Depixol Low Volume Injection
cis (Z)-flupentixol decanoate
Read all of this leaflet carefully before you start using this medicine
- Keep this leaflet. You may need to read it again
- If you have further questions, please 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
In this leaflet:
1. What Depixol Low Volume Injection is and what it is used for
2. Before Depixol Low Volume Injection is given
3. How Depixol Low Volume Injection is given
4. Possible side effects
5. How to store Depixol Low Volume Injection
6. Further information
What Depixol Low Volume Injection Is And What It Is Used For
How does Depixol Low Volume Injection work?
Depixol Low Volume Injection 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.
What is Depixol Low Volume Injection used for?
Depixol Low Volume Injection is used for the treatment of schizophrenia and other psychoses.
Your doctor, however, may prescribe Depixol Low Volume Injection for another purpose. Ask your doctor if you have any questions about why Depixol Low Volume Injection has been prescribed for you.
Before Depixol Low Volume Injection Is Given
Depixol Low Volume Injection is not given if you
- are allergic (hypersensitive) to flupentixol, other thioxanthine drugs or antipsychotic drugs or any of the other ingredients of Depixol Low Volume Injection (see What Depixol Low Volume Injection contains). Consult your doctor if you think you might be
- are feeling less alert than usual or are drowsy or sleepy, or have serious problems with your blood circulation
- are excited or agitated
Take special care with Depixol Low Volume Injection 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
Please talk to 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:
- 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.
Taking other medicines
The following medicines should not be taken at the same time as Depixol Low Volume Injection:
- Medicines that change the heartbeat (quinidine, amiodarone, sotalol, dofetilide, erythromycin, moxifloxacin, cisapride, lithium)
- Other antipsychotic medicines
Medicines may affect the actions 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.
- 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 Low Volume Injection can reduce the effect of adrenaline (epinephrine) and similar drugs.
Tell your doctor, dentist, surgeon or anaesthetist before any operation as Depixol Low Volume Injection can increase the effects of general anaesthetics, muscle relaxing drugs and drugs used to prevent clots.
Does Depixol Low Volume Injection interact with alcohol?
Depixol Low Volume Injection may increase the sedative effects of alcohol making you drowsier. It is recommended not to drink alcohol during treatment with Depixol Low Volume Injection.
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.
Depixol Low Volume Injection should not be used during pregnancy unless clearly necessary.
Your newborn baby might show side effects if this medicine is used during pregnancy.
Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are breastfeeding, ask your doctor for advice. Depixol Low Volume Injection should not be used when breast-feeding, as 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 being treated with Depixol Injection, 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.
How Depixol Low Volume Injection Is Given
A small amount of Depixol Low Volume Injection is drawn up into a syringe and then injected 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. If you need more than 2 ml of medicine it will probably be divided between 2 injection sites.
If you haven't received an injection like Depixol Low Volume Injection 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 Depixol tablets and you are being transferred to Depixol Low Volume 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.
If you have liver problems, the level of flupentixol in your blood may be checked.
Elderly patients (above 65 years)
Starting doses for elderly or frail patients are usually reduced to a quarter or a half of the dosage range.
Children
Depixol Low Volume Injection is not recommended for children.
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 Low Volume Injection 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.
If you get more Depixol Low Volume Injection than you should
Your medicine will be given by your doctor/nurse.
In the unlikely event that you receive too much Depixol Low Volume Injection you may experience some symptoms.
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
You will receive treatment for any of these symptoms from your doctor or nurse.
Possible Side Effects
Like all medicines, Depixol Low Volume Injection can cause side effects, although not everybody gets them. Elderly 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 Depixol 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 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
- Indigestion or stomach pain
- Flatulence (wind), constipation or diarrhoea
- Abnormal urination (such as a decrease in the frequency or amount)
- Increased sweating or greasy skin
- Itching, rashes or skin reactions (including sensitivity to sunlight)
- Skin reactions at injection site
- 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 Low Volume Injection), rare cases of the following side effects have been reported:
- Slow heartbeat and abnormal ECG heart tracing
- Life threatening irregular heart beats
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.
How To Store Depixol Low Volume Injection
Usually your doctor or nurse will store the medicine for you. If you keep it at home:
- Keep out of the reach and sight of children
- Do not use Depixol Low Volume Injection after the expiry date that is printed on the label. The expiry date refers to the last day of that month
- Store Depixol Low Volume Injection below 25°C
- Keep Depixol Low Volume Injection ampoules and vials in the box, so they are protected from light
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.
Further Information
What Depixol Low Volume Injection contains
The active substance is cis(Z)-flupentixol decanoate.
Each millilitre (ml) of Depixol Low Volume Injection contains 200 mg cis (Z)-flupentixol decanoate.
The other ingredient is thin vegetable oil (purified from coconut oil).
What Depixol Low Volume Injection looks like and contents of the pack
Depixol Low Volume Injection is a clear, colourless or pale-yellow liquid.
Depixol Low Volume Injection is available in:
Glass ampoules containing 1 ml (200 mg) or 2 ml (400 mg) in boxes of 5 ampoules. Single-packed vials of 5 ml (1000 mg).
Not all pack sizes may be marketed.
This injection is manufactured by:
For any information about this medicine, please contact the Marketing Authorisation holder:
This leaflet was last approved in January 2010.
Trademark
Depixol Low Volume Injection is made by H Lundbeck A/S, Denmark.
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