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Summary of Product Characteristics 1 SUMMARY OF PRODUCT CHARACTERISTICS 1 DENOMINATION OF THE MEDICINAL PRODUCT DELORAZEPAM ABC 1 mg/ml Oral drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION DELORAZEPAM ABC 1 mg/ml Oral drops, solution 1 ml of solution contains: Active principle: delorazepam 1 mg For the excipients, refer to 6.1. 3. Pharmaceutical form Oral drops, solution. 4. CLINIC INFORMATION 4.1 Therapeutical indications Dysphoria, Insomnia. The benzodiazepines are indicated only when the disorder is serious, disabling or the subject is submitted to serious uneasiness. 4.2 Posology and administration modality Anxiety trouble In general medicine -oral drops, solution: 13-26 drops, for 2-3 times a day. In neuro-psychiatry - oral drops, solution: 26-50 drops, for 2-3 times a day. The anxiety trouble treatment should be in terms of time as short as possible. The patient should be regularly re-valued and the necessity of a continued treatment should be attentively evaluated, particularly when the patient is without symptoms. The total treatment duration should not exceed, generally, 8-12 weeks, including a period of gradual suspension. In specific cases, the extension of treatment beyond the maximum period may be necessary; in such case, this should not occur without the patient condition re-evaluation. Insomnia -oral drops, solution: 13-26-52 drops, in the evening before going to sleep. The insomnia treatment, in terms of time, should be as brief as possible. The treatment duration, generally, varies from a few day to two weeks up to a maximum of four weeks, including a period of gradual suspension. In specific cases it may be necessary the extension beyond the period of maximum treatment; in such case, this should not happen without a previous re-evaluation, by the physician, of the patient conditions. The treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded. It is recommended to take DELORAZEPAM ABC drops with a little water. A drop of DELORAZEPAM ABC contains 38,5 mcg of clordemetildiazepam; 13 drops= 0,5 mg. Because of the variability of the individual responses the individual and daily posology will have to be adapted to the age, to the general conditions and to the clinic context. The dose for the old people and for the patients with hepatic and/or renal altered function must be carefully established by the physician who will have to evaluate a contingent reduction of the above-mentioned dosages. The posology must be fixed within prudential limits for the debilitated subjects or particularly sensitive, and for those patients with organic cerebral modifications (especially of the arteriosclerotic kind) or with respiratory insufficiency. In these subjects it is suggested to start with low dosages and to adjust subsequently the posology on the basis of the results obtained. The patient should be regularly controlled at the start of the treatment to reduce, if necessary, the dose or the frequency of the taking, in order to prevent the hyper-dosage due to the accumulation. 4.3 Contraindications Hypersensitivity to the benzodiazepine. Hypersensitivity to the active principle or to any of the excipients. Myasthenia gravis. Severe respiratory distress syndrome. Hepatic insufficiency. Night apnea syndrome. Pregnancy and breast feeding (see 4.6) 4.4 Special cautions and suitable use precautions Tolerance . A certain loss of efficacy towards the benzodiazepine hypnotic effects may develop after a repeated use for some weeks. Dependence . The use of benzodiazepine may lead to the development of physical and psychical addiction to these medicines. The risk of addiction increases with the dose and treatment duration; this is higher in patients with a story of drug or alcohol addiction. Once the physical dependence has been developed, the treatment abrupt interruption will be accompanied by abstinence symptoms. These may consist in headache, muscular ache, extreme anxiety, tension, restlessness, confusion and irritability. In the serious cases the following symptoms may be evidenced: de-realization, de-personalization, hyperacusia, extremities numbness and formication, hypersensitivity to the light, to the noise and to the physical contact, hallucinations or epileptic crises. Insomnia and rebound anxiety: at the treatment suspension it may occur a temporary syndrome in which the symptoms that have led to the treatment with the benzodiazepine return in an aggravated form. It may be associated to other reactions, including mood changes, anxiety, restlessness or sleep troubles. Since the risk of abstinence or rebound symptoms is greater after an abrupt treatment suspension, we recommend to adopt a gradual reduction of the dosage. Treatment duration. The treatment duration should be as brief as possible (see “posology and modality of administration”) depending on the indication and should not exceed the four weeks for the insomnia and eight-twelve weeks in the case of the anxiety, including a period of gradual suspension. The extension of this therapy, beyond these periods, should not occur without re-evaluation of the clinic situation. It may be useful to inform the patient when the treatment is started that it twill be of limited duration and to precisely explain that the dosage will be gradually reduced. In addition, it is important that the patient be informed of the possibility of rebound phenomena, minimizing thus the anxiety towards these symptoms, whether these should become present at the suspension of the medicine. When using the DELORAZEPAM ABC (tablets and oral solution), long action duration benzodiazepine it is important to warn the patient that is not advisable the abrupt change with a brief action duration benzodiazepine, since an abstinence syndrome might arise. In case of prolonged treatment it is advisable to proceed to the blood test analysis and hepatic function control. Amnesia The benzodiazepine can induce anterograde amnesia. This happens quite often several hours after the medicine assumption and then, to reduce the risk, it must be ascertained that the patient could have an unbroken sleep of 7-8 hours (refer to “Undesired effects”). Psychiatric and paradoxical reactions . When using benzodiazepine it is well-known that reactions may occur as relentlessness, agitation, irritability, aggressiveness, delirium, anger, nightmares, hallucinations, psychosis, behavior alterations. Should this happen, the use of the drug should be suspended. Such reactions are more frequent in children and old patients. Specific groups of patients . The benzodiazepine should not be administered to children without an attentive evaluation of the real necessity of the treatment; the treatment duration must be as short as possible. The ancients should take a reduced dose (refer to “Posology and administration mode”). Similarly, a reduced dose is recommended for patients suffering with chronic respiratory insufficiency because of the risk of a respiratory depression. The benzodiazepines are not indicated in patients with serious hepatic insufficiency since they may precipitate the hepatic encephalopathy. The benzodiazepines are not suggested for the primary treatment of the psychotic disease. The benzodiazepine should not be used as the sole remedy for treating the depressive disorder or the anxiety connected with the depression (suicide may be precipitated in such patients). The benzodiazepine should be used with extreme attention in patients with a story of drug addiction or alcohol abuse. DELORAZEPAM ABC in the 0,5 mg, 1 mg and 2 mg tablets confections contains lactose, therefore it is not fit for the subjects with deficit of lactase, galactosemia or glucose/galactose mal-absorption syndrome. DELORAZEPAM ABC drops, oral solution contains 13% vol/vol ethanol (alcohol) i.e. up to 211 mg per dose, equivalent to 5,2 ml of beer and to 2.16 ml of wine per dose. Harmful for alcohol- dependent persons. To be taken into consideration in pregnant women and breast-feeding women, children and high-risk groups as for instance patients with hepatic disorder and epileptic patients. 4.5 Interactions with other medicines and other forms of interaction The concurrent assumption of alcohol must be avoided. The sedative effect may be increased when the medicinal is assumed concurrently with alcohol. This negatively influences the driving capacity or the use of machineries. Association with medicines depressing the SNC (Central Nervous System): the central depressive effect may be increased in the cases of concurrent use of anti-psychotic (neuroleptics), hypnotics, tranquillizers/sedatives, anti-depressives, analgesics narcotics, anti-epileptics, anesthetics and antihistamine sedatives. In the case of the analgesics narcotics there may have an increase of the euphoria which may lead to an increase of the psychic dependence. The association with other psycho-medicine requires particular caution and vigilance by the physician in order to avoid unexpected undesired effects caused by interaction. Aggregates inhibiting determined hepatic enzymes (especially cytochrome P450) may increase the benzodiazepine activity. In a lower grade, this is applied also to the benzodiazepine which are metabolized only through conjugation. 4.6 Pregnancy and breast feeding. If the product is prescribed to a woman in fertile age, she will have to contact her own physician, either if she intend to initiate a pregnancy or if she suspect to be pregnant, as to what concerns the medicine interruption. The medicine must not be administered in the first quarter
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