Flupentixol decanoate 20mg/ml solution for injection
Flupentixol decanoate 40mg/ml solution for injection
Flupentixol decanoate 100mg/ml solution for injection
Package leaflet: Information for the patient
flupentixol decanoate
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
- 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Flupentixol decanoate Injection is and what it is used for
2. What you need to know before Flupentixol decanoate Injection is given
3. How Flupentixol decanoate Injection is given
4. Possible side effects
5. How to store Flupentixol decanoate Injection
6. Contents of the pack and other information
1. What Flupentixol decanoate Injection is and what it is used for
The name of your medicine is Flupentixol decanoate 20 mg/ml solution for injection (called Flupentixol decanoate Injection in this leaflet).
Flupentixol decanoate Injection contains the active substance flupentixol decanoate. Flupentixol decanoate 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.
Flupentixol decanoate Injection is used for the treatment of schizophrenia and other psychoses.
Your doctor, however, may prescribe Flupentixol decanoate Injection for another purpose. Ask your doctor if you have any questions about why Flupentixol decanoate Injection has been prescribed for you.
2. What you need to know before Flupentixol decanoate Injection is given
Flupentixol decanoate Injection is not given 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)
- are feeling less alert than usual or are drowsy or sleepy, or have serious problems with your blood circulation
- are excited or agitated
Warnings and precautions
Talk to your doctor, pharmacist or nurse before Flupentixol decanoate Injection is given if you:
- have a heart condition, including an irregular heartbeat (such as a slower heartbeat); 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 heartbeats
- 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 the formation of blood clots
- are treated for cancer
Children and adolescents
Flupentixol decanoate Injection 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.
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 Flupentixol decanoate Injection
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 Flupentixol decanoate Injection:
- Medicines that change the heartbeat (quinidine, amiodarone, sotalol, dofetilide, erythromycin, moxifloxacin, cisapride, lithium)
- Other antipsychotic medicines
Tell your doctor or pharmacist if you are taking any of the following medicines:
- Tricyclic anti-depressants
- 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 disturbed water or salt balance (too little potassium or magnesium in your blood)
- Medicines are known to increase the concentration of flupentixol in your blood
- Medicines used to treat epilepsy
- Medicines used to treat diabetes
Flupentixol decanoate Injection can reduce the effect of adrenaline (epinephrine) and similar drugs.
Tell your doctor, dentist, surgeon or anaesthetist before any operation as Flupentixol decanoate Injection can increase the effects of general anaesthetics, muscle relaxing drugs and drugs used to prevent clots.
Flupentixol decanoate Injection with alcohol
Flupentixol decanoate Injection may increase the sedative effects of alcohol making you drowsier. It is recommended not to drink alcohol during treatment with Flupentixol decanoate Injection.
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 or pharmacist for advice before taking this medicine.
Pregnancy
If you are pregnant or think you might be pregnant, tell your doctor. Flupentixol decanoate Injection should not be used during pregnancy unless clearly necessary.
The following symptoms may occur in newborn babies, of mothers that have used Flupentixol decanoate Injection 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.
Flupentixol decanoate Injection 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 Flupentixol decanoate 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.
3. How Flupentixol decanoate Injection is given
A small amount of Flupentixol decanoate 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. 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.
If you haven?t received an injection like Flupentixol decanoate 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 Flupentixol decanoate tablets and you are being transferred to Flupentixol decanoate 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.
Older patients (above 65 years)
Starting doses for older or frail patients are usually reduced to a quarter or a half of the dosage range.
Use in children
Flupentixol decanoate Injection 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 Flupentixol decanoate Injection is too strong or weak, talk to your doctor.
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 Flupentixol decanoate Injection than you should
Your medicine will be given by your doctor or nurse.
In the unlikely event that you receive too much Flupentixol decanoate 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 heartbeat including irregular heartbeat or slow heart rate
You will receive treatment for any of these symptoms from your doctor or nurse.
4. Possible side effects
Like all medicines, Flupentixol decanoate Injection 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 Flupentixol decanoate and seek medical advice immediately if you have any of the following allergic reactions:
Not known: frequency cannot be estimated from the available data
- 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:
Very rare: may affect up to 1 in 10,000 people
- 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 Flupentixol decanoate Injection and similar medicines
- Unusual movements of the mouth and tongue as these may 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 ?extrapyramidal? reaction.
- In rare cases, irregular heartbeats (arrhythmias) may have resulted in sudden death
- Any yellowing of the skin and the white in the eyes (jaundice); your liver may be affected
Rare: may affect up to 1 in 1,000 people
- 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)
Other side effects:
Side effects are most pronounced at the beginning of the treatment and most of them usually wear off during continued treatment.
Very common: may affect more than 1 in 10 people
- Drowsiness
- Dry mouth
- Muscle spasm
- The rigidity of the whole body
Common: may affect up to 1 in 10 people
- Changes in appetite or weight
- Insomnia
- Depression
- Nervousness or agitation
- Dizziness
- Headaches
- Reduction in your sex drive
- Poor concentration
- Blurred or abnormal vision
- Throbbing or fast heartbeats
- Shortness of breath
- Increase of saliva
- Vomiting
- Indigestion
- Diarrhoea
- Increased sweating or greasy skin
- Itching
- Muscle pain
- Tremor
- Abnormal urination (such as a decrease in frequency or amount)
- General weakness or pain, tiredness or feeling unwell
Uncommon: may affect up to 1 in 100 people
- Confusion
- Loss of coordination or altered muscle movements (including unusual movements of the mouth, tongue and eyeballs)
- Speech problems
- Fits
- Low blood pressure
- Hot flushes
- Stomach pain
- Feeling sick
- Flatulence (wind) and constipation
- Abnormal liver function tests
- Rashes or skin reactions (including sensitivity to sunlight)
- Stiff and floppy muscle
- Problems with ejaculation or erections in male
- Skin reactions at the injection site
Rare: may affect up to 1 in 1,000 people
- 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)
- Reduction in blood platelets (which increases the risk of bleeding or bruising) and other blood cell changes
- Raised blood levels of glucose or the hormone prolactin.
- Loss of control of blood sugar levels
- Breast enlargement in male
- Unexpected excretion of breast milk
- Women may experience an absence of menstrual periods
As with other medicines that work in a way similar to flupentixol decanoate (the active ingredient of Flupentixol decanoate Injection), rare cases of the following side effects have been reported:
- Slow heartbeat and abnormal ECG heart tracing.
- Life-threatening irregular heartbeats.
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.
5. How to store Flupentixol decanoate Injection
Usually, your doctor or nurse will store the medicine for you. If you keep it at home:
- 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
- Keep the ampoules in the outer carton in order to protect from light.
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 Flupentixol decanoate Injection contains
The active substance is flupentixol decanoate.
Each millilitre (ml) of Flupentixol decanoate Injection contains 40 mg flupentixol decanoate.
The other ingredient is thin vegetable oil (purified from coconut oil).
What Flupentixol decanoate Injection looks like and contents of the pack
Flupentixol decanoate Injection is a clear, colourless or pale yellow liquid.
Flupentixol decanoate Injection is available in:
Glass ampoules containing 1 ml (20 mg), 2 ml (40 mg) and 1 ml (100mg) in cartons of 10 ampoules.
7.Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)