Dormicum 15mg x 30
Product Information THIS ITEM DELIVERY IS NOT AVAILABLE FOR EU ( Except for the Netherlands ) . disappear with repeated administration. Other side effects of Dormicum like gastrointestinal disturbances, changes in libido or skin reactions have been reported occasionally. Amnesia on Dormicum : Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages. Amnesic effects may be associated with inappropriate behaviour. (see special precautions). Data from several sources suggest that anterograde amnesia may be observed at a higher rate with midazolam than with other hypnotics. However, conclusive evidence based on comparative studies is lacking. Depression on Dormicum : Pre-existing depression may be unmasked during midazolam use. Psychiatric and "paradoxical" reactions: Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using midazolam and other benzodiazepine-like agents. Should this occur the medication should be discontinued. They are more likely to occur in children and the elderly. Care may be needed in epileptic patients, in whom abrupt withdrawal of Dormicum may provoke seizures. Special Precautions on Dormicum : Tolerance: Some loss of efficacy to the hypnotic effects of short acting benzodiazepines may develop after repeated use of a few weeks. Dependence on Dormicum : Use of Dormicum ( midazolam )may lead to physical and psychic dependence. Discontinuation of Dormicum therapy may result in withdrawal or rebound phenomena. Psychic dependence may occur. Abuse of Dormicum has been reported in polydrug abusers. Once physical dependence has developed, abrupt termination will be accompanied by withdrawal symptoms. These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases the following symptoms may occur: derealization, depersonalization, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures. Rebound insomnia: A transient syndrome whereby the symptoms that led to treatment with midazolam recur in an enhanced form, may occur on withdrawal of hypnotic treatment. It may be accompanied by other reactions including mood changes, anxiety and restlessness. Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment it is recommended that the dosage is decreased gradually. Duration of treatment: The duration of Dormicum treatment should be as short as possible (see Dosage), but should not exceed 2 weeks. The tapering off process should be tailored to the individual. Extension beyond this period should not take place without re-evaluation of the situation.
It may be useful to inform the patients when treatment is started that it will be of limited duration and explain precisely how the dosage will be progressively decreased. Moreover, it is important that the patient should be aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms should they occur while the medicinal product is being discontinued. There are indications that, in the case of Dormicum (midazolam) withdrawal phenomena can become manifest within the dosage interval, especially when the dosage is high. Effects on ability to drive or to use machines: Sedation, amnesia, impaired concentration and impaired muscular function may adversely affect the ability to drive or to use machines. If insufficient sleep duration occurs, the likelihood of impaired alertness may be increased (see also Interactions). Specific patient groups: For the elderly: see dose recommendation. A lower dose is also recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression. Benzodiazepines are not indicated to treat patients with severe hepatic insufficiency as it may precipitate encephalopathy. Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse. Interactions for Dormicum : During the clinical-testing stage, Dormicum was administered together with various drugs, such as oral-diabetics, anticoagulants and cardiovascular agents. No interactions were observed. Not recommended: Concomitant with alcohol. The sedative effect may be enhanced when Dormicum (midazolam) is used in combination with alcohol. This affects the ability to drive or use machines. Take into account: Combination with CNS depressants. Enhancement of the central depressive effect may occur in cases of concomitant use with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, antiepileptic drugs, anaesthetics and sedative antihistamines. In the case of narcotic analgesics, enhancement of euphoria may also occur leading to an increase in psychic dependence. There is a potentially relevant interaction between midazolam and compounds which inhibit certain hepatic enzymes (particularly cytochrome P 450 III A). Data clearly indicate that these compounds influence the pharmacokinetics of midazolam and may lead to increased and prolonged sedation. At present this reaction is known to occur with cimetidine, ranitidine, erythromycin, diltiazem, verapamil, ketoconazole, itraconazole and saquinavir. Therefore prescription of midazolam in patients receiving the above compounds or others which inhibit P 450 III A should be avoided whenever possible. Otherwise the dose should be reduced by 50-75%. In such cases, the patient should be kept under careful surveillance.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF Dormicum TREATMENT: 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. Following overdosage with oral benzodiazepines ( Dormicum ), vomiting should be induced (within one hour) if the patient is conscious or gastric lavage undertaken, with the airway protected, if the patient is unconscious. If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption. Special attention should be paid to respiratory and cardiovascular functions in intensive care. Overdosage of benzodiazepines ( Dormicum ) is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion and lethargy. In more severe cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death. Flumazenil may be useful as an antidote.
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