Fluanxol 0.5 mg and 1 mg, coated tablets
flupentixol
Read all of this leaflet carefully before you start taking 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 are troubling, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
In this leaflet
1. What Fluanxol is and what it is used for
2. Before you take Fluanxol
3. How to take Fluanxol
4. Possible side effects
5. How to store Fluanxol
6. Further information
What Fluanxol Is And What It Is Used For
How does Fluanxol work?
Fluanxol belongs to a group of medicines known as antidepressants.
These medicines act on nerve pathways in specific areas of the brain and help to correct certain chemical imbalances that are causing the symptoms of your illness.
What is Fluanxol used for?
Fluanxol tablets are used to treat depression in patients who may, or may not, also be showing signs of anxiety.
Before You Take Fluanxol
Do not take Fluanxol
- If you are allergic (hypersensitive) to flupentixol, other thioxanthene drugs or antipsychotic drugs or to any of the other ingredients of Fluanxol (see What Fluanxol contains). Consult your doctor if you think you might be.
- If you are feeling less alert than usual, or are drowsy or sleepy, or have serious problems with your blood circulation
- If you suffer with severe depression, which needs you to stay in hospital or if you need electroconvulsive therapy (ECT)
- If you have suffer from periods of excitement, overactivity or mania.
Take special care with Fluanxol
- If you have a heart condition (including an irregular heart beat) or severe breathing problems (such as asthma or bronchitis)
- If you have liver, kidney or thyroid problems
- If you 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)
- If you suffer from Parkinson's disease, or myasthenia gravis (a condition causing severe muscular weakness)
- If you have an enlarged prostate or suffer from a condition known as phaeochromocytoma (a rare type of cancer of a gland near the kidney)
- If you suffer from glaucoma (raised pressure within the eye)
- If you are diabetic
- If 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.
Please consult 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 Fluanxol:
- Antipsychotics or other medicines that change the heartbeat (quinidine, amiodarone, sotalol, dofetilide, erythromycin, moxifloxacin, cisapride, lithium)
Medicines may affect the action 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.
Tell your doctor 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 used to treat epilepsy
- Medicines used to treat diabetes
Fluanxol can reduce the effect of adrenaline (epinephrine) and similar drugs.
Tell your doctor, dentist, surgeon or anaesthetist before any operation as Fluanxol can increase the effects of general anaesthetics, muscle relaxing drugs and drugs used to prevent clots.
Taking Fluanxol with food and drink
Fluanxol can be taken with or without food.
Fluanxol may increase the sedative effects of alcohol making you drowsier. It is recommended not to drink alcohol during treatment with Fluanxol.
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. Fluanxol should not be used during pregnancy unless it is necessary.
Your newborn baby might show side effects if this medicine is used.
Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. If you are breastfeeding, ask your doctor for advice. You should not use Fluanxol when breast-feeding your baby because 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 using Fluanxol 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.
Important information about some of the ingredients in Fluanxol coated tablets
This product contains lactose and sucrose. If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
How To Take Fluanxol
Always take Fluanxol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The dose varies and depends on the severity of the illness.
Adults
The starting dose is usually 1 mg daily taken as a single dose in the morning.
This may be increased to 2 mg per day after one week.
The maximum daily dose is 3 mg per day.
If you have liver problems, the level of flupentixol in your blood may be checked.
Elderly patients (above 65 years)
The starting dose is usually 0.5 mg daily taken as a single dose in the morning.
This may be increased to 1 mg per day after one week.
The maximum daily dose is 1.5 mg per day
Children
Fluanxol is not recommended for children.
How and when to take Fluanxol
Fluanxol can be taken with or without food.
Swallow the tablets with a drink of water. Do not chew them.
You may feel an improvement within two to three days.
If you think that the effect of Fluanxol is too strong or too weak, talk to your doctor or pharmacist.
Continue to take the tablets for as long as your doctor recommends. The underlying illness may persist for a long time and if you stop your treatment too soon your symptoms may return.
Never change the dose of the medicine without talking to your doctor first.
If you take more Fluanxol than you should
If you think that you or anyone else may have taken too many Fluanxol tablets contact your doctor or nearest hospital casualty department 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:
- 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 the heart beat including irregular heart beat or slow heart rate
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 have agreed this with your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Fluanxol Tablets Side Effects
Like all medicines, Fluanxol can cause side effects, although not everybody gets them. Elderly patients tend to be more prone to some of these effects than younger patients and this may mean your treatment is supervised more closely.
Serious side effects
Stop taking Fluanxol 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 Fluanxol 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
- 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 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 Fluanxol tablets), rare cases of the following side effects have been reported:
- slow heartbeat and abnormal ECG heart tracing.
- Life threatening irregular heart beats.
In rare cases irregular heart beats (arrhythmias) may have resulted in sudden death.
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 Fluanxol
- Keep out of the reach and sight of children
- Do not use Fluanxol after the expiry date that is printed on the label. The expiry date refers to the last day of that month
- Store Fluanxol below 25°C
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 Fluanxol contains
The active substance is flupentixol (as dihydrochloride).
Each Fluanxol coated tablet contains 0.5 mg or 1 mg flupentixol.
The other ingredients are lactose, potato starch, gelatin, talc, magnesium stearate, sucrose, beeswax, white wax, carnauba wax and the yellow colour E172 (yellow iron oxide).
What Fluanxol looks like and contents of the packs
Fluanxol 0.5 mg and 1 mg coated tablets are round, yellow tablets and are available in blister packs of 60 tablets.
These tablets are manufactured by:
For any information about this medicine, please contact the Marketing Authorisation holder:
This leaflet was last approved in January 2010.
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