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White to pale yellow, circular, flat bevelled-edge uncoated tablets impressed "C" and the identifying letters "ZM" on either side of Temaze tablets 10mg central division line on one face and blank on the reverse. Treatment should be tapered off gradually see section 4. Extension of use should not take place without further clinical evaluation. Chronic use not recommended little is known of the long-term safety and efficacy: potential for dependence- see section 4.
Patients who have received benzodiazepines for a long time may require an extended withdrawal period. A dose of 20mg will be found satisfactory for most patients. In extreme cases this may be increased to mg in patients who do not respond to the lower dose.
Elderly or debilitated or those with cerebrovascular disease or hepatic or renal impairment. It is recommended that patients should be accompanied home after medication with Temazepam prior to surgical or investigative procedures. Dosage should be reduced to possibly half the normal adult dose mg, one hour before the procedure. In general hypnotics should be avoided in the elderly as they are at risk of becoming ataxic and confused. Temaze tablets 10mg may lead to falls and injury.
Temazepam tablets are not recommended for use in children.
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The safety and efficacy in children less than 18 years old has not been established. Inadequate evidence of safety and efficacy. Elimination half-life of temazepam may be prolonged. The cause for insomnia should be determined prior to the use of temazepam, and it should not be used for first line treatment of psychotic illness.
Severe anaphylactic and anaphylactoid reactions, including rare Temaze tablets 10mg cases of anaphylaxis, have been reported in patients receiving temazepam. Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including temazepam.
The duration of treatment should be as short as possible see section 4. Extension beyond these periods should not take place without re-evaluation of the situation. It may be useful to inform the patient when treatment is started that it will be of limited duration and to explain precisely how the dosage will be progressively decreased.
Moreover it is important that the patient should be aware of the possibility of rebound Temaze tablets 10mg, thereby minimizing anxiety over such symptoms should they occur while temazepam is being discontinued. There are indications that, in the case of benzodiazepines with a short duration of action such as temazepam, withdrawal phenomena can become manifest between doses, especially when the dosage is high.
When benzodiazepines with a long duration of action are being used it is important to warn against changing to a benzodiazepine with a short duration of action, as withdrawal symptoms may develop. Limits of tolerance in patients with organic cerebral changes particularly arteriosclerosis or cardiorespiratory insufficiency may be very wide; care must be taken in adapting the dosage with such patients.
Care should be taken in patients with chronic renal or hepatic disease elimination half-life of temazepam may be prolonged. Sedatives given to patients with cirrhosis may precipitate encephalopathy. The risk of dependence physical or psychological increases with dose and duration of treatment and is greater in patients with a history of alcohol or drug abuse, or in patients with a marked personality disorder. If physical dependence has developed, abrupt termination of treatment in withdrawal symptoms.
These include headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability, sleep disturbance, diarrhoea and mood changes. In severe cases the following may occur: a Temaze tablets 10mg of unreality or of being separated from the body, depersonalisation, hyperacusis, confusional states, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, psychotic manifestations including hallucinations or epileptic seizures.
Withdrawal symptoms will be worse in patients who have been dependent on alcohol or other narcotic drugs in the past, but can occur following abrupt cessation of treatment in patients receiving normal therapeutic doses for a short period of time.
Symptoms including insomnia and anxiety may occur on withdrawal of treatment. It may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness. As this is greater after abrupt discontinuation, the dose should be decreased gradually see section 4. Anterograde amnesia may occur, most often several hours after ingestion.
To reduce the risk, patients should ensure that they will be able to have an uninterrupted sleep of hours see also section 4. Reactions such Temaze tablets 10mg restlessness, agitation, irritability, aggressiveness, excitement, confusion, delusions, rage, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects can occur. These reactions are more likely in children and the elderly, and extreme caution should be used in prescribing benzodiazepines to patients with personality disorders. Should they occur, treatment should be discontinued.
Complex sleep behaviour-related events such as 'sleep driving' i. These events can occur with sedative-hypnotics, including temazepam, alone at therapeutic doses.
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The use of alcohol and other CNS depressants with sedative-hypnotics appears to increase the risk of such behaviours, as does the use of sedative-hypnotics at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of sedative-hypnotics Temaze tablets 10mg be strongly considered for patients who report such events. Concomitant use of Temazepam and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs such as Temazepam with opioids should be reserved for patients for whom alternative treatment options are not possible.
If a decision is made to prescribe Temazepam concomitantly with opioids, the lowest effective dose should be used, and the duration of treatment should be as short as possible see also general dose recommendation in section 4. The patients should be followed closely for s and symptoms of respiratory depression and sedation.
In this respect, it is strongly recommended to inform patients and their caregivers where applicable to be aware of these symptoms see section 4. Temazepam should not be used alone to treat depression or anxiety associated with depression as suicide may be precipitated in such patients.
Avoid regular use in pregnant women risk of neonatal withdrawal symptoms ; Temaze tablets 10mg only if clear indication such as seizure control high doses during late pregnancy or labour may cause neonatal hypothermia, hypotonia and respiratory depression see also section 4. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Temazepam should not be used together with alcohol enhanced sedative effects: effect the ability to drive or operate machinery. The concomitant use of sedative medicines such as benzodiazepines or related drugs such as Temazepam with opioids increases the risk of sedation, respiratory depression, coma and death because of additive Temaze tablets 10mg depressant effect.
The dosage and duration of concomitant use should be limited see section 4. The elderly may require special supervision.
When used concurrently, side effects and toxicity may be more evident, particularly with hydantoins e. This requires extra care in adjusting dosage in the initial stages of treatment.
Compound that affect hepatic enzymes particularly cytochrome P Inhibitors e. Enhanced hypotensive effect with ACE-inhibitors, alpha-blockers, angiotensin-II-receptor antagonists, calcium channel blockers, adrenergic neurone blockers, beta-blockers, moxonidine, nitrates, hydralazine, minoxidil, sodium nitroprusside and diuretics. Concurrent use of zidovudine with benzodiazepines may decrease Zidovudine clearance.
Ritonavir may inhibit benzodiazepine hepatic metabolism. May enhance the activity of benzodiazepines. To a lesser degree this also applies to benzodiazepines that are metabolised only by conjugation.
The safety of temazepam has not been evaluated in humans and therefore its use should be avoided, especially in the first and third trimester. Avoid regular use risk of neonatal withdrawal symptoms ; use only if clear indication such as seizure control high doses during late pregnancy or labour may cause neonatal hypothermia, hypotonia and respiratory depression.
If the product is prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding discontinuance of the product if she intends to become or suspects that she is pregnant. If, for compelling medical reasons, the product is administered during the late phase of pregnancy, or during labour at high doses, effects on the Temaze tablets 10mg, such as hypothermia, hypotonia and moderate respiratory depression, can be expected, due to the pharmacological action of the compound. Moreover, infants born to mothers who took benzodiazepines chronically during the latter stages of pregnancy may have developed physical dependence and may be at some risk for developing withdrawal symptoms in the postnatal period.
Since benzodiazepines are found in the breast milk, benzodiazepines should not be given to breast feeding mothers. This medicine Temaze tablets 10mg impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act When prescribing this medicine, patients should be told:.
Patients should be advised that sedation, amnesia, impaired concentration, dizziness, blurred vision and impaired muscular function may occur and that, if affected, they should not drive or to use machines, or take part in other activities where this would put themselves or others at risk.
If insufficient sleep duration occurs, the likelihood of impaired alertness may be increased. Concurrent medication may increase these effects see section 4. At the start of treatment patients may suffer from drowsiness and light-headedness the next day; confusion and ataxia especially in the elderly ; amnesia may occur and dependence. Reduced alertness, dizziness, fatigue, muscle weakness, numbed emotions, double vision, respiratory depression or slurred speech.
These will normally disappear with continued treatment. Pre-existing depression may be unmasked during treatment with temazepam. Blood dyscrasias and increased liver enzymes have also been reported to occur occasionally.
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If any of these effects do occur, treatment should be discontinued. Other effects, including delusions, hallucinations, psychoses, irritability and restlessness, agitation, aggressiveness, nightmares and rages or other inappropriate behaviour and other adverse behavioural effects have also been reported to occur.
They are more likely to occur in children and the elderly. If any of these effects occur, treatment should be discontinued. Use even at therapeutic doses may lead to the development of physical dependence: discontinuation Temaze tablets 10mg the therapy may result in withdrawal or rebound phenomena see Warnings Temaze tablets 10mg precautions.
Depression, anxiety, headache, dizziness, impaired concentration, tinnitus, loss of appetite, tremor, perceptual disturbances, nausea, vomiting, abdominal cramps, palpitations, mild systolic hypertension, tachycardia, orthostatic hypotension, photophobia, hyperacusis, confusion, tensionnervousness, rebound insomnia, irritability, sweating and diarrhoea have been reported following abrupt cessation of treatment.
In rare cases, withdrawal following excessive dosages may produce confusional states, psychotic manifestations and convulsions. Broken sleep with vivid dreams may persist for some weeks after withdrawal. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www. As with other benzodiazepines, overdose should not present a threat to life unless combined with other CNS depressants including alcohol. In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken.
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Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Coma, hypotension and respiratory depression occasionally occur but are seldom serious if these drugs are taken alone. Coma usually lasts a few hours but in the elderly may be more protracted and cyclical.