Fluanxol 0,5 mg Tablets

F LUANXOL 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.

Do not take FLUANXOL - 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.

Warnings and precautions

Take special care with F LUANXOL - 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.

Other medicines and F LUANXOL

Tell your doctor if you are taking any of the following medicines: • 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 F LUANXOL with these medicines may cause undesirable interactions.

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.

Pregnancy, breastfeeding and fertility

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 F LUANXOL.

Breastfeeding

If you are breastfeeding, ask your doctor for advice. You should not use F LUANXOL when breastfeeding, 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 using FLUANXOL. If this happens, do not drive or use any tools or machines until these effects wear off. It is not always possible to predict to what extent FLUANXOL may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which FLUANXOL affects them.

F LUANXOL film-coated tablets contains lactose This product contains lactose. If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking F LUANXOL.

Do not share medicines prescribed for you with any other person. How much to take Always take F LUANXOL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Adults The usual starting dose is 1 mg per day. After a week your doctor may increase this to 2 mg per day. The maximum dose is 3 mg per day. Elderly patients (above 65 years) The usual starting dose is 0,5 mg. After a week your doctor may increase this to 1 mg per day. The maximum dose is 1,5 mg per day.

Children FLUANXOL is not recommended for children. If you have the impression that the effect of FLUANXOL is too strong or too weak, talk to your doctor or pharmacist.

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. FLUANXOL is usually taken as a single daily dose in the morning. Doses higher than 2 mg per day in adults (and 1 mg in the elderly) should be divided into a morning dose and an afternoon dose. Duration of treatment Patients often respond to FLUANXOL treatment quite quickly, but if you have been taking the maximum dose for a week or so and still do not feel better, your doctor may decide to stop the treatment. Your doctor decides the duration of treatment. Continue to take the tablets for as long as your doctor recommends. Never change the dose of the medicine without talking to your doctor first.

If you take more FLUANXOL than you should Symptoms of overdose may include: • Drowsiness • Unconsciousness • Muscle movements or stiffness • Convulsions In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Do this even if there are no signs of discomfort or poisoning. Take the Fluanxol box/container with you when you go to a doctor or hospital.

• Low blood pressure, weak pulse, fast heart rate, pallor, restlessness • High or low body temperature • Changes in heart beat including irregular heart beat or slow heart rate has been seen when FLUANXOL has been given in overdose together with medicines known to affect the heart.

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 are told to do so by your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.

FLUANXOL can cause side effects. Not all side effects reported for FLUANXOL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking FLUANXOL, please consult your healthcare provider for advice. If you experience any of the following symptoms you should contact your doctor or go to the hospital straight away:

Side Effects

Frequent: • Sleepiness (somnolence), inability to sit still or remain motionless (akathisia), involuntary movements (hyperkinesia), slow or diminished movements (hypokinesia) • Dry mouth. • Racing heart (tachycardia), a sensation of a rapid, forceful, or irregular beating of the heart (palpitations) • Tremor, twisting or repetitive movements or abnormal postures due to sustained muscle contractions (dystonia), dizziness, headache • Difficulties focusing on objects near to the eye (accommodation disorder), vision abnormalities • Difficulty breathing or painful breathing (dyspnoea) • Increased saliva secretion (salivary hypersecretion), constipation, vomiting, digestive problems or discomfort centered in the upper abdomen (dyspepsia), diarrhoea • Urination disorder (micturition disorder), lack of ability to urinate (urinary retention) • Increased sweating (hyperhidrosis), itching (pruritus) • Muscle pain (myalgia) • Increased appetite, increased weight • Fatigue, weakness (asthenia) • Sleeplessness (insomnia), depression, nervousness, agitation, decreased sexual drive (libido decreased).

Less frequent: • 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 inflammation of 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.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of FLUANXOL.

Keep out of the reach and sight of children. Do not use FLUANXOL after the expiry date, which is stated on the label. The expiry date refers to the last day of that month. Store FLUANXOL below 25 ºC. 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.