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CHLORPROMAZINE 50MG TABLETS

Active substance(s): CHLORPROMAZINE HYDROCHLORIDE / FLUOXETINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Chlorpromazine 25mg, 50mg, 100mg Tablets
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.

In this leaflet
1.
2.
3.
4.
5.
6.

What Chlorpromazine Tablets are and what they are used for
Before you take Chlorpromazine Tablets
How to take Chlorpromazine Tablets
Possible side effects
How to store
Further information

1. What Chlorpromazine Tablets are and what they are used for
Chlorpromazine tablets belong to a group of drugs known as phenothiazines, which act on the central nervous system. They are used to
treat the following conditions: schizophrenia and other psychosesparticularly paranoia(delusions and feelings of persecution),
mania (overactive behaviour and hypomania (elated moods and excitability), anxiety, agitation and violent or dangerously
impulsive behaviour.
Chlorpromazine is also used for prolonged periods of hiccups, nausea and vomiting (when other drugs have failed), to lower body
temperature and for childhood schizophrenia and autism (learning and communication difficulties).

2. Before you take Chlorpromazine Tablets
Do not take Chlorpromazine Tablets if you:


have had any unusual or allergic reactions to
Chlorpromazine, other phenothiazines or to any of the other
ingredients in the tablets (see Section 6).



are pregnant, likely to be pregnant or breast-feeding.

Check with your doctor before taking Chlorpromazine Tablets if you:
 or someone else in your family has a history of blood

have phaeochromocytoma (high blood pressure







clots, as medicines like these have been associated with
formation of blood clots
have liver or kidney disease
have epilepsy
have Parkinson’s disease
have hypothyroidism (reduced activity of the thyroid gland)
have heart disease such as heart failure
have myasthenia gravis (a condition where muscles become
easily tired and weak leading to difficulty breathing)





due to a tumour near the kidney)
have glaucoma (raised eyeball pressure)
have diabetes and are taking drugs to reduce
blood sugar (as Chlorpromazine Tablets may reduce
their effect)
have enlargement of the prostate.

Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained
without a prescription, (which may alter the effects of Chlorpromazine Tablets) especially:
 sedatives such as phenobarbitone

guanethidine (for lowering blood pressure)
 drugs to reduce blood pressure such as propranolol or atenolol

clonidine (for migraine and to lower blood pressure)
 anticholinergic drugs such as atropine and hyoscinehydrobromide

lithium, sulpiride, haloperidol or thioridazine (drugs to
(used in motion-sickness and pre-medication).
treat psychiatric disorders)
 central nervous system stimulants such as adrenaline or
amphetamines
 anti-Parkinson’s drugs such as levadopa, carbidopa (as these may
interfere with the absorption of Chlorpromazine Tablets)

Alcohol
Alcohol must not be used with Chlorpromazine.

Pregnancy and breast-feeding
Chlorpromazine Tablets should not be used in pregnancy or while breast-feeding, unless your doctor considers it absolutely necessary.
The following symptoms may occur in newborn babies, of mothers that have used Chlorpromazine Tablets 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
This medicine may cause some people, especially elderly patients, to become drowsy, dizzy, light-headed, clumsy, unsteady or less alert
than normal. If you are affected, do not drive or operate dangerous machinery.

Sugar intolerance

If a doctor has told you that you have an intolerance to some sugars, check with your doctor before taking these tablets, as they contain
a type of sugar called lactose.

3. How to take Chlorpromazine Tablets
You will be prescribed the lowest dose needed to control your symptoms. You should check with your doctor or pharmacist if you are
unsure. Do not stop taking your medicine or change the dose unless your doctor tells you to.
The tablets should be swallowed with a glass of water.

Dose for schizophrenia, other psychoses, anxiety and agitation
Adults: Start with 25mg three times a day or 75mg at bedtime.
This may be increased by 25mg a day to an effective dose. This is usually
75mg - 300mg daily, but some patients need up to 1000mg (1g) daily.
Elderly weak or infirm patients: Start with 1/3–1/2 usual adult
dose with a more gradual increase in dose.
Children 6-12 years: 1/3-1/2 adult dose to a maximum daily dose
of 75mg.
Children 1-5 years: 0.5mg per kg body weight every 4-6 hours
to a maximum daily dose of 40mg.
Children under 1 year: Not to be used unless the need is life saving.

Dose for nausea and vomiting
Adults: 10mg-25mg every 4-6 hours.
Elderly weak or infirm patients: Start with 1/3-1/2 adult
dose.
Your doctor will then increase the dose as needed.
Children 6-12 years: 0.5mg per kg bodyweight every 4-6
hours. Maximum daily dose 75mg.
Children 1-5 years: 0.5mg per kg bodyweight every 4-6
hours. Maximum daily dose 40mg.
Children under 1 year: Not to be used unless the need is
life saving.
Dose for hiccups

Adults, elderly, weak or infirm patients: 25-50mg 3-4
times a day.
Children: Not recommended in children.

If you don’t feel better

If you don’t feel the tablets are working as well after you have taken them for a short time (3-4 days), do not increase the dose; instead
check with your doctor.

If you take more than you should or if you forget to take the tablets

If you accidentally take more tablets or somebody else takes any tablets, contact a doctor or go to your nearest hospital casualty
department at once. Take any remaining tablets with you and the container or packaging, so they can be identified.
If you miss a dose, skip the missed dose and go back to your regular schedule. Do not take a double dose to make up for a forgotten
dose.

If you stop taking the tablets
Withdrawal symptoms can occur after you stop treatment (see Section 4), so gradual withdrawal is advisable. Do not stop taking the
tablets without talking to your doctor or pharmacist.

4. Possible side effects
Like all medicines Chlorpromazine can cause side effects. Do not be alarmed by this list of side effects. Most people take
Chlorpromazine without any problems.
If any of the following happen, stop taking the tablets and contact your doctor at once:

jaundice (yellowing of the skin and white of the eyes )

skin reactions such as rashes, inflammation and flaking of skin (exfoliative dermatitis), raised red patches of skin
which may blister (erythema multiforme).
Tell your doctor or pharmacist at once if you think you have any of these or problems with Chlorpromazine:
Less common side effects
Unknown Frequency:
- increased pigmentation of melanin in the skin, which may develop a bluish-grey
- blood clots in the veins especially in the legs
colour.
(symptoms include swelling, pain and redness in
- pigment deposits may also occur in the eye and other tissues and may affect
the leg), which may travel through blood vessels
vision.
to the lungs causing chest pain and difficulty in
breathing. If you notice any of these symptoms
Common side effects
seek medical advice immediately.
- drowsiness, sedation, reduced alertness, dry mouth, nasal stuffiness, weight gain
- high cholesterol levels
- postural hypotension (fall of blood pressure when moving from lying down or
- fits, feeling agitated, unable to sleep
sitting to a standing position), blurring of vision, rapid heart beat
- nausea, dizziness, headache, oedema (water
- constipation, difficulty passing urine or not being able to pass urine at all
retention)
- increased tendency to sunburn, therefore avoid prolonged exposure to
- swelling of breasts particularly in men and breast
sunlight and UV light.
milk production
Rare side effects
- a prolonged, painful erection. If this happens to
- impaired control of body temperature causing heat stroke in hot weather and
you, go to your nearest hospital
lowering of body temperature (hypothermia) in very cold weather, lowering of
- light periods or absence of periods.
blood pressure (particularly in the elderly)
-muscle rigidity, tremor (shaking), jerky body movements and inability to control
movements of the hand and body, disturbances in heart rhythm, heart attack
-hyperglycaemia (high levels of glucose in the blood). The symptoms of this are
feeling thirsty, urinating more often and tiredness.
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.
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.

5. How to store
Do not store above 25°C. Store in a dry place, protect from light. Keep the container tightly closed. Keep out of the reach and sight of
children. Do not use after the expiry date printed on the packaging. Return any unused tablets to your pharmacist for safe disposal .

8.

7. 6.Further information
The active ingredient (which makes the tablets work) is chlorpromazine hydrochloride. The tablets also contain lactose, maize
starch, povidone, sodium starch glycollate, colloidal anhydrous silica, magnesium stearate, hypromellose, purified water,
ethylcellulose, diethylphthalate and titanium dioxide (E171). The tablets are round, white, and film coated.
The 25mg tablets are marked with CPZ25. The 50mg tablets are marked with CPZ50. The 100mg tablets are marked with CPZ100 .
Marketing authorisation holder and manufacturer
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, Beverley, HU17 0LD, UK.
Leaflet revised September 2015 © Dr. Reddy’s Laboratories (UK) Ltd CZ01234P

Chlorpromazine 25mg Tablets PL08553/0074
Chlorpromazine 50mg Tablets PL08553/0075
Chlorpromazine 100mg tablets PL08553/0076

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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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