Israel - English - Ministry of Health
IL-067-22-3-134 / 133662
IL-626002 (067-02) / 119778
2014-11-28 / 14:17 / MOVB
Do not exceed the recommended dosage.
consult the doctor or pharmacist.
How to take Fluanxol
Swallow with a drink of water. Do not chew the tablets. There is no information
about crushing or splitting of the tablet.
Duration of treatment
As with other antipsychotic medicines it may take a few weeks before you feel any
Continue to take the tablets for as long as your doctor recommended.
Even if your medical situation has improved, do not stop taking the medicine
without consulting the doctor or the pharmacist.
If you stop your treatment too soon your symptoms may return.
If you mistakenly took higher dosage
If you think that you or anyone else may have taken too many Fluanxol tablets
contact your doctor or the nearest hospital 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:
Low blood pressure, weak pulse, fast heart rate, pallor, restlessness
High or low body temperature
Changes in heart rate including irregular heart beat or slow heart rate has been
seen when Fluanxol has been given in overdose together with medicines known
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 are told to do so
by your doctor.
Do not take medicines in the dark. Check the label and the dose each time you take
a medicine. Wear glasses if you need them.
If you have any further questions about the use of this medicine, ask your doctor or
You should contact your doctor or go to the hospital straight away if you
experience any of the following symptoms:
Unusual movements of the mouth and tongue, this may be an early sign of a
condition known as tardive dyskinesia.
if occurring with sweating and rapid pulse (these symptoms may be signs of a rare
condition called neuroleptic malignant syndrome (NMS) which has been reported
Yellowing of the skin and the white in the eyes this may mean that your liver is
Sleepiness, inability to sit still or remain motionless, involuntary movements,
slow or diminished movements, dry mouth.
Racing heart rate (tachycardia) or beating of the heart, tremor, repetitive movements
or abnormal postures due to sustained muscle contractions, dizziness, headache,
constipation, vomiting, digestive problems or discomfort centered in the upper
abdomen, diarrhoea, urination disorders, increased sweating, itching, muscle pain,
increased appetite, increased weight, fatigue or weakness, Sleeplessness (insomnia),
depression, nervousness, agitation, decreased sexual drive (libido decreased).
Involuntary movements of the face and limbs, parkinsonism, speech disorder,
convulsion, circular movement of the eyes, abdominal pain, nausea, flatulence,
rash, skin reaction due to sensitivity to light, eczema or inflammation of the skin,
muscle rigidity, decreased appetite, low blood pressure, hot flush, abnormal liver
function tests, sexual disturbance, state of confusion.
Low blood platelet count (thrombocytopenia), low white blood platelet count
(neutropenia), reduced white blood cell count (leukopenia), bone marrow
Increased level of prolactin in the blood (hyperprolactinaemia)
High blood sugar (hyperglycaemia), abnormal glucose tolerance
Over-sensitivity (hypersensitivity), acute systemic and severe allergic reaction
Development of breasts in men (gynaecomastia), excessive milk production
(galactorrhoea), lack of menstrual periods (amenorrhoea).
As with other medicines that work in a way similar to flupentixol (the active
QT prolongation (slow heart beat and change in the ECG)
Irregular heart beat
Torsades de Pointes - a special kind of irregular heart rate
In rare cases irregular heartbeats (arrhythmias) may have resulted in sudden death.
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
medical advice immediately.
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
HOW TO STORE THIS MEDICINE
Avoid poisoning! This medicine, and all other medicines, must be stored in a
safe place out of the reach of children and/or infants, to avoid poisoning.
Do not induce vomiting unless explicitly instructed to do so by a doctor!
expiry date refers to the last day of that month.
Do not throw away any Medicines via waste water or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help to protect the environment.
CONTENT OF THE PACK AND OTHER INFORMATION
In addition to the active ingredient this medicine also contains:
The other ingredients are:
beta cycllodextrin, lactose monohydrate, maize starch, hydroxypropylcellulose,
microcrystalline cellulose, croscarmellose sodium, talc, vegetable oil hydrogenated,
What Flunaxol look like and contents of the packs:
Flunaxol tablets-each tablet is round, biconvex, in a light brown color.
Licence Holder and address:
Manufacturer name and address: H. Lundbeck A/S, Valby, Denmark
Registration number in the national medicine book of the ministry of health:
Patient leaflet in accordance with the pharmacists' regulations (medical
To be marketed on prescription only.
Film coted tablets
Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet, you may need to read it again.
This leaflet contains essential information regarding this medicine. If you have
any further questions, ask your doctor or the pharmacist.
This medicine has been prescribed for the treatment of your illness. Do not pass
it on to others. It may harm them, even if their signs of illness are the same as
The medicine is not recommended for children and adolescents.
WHAT THIS MEDICINE IS USED FOR
group of medicines known as antipsychotics (also called neuroleptics).
correct certain chemical imbalances in the brain that are causing the symptoms of
Fluanxol is used for the treatment of schizophrenia and mania.
Your doctor, however, may prescribe Fluanxol for another purpose. Ask your doctor
if you have any questions about why Fluanxol has been prescribed for you.
Therapeutic group: Antipsychotic medicines - derivatives of thioxanthene
BEFORE YOU USE THIS MEDICINE
Do not use this medicine
If you are hypersensitive (allergic) to the active ingredient or to any of the other
If you have diminished consciousness.
Special warnings that relate to the use of the medicine
Do not use this medicine without consulting a physician before starting treatment
have diabetes (An adjustment of the antidiabetic therapy may be required)
poisoning with alcohol)
have risk factors for stroke (e.g. smoking, hypertension)
potassium or magnesium in your blood), or have a genetic predisposition for
any of these.
take or used to take other antipsychotic medicines
are more excited or overactive than normal, since this medicine may increase
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
During long-term treatment with this medicine blood and liver function test should
If you are sensitive to any type of food or medicine, inform your doctor before
If you take or took lately other medicines including non-prescription drugs and
food-additives, tell the doctor or pharmacist about it. You should inform the doctor
or the pharmacist especially if you take or have recently taken any of the following
Tricyclic antidepressant medicines
Medicines used to lower the blood pressure (e.g. Guanethidine and Clonidine)
Barbiturates (sleeping and sedative medicines)
Medicines used to treat epilepsy
Medicines used to treat Parkinson’s disease (e.g. Levodopa)
Metoclopramide (used in the treatment of gastro-intestinal disorders)
Piperazine (used in the treatment of worms infections in the digestive system).
Medicines that cause a disturbed water or salt balance (too little potassium or
magnesium in your blood)
Medicines known to increase the concentration of Fluanxol in your blood
The following medicines should not be taken at the same time as Fluanxol:
Medicines that change the heartbeat: quinidine, amiodarone, sotalol, dofetilide,
erythromycine, terfenadine, astemizole, gatifloxacin, moxifloxacin, cisapride,
Other antipsychotic medicines
Flunaxol with food
Flunaxol can be taken with or without food.
Flunaxol with alcohol
not to drink alcohol during treatment with Fluanxol.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you might be pregnant or are planning
to have a baby, ask your doctor for advice before taking this medicine
If you are pregnant or think you might be pregnant, consult a doctor before taking
the medicine. Fluanxol should not be used during pregnancy unless clearly
The following symptoms may occur in newborn babies of mothers that have used
Fluanxol in the last trimester (last three months of their pregnancy): shaking,
contact your doctor.
If you are breastfeeding, ask your doctor for advice before taking the medicine. You
should not use Fluanxol when breast-feeding, as small amounts of the medicine
can pass into the breast milk.
Driving and using machines
Do not drive or use dangerous machines during the treatment with Fluanxol, since
this medicine may cause drowsiness or dizziness.
Important information about some of the ingredients of the medicine
have intolerance to some sugars, contact your doctor before taking this medicinal
product. Lactose may cause allergic reaction in people sensitive to lactose.
HOW TO USE THIS MEDICINE
Always take Fluanxol exactly as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
The dosage and treatment regimen will be determined by the doctor only
The recommended dose is:
The dose should be adjusted individually for any patient, according to their
Begin with a small dosages and gradually increase until it reaches the optimal
dosage. The graduation in the dosage shoud be as quickly as possible in
accordance with the reaction for the treatment.
In the maintenance treatment Flunaxol can be taken as a single daily dose in the
higher dosage may be necessary.
Patients with special risks-Patients with liver complaints normally receive doses in
the lower end of the dosage range.
Physician Prescribing Information- Fluanxol tabs 3 mg
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE MEDICINAL PRODUCT
Fluanxol 3 mg coated tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluanxol 3 mg:
Each tablet contains 3 mg flupentixol (as 3.504 mg flupentixol
Excipients with known effect:
3 mg: Sunset yellow FCF (E110),
For the full list of excipients see section 6.1
Round,slightly biconvex, ochre-, film coated tablet.
Schizophrenia and mania
Posology and method of administration
Dosage should be individually adjusted according to the patient's condition. In
general, small doses should be used initially and increased to the optimal effective
level as rapidly as possible based on the therapeutic response. The maintenance
dose can usually be given as a single morning dose.
Initially 3-15 mg/day divided in two or three daily doses, increased, if necessary, to
Maintenance dose usually is 5-20 mg/day.
Older patients usually should receive dosages in the lower end of the dosage range.
Reduced renal function
Flupentixol can be given in usual doses to patients with reduced renal function.
Reduced liver function
Careful dosing and, if possible, a serum level determination is advisable .
Flupentixol is not recommended for use in children due to lack of clinical experience.
Method of administration
The tablets are swallowed with water.
Hypersensitivity to the active substance or to any of the excipients listed in section
Circulatory collapse, depressed level of consciousness due to any cause (e.g.
intoxication with alcohol, barbiturates or opiates), coma.
Special warnings and precautions for use
The possibility of development of neuroleptic malignant syndrome (hyperthermia,
muscle rigidity, fluctuating consciousness, instability of the autonomous nervous
system) exists with any neuroleptic. The risk is possibly greater with the more potent
agents. Patients with pre-existing organic brain syndrome, mental retardation, and
opiate and alcohol abuse are over-represented among fatal cases .
Treatment: Discontinuation of the neuroleptic. Symptomatic treatment and use of
general supportive measures. Dantrolene and bromocriptine may be helpful.
Symptoms may persist for more than a week after oral neuroleptics are discontinued
and somewhat longer when associated with the depot forms of the drug.
Like other neuroleptics flupentixol should be used with caution in patients with
organic brain syndrome, convulsion and advanced hepatic disease.
Not recommended for excitable or overactive patients in doses up to 25 mg/day since
its activating effect may lead to exaggeration of these characteristics. If previously
the patient has been treated with tranquillizers or neuroleptics with sedative effect,
these should be withdrawn gradually.
As described for other psychotropics flupentixol may modify insulin and glucose
responses calling for adjustment of the antidiabetic therapy in diabetic patients.
Patients on long-term therapy, particularly on high doses, should be monitored
carefully and evaluated periodically to decide whether the maintenance dosage can
As with other drugs belonging to the therapeutic class of antipsychotics, flupentixol
may cause QT prolongation. Persistently prolonged QT intervals may increase the
risk of malignant arrhythmias. Therefore, flupentixol should be used with caution in
susceptible individuals (with hypokalemia, hypomagnesia or genetic predisposition)
and in patients with a history of cardiovascular disorders, e.g. QT prolongation,
significant bradycardia (<50 beats per minute), a recent acute myocardial infarction,
uncompensated heart failure, or cardiac arrhythmia. Concomitant treatment with
other antipsychotics should be avoided (see section 4.5(.
Cases of venous thromboembolism (VTE) have been reported with antipsychotic
drugs. Since patients treated with antipsychotics often present with acquired risk
factors for VTE, all possible risk factors for VTE should be identified before and
during treatment with flupentixol and preventive measures undertaken
An approximately 3-fold increased risk of cerebrovascular adverse events have been
seen in randomised placebo controlled clinical trials in the dementia population with
some atypical antipsychotics. The mechanism for this increased risk is not known. An
increased risk cannot be excluded for other antipsychotics or other patient
populations. Flupentixol should be used with caution in patients with risk factors for
Increased Mortality in older people with Dementia
Data from two large observational studies showed that older people with dementia
who are treated with antipsychotics are at a small increased risk of death compared
with those who are not treated. There are insufficient data to give a firm estimate of
the precise magnitude of the risk and the cause of the increased risk is not known.
Flupentixol is not licensed for the treatment of dementia-related behavioural
The tablets contain lactose monohydrate. Patients with rare hereditary problems of
galactose intolerance, the Lapp lactase deficiency or glucose-galactose
malabsorption should not receive this medicine.The tablets also contains Sunset
yellow FCF(E110)which may cuase allergic reaction
Interactions with other medicinal products and other forms of
Combinations requiring precautions for use
Flupentixol may enhance the sedative effect of alcohol and the effects of barbiturates
and other CNS depressants.
Neuroleptics may increase or reduce the effect of antihypertensive drugs; the
antihypertensive effect of guanethidine and similar acting compounds is reduced.
Concomitant use of neuroleptics and lithium increases the risk of neurotoxicity.
Tricyclic antidepressants and neuroleptics mutually inhibit the metabolism of each
Flupentixol may reduce the effect of levodopa and the effect of adrenergic drugs.
Concomitant use of metoclopramide and piperazine increases the risk of
Increases in the QT interval related to antipsychotic treatment may be exacerbated
by the co administration of other drugs known to significantly increase the QT
interval. Co-administration of such drugs should be avoided. Relevant classes
Class Ia and III antiarrhythmics (e.g. quinidine, amiodarone, sotalol, dofetilide )
Some antipsychotics (e.g. thioridazine )
Some macrolides (e.g. erythromycin)
Some antihistamines (e.g. terfenadine, astemizole)
Some quinolone antibiotics (e.g. gatifloxacin, moxifloxacin)
The above list is not exhaustive and other individual drugs known to significantly
increase QT interval (e.g. cisapride, lithium) should be avoided.
Drugs known to cause electrolyte disturbances such as thiazidediuretica
(hypokalemia) and drugs known to increase the plasma concentration of flupentixol
should also be used with caution as they may increase the risk of QT prolongation
and malignant arrythmias (see section 4.4.)
Fertility, pregnancy and lactation
Flupentixol should not be administered during pregnancy unless the expected benefit
to the patient outweighs the theoretical risk to the foetus.
Neonates exposed to antipsychotics (including flupentixol) during the third trimester
of pregnancy are at risk of adverse reactions including extrapyramidal and/or
withdrawal symptoms that may vary in severity and duration following delivery. There
have been reports of agitation, hypertonia, hypotonia, tremor, somnolence,
respiratory distress, or feeding disorder. Consequently, newborns should be
Animal studies have shown reproductive toxicity (see section 5.3)
As flupentixol is found in breast milk in low concentrations it is not likely to affect the
infant when therapeutic doses are used. The dose ingested by the infant is less than
0.5% of the weight related maternal daily dose. Breast-feeding can be continued
during flupentixol therapy if considered of clinical importance but observation of the
infant is recommended, particularly in the first 4 weeks after giving birth.
In humans, adverse events such as hyperprolactinaemia, galactorrhoea,
amenorrhoea, libido decreased, erectile dysfunction and ejaculation failure have
been reported (see section 4.8). These events may have a negative impact on
female and/or male sexual function and fertility.
If clinical significant hyperprolactinaemia, galactorrhoea, amenorrhoea or sexual
dysfunctions occur, a dose reduction (if possible) or discontinuation should be
considered. The effects are reversible on discontinuation.
In preclinical fertility studies in rats, flupentixol slightly affected the pregnancy rate of
female rats. Effects were seen at doses well in excess of those applied during clinical
Effects on ability to drive and use machines
Fluanxol is a non-sedating drug in the low-moderate dosage range.
However, patients who are prescribed psychotropic medication may be expected to
have some impairment in general attention and concentration and should be
cautioned about their ability to drive or operate machinery.
4.8 Undesirable effects
Undesirable effects are for the majority dose dependent. The frequency and severity
are most pronounced in the early phase of treatment and decline during continued
Extrapyramidal reactions may occur, especially in the early phase of treatment. In
most cases these side effects can be satisfactorily controlled by reduction of dosage
and/or use of antiparkinsonian drugs. The routine prophylactic use of
antiparkinsonian drugs is not recommended. Antiparkinsonian drugs do not alleviate
tardive dyskinesia and may aggravate them. Reduction in dosage or, if possible,
discontinuation of flupentixol therapy is recommended. In persistent akathisia a
benzodiazepine or propranolol may be useful.
Frequencies are taken from the literature and spontaneous reporting. Frequencies
are defined as :
Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100),
rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be
estimated from the available data).
Blood and lymphatic
Nervous system disorders
Tremor, dystonia, dizziness,
Uncommon to Rare
Tardive dyskinesia, dyskinesia,
parkinsonism, speech disorder,
Accommodation disorder, vision
Respiratory, thoracic and
Abdominal pain, nausea,
Renal and urinary
Micturition disorder, urinary
Skin and subcutaneous
Rash, photosensitivity reaction,
connective tissue disorder
Metabolism and nutrition
Increased appetite, weight
Hypotension, hot flush.
General disorders and
Immune system disorders
Liver function test abnormal.
Reproductive system and
Ejaculation failure, erectile
nervousness, agitation, libido
As with other drugs belonging to the therapeutic class of antipsychotics, rare cases of
QT prolongation, ventricular arrythmias - ventricular fibrillation, ventricular
tachycardia, Torsade de Pointes and sudden unexplained death have been reported
for flupentixol (see section 4.4).
Abrupt discontinuation of flupentixol may be accompanied by withdrawal symptoms.
The most common symptoms are nausea, vomiting, anorexia, diarrhoea,
rhinorrhoea, sweating, myalgias, paraesthesias, insomnia, restlessness, anxiety, and
agitation. Patients may also experience vertigo, alternate feelings of warmth and
coldness, and tremor. Symptoms generally begin within 1 to 4 days of withdrawal and
abate within 7 to 14 days.
Somnolence, coma, movement disorder, convulsions, shock,
The highest orally administered single dose in clinical trials was 80 mg, and up to 320
mg/day has been given.
ECG changes, QT prolongation, Torsade de Pointes, cardiac arrest and ventricular
arrhythmias have been reported when administered in overdose together with drugs
known to affect the heart.
Treatment is symptomatic and supportive. Gastric lavage should be carried out as
soon as possible after oral ingestion and activated charcoal may be administered.
Measures to support the respiratory and cardiovascular systems should be instituted.
Epinephrine (adrenaline) should not be used as further lowering of blood pressure
may result. Convulsions may be treated with diazepam and extrapyramidal
symptoms with biperiden .
ATC-code: N 05 AF 01
Mechanism of action
Flupentixol is a neuroleptic of the thioxanthene group.
Flupentixol is a mixture of two geometric isomers, the active flupentixol and trans(E)
flupentixol, approximately in the ratio of 1:1.
The antipsychotic effect of neuroleptics is related to their dopamine receptor blocking
effect but possibly also 5 HT (5-hydroxytryptamine) receptor blockade contributes. In
vitro and in vivo flupentixol has high affinity for both dopamine D1 and D2 receptors
whereas fluphenazine is almost D2 selective in vivo. The atypical antipsychotic,
clozapine, shows – as flupentixol - equiaffinity to D1 and D2 receptors both in vitro
and in vivo.
Flupentixol has high affinity for α1-adrenoceptors and 5 HT2 receptors, although
lower than that of chlorprothixene, high-dose phenothiazines and clozapine, but no
affinity for cholinergic muscarine receptors. It has only slight antihistaminergic
properties and no α2 adrenoceptor blocking activity.
Flupentixol has proven to be a potent neuroleptic in all the behavioural studies for
neuroleptic (dopamine receptor blocking) activity. Correlation is found in the in vivo
test models, the affinity for dopamine D2 binding sites in vitro and the average, daily
oral antipsychotic doses.
Perioral movements in rats are dependent on D1 receptor stimulation or blockade of
the D2 receptor population. The movements can be prevented by flupentixol.
Likewise, the results from investigations in monkeys indicate that oral hyperkinesia is
more related to D1 receptor stimulation and to a less degree to D2 receptor
supersensitivity. This leads to the suggestion that D1 activation is responsible for
similar effects in man, i.e. dyskinesia. Therefore, blockade of D1 receptors should be
Flupentixol prolongs alcohol- and barbiturate-induced sleeping time in mice in only
very high doses indicating a very weak sedative action in clinical use.
Like most other neuroleptics, flupentixol dose-dependently increases the serum
Clinical efficacy and safety
In clinical use flupentixol has a broad spectrum of activity that varies according to the
Flupentixol in low dosages (1-2 mg/day) has antidepressant, anxiolytic and activating
In moderate dosages (3-25 mg/day) flupentixol is intended for the treatment of acute
and chronic psychoses. In this dosage range flupentixol has practically no unspecific
sedative effect and is not suited for patients with severe psychomotor agitation.
Besides causing a significant reduction or complete elimination of the nuclear
symptoms of schizophrenia such as hallucinations, delusions and thought
disturbances flupentixol also has disinhibiting (antiautistic and activating) and mood-
elevating properties making flupentixol particularly useful in the treatment of
apathetic, withdrawn, depressed and poorly motivated patients.
The antipsychotic effect increases with increasing dosage; in addition some sedation
should be anticipated. Flupentixol has within the whole dosage range a pronounced
anxiolytic effect and even in high-dose treatment the mood elevating and disinhibiting
effects of flupentixol are retained. High dose treatment does not increase the
frequency of extrapyramidal symptoms.
The following data concerns the active cis(Z)-isomer.
Oral administration results in maximum serum levels in about 4-5 hours. Oral
bioavailability is about 40
The apparent volume of distribution (Vd)β is about 14.1 l/kg. The plasma protein
binding is about 99
The metabolism of flupentixol proceeds along three main routes - sulphoxidation,
side chain N-dealkylation and glucuronic acid conjugation. The metabolites are
devoid of psychopharmacological activity. Flupentixol dominates over metabolites in
brain and other tissues.
The elimination half-life (T½ β) is about 35 hours and the mean systemic clearance
(Cls) is about 0.29 l/min.
Flupentixol is excreted mainly with faeces, but also to some degree with the urine.
When tritium labelled flupentixol was administered to man the excretion pattern
showed the excretion via faeces to be about 4 times the urinary excretion.
In nursing mothers flupentixol is excreted in small amounts with the breast milk. The
ratio milk conc./serum conc. in women is on an average 1.3.
The kinetics is linear. Steady state plasma levels are achieved in about 7 days. The
mean minimum steady state level corresponding to 5 mg flupentixol orally once-a-
day was about 1.7 ng/ml (3.9 nmol/l.)
Pharmacokinetic investigations have not been done in older patients. However, for
the related thioxanthene drug, zuclopenthixol, the pharmacokinetic parameters are
widely independent of the age of the patients.
Reduced renal function
Based on the above characteristics for elimination it is reasonable to assume that
reduced kidney function is likely not to have much influence on the serum levels of
Reduced hepatic function
No data available.
Pharmacokinetic / Pharmacodynamic relationship
A minimum (i.e. concentration measured just before administration of a dose) serum
(plasma) concentration of 1-3 ng/ml (2-8 nmol/l) is suggested as a guideline for
maintenance treatment of schizophrenic patients with a low-moderate degree of
Preclinical safety data
Flupentixol has low acute toxicity.
In chronic toxicity studies there were no findings of concern for the therapeutic use of
In fertility studies in rats, flupentixol slightly affected the pregnancy rate of female
rats. Effects were seen at doses well in excess of those applied during clinical use.
Animal reproduction studies in mice, rats and rabbits have not shown evidence of
teratogenic effects. Embryotoxic effects in terms of increased post implantation
loss/increased absorption rates or occasional abortions were seen in rats and rabbits
at doses associated with maternal toxicity.
Flupentixol has no carcinogenic potential.
List of excipients
Lactose monohydrate 30.6 mg,
Vegetable oil, hydrogenated,
Coating and colour
Polyvinyl alcohol, partly hydrolyzed,
Iron oxide yellow (E172),
Iron oxide red (E 172),
Titanium dioxide (E171),
Sunset yellow FCF (E110),
Special precautions for storage
Store below 30ºC.
Nature and contents of container
and 100 in container (Polypropylene or High Density
The screw cap of HDPE containers is child-resistant
Not all pack sizes may be marketed.
Special precautions for disposal
Any unused medicinal product or waste material should be disposed of in
accordance with local requirements.
MARKETING AUTHORISATION HOLDER
H. Lundbeck A/S
MARKETING AUTHORISATION NUMBER:
Lundbeck Israel Ltd.
ןולעב )תוחיטב ןולעב )תוחיטב
LUNDBECK ISRAEL LTD
4.6 Pregnancy and
Flupentixol should not be
pregnancy unless the
expected benefit to the
patient outweighs the
theoretical risk to the foetus.
The newborns of mothers
treated with neuroleptics in
late pregnancy, or labour,
may show signs of
intoxication such as
lethargy, tremor and
hyperexcitability and have a
low apgar score.
-reproduction studies have
given evidence of an
increased incidence of foetal
damage or other deleterious
effects on the reproduction
As flupentixol is found in
breast milk in low
concentrations it is not likely
to affect the infant when
therapeutic doses are used.
The dose ingested by the
infant is less than 0.5% of
the weight related maternal
daily dose. Breast-feeding
can be continued during
flupentixol therapy if
considered of clinical
importance but observation
of the infant is
Fertility, pregnancy and lactation
Flupentixol should not be administered during
pregnancy unless the expected benefit to the
patient outweighs the theoretical risk to the foetus.
Neonates exposed to antipsychotics (including
flupentixol) during the third trimester of
pregnancy are at risk of adverse reactions
including extrapyramidal and/or withdrawal
symptoms that may vary in severity and duration
following delivery. There have been reports of
agitation, hypertonia, hypotonia, tremor,
somnolence, respiratory distress, or feeding
disorder. Consequently, newborns should be
- Animal studies have shown reproductive toxicity
(see section 5.3)
As flupentixol is found in breast milk in low
concentrations it is not likely to affect the infant
when therapeutic doses are used. The dose
ingested by the infant is less than 0.5% of the
weight related maternal daily dose. Breast-feeding
can be continued during flupentixol therapy if
considered of clinical importance but observation
of the infant is recommended, particularly in the
first 4 weeks after giving birth.
In humans, adverse events such as
hyperprolactinaemia, galactorrhoea, amenorrhoea,
libido decreased, erectile dysfunction and
ejaculation failure have been reported (see section
4.8). These events may have a negative impact on
female and/or male sexual function and fertility.
If clinical significant hyperprolactinaemia,
galactorrhoea, amenorrhoea or sexual
in the first 4 weeks after
dysfunctions occur, a dose reduction (if possible)
or discontinuation should be considered. The
effects are reversible on discontinuation.
In preclinical fertility studies in rats,
flupentixol slightly affected the pregnancy rate of
female rats. Effects were seen at doses well in
excess of those applied during clinical use.
ןולעב :ןכרצל תורמחהה
תוירופו הקנה , ןוירה ,ןוירהב תאש תבשוח וא הקינמ וא ןוירהב תא םא ךלש אפורה תא ילאש ,ןוירהב תויהל תננכתמ וא הפורתה תחיקל ינפל תוירופ עיפשמ לוסקנאולפ יכ וחיכוה תויחב םירקחמב תוירופה לע
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