low white blood cell count
  • Phaecromocytoma, a rare tumour of the adrenal gland which is near the kidneys
  • Breast cancer

Chlorpromazine Mixture should not be used in people who have severe circulatory problems, severe heart disease, severe liver disease, reduced brain activity or blood imbalances.

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

Do not take Chlorpromazine Mixture after the expiry date (EXP) printed on the bottle.

Do not take Chlorpromazine Mixture if the packaging is damaged or shows signs of tampering.

Do not take Chlorpromazine Mixture which has not been properly stored.

If the bottle of Chlorpromazine Mixture has expired or is damaged, return it to your pharmacist for disposal.

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

Tell your doctor if:

You must tell your doctor if:

  • You have had an allergic reaction to similar medicines (ask your doctor to check your records)
  • You are pregnant or intend to become pregnant.
    Like most antipsychotic medicines, Chlorpromazine Mixture is not recommended for use during pregnancy. Your doctor will discuss with you the possible risks and benefits of using Chlorpromazine Mixture during pregnancy
  • You are breast feeding, or wish to breastfeed.
    It is recommended that you do not breastfeed while taking Chlorpromazine Mixture. This medicine may pass into the breast milk and there is a possibility that your baby may be affected. Your doctor will discuss with you the possible risks and benefits of using Chlorpromazine Mixture during breastfeeding.
  • You are likely to be exposed to very hot or very cold temperatures
  • You have received a radiological procedure in the last 24 hours or your doctor is planning to give you one in the next 48 hours.
  • You have any other medical conditions, especially the following:
    – epilepsy
    – Parkinson’s disease
    – decreased thyroid activity
    – prostate problems
    – low blood pressure
    – glaucoma (high pressure in the eye)
    – muscle weakness, especially of the eyes
    – breathing difficulties (e.g. asthma, emphysema)
    – a disease of the blood with a reduced number of red or white cells or platelets
    – kidney problems
    – liver diseases
    – heart disease
    – low blood calcium levels
    – Neuroleptic Malignant Syndrome (a reaction to some medicines, causing a sudden increase in body temperature with sweating, fast heart beat, muscle stiffness, fluctuation in blood pressure and convulsions)
    – Tardive Diskinesia (a reaction to some medicines, with worm-like movements of the tongue or other uncontrollable movements of the tongue, mouth, cheeks or jaws, sometimes progressing to the arms and legs)

If you have not told your doctor about any of the above, tell your doctor before you take Chlorpromazine Mixture.

Taking other medicines:

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

In particular, tell your doctor if you are taking any of the following medicines:

  • Alcohol
  • Benzodiazepines and other medicines used to treat anxiety or to help you sleep
  • Strong pain killers e.g. morphine
  • Anticonvulsants, medicines used to control epilepsy e.g. phenytoin, valproic acid
  • Medicines used to control depression e.g. imipramine, monoamine oxidase inhibitors (e.g. phenelzine)
  • Medicines used to control mood swings e.g. lithium
  • Antipsychotic medicines, used to treat mental illnesses
  • Medicines used to treat high blood pressure (hypertension) and heart conditions
  • Medicines used to treat fast or irregular heart beats (arrhythmia)
  • Medicines used to treat Parkinson’s Disease
  • Anticholinergic medicines, used to prevent travel sickness, relieve stomach cramps or treat Parkinson’s Disease
  • Medicines used to treat indigestion and heartburn e.g. antacids
  • Medicines used to treat diabetes
  • Medicines used to treat hayfever, coughs and colds
  • Adrenaline, a medicine used in emergency situations
  • Medicines to treat an overactive thyroid gland (including carbimazole and propylthiouracil)
  • Medicines used in radiological procedures, eg metrizamide, iohexol
  • Medicines used to prevent or treat malaria
  • Warfarin, and other medicines used to prevent blood clots

Some medicines may affect the way other medicines work. They may also react with Chlorpromazine Mixture resulting in untoward or sometimes dangerous side effects. Your doctor or pharmacist will be able to tell you which medicines are safe to take with Chlorpromazine Mixture.

This list is not exhaustive. Your doctor or pharmacist has more information on medicines to be careful with or to avoid while taking Chlorpromazine Mixture.

In future, before you start to take any other medicines, tell your doctor or pharmacist that you are taking Chlorpromazine Mixture.

How do I take Chlorpromazine Mixture?

Follow your doctor’s instructions about how to take Chlorpromazine Mixture.

Read the directions label of your Chlorpromazine Mixture carefully. If you have any concerns about how to take Chlorpromazine Mixture, talk to your doctor or pharmacist.

How much to take:

The usual adult starting dose is 25mg three times a day. The dose can be gradually increased to 100mg three times a day. In many cases, such doses will achieve the required effect, however some patients may require higher doses.

If you have heart, kidney or liver disease, are prone to seizures (fits) or are elderly, your doctor may start you on a lower dose and increase it more gradually to prevent untoward side effects.

Children over 1 year of age will be given a lower dose.

Your doctor or pharmacist will tell you how much Chlorpromazine Mixture you will need to take each day.

How to take it:

Shake the bottle well and accurately measure the dose with a medicine measure.

Shaking the bottle and using a medicine measure will make sure that you get the correct dose. You can buy a medicine measure from your pharmacist.

Take your mixture at about the same time each day. It will also help you to remember when to take it.

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

It is best to take Chlorpromazine Mixture before food.

How long to take it for:

Keep taking your Chlorpromazine Mixture for as long as your doctor tells you.

Chlorpromazine Mixture helps to control your condition, but does not cure it. Therefore, it is important that you keep taking Chlorpromazine Mixture every day. Your doctor will check your progress to make sure the medicine is working and will discuss with you how long your treatment should continue.

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 try and make up for the dose that you missed by taking more than one dose at a time. 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 you medicine, ask your pharmacist for some hints.

What do I do if I take too much? (Overdose)

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

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

Keep telephone numbers for these places handy.

Signs of overdose include drowsiness, confusion, restlessness, excitement, breathing difficulties, fast heart rate and muscle twitching.

While you are taking Chlorpromazine Mixture

Things you must do:

Tell your doctor if, for any reason, you have not taken your medicine exactly as directed.

Otherwise, your doctor may think that it was not working as it should and change your treatment unnecessarily.

Tell your doctor immediately if you notice any worm-like movements of the tongue, or other uncontrolled movements of the tongue, mouth, cheeks, or jaw, which may progress to the arms and legs.

These are symptoms of a condition called tardive dyskinesia, which may develop in people taking antipsychotic medicines, including Chlorpromazine Mixture.

This condition is more likely to occur during long term treatment with Chlorpromazine Mixture, especially in elderly women. In very rare cases, this may be permanent. However, if detected early, these symptoms are usually reversible.

Tell your doctor immediately if you develop a fever or a sore throat after you start taking Chlorpromazine Mixture.

Tell your doctor immediately if you become pregnant while taking Chlorpromazine Mixture.

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

If you are about to be started on any new medicines, remind you doctor, dentist or pharmacist that you are taking Chlorpromazine Mixture.

Your doctor will check your progress and may want to take some blood/ eye/ skin tests from time to time. This helps to prevent unwanted side effects.

Things you must not do:

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

Do not use Chlorpromazine Mixture to treat any other complaints unless your doctor says to.

Do not stop taking Chlorpromazine Mixture, or lower the dosage, even if you are feeling better, without checking with your doctor.

If you stop taking Chlorpromazine Mixture 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 Chlorpromazine Mixture you take each day before stopping the medicine completely.

Things to be careful of:

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

As with other antipsychotic medicines, Chlorpromazine Mixture may cause drowsiness in some people. Make sure you know how you react to Chlorpromazine Mixture before you drive a car, operate machinery, or do anything else that could be dangerous.

If Chlorpromazine Mixture makes you feel light-headed or faint, be careful when getting up from a sitting or lying position.

Getting up slowly may help. This will allow your body to get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.

Be careful when drinking alcohol while taking Chlorpromazine Mixture.

Chlorpromazine Mixture can increase the drowsiness caused by alcohol.

If outdoors, wear protective clothing and use at least a 15+ sunscreen. Do not use a sun lamp or tanning bed or booth.

Chlorpromazine Mixture may cause your skin to become much more sensitive to sunlight than it is normally. Exposure to sunlight may cause a skin rash, itching, redness, or severe sunburn. If your skin does appear to be burning, tell your doctor immediately.

Make sure you keep cool in hot weather and keep warm in cold weather.

Chlorpromazine Mixture may affect the way your body reacts to temperature changes.

What are the side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Chlorpromazine Mixture, even if the problem is not listed below.

Like other medicines, Chlorpromazine Mixture can sometimes cause unwanted 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 get any unwanted side effects, tell your doctor or pharmacist.

MILD EFFECTS

Tell your doctor if you notice any of the following that are troublesome or ongoing, and they worry you:

  • drowsiness or sedation (especially early on in the treatment)
  • constipation
  • dry mouth
  • stuffy nose
  • blurred vision
  • agitation, excitement and aggravation
  • confusion
  • painful, swollen breasts, or breast enlargement in men.
  • impotence
  • unusual secretion of breast milk
  • menstrual changes
  • nausea and/ or vomiting
  • loss of blood sugar control, including in diabetes
  • weight gain

These are more common side effects of Chlorpromazine Mixture. They are usually mild and in some cases short-lived.

MORE SERIOUS EFFECTS

Tell your doctor immediately if you notice any of the following:

  • low blood pressure (dizziness or faintness) or low blood pressure on standing up
  • muscle stiffness or weakness
  • skin reactions or colourations
  • difficulty in urinating
  • symptoms of sunburn (such as redness, itching, swelling or blistering of the skin) which occur more quickly than normal.

These may be serious side effects. You may need urgent medical attention.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:

  • sudden signs of allergy such as a rash, itching or hives on the skin; swelling of the face, lips, tongue or other parts of the body; wheezing or troubled breathing
  • convulsion, fits or seizures
  • sudden increase in body temperature, with sweating, fast heart beat, muscle stiffness and fluctuating blood pressure which may lead to coma (neuroleptic malignant syndrome)
  • collapse
  • unwanted movement of the mouth, tongue, jaw, cheeks, or arms and legs
  • fever, sore throat, mouth ulcers, ‘flu-like’ symptoms (chills, aching joints, swollen glands, lack of energy) or other signs of infection
  • fast or irregular heart beat
  • extremely high body temperature (fever)
  • signs that blood clots may have formed, such as sudden severe headache, sudden loss of coordination, blurred vision or sudden loss of vision, slurred speech, numbness in an arm or leg
  • yellowing of the eyes or skin

These are very serious side effects. You may need urgent medical attention or hospitalisation. Life threatening reactions can include coma and even death. These side effects are rare.

OTHER EFFECTS

There are also some side effects which you may not see. These include changes in hormone levels, eyesight, liver, blood cell count and blood pressure.

Please note that during your treatment with Chlorpromazine Mixture, your doctor may from time to time test your blood and eyes to look for any side effects which the medication could cause. Your doctor or pharmacist will have more information. Your doctor or pharmacist should discuss the possible side effects of Chlorpromazine Mixture with you.

This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

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

How do I store Chlorpromazine Mixture?

Storage:

Chlorpromazine Mixture should be stored in a safe place where children cannot reach it A locked cupboard at least one-and-a-half meters above the ground is a good place to store medicines.

Keep your Chlorpromazine Mixture in its bottle until it is time to take it.

Chlorpromazine Mixture should be stored below 25°C and kept away from light.

Do not leave Chlorpromazine Mixture in the car or on windowsills. Do not store medicines in the bathroom or near a sink. Heat and dampness can destroy some medicines.

Disposal:

If your doctor tells you to stop taking Chlorpromazine Mixture, ask your pharmacist what to do with any mixture that is left over.

Product Description

What it looks like:

Chlorpromazine Mixture 25mg/5mL
A 5mg per mL, almost clear solution. The solution is slightly viscous and is sticky. It comes in 500mL bottles.

Chlorpromazine Mixture Forte 100mg/10mL
A 10mg per mL, colourless mixture. The mixture has a hazy appearance and has a peppermint odour. It comes in 500mL bottles.

Ingredients:

Chlorpromazine Mixture 25mg/5mL

Active Ingredient:

Chlorpromazine hydrochloride

Inactive Ingredients:

  • Saccharin sodium
  • Chloroform
  • Ethanol
  • Glycerol
  • Sorbitol solution (70 per cent) (non crystallising)
  • Citric acid – anhydrous
  • Ascorbic acid
  • Water – purified
  • Natural peppermint flavour 07-7686

Chlorpromazine Mixture Forte 100mg/10mL

Active Ingredient:

Chlorpromazine hydrochloride

Inactive Ingredients:

  • Saccharin sodium
  • Methyl hydroxybenzoate
  • Ethanol
  • Glycerol
  • Sorbitol solution (non-crystallising)
  • Citric acid – anhydrous
  • Ascorbic acid
  • Water – purified
  • Natural peppermint flavour 07-7686

Where to go to 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.

Sponsor

Chlorpromazine Mixture is supplied in Australia by:

ORION Laboratories Pty Ltd
25 – 29 Delawney Street
Balcatta WA 6021

Australian Registration Number

Chlorpromazine Mixture 25mg/5mL: AUST R 21145

Chlorpromazine Mixture Forte 100mg/10mL: AUST R 11347

This leaflet was prepared in September 2003

Date of last amendment:
14th June 2006

Code: CHL01376_2_CMI

Published by MIMS November 2017