Fluanxol (Flupentixol)

Serious Warnings and Precautions

Neuroleptic malignant syndrome (NMS) is a rare, but life-threatening, disorder of the nervous system that has been linked with drugs such as FLUANXOL. It is characterized by high fever, unusual stiffness of the muscles, disorder of your consciousness, sweating and fast heart rate.

Like all medications FLUANXOL can cause some side effects. You may not experience any of them. For most patients these side effects are likely to be minor and temporary. However, some may be serious. Consult your doctor if you experience these or other side effects.

At the beginning of treatment, FLUANXOL may make you feel drowsy and dizzy, so you should not drive a car or use any tools or machines until you are sure FLUANXOL does not affect your mental alertness.

Side effects that have been reported by patients taking FLUANXOL include:

• an allergic reaction (symptoms include skin rash, hives, swelling, difficulty breathing).

• if you experience fever (increased temperature) or soreness of the mouth, gums, or throat that happens while you are taking FLUANXOL, contact your doctor IMMEDIATELY.

• muscle spasm, stiffness, shaking or uncontrolled body movements; this may indicate that you have a syndrome called Tardive Dyskinesia. These can happen in different parts of the body, such as the tongue, face, mouth, jaw, eyes, hands, arms and legs. Small uncontrollable movements of the tongue may be an early sign of the syndrome. If FLUANXOL is stopped when these symptoms are noticed, the syndrome may not develop further. Tardive Dyskinesia can sometimes be permanent, even if you stop taking FLUANXOL. Contact your doctor immediately if this happens to you.

• dry mouth, dizziness, blurred or altered vision, constipation, excessive salivation or sweating, trouble passing urine, decreases in blood pressure, increases in heart rate, weight changes, skin rash, decreased sexual interest or function, and changes in your monthly cycle (if you are female). Tell your doctor or pharmacist if you think you have any of these or other effects while taking FLUANXOL.

• a serious condition called Neuroleptic Malignant Syndrome; symptoms include fever, stiff muscles, confusion, reduced consciousness, irregular heart rate and sweating. Go to the nearest Emergency Room of a hospital if you think this is happening to you.

• 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.

As with other medicines that work in a way similar to flupentixol (the active ingredient of FLUANXOL), rare cases of the following side effects have been reported:

• QT prolongation (slow heart rate and changes to the ECG)

• Ventricular arrhythmias (irregular heart beat)

• Torsades de Pointes (a special kind of irregular heart beat)

In rare cases irregular heart beats (arrhythmias) may have resulted in sudden death.

Your doctor should check your body weight before starting FLUANXOL and continue to monitor it for as long as you are being treated.

Your doctor should take blood tests before starting FLUANXOL. They will monitor blood sugar, and the number of infection fighting white blood cells. Your doctor should continue to monitor your blood for as long as you are being treated.

If you have high levels of prolactin (measured with a blood test) and a condition called hypogonadism, you may be at increased risk of breaking a bone due to osteoporosis. This occurs in both men and women.

You should also tell you doctor if you notice any symptoms that worry you, even if you think the problems are not connected with FLUANXOL or are not listed here.

Drugs that may interact with FLUANXOL include:

• tricyclic antidepressant medicines

• guanethidine and similar medicines (used to lower the blood pressure)

• barbiturates and similar medicines

• levodopa and similar medicines (used to treat Parkinson's disease)

• metoclopramide (used in the treatment of gastro-intestinal disorders)

• other antipsychotic medicines (e.g. thioridazine)

• medicines that change the heartbeat (e.g. quinidine, amiodarone, sotalol, erythromycin, moxifloxacin, lithium)

Fluanxol may increase the sedative effects of alcohol making you drowsier. It is recommended not to drink alcohol during treatment with FLUANXOL.

Consult your doctor before taking other medications, including over-the-counter medicines and herbal remedies. Some drugs can produce additional side effects when they are used in combination with FLUANXOL.