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ҩƷ��Ϣ: Product Name : FLUANXOL TAB 0.5MG gistration No.: HK-19690 Certificate Holder: LUNDBECK EXPORT A/S Certificate Holder Address��FLAT 4303 43/F CENTRAL PLAZA, Ingredients: FLUPENTHIXOL ------------------------------------------------------- �������Ĵ������ϣ������ο��� ����ͨ�����ƣ����������� ���ڸ��ּ������Ծ������֢����ҩ���п��ƻþ������롢˼ά����־��Ϊ�ϰ�������֢״�����á���˼άƶ������е�Į���������˵�����֢״���нϺõ���Ч��������ҩ��ά����ЧԤ�����������ɽ�һ���������Բ��˵�֢״�� ���� 1.���ÿ�������ҩ��(�����ᱽ������)�ɼ�������ϵ֢״������ʹ�ñ�ҩӦע��ٷ����˶��ϰ��ķ�����
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---------------------------------------------------------------------- How does it work? Fluanxol tablets contain the active ingredient flupentixol (previously spelt flupenthixol in the ), which is a type of medicine called an antipsychotic. In high doses, flupentixol is used to treat schizophrenia and other psychotic illnesses (see the Depixol factsheets linked at the end of this page for more information about this use of flupentixol). Fluanxol tablets contain a lower dose of flupentixol and are used to treat depression. It is not fully understood how low doses of flupentixol work in treating depression, but its mechanism of action is not the same as that of other antidepressants. Flupentixol is thought to work by affecting the activity of a natural compound called dopamine in the brain. Dopamine is known as a neurotransmitter, and is involved in transmitting messages between brain cells. It is known to be involved in regulating mood and behaviour, amongst other things. Unlike other antidepressants, flupentixol usually starts to produce an antidepressant effect within two to three days. However, it may not make you feel fully better for at least few weeks. It is recommended that you avoid drinking alcohol while taking this medicine because it may make any drowsiness worse. Although it can cause drowsiness, this medicine can also have an alerting effect, so you should avoid taking it in the evening because it may cause you problems sleeping. Depression and other psychiatric illnesses are associated with an increased risk of suicide, self-harm, and thoughts about harming or killing yourself. You should be aware that although this medicine may start to work in two to three days, it may not make you feel fully better for at least few weeks. However, it is important that you keep taking it in order for it to work properly and for you to feel better. If you feel your depression or anxiety has got worse, or if you have any distressing thoughts, or feelings about suicide or harming yourself in the first few weeks of treatment, or indeed at any point during treatment or after stopping treatment, then it is very important to talk to your doctor. You should not suddenly stop taking this medicine unless your doctor tells you otherwise, as this may cause withdrawal symptoms such as nausea, vomiting, diarrhoea, sweating, pins and needles sensations, difficulty sleeping, restlessness, anxiety or tremor. Withdrawal symptoms are temporary and are not due to addiction or dependence on the medicine. They can usually be avoided by stopping the medicine gradually. Follow the instructions given by your doctor when it is time to stop treatment with this medicine. If you experience any abnormal movements of your hands, legs, face, neck or tongue while taking this medicine, for example tremor, twitching or rigidity, you should let your doctor know as your treatment may need to be stopped. Consult your doctor immediately if you experience the following symptoms while taking this medicine: high fever, sweating, muscle stiffness, faster breathing and drowsiness or sleepiness. These symptoms may be due to a rare side effect known as the neuroleptic malignant syndrome, and if so your treatment should be stopped. --------------------------------------------------------- Use with caution in History of suicidal behaviour or thoughts. Liver disease. Kidney failure. Severe disease affecting the lungs or airways. Disease involving the heart and blood vessels (cardiovascular disease). People who have recently had a heart attack. Heart failure. Irregular heart beats (arrhythmias). Personal or family history of a type of abnormal heart rhythm, seen on a heart monitoring trace (ECG) as a 'prolonged QT interval'. Very slow heart rate (bradycardia). People with disturbances in the normal levels of salts (electrolytes) in their blood, for example low magnesium or potassium levels. Elderly people with dementia (antipsychotic medicines have been shown to increase the risk of stroke and death in this group of patients). People with risk factors for having a stroke, for example a history of stroke or mini-stroke (TIA), smoking, diabetes, high blood pressure, or a type of irregular heartbeat called atrial fibrillation. Epilepsy. People with conditions that increase the risk of convulsions, eg brain damage or withdrawal from alcohol. arkinson's disease. Abnormal muscle weakness (myasthenia gravis). Closed angle glaucoma. Enlarged prostate gland (prostatic hypertrophy). Tumour of the adrenal gland (phaeochromocytoma). Underactive or overactive thyroid gland. Diabetes. Hereditary blood disorders called porphyrias. Allergy to other similar antipsychotic medicines, eg zuclopenthixol. This medicine is not recommended for excitable or agitated people. People with a decreased level of consciousness due to any cause (eg, intoxication with alcohol, barbiturates or opiates). Unresponsive unconscious states (comatose states). Failure of the blood circulatory system (circulatory collapse). Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Fluanxol tablets contain lactose). Rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency (Fluanxol tablets contain sucrose). This medicine is not recommended for use in children and adolescents under 18 years of age. This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately. -------------------------------------------------------------------Pregnancy and breastfeeding Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine. The safety of this medicine for use during pregnancy has not been established. It should be avoided during pregnancy, particularly in the first and third trimesters, unless the expected benefit to the mother outweighs any possible risks to the developing baby. Seek medical advice from your doctor. If you do get pregnant while taking this medicine it is important to consult your doctor straight away for advice. You should not suddenly stop taking this medicine unless your doctor tells you to, as this could cause withdrawal symptoms (see warning above). This medicine passes into breast milk and could have harmful effects on a nursing infant. The manufacturer recommends that mothers who need to take this medicine should not breastfeed and bottlefeed instead. Seek further medical advice from your doctor. ---------------------------------------------------- Label warnings This medication may cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic dMedicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect. Abnormal movements of the hands, legs, face, neck and tongue, eg tremor, twitching, rigidity (extrapyramidal effects). Anxiety, restlessness and agitation (akathisia). Increased salivation or dry mouth. Sleepiness. Rhythmical involuntary movement of the tongue, face, mouth and jaw, which may sometimes be accompanied by involuntary movements of the arms and legs (tardive dyskinesia - see warning section above). Increased heart rate (tachycardia). Irregular heart beats (arrhythmias). A drop in blood pressure (hypotension) that may cause dizziness. Interference with the body's temperature regulation (this is more common in elderly people and may cause heat stroke in very hot weather or hypothermia in very cold weather). Headache. Changes in appetite and weight. Problems with attention or speech. Feelings of being mentally dulled or slowed down. Difficulty sleeping (insomnia). Visual disturbances. Disturbances of the gut such as constipation, indigestion, nausea and vomiting. Difficulty passing urine, increased need to pass urine, or urinary incontinence. Excessive sweating. Skin reactions such as rashes, itching, increased sensitivity to sunlight. Sexual problems, such as erectile dysfunction. Seizures (convulsions). High blood prolactin (milk producing hormone) level (hyperprolactinaemia). Sometimes this can lead to symptoms such as breast enlargement, production of milk and stopping of menstrual periods. High temperature combined with falling levels of consciousness, paleness, sweating and a fast heart beat (neuroleptic malignant syndrome). Requires stopping the medicine and immediate medical treatment - see warning section above. Uncontrolled rolling of the eyes and neck (oculogyric crisis). Requires immediate treatment. Disturbances in the normal numbers of blood cells in the blood. Tell your doctor if you get a fever, sore throat, mouth ulcers or other signs of infections while taking this medicine, as these symptoms could suggest a problem with your white blood cells. Your doctor may want you to have a blood test to check the numbers of blood cells in your blood. Liver problems. The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist. ---------------------------------------------------------------------- ��2011-03-08���� |
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