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CHLORACTIL 50MG

Active substance(s): CHLORPROMAZINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

CHLORACTIL

10 mg, 25 mg, 50 mg & 100 mg TABLETS
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
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.

THIS LEAFLET CONTAINS
1. What Chloractil is for
2. Before you take Chloractil
3. How to take Chloractil
4. Possible side effects
5. How to store Chloractil
6. Further information

1. WHAT CHLORACTIL IS FOR
The name of your medicine is Chloractil. It contains the active
ingredient chlorpromazine hydrochloride. This belongs to a
group of medicines called phenothiazines.
Chloractil acts on the brain to calm your emotions.
Chloractil 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.
Chloractil 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 CHLORACTIL
Do not take Chloractil and tell your doctor if you:
 are allergic to chlorpromazine, other phenothiazines (such
as prochlorperazine or trifluoperazine) or any other
ingredient in Chloractil 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 Chloractil.
Take special care with Chloractil
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 Chloractil have been associated
with formation of blood clots.

 The elderly should take Chloractil 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 Chloractil.
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 Chloractil.
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 Chloractil can affect the
way some other medicines work. Also some medicines can
affect the way Chloractil 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 Chloractil.
Taking Chloractil 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
Chloractil
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 CHLORACTIL
Always take Chloractil 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.

 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.

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.

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.

If you take more Chloractil 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 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.

If you forget to take Chloractil
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 Chloractil
Keep taking Chloractil 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, Chloractil 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

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.

5. HOW TO STORE CHLORACTIL
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 Chloractil 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 Chloractil tablets look like and contents of the pack
Chloractil tablets are biconvex, odourless, white film-coated
tablets.
The 10 mg tablets are plain on both sides.
The 25 mg tablets are engraved 'CHLORACTIL 25' on one side
and plain on the other side.
The 50 mg tablets are engraved 'CHLORACTIL 50' on one side
and plain on the other side.
The 100 mg tablets are engraved 'CHLORACTIL 100' on one
side and plain on the other side.
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, P.C. 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 12/2015

CL0129-0130-0131-0132/O/PIL-Br/CL2

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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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