HALOPERIDOL CAPSULES 500MCG

Active substance: HALOPERIDOL

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SERENACE 500 microgram CAPSULES
Haloperidol

PACKAGE LEAFLET: INFORMATION
FOR THE USER

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 of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

352 mm
160 mm
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Dimensions:

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231-10-01652
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(PANTONE® is a registered
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PL 00289/1613.
Teva UK Limited Licence (Post Licence Regulatory Team). Packed at NPIL Pharmaceuticals (UK) Ltd, Northumberland.
V1: Text update.

210016
Trackwise Parent:

PL Number(s),
MA Holder & Packer:
Reason for revision:

1
Version:

Child:

231-30-01046-D LEA SERENACE (HALOPERIDOL) 500mcg CAP TUK Ref:

210018

PANTONE® GREEN C

10 July 2013

IN THIS LEAFLET:

1. What Serenace is and what it is used for
2. Before you take Serenace
3. How to take Serenace
4. Possible side effects
5. How to store Serenace
6. Further information

1

WHAT SERENACE IS AND WHAT IT IS USED FOR

Serenace Capsules contain haloperidol, which belongs to
a group of drugs known as antipsychotics.
Serenace Capsules are used to treat:
• schizophrenia and other similar mental disorders
such as mania (feeling elated or over-excited, which
causes unusual behaviour), and paranoia, violent or
dangerous impulsive behaviour
• aggression, overactivity and self-mutilation in
patients who are mentally ill and are likely to behave
dangerously
• Tourette’s syndrome, tics (repeated and largely
involuntary movements)
• restlessness and agitation in the elderly
• nausea and vomiting
• with other therapy, the short-term management of
anxiety
• behavioural disorders in children, especially those
associated with hyperactivity and aggression.

2

BEFORE YOU TAKE SERENACE

DO NOT take Serenace and talk to your doctor if you:
• are allergic (hypersensitive) to haloperidol or any of
the other ingredients of this medicine
• are breast-feeding
• have been told by your doctor that you have a
condition that affects part of your brain called the
“basal ganglia”
• suffer from Parkinson’s disease, Huntington’s Chorea
or a related movement disorder
• suffer from uncorrected hypokalaemia (low levels of
potassium in the body)
• have severe heart problems e.g. recent heart attack,
heart failure, irregular heart beat for which you need
to take medicine
• have a family history of unexplained fainting,
blackouts or heart attacks
• are taking certain other medicines which can affect the
heart (see ‘Taking other medicines’)
• have a rare hereditary problem of galactose
intolerance, the Lapp lactose deficiency or
glucose-galactose malabsorption
• are less aware of things around you or your reactions
become slower.
Serenace should not be given to patients if they are in a
coma.
Warnings and precautions
Talk to your doctor before you start to take this medicine
if you:
• are elderly as you may be more sensitive to the effects
of Serenace
• are at risk of blood clot in the vein (deep vein
thrombosis)
• have or someone else in your family has a history of
blood clots, as medicines like these have been
associated with formation of blood clots
• suffer from epilepsy or conditions that might cause
epilepsy such as alcohol withdrawal or brain damage
• have diseased arteries
• suffer from dementia
• suffer from depression
• have low blood pressure, calcium or magnesium
levels or have not eaten for a prolonged length of time
• have problems with alcohol abuse or alcoholism
• have ever had any problems with your liver, kidneys
or heart, or there is a history in your family of heart
problems or sudden death
• have ever had a stroke, transient ischaemic attack
(TIA) or have a family history of strokes
• have ever had a growth in your adrenal gland
(phaeochromocytoma) or trouble with your thyroid
gland, which causes too much thyroid hormone to be
made (thyrotoxicosis)
• have been fasting.
You may need to be more closely monitored, and the
amount of Serenace Capsules you take may have to be
altered. If you are not sure if any of the above apply to
you, talk to your pharmacist before taking Serenace
Capsules.
Medical check ups
Your doctor may want to take an electrocardiogram
(ECG) before or during your treatment with Serenace
Capsules. The ECG measures the electrical activity of
your heart.
Blood tests
Your doctor may want to check the levels of minerals
(electrolytes) in your blood.

Available safety data in the paediatric population
indicate a risk of extrapyramidal symptoms, including
tardrive dyskinesia (involuntary, repetitive body
movements), and sedation. No long-term safety data
available.
Taking other medicines
Special monitoring may be needed if you are taking
lithium and Serenace Capsules at the same time. Tell
your doctor straight away and stop taking both
medicines if you get:
• confused, disoriented, a headache, balance problems
and feel sleepy. These are signs of serious conditions.
DO NOT take Serenace if you are taking:
• certain other medicines which can affect the heart e.g.
quinidine, bretylium, disopyramide, procainamide,
amiodarone, sotalol, dofetilide.
Talk to your doctor if you are taking any of the following:
• any other medicine similar to Serenace known as a
neuroleptic e.g. phenothizaines, sertindole, pimozide,
promazine, amisulpride
• certain medicines for the treatment of depression e.g.
fluoxetine, amitriptyline, maprotiline, lithium,
paroxetine
• sleeping capsules, sedatives or strong pain killers
• medicines for changes in your heart beat or are taking
medicines that affect your heart beat
• medicines which can affect the chemicals in your
bloodstream known as electrolytes, such as diuretics,
e.g. furosemide
• certain antibiotics e.g. moxifloxacin, sparfloxacin,
erythromycin
• levodopa, for Parkinson’s disease
• buspirone, for anxiety
• quinine and mefloquine, for malaria
• indometacin, for rheumatoid arthritis
• methyldopa, to lower your blood pressure
• carbamazepine, for epilepsy
• any antihistamine, for an allergy or hay-fever
• sympathomimetic agents e.g. found in cold and flu
remedies – please check with your pharmacist
• adrenaline, used in emergency situations e.g. to treat
severe allergic reactions
• medicines for thinning the blood, such as phenindione
• medicines for a fungal infection, such as ketoconazole
• levothyroxine.
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription. If you suffer
from a disorder with related memory loss, you should
talk first to your doctor, who will decide if you can be given
Serenace and will explain the possible risks of its use.
Important information about some of the ingredients of
Serenace
• Patients who are intolerant to lactose should note that
Serenace capsules contain a small amount of lactose.
If your doctor has told you that you have an
intolerance to some sugars, contact your doctor
before taking this medicine.
• This medicine contains tartrazine (E102) as a colouring
agent. It can cause allergic type reactions including
asthma. If you are allergic to aspirin, you are more
likely to suffer a reaction.
Taking Serenace with food and drink
• DO NOT drink alcohol whilst taking Serenace.
Pregnancy and breast-feeding
• The following symptoms may occur in newborn
babies, of mothers that have used Serenace 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 take Serenace if you are breast-feeding. This
is because small amounts may pass into mother’s milk.
• If you are pregnant or planning to become pregnant
ask your doctor for advice before taking this medicine.
Driving and using machines
• Serenace may cause drowsiness or impaired
alertness, especially at the start of treatment. If you
are affected, DO NOT drive or operate machinery
without discussing this with your doctor first.

3

HOW TO TAKE SERENACE

Always take Serenace exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure.
You may not feel better for several weeks after you start
to take your capsules.
The capsules should be swallowed whole preferably
with a drink of water.
If you are taking high doses of Serenace, your doctor will
give you a higher strength product so that you do not
need to take a large number of capsules each day. The
usual dose is:
Adults
• Psychotic and behavioural conditions:
The usual starting dose is between 1.5 mg (3 capsules)
and 20 mg (40 capsules) a day, taken either as a single
dose or two smaller doses.
Your doctor may increase this dose up to a maximum
of 30 mg a day (60 capsules) in some cases.
When your doctor is happy that you are responding to
your treatment, they may gradually reduce the dose.
This could be as low as 3 mg (6 capsules) to 10 mg (20
capsules) daily.
• Tourette's Syndrome:
The starting dose is usually 2 mg (4 capsules) a day.
Your doctor may increase this dose to between
6 mg (12 capsules) and 30 mg (60 capsules) a day in
some cases.

352 mm
160 mm
L:
W:

Dimensions:

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

BLACK

231-10-01652
N/A
TBC
N/A
Variants of Univers.
7.25 pt
F. P. Code:
EAN Code:
Pharma Code:
Third party code:
Fonts:
Base Font Size:

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PL 00289/1613.
Teva UK Limited Licence (Post Licence Regulatory Team). Packed at NPIL Pharmaceuticals (UK) Ltd, Northumberland.
V1: Text update.
PL Number(s),
MA Holder & Packer:
Reason for revision:

Trackwise Parent:

210016

Child:

1
Version:

210018

PANTONE® GREEN C

10 July 2013

231-30-01046-D LEA SERENACE (HALOPERIDOL) 500mcg CAP TUK Ref:

When your symptoms are controlled your doctor will
gradually reduce your dose to around 4 mg
(8 capsules) a day.
• Nausea and vomiting:
The usual dose is 1 mg (2 capsules) a day.
• Anxiety:
The usual dose is 500 micrograms (1 capsule) twice a
day.
The Elderly
If you are elderly, your doctor will probably give you half
the doses mentioned above.
Children
Your doctor will work out the dose depending on your
child’s weight. The usual dose is 25 to 50 micrograms for
each kilogram (kg) of body weight up to a maximum of
10 mg. Teenagers may be given up to 30 mg a day.
If you take more Serenace than you should
If you (or someone else) swallow a lot of the capsules all
together, or if you think a child has swallowed any of the
capsules, contact your nearest hospital casualty
department or your doctor immediately.
An overdose is likely to cause muscle weakness, muscle
stiffness, shaking, low blood pressure, drowsiness.
Please take this leaflet, any remaining capsules and the
container with you to the hospital or doctor so that they
know which capsules were consumed.
If you forget to take Serenace Capsules
If you forget to take a capsule, take one as soon as you
remember, unless it is nearly time to take the next one.
DO NOT take a double dose to make up for a forgotten
dose. If it is nearly time to take the next dose, wait until
then and then carry on as before.
If you stop taking Serenace
DO NOT stop taking Serenace without talking to your
doctor first even if you feel better.
When you stop taking Serenace, your doctor will reduce
the dose gradually to avoid the possibility of withdrawal
symptoms, such as feeling and being sick and being
unable to sleep, or the recurrence of your original
condition.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

• rash
• unable to pass urine
• weight changes (increase or decrease)
• dizziness or sleepiness.
Uncommon (affecting less than one person in 100 but
more than one person in 1,000):
• a fall in the number of white blood cells which can
cause frequent infections
• confusional state
• epileptic fits or seizures (convulsion)
• blurred vision
• rapid heart beat
• shortness of breath
• inflammation of the liver, jaundice (your skin and the
whites of your eyes may become yellow) or, due to a
change in the way your liver works
• itching, sweating more than usual
• if you are a woman, you may unexpectedly produce
milk, having painful breast and your periods may
become infrequent or stop
• shuffling, unbalanced walk, neck tilted to one side
• feeling too warm (hyperthermia)
• fluid may build up in your body causing swollen feet
or ankles.
Rare (affecting less than one person in 1000 but more
than one person in 10,000):
• if you are a woman, your body may make too much of
the hormone prolactin
• getting excited, symptoms of psychosis such as
abnormal thoughts or vision, or hearing abnormal
sounds
• difficulty breathing or wheezing
• difficulties opening the mouth (Trismus)
• muscle twitching
• abnormal heavy and prolonged menstrual periods at
regular intervals
• abnormal heart rhythms.
Other side effects
• blood abnormalities, which can cause fever or chills,
sore throats and ulcers in your mouth and throat
• feeling unwell, confused or weak, feeling sick (nausea),
loss of appetite, feeling irritable. This could be an
illness called ‘syndrome of inappropriate anti-diuretic
hormone secretion’ (SIADH).
POSSIBLE SIDE EFFECTS
• low level of blood glucose (hypoglycaemia)
4
• drowsiness
Like all medicines, Serenace can cause side effects,
• vertigo (a sensation that the world is spinning around
although not everybody gets them.
you)
Stop taking the capsules and tell your doctor
• heart problems causing symptoms such as
immediately or go to the casualty department at your
palpitations, abnormal heart rhythms, fainting,
nearest hospital if the following happens:
blackouts or rarely heart attacks
• an allergic reaction causing swelling of the lips, face
• swelling of the voice box or contraction of the muscle
or neck leading to severe difficulty in breathing,
in the voice box
severe skin rash or hives.
• loss of appetite
This is a very serious but rare side effect. You may need
• indigestion
urgent medical attention or hospitalisation.
• acute liver failure
• inflammation of blood vessels
See your doctor immediately if you suffer from any of
• flaking or peeling of the skin
the following, as your treatment will need to be
• inflamed skin (red, hot to the touch and tender)
reviewed:
• uncontrolled movements, especially in your limbs and • sudden unexplained death has occurred in rare cases
but it is not known if this was due to the medicine
face, mouth and jaw, tremors, tics and muscle spasm
• swelling of face
in your shoulders, neck, body and arms. These are
very common side effects. However rarely this can be • feeling too cold.
severe enough to cause breathing difficulties. The first If you are concerned about any of these side effects, or if
signs may be uncontrolled movements of your tongue. you notice any side effects not listed in this leaflet,
• your muscles begin to feel rigid; body adopts rigid
please tell your doctor or pharmacist.
posture or a mask like face. These are common side
effects.
5 HOW TO STORE SERENACE
• extreme restlessness, loss of normal muscle control,
difficulty in moving, shakiness and loss of movement Keep out of the reach and sight of children.
• you feel feverish and become less alert than usual, or Store the capsules in a dry place below 30°C. Keep them
you feel hot, you start sweating and your heartbeat
in the original package, do not put them into another
speeds up
container.
• blood clots in the veins especially in the legs
Do not use Serenace after the expiry date that is stated
(symptoms include swelling, pain and redness in the
on the outer packaging. The expiry date refers to the last
leg), which may travel through blood vessels to the
day of that month.
lungs causing chest pain and difficulty in breathing
Medicines should not be disposed of via wastewater or
• in elderly people with dementia, a small increase in
household waste. Ask your pharmacist how to dispose of
the number of deaths has been reported for patients
medicines no longer required. These measures will help
taking antipsychotics compared with those not
to protect the environment.
receiving antipsychotics
• a serious problem called “neuroleptic malignant
6 FURTHER INFORMATION
syndrome” The signs may include:
• Fast heart beat, changing blood pressure and
What Serenace Capsules contain:
sweating followed by fever
• The active ingredient is haloperidol 500 micrograms
• Faster breathing, muscle stiffness, reduced
• The other ingredients are lactose and corn starch. The
consciousness and coma
capsule shell contains Titanium Dioxide (E171),
• Raised levels of a protein in your blood (an enzyme
Tartrazine (E102), and Patent Blue V (E131).
called creatine phosphokinase).
What Serenace Capsules look like and contents of the
If you notice any of these symptoms seek medical advice pack:
immediately.
• Serenace Capsules are hard gelatin capsules. Two-tone
green printed ‘Norton 500’ on one half and SERENACE
You may also experience difficulties with sex such as:
on the other.
erectile dysfunction (inability to develop or maintain an
• The capsules are available in packs of 7, 14, 21, 28, 30,
erection of the penis), decreased sexual desire, and
50, 56, 60, 84, 90, 100, 112, 120, 250, 1000 and 5000
some men may experience swelling of the breasts or
• Not all pack sizes may be marketed.
painful and prolonged erection.
Marketing Authorisation Holder and Manufacturer
The following side effects have been reported at the
The company responsible for manufacture is Piramal
approximate frequencies shown:
Healthcare UK Limited, Whalton Rd, Morpeth,
Very common (affecting more than one person in 10):
Northumberland, NE61 3YA.
• feeling agitated or having difficulty sleeping
The Marketing Authorisation holder is
• headache.
TEVA UK Limited, Eastbourne, BN22 9AG.
Common (affecting less than one person in 10 but more
This leaflet was last revised: June 2013
than one person in 100):
• depression, mental problems
PL 00289/1613
• rolling of the eyes
• problems with sight
• a fall in blood pressure on standing up which causes
dizziness, light-headedness or fainting
• constipation, dry mouth, excessive mouth watering,
feeling sick, being sick
• abnormal liver function (which may be detected by
01046-D
blood tests)
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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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