FLUANXOL 0.5 MG FILM-COATED TABLETS

Active substance: FLUPENTIXOL DIHYDROCHLORIDE

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GB-6436

Fluanxol 0.5 mg and 1 mg film-coated tablets
flupentixol
®

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 are troubling, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist
In this leaflet:
1. What Fluanxol is and what it is used for
2. Before you take Fluanxol
3. How to take Fluanxol
4. Possible side effects
5. How to store Fluanxol
6. Further information
1. WHAT FLUANXOL IS AND WHAT IT IS USED FOR
How does Fluanxol work?
Fluanxol belongs to a group of medicines known as
antidepressants.
These medicines act on nerve pathways in specific areas of
the brain and help to correct certain chemical imbalances
in the brain that are causing the symptoms of your illness.
What is Fluanxol used for?
Fluanxol tablets are used to treat depression in patients
who may, or may not, also be showing signs of anxiety.
2. BEFORE YOU TAKE FLUANXOL
Do not take Fluanxol
• f you are allergic (hypersensitive) to flupentixol, other
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thioxanthine drugs or antipsychotic drugs or to any of
the other ingredients of Fluanxol (see What Fluanxol
contains). Consult your doctor if you think you might be
• If you are feeling less alert than usual, or are drowsy or
sleepy, or have serious problems with your blood
circulation
• f you suffer with severe depression, which needs you to
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stay in hospital or if you need electroconvulsive therapy
(ECT)
• f you suffer from periods of excitement, overactivity or
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mania

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Take special care with Fluanxol
• f you have a heart condition (including an irregular heart
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beat) or severe breathing problems (such as asthma or
bronchitis)
• f you have liver, kidney or thyroid problems
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• f you suffer from epilepsy, or have been told that you
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are at risk of having fits (for example because of a brain
injury or because of alcohol withdrawal)
• f you suffer from Parkinson’s disease, or myasthenia
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gravis (a condition causing severe muscular weakness)
• f you have an enlarged prostate or suffer from a
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condition known as phaeochromocytoma (a rare type of
cancer of a gland near the kidney)
• f you suffer from glaucoma (raised pressure within the eye)
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• f you are diabetic
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• 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.
Please consult your doctor, even if these statements were
applicable to you at any time in the past.
Thoughts of suicide and worsening of your depression or
anxiety disorder
If you are depressed and/or have anxiety disorders,
you can sometimes have thoughts of harming or killing
yourself. These may be increased when first starting
antidepressants, since these medicines all take time to
work, usually about two weeks but sometimes longer.
You may be more likely to think like this:
-  you have previously had thoughts about killing or
If
harming yourself
-  you are a young adult. Information from clinical trials
If
has shown an increased risk of suicidal behaviour
in adults aged less than 25 years with psychiatric
conditions who were treated with an antidepressant
If you have thoughts of harming or killing yourself at any
time, contact your doctor or go to a hospital straight away.

Medicines may affect the action of other medicines and this
can sometimes cause serious adverse reactions. Please tell
your doctor or pharmacist if you are taking, or have recently
taken, any other medicines, including medicines obtained
without a prescription.
Tell your doctor if you are taking any of the following medicines:
• Tricyclic anti-depressants
• Barbiturates or other medicines that make you feel drowsy
• Anticoagulant drugs used to prevent blood clots (e.g.
warfarin)
•  nticholinergic drugs (contained in some cold, allergy or
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travel sickness remedies as well as other medicines)
• Metoclopramide (used to treat nausea and other
stomach conditions)
•  iperazine (used to treat worm infections)
P
• Levodopa or other medicines used to treat Parkinson’s
disease
•  ibutramine (used to reduce appetite)
S
•  igoxin (to control heart rhythm)
D
•  orticosteroids (e.g. prednisolone)
C
• Medicines used to lower the blood pressure such as
hydralazine, alpha blockers (e.g. doxazosin) betablockers, methyldopa, clonidine or guanethidine
•  edicines used to treat epilepsy
M
• Medicines used to treat diabetes
Fluanxol can reduce the effect of adrenaline (epinephrine)
and similar drugs.
Tell your doctor, dentist, surgeon or anaesthetist before any
operation as Fluanxol can increase the effects of general
anaesthetics, muscle relaxing drugs and drugs used to
prevent clots.
Taking Fluanxol with food and drink
Fluanxol can be taken with or without food.
Fluanxol may increase the sedative effects of alcohol
making you drowsier. It is recommended not to drink
alcohol during treatment with Fluanxol.
Pregnancy
Ask your doctor or pharmacist for advice before taking any
medicine.
If you are pregnant or think you might be pregnant, tell
your doctor. Fluanxol should not be used during pregnancy
unless it is necessary.
Your newborn baby might show side effects if this medicine
is used.
The following symptoms may occur in newborn babies,
of mothers that have used Fluanxol 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.
Breast-feeding
Ask your doctor or pharmacist for advice before taking
any medicine. If you are breastfeeding, ask your doctor for
advice. You should not use Fluanxol when breast-feeding
your baby because small amounts of the medicine can pass
into the breast milk.
Driving and using machines
There is a risk of feeling drowsy and dizzy when using
Fluanxol especially at the start of your treatment. If this
happens do not drive or use any tools or machines until you
know you are not affected in this way.
Do not drive if you have blurred vision.
Important information about some of the ingredients in
Fluanxol
This product contains lactose. If your doctor has told you
that you have intolerance to some sugars, contact your
doctor before taking this medicinal product.
3. HOW TO TAKE FLUANXOL
Always take Fluanxol exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are
not sure.
The dose varies and depends on the severity of the illness.
Adults
The starting dose is usually 1 mg daily taken as a single
dose in the morning.
This may be increased to 2 mg per day after one week.
The maximum daily dose is 3 mg per day.
If you have liver problems, the level of flupentixol in your
blood may be checked.

You may find it helpful to tell a relative or close friend
that you are depressed or have an anxiety disorder, and
ask them to read this leaflet. You might ask them to tell you
if they think your depression or anxiety is getting worse, or
if they are worried about changes in your behaviour.

Elderly patients (above 65 years)
The starting dose is usually 0.5 mg daily taken as a single
dose in the morning. This may be increased to 1 mg per day
after one week.
The maximum daily dose is 1.5 mg per day.

Taking other medicines
The following medicines should NOT be taken at the same
time as Fluanxol:
•  ntipsychotics or other medicines that change the
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heartbeat (quinidine, amiodarone, sotalol, dofetilide,
erythromycin, moxifloxacin, cisapride, lithium)

Children
Fluanxol is not recommended for children.
How and when to take Fluanxol
Fluanxol can be taken with or without food.
Swallow the tablets with a drink of water. Do not chew them.
You may feel an improvement within two to three days.

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PACKAGE LEAFLET: INFORMATION FOR THE USER

If you think that the effect of Fluanxol is too strong or too
weak, talk to your doctor or pharmacist.
Continue to take the tablets for as long as your doctor
recommends. The underlying illness may persist for a
long time and if you stop your treatment too soon your
symptoms may return.
Never change the dose of the medicine without talking to
your doctor first.
If you take more Fluanxol than you should
If you think that you or anyone else may have taken too
many Fluanxol tablets contact your doctor or nearest
hospital casualty department immediately. Do this even
if there are no signs of discomfort or poisoning. Take the
Fluanxol container with you if you go to a doctor or hospital.
Symptoms of overdose may include:
• Drowsiness
• Unconsciousness
• Muscle movements or stiffness
• Fits
•  ow blood pressure, weak pulse, fast heart rate, pale
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skin, restlessness
• High or low body temperature
•  hanges in the heart beat including irregular heart beat
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or slow heart rate
If you forget to take Fluanxol
If you forget to take a dose, take the next dose at the usual
time. Do not take a double dose to make up for a forgotten
tablet.
If you stop taking Fluanxol
Do not stop taking Fluanxol even if you begin to feel better,
unless you have agreed this with your doctor.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Fluanxol can cause side effects, although
not everybody gets them. Elderly patients tend to be more
prone to some of these effects than younger patients and
this may mean your treatment is supervised more closely.
Serious side effects
Stop taking Fluanxol and seek medical advice immediately
if you have any of the following allergic reactions:
- 
Difficulty in breathing
- 
Swelling of the face, lips, tongue or throat which causes
difficulty in swallowing or breathing
- 
Severe itching of the skin (with raised lumps)
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.
If you get any of the following symptoms you should
contact your doctor immediately as your dose may need to
be reduced or stopped:

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•  igh fever, unusual stiffness of the muscles and changes
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in consciousness, especially if occurring with sweating
and fast heart rate. These symptoms may be signs of a
rare but serious condition called neuroleptic malignant
syndrome that has been reported with the use of
Fluanxol and similar medicines
• Unusual movements of the mouth and tongue as these
may be early signs of a condition known as tardive
dyskinesia
• Unusual muscle movements (such as circular
movements of the eyes), stiffness, tremor and
restlessness (for example difficulty in sitting or standing
still) as these may be signs of a so-called “extra
pyramidal” reaction
• Any yellowing of the skin and the white in the eyes
(jaundice); your liver may be affected
Other side effects:
Side effects are most pronounced in the beginning of
the treatment and most of them usually wear off during
continued treatment.
• Throbbing or fast heartbeats
• Reduction in blood platelets (which increases the risk
of bleeding or bruising) and other blood cell changes
• Drowsiness
• Loss of co-ordination or altered muscle movements
(including unusual movements of the mouth, tongue
and eyeballs)
• Tremor
• Stiff or floppy muscles
• Dizziness
• Headache
• Poor concentration or confusion
• Rigidity of the whole body
• Speech problems
• Fits
• Blurred or abnormal vision
• Shortness of breath
• Dry mouth or increase in saliva
• Feeling sick or vomiting
• Indigestion or stomach pain

• Flatulence (wind) constipation or diarrhoea
• Abnormal urination (such as decrease in the frequency
or amount)
• Increased sweating or greasy skin
• Itching, rashes or skin reactions (including sensitivity to
sunlight)
• Muscle pain
• Raised blood levels of glucose or the hormone prolactin
• Loss of control of blood sugar levels
• Changes in appetite or weight
• Low blood pressure
• Hot flushes
• General weakness or pain, tiredness or feeling unwell
• Abnormal liver function tests
• Unexpected excretion of breast milk
• Insomnia
• Depression
• Nervousness or agitation
• Reduction in your sex drive
• Men may experience breast enlargement or problems
with ejaculation or erections
• Women may experience an absence of menstrual periods
As with other medicines that work in a way similar to
flupentixol (the active ingredient of Fluanxol tablets), rare
cases of the following side effects have been reported:
• Slow heartbeat and abnormal ECG heart tracing.
• Life threatening irregular heart beats.
In rare cases irregular heart beats (arrhythmias) may have
resulted in sudden death.
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.
If any of the side effects are troubling, or if you notice any
side effects not listed in this leaflet please tell your doctor
or pharmacist.
5. HOW TO STORE FLUANXOL
• Keep out of the reach and sight of children
• Do not use Fluanxol after the expiry date that is printed
on the label. The expiry date refers to the last day of that
month
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 Fluanxol contains
The active substance is flupentixol (as dihydrochloride).
Each Fluanxol film-coated tablet contains 0.5 mg or 1 mg
flupentixol.
The other ingredients are betadex, lactose monohydrate,
maize starch, hydroxypropylcellulose, microcyrstalline
cellulose, croscarmellose sodium, talc, hydrogenated
vegetable oil and magnesium stearate.
Coating and colour: macrogol 6000, polyvinyl alcohol,
macrogol 3350, talc, iron oxide yellow (E172) and titanium
dioxide (E171).
What Fluanxol looks like and contents of the packs
Fluanxol 0.5 mg film-coated tablets are round, slightly
biconvex, yellow, marked FD.
Fluanxol 1 mg film-coated tablets are oval, slightly
biconvex, yellow, marked FF.
They are available in blister packs of 60 tablets.
These tablets are manufactured by:
H. Lundbeck A/S
Ottiliavej 9
DK-2500 Valby
Denmark
For any information about this medicine, please contact the
Marketing Authorisation holder:
Lundbeck Limited
Lundbeck House
Caldecotte Lake Business Park
Caldecotte
Milton Keynes MK7 8LG
UK
This leaflet was last revised in 04/2012.
To request a copy of this leaflet in braille, large print or
audio please call free of charge:
0800 198 5000
Please be ready to give the following information:
Product name

Product code number

Fluanxol 0.5 mg film-coated tablets PL 0458/0011R
Fluanxol 1 mg film-coated tablets

PL 0458/0037

This is a service provided by the Royal National Institute of
Blind People.

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GB-6436

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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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