Fluanxol Side Effects

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Answer the side-effect intent for fluanxol without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Fluanxol?

Fluanxol contains the active ingredient Flupentixol dihydrochloride.

• Active ingredient — Flupentixol dihydrochloride
• Registration number — B/2.6.5/1372; B/2.6.5/1380
• Registration holder — H.Lundbeck (Pty) Ltd

It is approved for:

• FLUANXOL contains the active substance flupentixol
• FLUANXOL belongs to a group of medicines that work by relieving the symptoms of depressed mood
• FLUANXOL is used to treat depression in patients who may, or may not, also be showing signs of anxiety

Common side effects of Fluanxol

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Less frequent side effects

• Unusual movements of the mouth and tongue; this may be an early sign of a condition known as tardive dyskinesia
• High fever, unusual stiffness of the muscles and disorder of your consciousness, especially if occurring with sweating and fast heart rate; these symptoms may be signs of a condition called neuroleptic malignant syndrome
• Yellowing of the skin and the white in the eyes, this may mean that your liver is affected and a sign of a condition known as jaundice
• Jerky movements (dyskinesia), parkinsonism, speech disorder, convulsion
• Circular movement of the eye (oculogyration)
• Abdominal pain, nausea, flatulence
• Rash, skin reaction due to sensitivity to light (photosensitivity reaction), eczema or inflammationof the skin (dermatitis)
• Muscle rigidity
• Decreased appetite
• Low blood pressure (hypotension), hot flushes
• Abnormal liver function tests
• Sexual disturbance (delayed ejaculation, problems with erection)
• State of confusion
• Low blood platelet count (thrombocytopenia), low white blood platelet count (neutropenia), reduced white blood cell count (leukopenia), bone marrow poisoning (agranulocytosis)
• Increased level of prolactin in the blood (hyperprolactinaemia)
• High blood sugar (hyperglycaemia), abnormal glucose tolerance
• Over-sensitivity (hypersensitivity), acute systemic and severe allergic reaction (anaphylactic reaction)
• Development of breasts in men (gynaecomastia), excessive milk production (galactorrhoea), lack of menstrual periods (amenorrhoea)
• QT prolongation (slow heart beat and change in the ECG)
• Irregular heart beat (ventricular dysrhythmias, ventricular fibrillation, ventricular tachycardia)
• Torsades de Pointes (a special kind of irregular heart beat)
• Irregular heartbeats (dysrhythmias) may have resulted in sudden death. 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. In elderly people with dementia, an 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• If you are allergic (hypersensitive) to flupenthixol or to any of the other ingredients of FLUANXOL (listed in section 6 WHAT FLUANXOL CONTAINS). Consult your doctor if you think you might be allergic
• If you are more excited or overactive than normal, since this medicine may increase these feelings
• If you have diminished consciousness FLUANXOL tablets are not recommended for children. FLUANXOL tablets are not suitable if you have a severe depression, for example if you are required to stay in hospital or requiring electroconvulsive therapy (ECT). FLUANXOL must also not be given in the event of pre-existing suppression of the central nervous system or coma, bone marrow suppression or phaeochromocytoma

Use with care, and tell your doctor, if

• If you have a liver problem
• If you have a history of convulsions or fits
• If you have diabetes (you may need an adjustment of your antidiabetic therapy)
• If you have an organic brain syndrome (which may be the result of poisoning with alcohol or organic solvents)
• If you have risk factors for stroke (e.g. smoking, hypertension)
• If you have hypokalaemia or hypomagnesaemia (too little potassium or magnesium in your blood or genetic predisposition for any of these)
• If you have a history of cardiovascular disorders
• If you use other antipsychotic medicine
• 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

Pregnancy and breastfeeding

• FLUANXOL should not be used during pregnancy or breastfeeding
• Pregnancy The general condition of your newborn baby might be affected by FLUANXOL
• Hence FLUANXOL is not recommended for women who are pregnant
• The following symptoms may occur in newborn babies, of mothers that have used FLUANXOL 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
• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby please consult your doctor, pharmacist or other healthcare provider for advice before taking FLUANXOL

Interactions and medicines to check

The approved leaflet names these interactions.

• Tricyclic antidepressant medicines
• Medicines used to lower the blood pressure
• Barbiturates (medicines that make you feel drowsy)
• Medicines used to treat epilepsy
• Levodopa and similar medicines (used to treat Parkinson’s disease)
• Metoclopramide (used in the treatment of gastro-intestinal disorders)
• Piperazine (used in the treatment of roundworm and threadworm infections) Always tell your health care provider if you are taking / using other medicines on a regular basis, including complementary or traditional medicines. The use of FLUANXOL with these medicines may cause undesirable interactions
• Medicines that cause a disturbed water or salt balance (too little potassium or magnesium in your blood)
• Medicines known to increase the concentration of FLUANXOL in your blood. The following medicines should not be taken at the same time as FLUANXOL:
• Medicines that change the heartbeat (quinidine, amiodarone, sotalol, dofetilide, erythromycin, astemizole, gatifloxacin, moxifloxacin, cisapride, lithium)
• Other antipsychotic medicines. FLUANXOL with food, drink and alcohol 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

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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