GB-067-22-3-13402 REG

Package leaflet: Information for the user

Depixol® 3 mg film-coated tablets flupentixol

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 Depixol Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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.

The following medicines should not be taken at the same time as Depixol Tablets:

•    Medicines that change the heartbeat (quinidine, amiodarone, sotalol, dofetilide, erythromycin, moxifloxacin, cisapride, lithium)

•    Other antipsychotic medicines

What is in this leaflet:

1.    What Depixol Tablets are and what they are used for

2.    What you need to know before you take Depixol Tablets

3.    How to take Depixol Tablets

4.    Possible side effects

5.    How to store Depixol Tablets

6.    Contents of the pack and other information

1. What Depixol Tablets are and what they are used for

The name of your medicine is Depixol 3 mg film-coated tablets (called Depixol Tablets in this leaflet).

Depixol Tablets contain the active substance flupentixol. Depixol Tablets belong 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.

Tell your doctor if you are taking any of the following medicines:

Tricyclic antidepressants

Barbiturates or other medicines that make you feel drowsy

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 that cause a disturbed water or salt balance (too little potassium or magnesium in your blood) Medicines known to increase the concentration of flupentixol in your blood Medicines used to treat epilepsy Medicines used to treat diabetes

Depixol Tablets can reduce the effect of adrenaline (epinephrine) and similar drugs.

Depixol Tablets are used for the treatment of schizophrenia and other psychoses.

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

2. What you need to know before you take Depixol Tablets

Do not take Depixol Tablets:

•    If you are allergic (hypersensitive) to flupentixol, other thioxanthene drugs or antipsychotic drugs or 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 are excited or agitated

Warnings and precautions

Talk to your doctor or pharmacist before taking Depixol

Tablets if you:

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

•    have 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)

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

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

•    use other antipsychotic medicines

•    suffer from diabetes

•    or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots

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

Depixol Tablets with food, drink and alcohol

Depixol Tablets can be taken with or without food.

Depixol Tablets may increase the sedative effects of alcohol making you drowsier.

It is recommended not to drink alcohol during treatment with Depixol Tablets.

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. Depixol Tablets should not be used during pregnancy unless clearly necessary.

The following symptoms may occur in newborn babies, of mothers that have used Depixol 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 breast-feeding, ask your doctor for advice. Depixol Tablets should not be used when breast-feeding, as 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 being treated with Depixol Tablets, 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.

Children and adolescents

Depixol Tablets are 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.

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.

Depixol Tablets contain lactose and sunset yellow (E110)

If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

This product also contains the colouring agent sunset yellow (E110), which may cause allergic reactions.

3. How to take Depixol Tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The dose varies and depends on the severity of the illness.

Adults

The usual dose is 1 to 3 tablets, twice a day. The maximum daily dose is 6 tablets (18 mg).

If you have liver problems, the level of flupentixol in your blood may be checked.

Older patients (above 65 years)

The initial dose is between a quarter and a half of the adult dose.

GB-067-22-3-13402 REG

Use in children

Depixol Tablets are 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 Depixol Tablets is too strong or weak, talk to your doctor or pharmacist.

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.

Effects when treatment with Depixol Tablets is stopped

When you have completed your course of treatment, the dose of Depixol Tablets is usually reduced gradually.

Stopping this medicine quickly may cause symptoms such as dizziness, nausea, vomiting, sweating, difficulty in sleeping or unusual muscle movements.

If you take more Depixol Tablets than you should

If you think that you or anyone else may have taken too many Depixol Tablets contact your doctor or nearest hospital casualty department immediately. Do this even if there are no signs of discomfort or poisoning. Take the Depixol Tablets 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 heart beat including irregular heart beat or slow heart rate

If you forget to take Depixol Tablets

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 have any further questions on the use of this medicine, ask your doctor or pharmacist.

•    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 Depixol Tablets), rare cases of the following side effects have been reported:

•    Slow heartbeat and abnormal ECG heart tracing

•    Life threatening irregular heart beats

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 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.

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 taking Depixol Tablets 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 Depixol Tablets 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.

•    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

5. How to Store Depixol Tablets

•    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 Depixol Tablets contain

The active substance is flupentixol (as dihydrochloride).

Each film-coated tablet contains 3 mg of flupentixol.

The other ingredients are betadex, lactose monohydrate, maize starch, hydroxypropylcellulose, microcrystalline cellulose, croscarmellose sodium, talc, hydrogenated vegetable oil and magnesium stearate.

Coating and colour: macrogol 6000, polyvinyl alcohol, macrogol 3350, talc, iron oxide yellow (E172), titanium dioxide (E171), iron oxide red (E172) and sunset yellow (E110).

What Depixol Tablets look like and contents of the pack

Depixol Tablets are round, slightly biconvex, ochre, film-coated tablets marked FI and are available in plastic containers containing 100 tablets.

Marketing Authorisation Holder

For any information about this medicine, please contact the Marketing Authorisation holder:

Lundbeck Limited Building K1 Timbold Drive Kents Hill

Milton Keynes MK7 6BZ UK

01908638972

Manufacturer

H.Lundbeck A/S Ottiliavej 9 DK-2500 Valby Denmark

This leaflet was last revised in 03/2015

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