LARGACTIL 25MG/ML SOLUTION FOR INJECTION

Active substance: CHLORPROMAZINE HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Largactil® 25mg/ml
Solution for Injection
Chlorpromazine
hydrochloride
Is this leaflet hard to see or read?
Phone 01483 505515 for help
Read all of this leaflet carefully before you are given this medicine
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor, nurse or pharmacist
• If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor, nurse or pharmacist
In this leaflet:
1. What Largactil is and what it is used for
2. Before you are given Largactil
3. How Largactil is given
4. Possible side effects
5. How to store Largactil
6.Further Information

1. What Largactil is and what it is used for

▲ You are elderly (65 years of age or older).
▲ You are elderly, particularly during very hot or very cold weather. In these
conditions, you could be at risk of hyperthermia or hypothermia
▲ You have low blood pressure or feel dizzy when you stand up
▲ You are diabetic or have high levels of sugar in your blood (hyperglycaemia). Your
doctor may want to monitor you more closely
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist
before being given Largactil.

2. Before you are given Largactil

i

Largactil contains a medicine called chlorpromazine. This belongs to a group of
medicines called ‘phenothiazines’. It works by blocking the effect of a chemical in the
brain.
Largactil can be used for:
• Schizophrenia in adults and children
• Short term treatment of anxiety
• Hiccups
• Feeling or being sick (where other anti-sickness medicines have not worked)
• Autism

Do not have this medicine and tell your doctor if:
X You are allergic (hypersensitive) to chlorpromazine or any of the other ingredients of
Largactil (listed in Section 6). Signs of an allergic reaction include: a rash, swallowing
or breathing problems, swelling of your lips, face, throat or tongue
X You have a low number of blood cells (bone marrow depression).
X You have increased pressure in the eye (glaucoma)
X You are taking a dopaminergic antiparkinsonism drug
X You are breast feeding
X You are taking citalopram for escitalopram
X You have a history of a low white blood cell count
X You have urine retention due to a prostate disorder
Do not have this medicine if any of the above apply to you. If you are not sure, talk
to your doctor or nurse before being given Largactil



















Taking other medicines
Please tell your doctor or nurse if you are taking or have recently taken any other
medicines. This includes medicines you buy without a prescription, including herbal
medicines. This is because Largactil can affect the way some other medicines work. Also
some medicines can affect the way Largactil works.
In particular, check with your doctor 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
Taking Largactil with food and drink
Do not drink alcohol while being treated with Largactil. This is because alcohol can
increase the effects of Largactil and cause serious breathing problems.

Take special care with Largactil
Check with your doctor or nurse before you have this medicine if:
You have liver or kidney problems
You have thyroid problems
You have heart problems or a family history of heart problems
You have ever had a stroke
You have Parkinson’s disease
You have epilepsy or have had fits (seizures)
You have depression
You have ever had alcohol problems
You have an enlarged prostate gland
You have had glaucoma (painful eyes with blurred vision)
You have a tumour on the adrenal gland called ‘phaeochromocytoma’
You have a form of muscle weakness called ‘myasthenia gravis’
You have a low number of white blood cells (agranulocytosis). This means you may
get infections more easily than usual
You have low blood levels of potassium, calcium and magnesium. Your doctor may
do blood tests to check on these
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
You are not eating properly
You are allergic to other phenothiazine medicines such as prochlorperazine

CROMinFOTO s.n.c.

Via G. Tartini, 2 - 20158 - MILANO
Tel. 02.375787 • e-mail: crominfoto@tiscali.it

GRAFICA - FOTOCOMPOSIZIONE

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

TYPE OF MATERIAL:

LEAFLET

DESCRIPTION:

9 pt.

89026373

VERSION:

2 a

02 MAG 2013

COUNTRY:

LARGACTIL

MIN. FONT SIZE: CODE:

89026373
(int. version 2)

LOGO VERSION:

//

UK
OLD CODE:

DIMENSION mm:

89025248 420 x 160 (PREP. 210 x 160)

COLOURS N°: COLOUR 1:

1

REFLEX BLUE

Pregnancy and breast-feeding and fertility
Talk to your doctor or nurse 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
Largactil 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 Largactil. This is because small amounts may
pass into mothers’ milk. If you are breastfeeding or planning to breast-feed talk to your
doctor or nurse before taking this medicine.
Ask your doctor or nurse for advice before taking any medicine if you are pregnant or
breastfeeding.
Largactil may make it more difficult for a woman to get pregnant due to it reducing her
fertility.

Driving and using machines
You may feel sleepy after having this medicine.
If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of Largactil
• Sodium. This injection contains 4.78mg of sodium in each 50mg dose and is
essentially ‘sodium-free’.
• Small amounts of sulphites. These may cause severe allergic reactions
(hypersensitivity) and difficulty in breathing (bronchospasm).
This is more likely to happen if you have a history of asthma or allergies. The chances
of this happening are rare. Tell a doctor or nurse straight away if you get a rash,
swallowing or breathing problems and swelling of your lips, face, throat or tongue.

3. How Largactil is given
Largactil is normally given by a doctor or nurse.
This is because it needs to be given as a deep injection into a muscle.
How much Largactil is given
If you are not sure why you are being given Largactil or have any questions
about how much Largactil is being given to you, speak to your doctor or
nurse. The usual doses are:

Schizophrenia
Adults:
Elderly:
Children 1-5 years:
Children 6-12 years:
Anxiety
Adults:
Elderly:
Children 6-12 years:

25-50mg every 6-8 hours
25mg every 8 hours
0.5mg/kg body-weight every 6-8 hours
(Maximum dose in a day is 40mg)
0.5mg/kg body-weight every 6-8 hours
(Maximum dose in a day is 75mg)
25-50mg every 6-8 hours
25mg every 8 hours
0.5mg/kg body-weight every 6-8 hours
(Maximum dose in a day is 75mg)

Hiccups
Adults:
25-50mg
Feeling or being sick
Adults:
25-50mg every 3-4 hours
Children 1-5 years:
0.5mg/kg body-weight every 6-8 hours (Maximum dose in a
day is 40mg)
Children 6-12 years: 0.5mg/kg body-weight every 6-8 hours (Maximum dose in a
day is 75mg)
Autism
Children 1-5 years:
0.5mg/kg body-weight every 6-8 hours (Maximum dose in a
day is 40mg)
Children 6-12 years: 0.5mg/kg body-weight every 6-8 hours. (Maximum dose
in a day is 75mg)
Children under 1 year
Largactil is not usually given to children under 1 year.
Exposure to sunlight
Largactil can make your skin more sensitive to sunlight. Keep out of direct sunlight
while having this medicine.
Tests
Before and during treatment your doctor may want to carry out some tests. These might
include blood tests and an ECG to check your heart is working properly and eye tests.
Your doctor may want to carry out tests every year during your child's treatment to
evaluate your child's learning capacity.
If you have more Largactil than you should
It is unlikely that your doctor or nurse will give you too much medicine. Your doctor and
nurse will monitor your progress, and check the medicine you are given. Always ask if
you are not sure why you are getting a dose of medicine.
Having too much Largactil may make you feel drowsy or dizzy with increased or rapid
heartbeat. You may also feel very cold and restless, with writhing movements, stiffness
or shaking. If you start getting any of these symptoms tell your doctor or nurse straight
away. If you are away from the hospital, return straight away and speak to your doctor
or nurse or go to the casualty department.

• 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 a nurse or doctor 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)
Frequency unknown
• You are breathing more slowly or less deeply than normal
• Changes in skin or eye colour after having Largactil 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 to 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
Talk to your doctor or nurse if any of the following side effects gets serious or lasts
longer than a few days:
Very common (affects more than 1 in 10 people)
• Dry mouth
• Feeling drowsy or sleepy
• Putting on weight
Common (affects 1 to 10 people in a 100 people)
• Abnormal production of breast milk in men and women
• Loss of menstrual periods
• Feeling anxious
Frequency unknown
• Breast enlargement in men
• Difficulty in getting or keeping an erection (impotence)
• Reduced sexual desire in women
• Difficulty sleeping (insomnia)
• Feeling agitated

If you miss a dose of Largactil
Your doctor or nurse will have instructions on when to give you this medicine. It is
unlikely that you will not be given the medicine as it has been prescribed. However, if
you do think you have missed a dose, tell your doctor or nurse.
If you stop having Largactil
Keep having Largactil until your doctor tells you to stop. If you stop having Largactil
your illness may come back and you may have other effects such as feeling or being sick
and difficulty sleeping. Your doctor will gradually stop your medicine to prevent these
effects happening.

4. Possible side effects
Like all medicines, Largactil can cause side effects, although not everybody gets them.
Tell a doctor or nurse or go to a hospital straight away if:
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)
Frequency unknown
• 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.

CROMinFOTO s.n.c.

Via G. Tartini, 2 - 20158 - MILANO
Tel. 02.375787 • e-mail: crominfoto@tiscali.it

GRAFICA - FOTOCOMPOSIZIONE

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

TYPE OF MATERIAL:

LEAFLET

DESCRIPTION:

9 pt.

89026373

VERSION:

2 a

02 MAG 2013

COUNTRY:

LARGACTIL

MIN. FONT SIZE: CODE:

89026373
(int. version 2)

LOGO VERSION:

//

UK
OLD CODE:

DIMENSION mm:

89025248 420 x 160 (PREP. 210 x 160)

COLOURS N°: COLOUR 1:

1

REFLEX BLUE






Being more sensitive to the sun than usual
Stuffy nose
Skin rashes
Tiredness, low mood

5. How to store Largactil
This medicine will be kept by your doctor or pharmacist in a safe place where children
cannot see or reach it.
Do not use Largactil after the expiry date which is stated on the label and carton. The
expiry date refers to the last day of that month.
Keep the Ampoules in the outer carton in order to protect from light.
Discoloured solution should not be used.
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 Largactil contains
• Each 1ml of solution contains 25mg of the active substance, chlorpromazine
hydrochloride
• The other ingredients are: Sodium sulphite (E221), Sodium citrate, Sodium
metabisulphite (E223), Sodium chloride, Water for Injection
What Largactil looks like and contents of the pack
• Largactil is a clear, colourless solution
• Largactil is available in boxes containing 10 x 1ml or 10 x 2ml glass ampoules
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder for Largactil is:
Sanofi, One Onslow Street, Guildford,
Surrey, GU1 4YS, UK
Tel: 01483 505515
Fax: 01483 535432
email: uk-medicalinformation@sanofi.com
The Manufacturer of Largactil is:
SANOFI-AVENTIS S.P.A.
Loc. Valcanello
03012 Anagni (FR)
ITALY
This leaflet does not contain all the information about your medicine. If you have any
questions or are not sure about anything, ask your doctor or nurse.
This leaflet was last revised in 05/2013
© Sanofi, 1973 - 2013
89026373

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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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