7,5 mg Tablets 15 mg Tablets COMPOSITION: Dormicum tablets contain as active ingredient 7,5 mg or 15 mg midazolam (8-chloro-6-(2- fluorophenyl)-1-methyl-4H-imidazo [1,5-a] [1,4] benzodiazepine) - in the form of the maleate. PHARMACOLOGICAL CLASSIFICATION OF DORMICUM / MIDAZOLAM: Category A: 2.2 - Sedatives, hypnotics. PHARMACOLOGICAL ACTION OF DORMICUM / MIDAZOLAM: Midazolam is a benzodiazepine, it has anxiolytic, sedative and hypnotic characteristics as well as possible muscle relaxant and anticonvulsant characteristics. Pharmacokinetics: With a dose of 15 mg a Cmax is reached of 154 + 51 ng/mL at Tmax of 0,5-1,5 hours. The elimination half-life is 2,1-3,5 hours. The volume of distribution ranges from 0,7 -1,2 L/kg. Midazolam is metabolised via cytochrome P450. There is one active metabolite alpha-hydroxymidazolam, which has a t½ of 0,8-1,0 hours. Dormicum is 96 - 98 % bound to plasma proteins. DORMICUM / MIDAZOLAM INDICATIONS: Short term treatment of insomnia. Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. Anaesthetic premedication. DORMICUM / MIDAZOLAM CONTRA-INDICATIONS: Hypersensitivity to benzodiazepines. Myasthenia gravis. Benzodiazepines are not recommended for the primary treatment of psychotic illness. Benzodiazepines should not be used alone to treat depression or anxiety associated with depression (suicide may be precipitated in such patients). Severe hepatic impairment. Insufficient data are available on midazolam to assess its safety during pregnancy. 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, exceptionally, it is considered by a physician that administration of the medicinal product during the last three months of pregnancy or during labour is essential, effects on the neonate such as hypothermia, hypotonia and moderate respiratory depression, can be expected, due to the pharmacological action of the product. 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. Midazolam is excreted in breast milk. Do not use during lactation. This product is not suitable for use in children. Severe respiratory insufficiency. Sleep apnoea syndrome. DOSAGE AND DIRECTIONS OF DORMICUM / MIDAZOLAM: Patients should be advised to take Dormicum for short-term treatment only. Generally the duration of treatment varies from a few days to a maximum of two weeks. The tapering off process should be tailored to the individual. In certain cases extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient's status. The product should be taken just before going to bed. Doses for insomnia: Adults - Initial dose: 7,5 mg Dosage range: 7,5 mg - 15 mg Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded because of the increased risk of unacceptable CNS adverse effects. Patients with impaired liver function should have a reduced dose. In premedication, a 15 mg Dormicum tablet should be given orally 30-60 minutes before the operation, unless the parenteral route is preferred. DORMICUM / MIDAZOLAM SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Drowsiness during the day, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia or double vision. These phenomena occur predominantly at the start of the therapy and usually disappear with repeated administration. Other side effects like gastrointestinal disturbances, changes in libido or skin reactions have been reported occasionally. Amnesia: 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: 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: Tolerance: Some loss of efficacy to the hypnotic effects of short acting benzodiazepines may develop after repeated use of a few weeks. Dependence: Use of midazolam may lead to physical and psychic dependence. Discontinuation of therapy may result in withdrawal or rebound phenomena. Psychic dependence may occur. Abuse 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 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 midazolam withdrawal phenomena can become manifest within the dosage interval, especially when the dosage is high. Amnesia: Midazolam may induce anterograde amnesia. The condition occurs most often several hours after ingesting the product and therefore, to reduce the risk, patients should ensure that they will be able to have an uninterrupted sleep of 7-8 hours (see Side effects). 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: 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 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 / MIDAZOLAM: 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, 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 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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