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Urbanol

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Indications:

* Short-term (two to four weeks only) treatment of severe anxiety that is disabling or causing the individual to unacceptable distress. * Epilepsy.

Contraindications:

* History of alcoholism or drug abuse. * Abnormal muscle weakness (myasthenia gravis). * Syndrome involving short spells when breathing stops during sleep (sleep apnoea syndrome). * Children under three years of age. * Severely decreased liver function. * Breastfeeding. * Long-term psychotic illness. This medicine should not be used if you are allergic to one 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 lactation: * This medicine may be harmful to a developing baby and it should be avoided during pregnancy unless considered essential by your doctor. This is particularly important during the first and third trimesters of pregnancy and before or during labour. Regular use during pregnancy should especially be avoided, as the baby could become dependent on the medicine and then suffer withdrawal symptoms after the birth. If this medicine is used in late pregnancy or during labour it may cause floppiness, low body temperature and breathing or feeding difficulties in the baby after birth. Ask your doctor for further information. * This medicine should not be used during pregnancy or breastfeeding. Seek medical advice from your doctor. * Significant amounts of this medicine may pass into breast milk. It should not be used by breastfeeding mothers as it may be harmful to the nursing infant. Seek medical advice from your doctor.

Adverse reactions:

* Drowsiness. * Dry mouth. * Dizziness. * Disturbances of the gut such as constipation, nausea. * Decreased appetite * Shaking, usually of the hands (tremor). * Confusion. * Shaky movements and unsteady walk (ataxia). * Headache. * Loss of memory (amnesia). * Slurred speech. * Skin rashes. * Muscle weakness. * Difficulty in passing urine (urinary retention). * Urinary incontinence. * Visual disturbances such as blurred vision, double vison. * Rarely, unexpected effects such as increase in aggression, excitement, restlessness, irritability, rages, nightmares, hallucinations, psychotic reactions (see Warning section above). * Changes in sex drive. The side effects listed above may not include all of the side effects reported by the medicine’s manufacturer.

Interactions:

There may be an increased risk of drowsiness and sedation if clobazam is taken with any of the following (which can also cause drowsiness): * alcohol * antipsychotics, eg chlorpromazine, clozapine * barbiturates, eg phenobarbital * other benzodiazepines, eg temazepam * monoamine oxidase inhibitors antidepressants, eg phenelzine * sedating antihistamines, eg chlorphenamine * sleeping tablets, eg zopiclone * strong opioid painkillers, eg morphine, codeine, dihydrocodeine * tricyclic antidepressants, eg amitriptyline. The amount of clobazam in the blood may be increased by cimetidine. If clobazam is used with strong opioid painkillers, such as morphine, this may result in an increase in the euphoric effect that these painkillers can have. This could lead to an increased risk of psychological dependence on the painkiller. Clobazam may increase or decrease blood levels of anticonvulsant medicines, such as carbamazepine, phenytoin or sodium valproate.

Warnings:

* Elderly people. * Decreased kidney function. * Decreased liver function. * Severe or sudden decrease in lung function (severe or acute pulmonary insufficiency). * Personality disorders. * Phobias or obsessional states. * Shaky or unsteady voluntary movements, eg walking (cerebellar ataxia).

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