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CHLORPROMAZINE 25MG/5ML SOLUTION

Active substance(s): CHLORPROMAZINE HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET
CHLORPROMAZINE 25mg / 5ml SOLUTION
Chlorpromazine hydrochloride

3. HOW TO TAKE CHLORPROMAZINE
Always take Chlorpromazine exactly as your doctor has told you. Your doctor will advise you, as the dosage is likely to be increased from the initial dose. You
should check with your doctor if you are not sure about the dose you should take.
This medicine should only be taken by mouth. Shake well before use.
Usual doses are:

Read all of this leaflet carefully before you start taking this medicine
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Adults

1. WHAT CHLORPROMAZINE IS AND WHAT IT IS USED FOR
Chlorpromazine 25mg / 5ml Solution belongs to a group of medicines called phenothiazine neuroleptics, which have a tranquillising effect, reducing anxiety
and tension, stabilising mood swings and controlling aggression. Chlorpromazine is also a short-term treatment for persistent hiccup, and is used in childhood
schizophrenia and autism. Chlorpromazine may also be used to control nausea and vomiting in some patients.

sedatives including alcohol, barbiturates e.g. phenobarbital (used to treat anxiety or fits), benzodiazepines e.g. diazepam (used to treat
nervousness), neuroleptic drugs e.g. haloperidol (used to treat mental conditions)
high blood pressure medication e.g. clonidine, guanethidine, cyclopenthiazide, propranolol, atenolol, nifedipine
anticholinergic drugs e.g. atropine sulphate, procyclidine hydrochloride, benzatropine mesilate (used as a muscle relaxant)
amphetamines, nerve stimulants e.g. dexamphetamine sulphate (used as a stimulant)
adrenaline - for severe allergic reactions
drugs for diabetes e.g. chlorpropamide, metformin hydrochloride, insulin, (doses may need to be increased)
antacids for indigestion, gastritis or ulcers e.g. aluminium hydroxide, sodium bicarbonate, calcium carbonate
drugs used to treat Parkinson's disease e.g. levodopa
lithium used to treat mental illness
desferrioxamine (absorbs excess iron in the body)
prochlorperazine (treats nausea)

Warning: Avoid direct contact with the skin as it may cause dermatitis. If in contact, wash the area thoroughly.
Pregnancy and breast-feeding
Do not use Chlorpromazine if you are pregnant, trying to become pregnant or are breast-feeding. Always speak to your doctor before taking any medicine.
The following symptoms may occur in newborn babies, of mothers that have used Chlorpromazine in the last trimester (last three months of their pregnancy):
shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems and difficulty in feeding. If your baby develops any of these symptoms
you may need to contact your doctor.
Driving and using machines
Chlorpromazine may cause drowsiness at the start of treatment. If you are affected, do not drive or operate machinery until you are sure how this medicine
affects you. Alcohol increases these effects.
Important information about some of the ingredients of this medicine
Chlorpromazine Solution contains:
Ethanol: Each 5ml dose contains 0.02g of ethanol, equivalent to 0.48ml beer, 0.2ml wine. Harmful for those suffering from alcoholism. To be taken into
account in pregnant or breast-feeding women, children and high risk groups such as patients with liver disease, or epilepsy.
Sorbitol (E420): If you have an intolerance to some sugars, contact your doctor before taking this product.
Aspartame (E951): Contains a source of phenylalanine. May be harmful for people with phenylketonuria.
Colour Sunset Yellow (E110): May cause an allergic reaction, and this is more common in people who are also allergic to aspirin.



blood clots in the vein especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through the blood vessels to the
lungs causing chest pain and difficulty breathing. If you notice any of these symptoms seek medical advice immediately.
• liver effects including jaundice (maybe a fever, followed by yellowing of the skin and eyes). Your doctor may stop your treatment.
• skin rashes on contact of Chlorpromazine with the skin, and sensitivity to sunlight, with development of a grey/mauve skin colour.
• fever or infection which may be due to changes in the numbers of white blood cells (agranulocytosis, mild leukopenia). Your doctor may test your blood.
• nerve and muscular effects such as quivering, restlessness, jerking movements, tremor, inability to sit still, exaggerated reflexes, rigidity, unusual posture,
irregular eye movements, disjointed movements.
• in women, irregular or absent periods, spontaneous discharge of milk.
• in men, breast development, as well as impotence.
• fast or irregular heartbeat, increase or instability in blood pressure, difficulty breathing, lightheadedness, heat stroke, feeling cold.
• extremely high body temperatures, heavy sweating, fast heart rate, fast breathing, rapid rise and fall in blood pressure, impaired consciousness, tremor,
stiff muscles and going into a fixed stare (symptoms of neuroleptic malignant syndrome).
• fall in blood pressure when you stand up quickly after sitting down (postural hypotension).
• in elderly people with dementia, a small increase in the number of deaths has been reported for patients taking antipsychotics compared with those not
receiving antipsychotics.
If you suffer any unusual effects not listed, please tell your doctor immediately.
Other side effects include:
• stuffiness in the nose or dry mouth
• sleeplessness, agitation, restlessness or anxiety
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of
this medicine.
5. HOW TO STORE CHLORPROMAZINE
Keep this medicine out of the sight and reach of children. Do not store above 25˚C. Keep container in the outer carton.
Do not use Chlorpromazine after the expiry date which is stated on the label or carton.
The expiry date refers to the last day of that month.
Once opened, the solution must be used within one month. Take any unused product to your pharmacist for safe disposal.
6. FURTHER INFORMATION
What this product contains
• The active ingredient is chlorpromazine hydrochloride 25mg/5 ml.
• The other ingredients are hydroxyethylcellulose, glycerol (E422), sorbitol (E420), hydrochloric acid, aspartame (E951), citric acid monohydrate, Sunset
Yellow (E110), polysorbate 20, ethanol, star anise oil, sodium benzoate (E211), purified water.
What Chlorpromazine looks like and contents of the pack
Chlorpromazine is a clear orange coloured liquid, and is available in amber glass bottles of 100ml, 150ml and 200ml.
Marketing Authorisation Holder and Manufacturer
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland
PL 04917/0036
This leaflet was last updated in 04/2015
220878 P-094/1 MH/DRUGS/AD/091 106152/2

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0.5mg per kg
Initially one third to one half the
bodyweight every 4 to adult dose. The doctor will judge
6 hours (up to 75mg
the amount needed for you.
daily).

You should contact your doctor immediately if you experience any of the following:

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Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, but particularly:





Your doctor will advise. Your doctor will advise.

You should STOP using Chlorpromazine and contact your doctor immediately if you experience a rare allergic reaction, including swelling of the
skin and rashes, difficulty breathing, loss of consciousness, and fever or shock. Do not stop taking your medicine without speaking with your
doctor first.

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in very hot or cold weather, or if you get low blood pressure when you stand up.

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Take special care if you are elderly, particularly:



Initially one third to one half
the adult dose with a gradual
increase in the dose.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Chlorpromazine can cause side effects, although not everybody gets them.

liver or kidney problems
epilepsy
Parkinson's disease
low thyroid activity
heart problems
an enlarged prostate
a benign tumour of the adrenal gland (phaeochromocytoma - non cancerous growths found above the kidneys)
myasthenia gravis disease of the nervous system - symptoms are tiredness and muscle weakness in the face and neck where movement is lessened.

Take Special Care
If you or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots.












Initially one - third to
half the adult dose to
a maximum of 75mg
daily.

If you stop taking Chlorpromazine
Do not stop taking Chlorpromazine without asking your doctor first. Your dose needs to be reduced gradually otherwise you may experience the following
sudden withdrawal symptoms: feeling sick, vomiting, sweating, insomnia, reccurance of psychotic symptoms and involuntary movement disorders.

sensitivity to the phenothiazine group of medicines
narrow angle glaucoma (eye condition)

Tell your doctor if you have



Elderly or debilitated
patients

If you forget to take Chlorpromazine
If you miss a dose, take it as soon as you remember and take any remaining doses for that day at evenly spaced times. Do not take a double dose to make up
for the forgotten dose. Ignore the dose you missed and take it as soon as you remember and carry on as before. If you take more than the stated dose, contact
a doctor immediately or go to your nearest hospital casualty department and take your medicine with you if you can.

Take special care
Do not use Chlorpromazine if you have:



Children 6 - 12 years

If you take more Chlorpromazine than you should
If you have taken more Chlorpromazine than you should, go to your doctor or nearest hospital casualty department immediately.

2. BEFORE YOU TAKE CHLORPROMAZINE
Do not take Chlorpromazine
• if you are allergic (hypersensitive) to chlorpromazine or any of the other ingredients in the product (see Section 6 and end of Section 2).










Children under 1 year Children 1 - 5 years

For schizophrenia, other psychoses, anxiety, childhood schizophrenia and autism:
Initially, 25mg three times a day or
Do not use unless
0.5mg per kg
75mg at bedtime,increasing to a dose
the need is life-saving. bodyweight every 4 to
effective for you (usually 75mg to
6 hours to a maximum
300mg, but could be up to 1g daily).
of 40mg daily
Hiccup:
25 - 50mg three or four times a day.
Your doctor will advise. Your doctor will advise.
Nausea and Vomiting in Serious illness:
10 - 25mg every 4 to 6 hours.
Do not use unless the 0.5mg per kg
need is life-saving.
bodyweight every 4 to
6 hours (up to 40mg
daily).

In this leaflet:
1. What Chlorpromazine is and what it is used for
2. Before you take Chlorpromazine
3. How to take Chlorpromazine
4. Possible side effects
5. How to store Chlorpromazine
6. Further information




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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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