Chlorpromazine 25mg/5ml Solution
PATIENT INFORMATION LEAFLET CHLORPROMAZINE 25mg /5ml SOLUTION Chlorpromazine hydrochloride
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.
In this leaflet:
1.
2.
3.
4.
5.
6.
What Chlorpromazine is and what it is used for
Before you take Chlorpromazine
How to take Chlorpromazine
Possible side effects
How to store Chlorpromazine
Further information
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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.
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).
Take special care
Do not use Chlorpromazine if you have:
• sensitivity to the phenothiazine group of medicines
• narrow angle glaucoma (eye condition)
Tell your doctor if you have
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.
Take special care if you are elderly, particularly:
• in very hot or cold weather, or if you get low blood pressure when you stand up.
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:
• 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.
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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:
|
Adults |
Children under 1 year |
Children 1 - 5 years |
Children 6 -12 years |
Elderly or debilitated patients |
|
For schizophrenia, other psychoses, a Initially, 25mg three times a day or 75mg at bedfime increasing to a dose effective for you (usually 75mg to 300mg, but could be up to 1g daily). |
nxiety, childhood schiz Do not use unless the need is life-saving. |
ophrenia and autism: 0.5mg per kg bodyweight every 4 to 6 hours to a maximum of 40mg daily |
Initially one - third to half the adult dose to a maximum of 75mg daily. |
Initially one third to one half the adult dose with a gradual increase in the dose. |
|
Hiccup: 25 - 50mg three or four times a day. |
Your doctor will advise. | Your doctor will advise. |
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 need is life-saving. |
0.5mg per kg bodyweight every 4 to 6 hours (up to 40mg daily). |
0.5mg per kg bodyweight every 4 to 6 hours (up to 75mg daily). |
Initially one third to one half the adult dose. The doctor will judge the amount needed for you. |
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.
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.
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Chlorpromazine can cause side effects, although not everybody gets them.
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.
You should contact your doctor immediately if you experience any of the following:
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/rnauve 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 :his 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.
S. 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 (Ell0), 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
3inewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland
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