Skip to Content

CHLORPROMAZINE 100MG TABLETS

Active substance(s): CHLORPROMAZINE HYDROCHLORIDE / FLUOXETINE HYDROCHLORIDE / CHLORPROMAZINE HYDROCHLORIDE / FLUOXETINE HYDROCHLORIDE / CHLORPROMAZINE HYDROCHLORIDE / FLUOXETINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER
Chlorpromazine 25mg, 50mg, 100mgTablets
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. See section 4.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Chlorpromazine Tablets are and what they are used for
What you need to know before you take Chlorpromazine Tablets
How to take Chlorpromazine Tablets
Possible side effects
How to store Chlorpromazine Tablets
Contents of the pack and other 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 psychoses particularly 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, feeling or being sick (when other drugs have failed), to lower body temperature
and for childhood schizophrenia and autism (learning and communication difficulties).

2. What you need to know before you take Chlorpromazine Tablets
Do not take Chlorpromazine Tablets and tell your doctor if you:
are allergic (hypersensitive) to Chlorpromazine, other
phenothiazines or to any of the other ingredients in the
tablets (see Section 6). Signs of an allergic reaction
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 an increased pressure in the eye (glaucoma)
are taking a dopaminergic antiparkinsonism drug
are breast-feeding
are taking citalopram or escitalopram
have a history of low white blood cell count
have urine retention due to a prostate disorder.

Warnings and precautions
Talk to your doctor or pharmacist before taking Chlorpromazine Tablets if you:
or someone else in your family has a history of blood
easily tired and weak leading to difficulty breathing)
clots, as medicines like these have been associated with
have phaeochromocytoma (high blood pressure due to a
tumour near the kidney)
formation of blood clots
have glaucoma (raised eyeball pressure)
have liver or kidney disease
have diabetes and are taking drugs to reduce blood sugar
have epilepsy or have had fits (seizures)
(as Chlorpromazine Tablets may reduce their effect)
have Parkinson’s disease
have enlargement of the prostate.
have hypothyroidism (reduced activity of the thyroid
have depression
gland)
have ever had alcohol problems
have heart disease such as heart failure
have a low number of white blood cells (agranulocytosis). This
have ever had a stroke
means you may get infections more easily than normal
have myasthenia gravis (a condition where muscles
become
you are elderly (65 years of age or older).

Other medicines and Chlorpromazine Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines especially:
medicines for indigestion and heartburn (antacids)
some medicines used for high blood pressure such as guanethidine,
clonidine or propranolol
medicines for diabetes
some medicines used for infections (antibiotics) such as moxifloxacin
medicines for high blood pressure or prostate problems such
as doxazosin and terazosin
some medicines used for cancer (cytotoxics)
medicines for Parkinson’s disease such as levodopa
medicines which can alter electrolytes (salt levels) in your blood
medicines for fits (epilepsy) such as carbamazepine or
amphetamines – used for Attention Deficit Hyperactivity Disorder
phenobarbital
(ADHD)
medicines to control your heartbeat such as amiodarone,
anticholinergic medicines – includes some medicines used for irritable
disopyramide or quinidine
bowel syndrome, asthma or incontinence
medicines to help you sleep (sedatives)
adrenaline – used for life threatening allergic reactions
medicines for depression or amphetamines
deferoxamine – used when you have too much iron in your blood
other medicines used to calm emotional and mental problems
lithium – used for some types of mental illness.
such as olanzapine or prochlorperazine

Chlorpromazine Tablets with alcohol
Alcohol must not be used with Chlorpromazine. This is because alcohol can increase the effects of Chlorpromazine and cause serious
breathing problems.

Pregnancy and breast-feeding
Talk to your doctor or pharmacist before having this medicine if you are pregnant, might become pregnant or think you may be pregnant. 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.
Do not breast-feed if you are being given Chlorpromazine. This is because small amounts may pass into the mother’s milk. If you are breastfeeding or planning to breast-feed talk to your doctor or pharmacist before taking this medicine.
Chlorpromazine may make it difficult for a woman to get pregnant due to it reducing her fertility.

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.

Chlorpromazine Tablets contain lactose
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
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
You will be prescribed the lowest dose needed to control your symptoms. 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 Chlorpromazine Tablets than you should
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 forget to take Chlorpromazine Tablets
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 Chlorpromazine 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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects although not everybody gets them. Do not be alarmed by this list of side effects. Most
people take Chlorpromazine without any problems

Tell your doctor or pharmacist or go to a hospital straight away if:
Very common (may affect 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 that usual or feeling restless
Common (may affect up to 1 in 10 people)
you have a fit (seizure)
alteration of the heart rhythm (called ‘prolongation of the 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 or 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 an obstruction or blockage of the intestine
you have pain in your abdomen with vomiting and 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 (may affect 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.
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.
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 Chlorpromazine Tablets
Do not store above 25°C.Store in a dry place, protect from light. Keep the container tightly closed. Keep this medicine out of the sight and reach
of children. Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. 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 throw away medicines you
no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Chlorpromazine Tablets contain
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).
What Chlorpromazine Tablets look like and contents of the pack
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. Available pack sizes are 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1,000 tablets. Not all pack sizes may be
marketed.
Marketing authorisation holder and manufacturer
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, Beverley,
HU17 0LD, UK.
Leaflet revised 03/2016© Dr. Reddy’s Laboratories (UK) Ltd
CZ01234P

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

Expand Transcript

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.

Hide