Psytixol 20 mg/ml, 100 mg/ml & 200 mg/ml Injection

(flupentixol decanoate)

INFORMATION FOR THE HEALTHCARE PROFESSIONAL

CONSULT THE SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL INFORMATION ON THIS PRODUCT PHARMACEUTICAL FORM

Solution for injection.

A clear, colourless to pale yellow, oily solution for deep intramuscular use. THERAPEUTIC INDICATIONS Psytixol is indicated for the treatment of schizophrenia and other psychoses.

Use of flupentixol should be restricted to those stabilised on oral therapy. POSOLOGY AND METHOD OF ADMINISTRATION

Adults - The usual dosage of Psytixol is between 50 mg every 4 weeks and 300 mg every 2 weeks. However, some patients may require up to 400 mg weekly. The maximum single dose at any one time is 400 mg. For example, 800 mg every 2 weeks should not be given. Other patients may be adequately maintained on dosages of 20-40 mg Psytixol every 2-4 weeks. For patients who have not previously received depot antipsychotic, treatment is usually started with a small dose (e.g. 20 mg) to assess tolerability.

An interval of at least one week should be allowed before the second injection is given at a dose consistent with the patient's condition.

Adequate control of severe psychotic symptoms may take up to 4 to 6 months at high enough dosage. Once stabilized, lower maintenance doses may be considered, but must be sufficient to prevent relapse. The appropriate presentation of Psytixol should be selected to achieve an injection volume which does not exceed 2 ml. Volumes greater than 2 ml should be distributed between two injection sites. When transferring patients from oral to depot neuroleptic treatment, the oral medication should not be discontinued immediately, but gradually withdrawn over a period of several days after administering the first injection. Elderly - In accordance with standard medical practice, initial dosage may need to be reduced to a quarter or half the normal starting dose in the frail or older people.

Paediatric population - Psytixol is not indicated for children due to lack of clinical experience.

Renal impairment - Flupentixol has not been studied in renal impairment. Increased cerebral sensitivity to antipsychotics has been noted in severe renal impairment.

Package leaflet: information for the user

Psytixol 20 mg/ml,

100 mg/ml and 200 mg/ml Injection

(flupentixol decanoate)

Psytixol 20 mg/ml, 100 mg/ml and 200 mg/ml injection are referred to as Psytixol throughout the leaflet.

Read all of this leaflet carefully before you start using 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, pharmacist or nurse.

•    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Psytixol is and what it is used for

2.    What you need to know before you are given Psytixol

3.    How Psytixol is given

4.    Possible side effects

5.    How to store Psytixol

6.    Contents of the pack and other information

1.    What Psytixol is and what it is used for

Psytixol contains the active substance Flupentixol decanoate. Psytixol belongs to a group of medicines known as antipsychotics (also called neuroleptics). 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.

Psytixol is used for the treatment of schizophrenia and other psychoses.

Your doctor, however, may prescribe Psytixol for another purpose. Ask your doctor if you have any questions about why Psytixol has been prescribed for you.

2.    What you need to know before you are given Psytixol

You must not be given Psytixol if you

•    are allergic to flupentixol or the oil it is dissolved in (listed in section 6)

•    are feeling less alert than usual, or are drowsy or sleepy, or have serious problems with your blood circulation

•    have taken an excess of alcohol, barbiturates or opiate medicines such as morphine

•    are excited or agitated Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given Psytixol if you:

•    are allergic to similar neuroleptic medicines

•    suffer from kidney or liver disease

•    have a heart condition, including an irregular heartbeat (such as a slower heart beat); have had a recent heart attack or have problems that cause ankle swelling or shortness of breath

•    have risk factors for stroke (e.g. smoking, hypertension)

•    suffer from Parkinson's disease

•    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 an over or under active thyroid

•    have severe breathing problems (such as asthma or bronchitis)

•    suffer from glaucoma (raised pressure in the eye)

•    suffer from a condition causing severe muscular weakness (myasthenia gravis)

•    have a rare type of cancer of the adrenal gland which sits near the kidney (phaeochromocytoma)

•    have an enlarged prostate

•    have too little potassium or magnesium in your blood or a family history of irregular heart beats

•    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 diabetes

•    use other antipsychotic medicines Thoughts of suicide and worsening of your depression or anxiety disorder Flupentixol is also available in tablet form and at lower doses can be used to treat depression. If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when you first start taking your medicine, since these medicines all take time to work, usually about two weeks but sometimes longer. 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 thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

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. Other medicines and Psytixol Tell your doctor, pharmacist or nurse 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 flupentixol:

•    treatments for an irregular heartbeat such as quinidine, disopyramide, amiodarone, sotalol, bretylium, dofetilide.

•    antibiotics such as moxifloxacin, erythromycin

•    antimalarials such as quinine and mefloquine

•    antihistamines (for hay fever or allergies)

•    treatments for gastroesophageal reflux disease such as cisapride

•    other medicines used to treat schizophrenia and other mental illness such as lithium, chlorpromazine, haloperidol, pimozide, sertindole, thioridazine

Medicines may affect the actions of other medicines and this can sometimes cause serious adverse reactions.

Please tell your doctor, pharmacist or nurse if you are taking, any of the following medicines:

•    antidepressants such as amitriptyline

•    sleeping tablets or sedatives such as barbiturates (e.g. amobarbital)

•    piperazine (for treating worms)

•    cough and cold remedies including those bought over the counter

•    medicines containing adrenaline, flupentixol can reduce the effect of adrenaline and similar drugs

•    corticosteroids for inflammatory conditions such as arthritis e.g. prednisolone

•    treatment for Parkinson's disease such as levodopa

•    metoclopramide (anti-sickness medicine)

•    treatments for hypertension (high blood pressure) such as guanethidine, hydralazine, methyldopa or doxazosin

•    digoxin to control heart rhythm

•    treatments for epilepsy such as phenytoin, carbamazepine

•    anticoagulants such as warfarin, used to prevent blood clots

•    medicines for diabetes such as insulin or metformin as the dose of your diabetic medicine may need to be adjusted

•    sibutramine used to reduce appetite

•    medicines containing atropine (often used for colic)

•    medicines that cause a disturbed water or salt balance (too little potassium

or magnesium in your blood) such as diuretics for water retention and hypertension

Tell your doctor, dentist, surgeon or anaesthetist before any operation as flupentixol can increase the effects of general anaesthetics, muscle relaxing drugs and drugs used to prevent blood clots.

Psytixol with alcohol You should not drink alcohol while being treated with this medicine because it may increase the sedative effects of alcohol, making you drowsier.

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. Psytixol should not be given to pregnant or breast-feeding mothers unless the benefits to the mother outweigh the risks to the baby.

Tell your doctor if you are pregnant or planning to become pregnant. Psytixol should not be given to you in the first or last three months of pregnancy as it can affect the growth of your unborn baby and may also affect your labour.

The following symptoms may occur in newborn babies of mothers that have used Psytixol 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.

While you are being given Psytixol, do not breast-feed your baby, as small amounts of flupentixol can pass into breast milk. Driving and using machines Do not drive or operate machinery during the early stages of treatment or if you drink alcohol as Psytixol may reduce your alertness. Do not drive if you have blurred vision.

Talk to your doctor before you drive or operate machinery.

3. How Psytixol is given

Your doctor will usually give you this injection deep into the muscle of your buttock or thigh.

Your doctor will decide on the correct amount of medicine to give, and how often to give it. The medicine is slowly released from the injection site so that a fairly constant amount of medicine gets into your blood during the period between each dose.

Adults

The usual dose lies between 50 mg every 4 weeks to 300 mg every 2 weeks but some patients require 400 mg every week. The maximum single dose at any one time is 400 mg. If you need more than 2 ml of medicine it will probably be divided between 2 injection sites.

Hepatic impairment - Flupentixol has not been studied in hepatic impairment. It is extensively metabolised by the liver and particular caution should be used in this situation and serum level monitoring is advised. Psytixol should be initiated at low doses orally to check for tolerability before switching to the depot formulation.

ROUTE OF ADMINISTRATION Deep intramuscular injection into the upper outer buttock or lateral thigh. Dosage and dosage interval should be adjusted according to the patient's symptoms and response to treatment. Note: As with all oil based injections it is important to ensure, by aspiration before injection, that inadvertent intravascular entry does not occur. CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients.

Circulatory collapse, depressed level of consciousness due to any cause (e.g. intoxication with alcohol, barbiturates, or opiates), coma.

Not recommended for excitable or agitated patients.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Please consult the Summary of Product Characteristics for full information on this product.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

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If you have not received an injection like Psytixol before, a small dose of 20 mg is usually given one week before your normal dose to test how well you tolerate the medicine.

If you have been treated with flupentixol tablets and you are being transferred to Psytixol injection you may be asked to continue taking the tablets for several days after the first injection.

Your doctor may decide to adjust the amount given, or the interval between injections, from time to time.

Patients with liver problems:

If you have liver problems, the level of flupentixol in your blood may be checked. Elderly patients (above 65 years)

In older or frail patients, the starting dose may be reduced to a quarter or half the normal starting dose.

Use in children

Psytixol is not recommended for children. Duration of treatment It may take between four and six months before you feel better. Your doctor will decide the duration of treatment.

If you feel that the effect of Psytixol injection is too strong or weak, talk to your doctor, pharmacist or nurse.

It is important that you continue to receive your medicine at regular intervals even if you are feeling completely well because the underlying illness may persist for a long time. If you stop your treatment too soon, your symptoms may return.

If you get more Psytixol than you should

Your medicine will be given by your doctor or nurse.

In the unlikely event that you receive too much Psytixol, you may experience some symptoms of overdose such as:

•    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 heart beat including irregular heart beat or slow heart rate

You will receive treatment for any of these symptoms from your doctor or nurse.

If you stop your treatment with Psytixol

Even if you feel better after your treatment has started, you should see your doctor at the time they ask for further treatment.

If you stop your treatment too soon your illness may return over the course of several weeks or months. Your doctor will decide when it is possible to stop your treatment and will gradually reduce the amount you receive to avoid any unpleasant symptoms that might occur if it is stopped abruptly (e.g. unusual movements, feeling or being sick, difficulty sleeping).

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 likely to suffer from some of these effects than younger patients and this may mean your treatment is supervised more closely. Serious side effects Stop using Psytixol 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 any of the following happen, tell your doctor immediately or go to your nearest hospital emergency department:

•    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 Psytixol 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

•    In rare cases irregular heart beats (arrhythmias) may have resulted in sudden death

•    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.

•    Blood disorders such as lack of white blood cells, which may be characterised by fever or chills, sore throat, ulcerated

Please consult the Summary of Product Characteristics for full information on this product.

OVERDOSAGE

Overdosage may cause somnolence, or even coma, extrapyramidal symptoms, convulsions, hypotension, shock, hyper-or hypothermia. ECG changes, QT prolongation, Torsades 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, with measures aimed at supporting the respiratory and cardiovascular systems.

The following specific measures may be employed if required.

•    anticholinergic antiparkinson drugs if extrapyramidal symptoms occur.

•    sedation (with benzodiazepines) in the unlikely event of agitation or excitement or convulsions.

•    noradrenaline in saline intravenous drip if the patient is in shock. Adrenaline must not be given.

PHARMACEUTICAL PRECAUTIONS

Do not store above 25°C. Store in the original package. Psytixol should not be mixed with any other injection fluids. MARKETING AUTHORISATION HOLDER Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom. Date of revision: August 2016.

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mouth or throat, or decrease in the number of blood platelets which is characterised by unusual bleeding or unexplained bruising

•    High prolactin levels in the blood

•    An increase or decrease in appetite, increase in weight

•    Raised blood levels of glucose, loss of control of blood sugar levels

•    Difficulty in sleeping

•    Depression

•    Feeling nervous, agitated

•    Decreased sexual drive

•    Sleepiness, sedation

•    Restlessness or difficulty in standing still

•    Unusually overactive

•    Reduced or slow body movements

•    Tremor, uncontrollable muscle spasms affecting the eyes, head, neck and body, uncontrollable twitching, jerking or writhing movements

•    Dizziness

•    Headache

•    Lack of concentration

•    Disorder of the central nervous system, seen usually in the elderly , in which there is muscle weakness, trembling, sweating and slowing of movements (parkinsonism), speech disorder, fits

•    Higher (hyperthermia) or lower (hypothermia) body temperature than normal

•    Blurred eyesight

•    Fast heartbeat, changes in the electrical tracing of the heart (ECG), irregular or abnormal heart rhythm and heart block have been reported for this type of medicine

•    A fall in blood pressure, which may make you feel dizzy and unwell, especially when you stand quickly

•    Hot flush

•    Shortness of breath

•    Dry mouth, increase in the amount of saliva produced

•    Constipation, being sick (vomiting), indigestion, diarrhoea, stomach pain, feeling sick (nausea), wind

•    Abnormal liver enzyme tests (seen in a blood test)

•    Increased sweating, itching

•    Skin rashes or increased sensitivity to sunlight, redness, pain or painful lumps at the site of injection

•    Muscle pain and muscle stiffness

•    Passing urine when you do not mean to, passing urine more often than usual or unable to pass urine

•    Fluid retention (oedema)

•    Feeling tired, unusual weakness

•    Irregular or complete disappearance of periods

•    Enlargement of the breasts in men and production of milk in both men and women

•    Loss of sex drive, difficulty in getting and keeping an erection and difficulty in ejaculation

•    In elderly patients 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

5.    How to store Psytixol

Keep this medicine out of the sight and reach of children.

Your doctor will not use Psytixol after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Your doctor will store this medicine below 25°C and in the original package. Medicines should not be disposed of via wastewater or household waste. Your doctor will dispose of medicines no longer required. These measures will help protect the environment.

6.    Contents of the pack and other information

What Psytixol contains

The active substance is flupentixol decanoate.

The other ingredient is medium chain triglycerides.

What Psytixol looks like and contents of the pack

Your medicine is in the form of an oily solution for deep intramuscular injection. Psytixol is supplied in amber glass ampoules and is available in the following strengths and pack sizes:

•    Psytixol 20 mg/ml injection is supplied in packs of 1,5 or 10 ampoules. Each ampoule contains 1 or 2 ml of solution.

•    Psytixol 100 mg/ml injection is supplied in packs of 1,5 or 10 ampoules. Each ampoule contains 0.5 or 1 ml of solution.

•    Psytixol 200 mg/ml injection supplied in packs of 5 or 10 ampoules where each ampoule contains 1 ml of solution.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Mylan,

Station Close,

Potters Bar, Herts, EN61TL, UK

Manufacturer:

Haupt Pharma Wulfing GmbH,

Bethelner Landsra^e 18,

31028 Gronau/Leine,

Germany

Date of last revision: August 2016.

979294

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v1/May 2015