FLUANXOL 0.5 MG FILM-COATED TABLETS

Active substance: FLUPENTIXOL DIHYDROCHLORIDE

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Package leaflet: Information for the user

Fluanxol® 0.5 mg and 1 mg film-coated tablets
flupentixol
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. What Fluanxol is and what it is used for
2. What you need to know before you take Fluanxol
3. How to take Fluanxol
4. Possible side effects
5. How to store Fluanxol
6. Contents of the pack and other information
1. What Fluanxol is and what it is used for
Fluanxol contains the active substance flupentixol. 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 that are
causing the symptoms of your illness.
Fluanxol is used to treat depression in patients who may, or
may not, also be showing signs of anxiety.
2. What you need to know before you take Fluanxol
Do not take Fluanxol
• If you are allergic (hypersensitive) to flupentixol, other
thioxanthene drugs or antipsychotic drugs or to any of the
other ingredients of this medicine (listed in section 6).
• If you are feeling less alert than usual, or are drowsy
or sleepy, or have serious problems with your blood
circulation
• If you suffer with severe depression, which needs you to
stay in hospital or if you need electroconvulsive therapy
(ECT)
• If you suffer from periods of excitement, overactivity or
mania.

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Warnings and precautions
Talk to your doctor or pharmacist before taking Fluanxol if you:
• have a heart condition (including an irregular heart beat) or
severe breathing problems (such as asthma or bronchitis)
• have liver, kidney or thyroid problems
• suffer from epilepsy, or have been told that you are at risk
of having fits (for example because of a brain injury or
because of alcohol withdrawal)
• suffer from Parkinson’s disease, or myasthenia gravis (a
condition causing severe muscular weakness)
• have an enlarged prostate or suffer from a condition known
as phaeochromocytoma (a rare type of cancer of a gland
near the kidney)
• suffer from glaucoma (raised pressure within the eye)
• are diabetic
• or someone else in your family has a history of blood
clots, as medicines like these have been associated with
formation of blood clots.
Children and adolescents
Fluanxol is not recommended in these patients.
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.

• Anticoagulant drugs used to prevent blood clots (e.g.
warfarin)
• Anticholinergic drugs (contained in some cold, allergy or
travel sickness remedies as well as other medicines)
• Metoclopramide (used to treat nausea and other stomach
conditions)
• Piperazine (used to treat worm infections)
• Levodopa or other medicines used to treat Parkinson’s
disease
• Sibutramine (used to reduce appetite)
• Digoxin (to control heart rhythm)
• Corticosteroids (e.g. prednisolone)
• Medicines used to lower the blood pressure such as
hydralazine, alpha blockers (e.g. doxazosin) beta-blockers,
methyldopa, clonidine or guanethidine
• Medicines used to treat epilepsy
• 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.
Fluanxol with food, drink and alcohol
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, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Pregnancy
If you are pregnant or think you might be pregnant, tell your
doctor. Fluanxol should not be used during pregnancy unless
it is necessary.
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
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.
Fertility
Flupentixol may decrease your sexual activity and fertility.
These are not lasting effects. Please talk to your doctor about
any problems.
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.
Fluanxol film-coated tablets contain 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 this medicine 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.

You may be more likely to think like this:
• If you have previously had thoughts about killing or
harming yourself
• If you are a young adult. Information from clinical trials
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 liver problems, the level of flupentixol in your blood
may be checked.

If you have thoughts of harming or killing yourself at any time,
contact your doctor or go to a hospital straight away.

Use in children
Fluanxol is not recommended for children.

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.

How and when to take Fluanxol
Swallow the tablets with a drink of water. Do not chew them.

Other medicines and Fluanxol
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
The following medicines should NOT be taken at the same time
as Fluanxol:
• Antipsychotics or other medicines that change the
heartbeat (quinidine, amiodarone, sotalol, dofetilide,
erythromycin, moxifloxacin, cisapride, lithium)
Tell your doctor if you are taking any of the following medicines:
• Tricyclic anti-depressants
• Barbiturates or other medicines that make you feel drowsy

Older 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.

You may feel an improvement within two to three days.
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.

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If you take more Fluanxol than you should
If you think that you or anyone else may have taken too many
Fluanxol film-coated 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
• Low blood pressure, weak pulse, fast heart rate, pale skin,
restlessness
• High or low body temperature
• Changes in the heart beat including irregular heart beat 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 medicine,
ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them. Older 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:
• High fever, unusual stiffness of the muscles and changes
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

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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 film-coated
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 older people with dementia, a small increase in the number
of deaths has been reported for patients taking antipsychotics
compared with those not receiving antipsychotics.
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 (see details
below).
By reporting side effects you can help provide more information
on the safety of this medicine.
United Kingdom
Via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Alternatively you can call Freephone 0808 100 3352 (available
between 10am-2pm Monday – Friday) or fill in a paper form
available from your local pharmacy.
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
5. How to store Fluanxol
• Keep this medicine out of the sight and reach of children
• Do not use this medicine after the expiry date that is
printed on the label. The expiry date refers to the last day
of that month
• This medicinal product does not require any special
storage conditions.
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 to protect the
environment.
6. Contents of the pack and other information
What Fluanxol contains
The active substance is flupentixol (as dihydrochloride).
Each 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.
Marketing Authorisation Holder
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
Manufacturer
H. Lundbeck A/S
Ottiliavej 9
DK-2500 Valby
Denmark
This leaflet was last revised in 05/2014
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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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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