Chloractil
Out of date information, search anotherRead all of this leaflet carefully before you start taking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 or pharmacist.
- 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 side effects become serious please tell your doctor or pharmacist.
PACKAGE LEAFLET: INFORMATION FOR THE USER
CHLORPROMAZINE
10 mg, 25 mg, 50 mg & 100 mg TABLETS
Chlorpromazine Hydrochloride
THIS LEAFLET CONTAINS
1. What Chlorpromazine is for
2. Before you take Chlorpromazine
3. How to take Chlorpromazine
4. Possible side effects
5. How to store Chlorpromazine
6. Further information
1. WHAT CHLORPROMAZINE IS FOR
Chlorpromazine belongs to a group of medicines called phenothiazines. It acts on the brain to calm your emotions.
Chlorpromazine can be used to treat:
• schizophrenia
• feeling or being sick, when you have a terminal illness
• persistent hiccups
• schizophrenia and autism in children
• or to calm your emotions particularly if you feel anxious, agitated, over-excited, violent or dangerously impulsive.
Chlorpromazine can also be used to prevent shivering.
If you are not sure why you have been prescribed this medicine then please ask your doctor.
2. BEFORE YOU TAKE CHLORPROMAZINE
Do not take Chlorpromazine and tell your doctor if you:
• are allergic to chlorpromazine, other phenothiazines (such as prochlorperazine or trifluoperazine) or any other ingredient in Chlorpromazine tablets (listed in section 6). The signs of an allergic reaction can include a rash, itching or shortness of breath
• have a history of blood problems
• have dulled senses such as feeling sleepy or uncoordinated, have blurred vision, slurred speech or are less aware of your surroundings (CNS depression).
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Chlorpromazine.
Take special care with Chlorpromazine
Tell your doctor before you take this medicine if you:
• have heart problems including unusual heart beats, heart disease or heart failure
• have lung and breathing problems
• have liver or kidney problems
• have Parkinson’s disease
• have or have had in the past narrow angle glaucoma (this is abnormal pressure in the eye accompanied by pain and blurred vision)
• have an enlarged prostate gland
• have epilepsy or have had fits (seizures) in the past
• have a condition that causes muscle weakness with tiredness, called myasthenia gravis
• have a tumour of your adrenal gland that causes high blood pressure (phaeochromocytoma)
• have an underactive thyroid gland
• are feeling depressed
• have had a stroke or have any of the following that can increase your risk of having a stroke:
- a heart attack
- a TIA (transient ischaemic attack). This is a type of stroke where symptoms last less than 24 hours
- an artificial heart valve
- uncontrolled high blood pressure
- diabetes
- high cholesterol
- a family history of strokes
- you smoke or drink excess alcohol
• you or someone else in your family has a history of blood clots, as medicines like Chlorpromazine have been associated with formation of blood clots.
• The elderly should take Chlorpromazine with caution in very hot or cold weather. This is because this medicine may cause a higher body temperature than usual in hot weather (hyperthermia) and a lower body temperature in cold weather (hypothermia)
• If you are going to be given an anaesthetic, tell your doctor or dentist that you are taking Chlorpromazine.
Other important information to take into account before
you take this medicine:
• if you or members of your family have heart problems (including heart failure, heart attack or uneven heart beats) or you have low levels of calcium, potassium or magnesium in your blood, your doctor may do some tests on your heart and blood before giving you this medicine
• your doctor may also want to give you regular blood tests in the first few months of your treatment
• do not go into direct sunlight if you are taking high doses of this medicine. This is because you may become more sensitive to strong sunlight while taking this medicine
• do not put this medicine in contact with your skin as it may cause a skin problem called dermatitis (a skin rash with itching). If the medicine does have contact with your skin, wash the area thoroughly.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Chlorpromazine.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines bought without a prescription. This is because Chlorpromazine can affect the way some other medicines work. Also some medicines can affect the way Chlorpromazine works.
In particular, tell your doctor or pharmacist if you are taking any of the following:
• heart medicines such as quinidine, disopyramide, procainamide, amiodarone, sotalol, dofetilide, calcium channel blockers such as verapamil, ACE inhibitors such as captopril
• medicines to treat high blood pressure such as propranolol, guanethidine, methyldopa, minoxidil, clonidine
• medicines that control your emotions such as anxiety medicines, antidepressants (such as amitriptyline), pimozide, sertindole, haloperidol, lithium, trazodone
• medicines that help you sleep such as sedatives or hypnotics such as temazepam
• medicines to treat epilepsy such as barbiturates, phenytoin, primidone, carbamazepine, oxcarbazepine, ethosuximide, valproate
• medicines to treat malaria such as quinine, artemether and lumefantrine
• antibiotics such as sparfloxacin, moxifloxacin and intravenous erythromycin
• medicines to treat Parkinson’s disease such as levodopa, bromocriptine, amantadine and pergolide
• medicines to treat allergies such as hayfever (antihistamines) for example terfenadine and astemizole
• medicines to treat stomach problems such as cimetidine or cisapride
• medicines to treat diabetes such as gliclazide or tolbutamide
• strong painkillers such as codeine or methadone
• medicines to treat cancer
• tetrabenazine to treat disorders that cause unnatural movements
• medicines that help the body get rid of water and affect electrolyte balance (diuretics) such as furosemide
• metoclopramide or droperidol to treat nausea (feeling sick) and vomiting
• atomoxetine, amphetamine or dexamfetamine to treat Attention Deficit Hyperactive Disorder (ADHD)
• adrenaline to treat allergic reactions or cardiac arrest
• ritonavir to treat viral infections
• pentamidine isetionate to treat lung infections
• sibutramine to help you lose weight
• antacids to treat indigestion or heartburn. You should take these at least two hours after taking Chlorpromazine.
Taking Chlorpromazine with food and drink
You must not drink alcohol whilst taking this medicine. This is because this medicine may make you feel drowsy and drinking alcohol will make you even more drowsy. Drinking alcohol may also cause serious breathing problems.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, planning to become pregnant or are breast-feeding. You should not use this medicine if you are pregnant or breast-feeding unless your doctor feels it is absolutely necessary.
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
Do not drive or use tools or machines if this medicine makes you drowsy or if it has affected your eyesight.
Important information about some of the ingredients of Chlorpromazine
This medicine contains lactose (a type of sugar). If your doctor has told you that you cannot tolerate some sugars, check with your doctor before taking this medicine.
3. HOW TO TAKE CHLORPROMAZINE
Always take Chlorpromazine tablets exactly as your doctor has told you. Take this medicine by mouth.
Adults
• The usual dose for adults is 40 mg to 300 mg daily in divided doses
• The dose prescribed and how often you should take the doses will depend upon the condition being treated and on your response. You will start treatment on a low dose which will be increased as necessary by your doctor
• Elderly, weak or feeble patients will need to take one third or half the usual adult dose. Your doctor will gradually increase this dose.
Children
• Children under 1 year should not take this medicine
• Children aged 1 to 5 years: the maximum dose should be no more than 40 mg a day. You must split this dose over the day
• Children aged 6 to 12 years: the maximum dose should be no more than 75 mg a day. You must split this dose over the day.
Your doctor will work out the dose for your child according to their age and weight.
If you take more Chlorpromazine than you should
Talk to a doctor to go to a hospital straight away. Take the medicine pack with you so the doctor knows what you have taken. Signs of an overdose may include drowsiness, low body temperature, low blood pressure, twisting of your limbs, stiffness, shaking, unusual heart beats and coma.
If you forget to take Chlorpromazine
Do not take a double dose (two doses at the same time) to make up for the forgotten dose. Skip the missed dose then go on as before.
If you stop taking Chlorpromazine
Keep taking Chlorpromazine until your doctor tells you to stop. The doctor will lower your dose gradually. If you stop taking the medicine suddenly you may get withdrawal symptoms. Signs include:
• feeling or being sick and difficulty sleeping (insomnia)
• your original symptoms becoming worse
• movements that you cannot control.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Chlorpromazine can cause side effects,
although not everybody gets them.
Stop taking the medicine straight away and see your
doctor if you:
• have an allergic reaction to chlorpromazine
an allergic reaction may include any kind of skin rash, flaking skin, red and raised lumps (hives), joint pain, fever, sore lips and mouth, sudden wheezing, fluttering or tightness of your chest or collapse
• have any of the following symptoms: unusually fast heart beat, unstable blood pressure (feeling dizzy, light-headed or faint), sweating, very high body temperature, muscle stiffness or a change in consciousness leading to coma. These are warning signs of a disorder called neuroleptic malignant syndrome
• a prolonged painful erection. If this happens to you, go to your nearest hospital
• get blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing
• yellowing of the skin and whites of your eyes (jaundice) with fever and possible liver damage.
If you get any of the following side effects, see your doctor
as soon as possible:
• feeling excited, agitated, lack of emotion
• fits
• breathing problems
• blood problems. You may notice signs such as high temperature or chills, sore throat, ulcers in your mouth or throat, unusual tiredness, unexplained bleeding or bruising
• heart changes including fast heart beats, unusual heart beats, heart attack causing chest pain or shortness of breath. If you get these see a doctor straight away. Unexplained deaths have been reported but it is not proven that they were caused by chlorpromazine
• higher or lower body temperature than usual
• low blood pressure. You may feel dizzy when standing up. This may affect the elderly more
• unusual movements, often of the mouth, lips, eyes and tongue. These movements can also include trembling and shaking of the hands and feet, twisting of the body, shuffling walk and stiffness of the arms and legs and unable to sit still
• eye changes, such as problems with your eyesight or change in eye colour
• high levels of glucose in the blood (hyperglycaemia). The symptoms of this are feeling thirsty, urinating more often and tiredness
• changes in bowel habits including constipation.
Tell your doctor if you get any of these side effects:
• difficulty sleeping (insomnia)
• drowsiness, dizziness, headache, confusion
• changes in your level of alertness
• dry mouth, blocked nose
• stomach pain
• difficulty passing urine
• skin rash caused by placing the medicine in contact with your skin, skin rashes, skin reaction to direct sunlight, change in skin colour
• swelling of the breasts (particularly in men) and breast milk production
• light periods or absence of periods
• decrease in sexual performance
• weight gain
• high cholesterol levels.
In elderly people with dementia, a small increase in the number of deaths has been reported for patients taking antipsychotics compared with those not taking antipsychotics.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE CHLORPROMAZINE
Keep out of the reach and sight of children.
Store below 25°C in a dry place and protect from light. Store in the original package or container and keep the container tightly closed.
Do not use the tablets after the expiry date, which is stated on the package or container. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Chlorpromazine tablets contain
The active ingredient (the ingredient that makes the tablets work) is chlorpromazine hydrochloride.
The other ingredients are lactose, maize starch, povidone, sodium starch glycollate, colloidal anhydrous silica, magnesium stearate, purified water, hydroxypropylmethyl cellulose, ethylcellulose, diethylphthalate and titanium dioxide (E171).
What Chlorpromazine tablets look like and contents of the pack
Chlorpromazine tablets are round white film-coated tablets.
The 10 mg tablets are marked with DDSA on one side.
The 25 mg tablets are marked with DDSA on one side and CHLORACTIL 25 on the other.
The 50 mg tablets are marked with DDSA on one side and CHLORACTIL 50 on the other.
The 100 mg tablets are marked with DDSA on one side and CHLORACTIL 100 on the other.
The tablets come in blister packs and containers of 28, 30, 50, 56, 60, 84, 100, 250, 500, 1000 and 5000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Chelonia Healthcare Limited,
11 Boumpoulinas, Nicosia, PC. 1060, Cyprus
Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road, London, SW5 9JQ
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last revised in 10/2014
CL0129-0130-0131-0132/O/PIL/CL1