SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT PRAZEPAM EG 10 mg tablets PRAZEPAM EG 20 mg tablets PRAZEPAM EG 15 mg/ml oral drops, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Prazepam EG 10 mg tablets: each tablet contains 10 mg prazepam. Excipient with known effect: Lactose: 119,60 mg Prazepam EG 20 mg tablets: each tablet contains 20 mg prazepam. Excipient with known effect: Lactose: 83,80 mg Prazepam EG 15 mg/ml oral drops, solution: each ml contains 15 mg prazepam (equivalent to 30 drops). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. Prazepam EG 10 mg tablets: Blue, round, flat tablets, scored on one side. Prazepam EG 20 mg tablets: White, round, flat tablets, scored on one side. The tablet can be divided into equal doses. Oral drops, solution. Prazepam EG 15 mg/ml oral drops, solution: Blue solution characterised by mint and anethole odour and taste. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Symptomatic treatment of anxiety. Benzodiazepines are indicated in the event of severe incapacitating symptoms or if these symptoms lead to an extreme suffering for the patient. 4.2 Posology and method of administration Posology Adults The recommended dose should be of 10-30 mg/day, and higher doses up to 60 mg should be reserved for most severe anxious conditions in psychiatric patients. This dosage can be administered in one or several doses every 24 hours, e.g.: 1/11 a.) a full dose at night or b.) ¼ of the dose in the morning, ¼ at midday and ½ at night or c.) ½ of the dose in the morning and ½ at night. Elderly patients In elderly or debilitated patients, it is advisable to start treatment with a 10 or 15 mg dose of prazepam, distributed over the day, and to subsequently increase it if necessary. Usually the therapeutic response can be obtained with half dose (see section 4.4). Paediatric population Adolescents (12-17 years of age). It is advisable to decrease the dosage depending on the age and weight of the patient and to not exceed 1 mg per kg body weight per day. The recommended dose should be of 10-30 mg/day, and higher doses up to 60 mg should be reserved for most severe anxious conditions in psychiatric patients. There are no clinical data on the use of prazepam in children under 6 years of age (see section 4.3, 4.4). The use of benzodiazepines in children below 6 years of age is only permitted after evaluation and under the surveillance of a specialist (neuropaediatrician, psychiatrist) who will decide on its posology. In many cases the administration of benzodiazepines meets an occasional or temporary need and so will be of short duration. Renal impairment, hepatic impairment A decrease in dose should be considered in patients with impaired renal or mild to moderate impaired hepatic function. Method of administration In some cases the patient’s state of health may necessitate longer-term administration. Each case where benzodiazepines are used over a prolonged period should be regularly re-evaluated by the doctor. Caution is advised when treatment is stopped. A decrease in dose should be considered in patients with impaired renal or mild to moderate impaired hepatic function. Duration of treatment Treatment should be as short as possible. The patient’s state of health should be regularly re- evaluated and the need for continued treatment re-examined, especially if the patient has no symptoms. Total duration of treatment should normally not exceed 8-12 weeks, including the dose withdrawal phase. In some cases, it may be necessary to prolong treatment beyond the maximum recommended period; if this happens, the patient’s state of health should be re-evaluated first by a doctor. Treatment should be initiated at the minimum recommended dose. The maximum dose should not be exceeded. 4.3 Contraindications Patients with a history of hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with a history of hypersensitivity to other benzodiazepines. Cases of myasthenia gravis. 2/11 Children under 6 years of age; use in children below 6 years of age is intended for rare and specific indications after evaluation and under the surveillance of a specialist (neuropaediatrician, psychiatrist) Patients with severe respiratory insufficiency. Sleep apnoea syndrome. Benzodiazepines are contraindicated in patients with severe hepatic insufficiency as it may precipitate encephalopathy. 4.4 Special warnings and precautions for use Prazepam EG is not recommended in psychiatric disorders and psychotic states where anxiety is not one of the major factors. As a result, prazepam should only be used as an adjuvant in psychoses. Elderly patients. Minor drowsiness and/or a decrease in ability to concentrate, as well as a reduction in muscle tone may present in the elderly or in those with weak muscles. In the elderly or very weak, it is advisable to start treatment at a lower dose e.g. 10 or 15 mg dose of prazepam, distributed over the day, and to subsequently increase it if necessary. Paediatric population There are no clinical data on the use of prazepam in children under 6 years of age. Benzodiazepines must not be administered to children without careful evaluation of the need of such treatment. Duration of treatment should be as short as possible. The use of benzodiazepines in children below 6 years of age is intended for rare and specific indications after evaluation and under the surveillance of a specialist (neuropaediatrician, psychiatrist) (see section 4.3. Contraindications). In children 6 to 18 years of age, dose reduction is recommended depending on the patient’s age and body weight. Prazepam EG should only be prescribed to children after thourough evaluation of the indication. There are no clinical data as to the use of Prazepam EG in children below 6 years of age. Children are more sensitive to the effects of benzodiazepines on the CNS, because development of the metabolism scheme is still incomplete so that formation of inactive metabolites might not be possible or not be complete. Renal impairment. A decrease in dose should be considered in patients with impaired renal function. Hepatic impairment. A decrease in dose should be considered in patients with mild to moderate impaired hepatic function. Benzodiazepines are contraindicated in patients suffering from severe hepatic impairment, as they may precipitate encephalopathy. Tolerance. Benzodiazepines can induce symptoms of tolerance. Dependence. Administration of benzodiazepines can lead to the development of physical and psychological dependence. The risk of dependence increases with the dose and duration of treatment. Furthermore, it is greater in patients with a history of alcoholism or drug dependence. Once a person has become physically dependent, sudden withdrawal of treatment is accompanied by symptoms of withdrawal. These might be headache, muscular pains, extreme anxiety, tension, agitation, confusion and irritability. In severe cases, following symptoms may appear: 3/11 derealisation, depersonalisation, hyperacusis, numbness and tingling in the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic fits. Rebound anxiety: when treatment is stopped a temporary syndrome may occur, in which the symptoms that led to benzodiazepines being prescribed reappear in an amplified form. It may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness. As the risk of withdrawal or rebound symptoms is greater after sudden withdrawal of treatment, a gradual reduction in dose is recommended. Progressive discontinuation of treatment The procedure should be clearly detailed to the patient. Besides the need of progressive dose tapering phase, patients should be informed of the risk of rebound phenomena in order to minimise the anxiety that might follow the symptoms linked with discontinuation, even if progressive. The patient should be informed about the possibly uncomfortable nature of this period. Duration of treatment. Duration of treatment should be as short as possible (see “Posology and Method of Administration”) and should not exceed 8-12 weeks, including the dose withdrawal phase. If the treatment is to be extended beyond this period, the situation should be re-evaluated. For patients with a history of dependence, see the section “Undesirable effects”. Amnesia. Benzodiazepines can cause anterograde amnesia which generally occurs within a few hours after ingestion of the product. As a consequence, in order to minimise this risk, patients need to be sure that they will have 7 to 8 hours of uninterrupted sleep following intake of the medicinal product (see also section “Indesirable effects”). For patients with a history of dependence, see the section “Undesirable effects”. Epilepsy Although epileptic fits may occur following the abrupt withdrawal of treatment, this risk will probably be greater with benzodiazepines that have a short half-life. One should bear this in mind when treating patients who have already suffered from epilepsy. Psychiatric and paradoxical reactions. Reactions like restlessness, agitation, irritability, aggressiveness, delirium, rage, nightmares, delusions, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines. If these paradoxical reactions occur, Prazepam EG should be discontinued. These reactions are more likely to occur in children and the elderly. Benzodiazepines are not indicated in the primary treatment of psychotic disorders. Benzodiazepines should not be used as monotherapy in the treatment of depression or anxiety associated with depression (as they may trigger suicide in these patients). Alcohol Benzodiazepines should be used with extreme caution in patients with a history of alcoholism or drug dependence. As far as the concomitant intake of alcohol is concerned, see the section “Interaction with other medicinal products and other forms of interaction”. 4/11 Risk from concomitant use of opioids Concomitant use of Prazepam EG and opioids may result in sedation, respiratory depression, coma and death.