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CHLORACTIL

Active substance(s): CHLORPROMAZINE HYDROCHLORIDE / 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 because it contains important information
for you.
- 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 only. Do
not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.

WHAT IS IN THIS LEAFLET
1. What Chloractil is and what it is used for
2. What you need to know before you take
Chloractil
3. How to take Chloractil
4. Possible side effects
5. How to store Chloractil
6. Contents of the pack and other information

1. WHAT CHLORACTIL IS AND
WHAT IT IS USED FOR
The name of your medicine is Chloractil. It contains the active
ingredient chlorpromazine hydrochloride. This belongs to a
group of medicines called phenothiazines. It works by blocking
the effect of a chemical in the brain.
Chloractil can be used to treat:
 Schizophrenia in adults and children
 short term treatment of anxiety
 feeling or being sick, (where other anti-sickness medicines
have not worked) when you have a terminal illness
 hiccups
 autism
 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. You must talk to a doctor if you do
not feel better or if you feel worse.

2. WHAT YOU NEED TO KNOW BEFORE
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, swallowing or
breathing problems, swelling of your lips, face, throat or
tongue.
 have a low number of blood cells (bone marrow depression).
 have increased pressure in the eye (glaucoma).
 are taking a dopaminergic antiparkinsonism drug.
 are breast-feeding.
 are taking citalopram for escitalopram.
 have a history of a low white blood cell count. have urine
retention due to a prostate disorder.
 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
Warnings and precautions
Talk to your doctor or pharmacist before taking Chloractil
Tablets 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
 have liver or kidney disease
 have epilepsy or have had fits (seizures)
 have Parkinson’s disease
 have hypothyroidism (reduced activity of the thyroid gland)
 have heart disease such as heart failure
 have ever had a stroke
 have myasthenia gravis (a condition where muscles
become easily tired and weak leading to difficulty breathing)
 have phaeochromocytoma (high blood pressure due to a
tumour near the kidney
 have glaucoma (raised eyeball pressure)
 have diabetes and are taking drugs to reduce blood sugar
(as Chloractil Tablets may reduce their effect)
 have enlargement of the prostate
 have depression
 have ever had alcohol problems
 have a low number of white blood cells (agranulocytosis).
This means you may get infections more easily than normal
 are elderly (65 years of age or older)

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)
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.
Other medicines and Chloractil
Tell your doctor or pharmacist if you are taking, have recently
taken or might take 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:
 Medicines for indigestion and heartburn (antacids)
 Medicines for diabetes
 Medicines for high blood pressure or prostate problems
such as doxazosin and terazosin
 Medicines for Parkinson’s disease such as levodopa
 Medicines for fits (epilepsy) such as carbamazepine or
phenobarbital
 Medicines to control your heartbeat such as amiodarone,
disopyramide or quinidine
 Medicines to help you sleep (sedatives)
 Medicines for depression
 Other medicines used to calm emotional and mental
problems such as olanzapine or prochlorperazine
 Some medicines used for high blood pressure such as
guanethidine, clonidine or propranolol
 Some medicines used for infections (antibiotics) such as
moxifloxacin
 Some medicines used for cancer (cytotoxics)
 Medicines which can alter electrolytes (salt levels) in your
blood
 Amphetamines - used for Attention Deficit Hyperactivity
Disorder (ADHD)
 Anticholinergic medicines - includes some medicines used
for irritable bowel syndrome, asthma or incontinence
 Adrenaline - used for life threatening allergic reactions
 Deferoxamine - used when you have too much iron in your
blood
 Lithium - used for some types of mental illness
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, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine. 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 chloractil 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.
Chloractil may make it more difficult for a woman to get pregnant
due to it reducing her fertility.
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.
Chloractil contains lactose
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. Check with your doctor or pharmacist if you are not sure.
Take this medicine by mouth.
The recommended dose is:
Adults
 The recommended 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 recommended 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 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 you forget to take Chloractil
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 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.
Tell your doctor or pharmacist or go to a hospital straight
away if you have any of the following serious side effects:
Very common (affects more than 1 in 10 people)
 You have movements that you cannot control, mainly of the
tongue, mouth, jaw, arms and legs
 Trembling, muscle stiffness or spasm, slow movement,
producing more saliva than usual or feeling restless
Common (affects 1 to 10 people in a 100 people)
 You have a fit (seizure)
 Alteration of the heart rhythm (called ‘prolongation of QT
interval’, seen on ECG, electrical activity of the heart)
Not known (frequency cannot be estimated from the
available data)
 You have an allergic reaction. The signs may include: rash,
itching, fever, difficulty in breathing or wheezing, chills,
swollen eyelids, lips, tongue or throat
 You have a very fast, uneven or forceful heartbeat
(palpitations). You may also have breathing problems such
as wheezing, shortness of breath, tightness in the chest and
chest pain. These could be signs of very serious life
threatening heart problems
 You have joint aches and pains, swollen joints, feel tired or
weak, with chest pain and shortness of breath. These could
be signs of an illness called ‘systemic lupus erythematosus’
(SLE)
 You have yellowing of the skin or eyes (jaundice) and your
urine becomes darker in colour. These could be signs of
liver damage
 You have frequent infections such as fever, severe chills,
sore throat or mouth ulcers. These could be signs of a blood
problem called ‘leucopenia’
 You have a high temperature, sweating, stiff muscles, fast
heartbeat, fast breathing and feel confused, drowsy or
agitated. These could be signs of a serious but rare side
effect called ‘neuroleptic malignant syndrome
 You get a bloated feeling and cramping pain in the abdomen
(stomach) be sick (vomit) have indigestion, heartburn, upset
stomach, constipation, loss of appetite, dry mouth. This
could be caused by and obstruction or blockage of the
intestine.
 You have pain in your abdomen with vomiting or diarrhoea
 You have a long lasting, painful erection of the penis
 You bruise more easily than usual. This could be because of
a blood disorder called ‘thrombocytopenia’
 You have 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 in breathing. If you notice any of
these symptoms seek medical advice immediately
Tell your doctor or pharmacist as soon as possible if you
have any of the following side effects:
Very common (affects more than 1 in 10 people)
 feeling dizzy, lightheaded or faint when you stand or sit up
quickly (due to low blood pressure)
Not known (frequency cannot be estimated from the
available data)
 you are breathing more slowly or less deeply than normal
 changes in skin or eye colour after having Chlorpromazine
for a long time
 problems with eyesight

 rigid or stiff muscles, trembling or shaking, difficulty moving
 passing large amounts of urine, excessive thirst and having
a dry mouth or skin. You may be more likely get infections
such as thrush. This could be due to too much sugar in your
blood (hyperglycaemia)
 unusual eye movements (including rolling of the eyes)
 your neck becomes twisted to one side
 your jaw is tight and stiff
 you have difficulty in passing water (urine)
 feeling tired, weak, confused and have muscles that ache,
are stiff or do not work well. This may be due to low sodium
levels in your blood.
Tell your doctor or pharmacist if any of the following side
effects gets serious or lasts longer than a few days
Very common (may affect more than 1 in 10 people)
 Dry mouth
 Feeling drowsy or sleepy
 Putting on weight
Common (May affect up to 1 in 10 people)
 Abnormal production of breast milk in men and women
 Loss of menstrual periods
 Feeling anxious
Not known (frequency cannot be estimated from the
available data)
 Breast enlargement in men
 Difficulty in getting or keeping an erection (impotence)
 Reduced sexual desire in women
 Difficulty sleeping (insomnia)
 Feeling agitated
 Being more sensitive to the sun than usual
 Stuffy nose
 Skin rashes
 Tiredness, low mood
Withdrawal effects:
If this medicine is stopped suddenly nausea, vomiting and
difficulty sleeping (insomnia), tremor (shaking), jerky body
movements and the inability to control movements of the hands
and body can occur.
If any of the side effects get serious, or if you notice any side
effects not mentioned in this leaflet, please tell your doctor or
pharmacist.
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 CHLORACTIL
Keep out of the sight and reach 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.
Do not throw away any medicines 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. CONTENTS OF THE PACK AND
OTHER 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 05/2017.
CL0129-0130-0131-0132/O/PIL-Br/CL3

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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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