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SUMMARY of PRODUCT CHARACTERISTICS 1. NAME of the MEDICINAL PRODUCT Zolpidem Dune, 5 Mg Film-Coated Tablet 2. QUALITATIVE and QU

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SUMMARY of PRODUCT CHARACTERISTICS 1. NAME of the MEDICINAL PRODUCT Zolpidem Dune, 5 Mg Film-Coated Tablet 2. QUALITATIVE and QU SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Zolpidem Dune, 5 mg film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg zolpidem tartrate. Excipient with known effect: Lactose monohydrate 49 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets 5 mg: Zolpidem Dune, film-coated tablets are white, oval shaped, biconvex tablets with “5 mg" embossed on one side. Length 8 mm, width 4 mm and thickness 3.0-3.4 mm. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Short-term treatment of insomnia in situations where the insomnia is severe, disabling or subjecting the individual to extreme distress. 4.2 Posology and method of administration The treatment should be as short as possible. In general treatment should vary from a few days to two weeks with a maximum treatment period of four weeks including the tapering off process. In certain cases extension beyond the maximum treatment period may be necessary. However, this should not take place without re-evaluation of the patient’s status. This medicine should be taken immediately before bedtime or in bed. For oral use only. Posology The treatment should be taken in a single intake and not be re-administered during the same night. Adults: The recommended daily dose for adults is 10 mg to be taken immediately at bedtime. The lowest effective daily dose of zolpidem should be used and must not exceed 10 mg. Children: The drug should not be used in children under 18 years, as there is no data on safety and efficacy in children (see section 4.4). Elderly and debilitated patients: Because elderly or debilitated patients may be especially sensitive to the effects of zolpidem, a dose of 5 mg is recommended, and the total dose should not exceed 10 mg. Hepatic impairment: Since clearance and excretion of zolpidem is decreased in patients with hepatic impairment, the starting dose should be 5 mg in this patient population, with special attention to older patients. In adults under 65 years, the dose may be increased to 10 mg if insufficient clinical response and if the drug is well tolerated. The daily dose should for all patient groups never exceed 10 mg. 4.3 Contraindications Zolpidem Dune is contraindicated in the following cases: • Children and adolescents under 18 years. • Myasthenia gravis. • Sleep apnea syndrome. • Severe hepatic impairment. • Acute and / or severe respiratory insufficiency. • Hypersensitivity to zolpidem or to any of the excipients listed in section 6.1. 4.4 Special warnings and precautions for use General If possible, the cause of insomnia should be clarified. The underlying factors should be treated before a hypnotic is prescribed. The failure of insomnia to remit after a 7-14 day course of treatment may indicate the presence of a primary psychological or physical disorder, which should be evaluated. Children and adolescents Safety and efficacy of zolpidem have not been established in patients below the age of 18 years. In an 8- week study of children and adolescents (aged 6-17 years) with insomnia associated with attention- deficit/hyperactivity disorder (ADHD) the most frequent sudden side effects of treatment with zolpidem versus placebo was psychological symptoms and disorders of the nervous system and included furthermore dizziness (23.5% vs. 1.5%), headache (12.5% vs. 9.2%) and hallucinations (7.4% vs. 0%). General information relating to effects that have been reported after administration of benazepines or other hypnotic agents which should be taken into account by the prescribing physician are described below. Tolerance: Some loss of the hypnotic effects of short-acting benzodiazepines and benzodiazepine-like agents may develop after repeated use for a few weeks. Dependence: Use of benzodiazepines or benzodiazepine-like agents may lead to physical or psychological dependence upon these products. The risk of dependence increases with dose and duration of treatment and is also greater in patients with a history of alcohol or drug abuse. If physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may include headache or muscle pain, extreme anxiety or tension, restlessness, confusion, irritability or insomnia. In severe cases the following symptoms may occur: derealisation and depersonalisation, hyperacusis, numbness and tingling of extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures. Rebound effect: A transient syndrome whereby the symptoms that led to treatment with a benzodiazepine or benzodiazepine-like agent 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. It is important that the patient should be aware of the possibility of rebound phenomena; thereby minimizing anxiety over such symptoms should they occur when the medicinal product is being discontinued. There are indications that, in the case of benzodiazepines and benzodiazepine-like agents with a short duration of action, withdrawal phenomena can become manifest within the dosage interval, especially when the dosage is high. As the risk of withdrawal symptoms/rebound phenomena are most likely to develop after abrupt discontinuation of treatment, it is recommended to decrease the dose gradually. Duration of treatment: The duration of treatment should be as short as possible (se section 4.2), but should not exceed four weeks including the tapering off process. Extension beyond these periods 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. Next-day psychomotor impairment: The risk of next-day psychomotor impairment, including impaired driving ability, is increased if: • zolpidem is taken within less than 8 hours before performing activities that require mental alertness (see section 4.7); • a dose higher than the recommended dose is taken; • zolpidem is co-administered with other CNS depressants or with other drugs that increase the blood levels of zolpidem, or with alcohol or illicit drugs (see section 4.5). Zolpidem should be taken in a single intake immediately at bedtime and not be re-administered during the same night. Amnesia: Benzodiazepines or benzodiazepine-like agents may induce anterograde amnesia. The condition usually occurs several hours after ingesting the product. In order to reduce the risk, patients should ensure that they will be able to have an uninterrupted sleep of 8 hours (see section 4.8). Psychiatric and "paradoxical" reactions: By using benzodiazepines or benzodiazepine-like agents reactions such as restlessness, agitation, irritability, aggressiveness, delusions, rages, nightmares, hallucinations, psychosis, sleep walking, inappropriate behavior, increased insomnia and other adverse behavioral effects are known to occur. If these reactions occur, the use of the product should be discontinued. These reactions are more likely to occur in the elderly. Somnambulism and associated behaviors: Sleep walking, “sleep driving”, preparing and eating food, making phone calls or having sex, with amnesia for the events, have been reported in patients who had taken zolpidem. The use of alcohol and other CNS-depressants with zolpidem appears to increase the risk of such behaviour, as does the use of zolpidem at doses exceeding the maximum recommended dose. Discontinuation of zolpidem should be strongly considered for patients who sleep walk or with other associated automatisms (eg. “sleep driving”), because they might be a danger to themselves and others. Specific patient groups Elderly or debilitated patients should receive a lower dose: see recommended dosage (section 4.2). Due to the muscle relaxant effects there is a risk of falls and consequently of hip fractures particularly for elderly patients when they get up at night. Although dose adjustments are not necessary in patients with renal insufficiency, caution should be exercised (see section 5.2). Zolpidem Dune should be used with caution in patients with sleep apnea syndrome and myasthenia gravis. Caution should be exercised when prescribing Zolpidem Dune to patients with chronic respiratory insufficiency since benzodiazepines have been shown to impair respiratory function (see section 4.8). It should also be taken into consideration that anxiety or agitation has been described as signs of uncompensated respiratory insufficiency. Benzodiazepines and benzodiazepine-like agents are not indicated for the treatment of patients with severe hepatic impairment as they may precipitate encephalopathy. The initial dose should therefore be 5 mg in this patient group, with special attention to elderly patients. Benzodiazepines and benzodiazepine-like agents are not recommended for the primary treatment of psychosis. Despite the fact that relevant clinical, pharmacokinetic, and pharmacodynamic interactions with SSRI have not been demonstrated, Zolpidem Dune should be administered with caution in patients exhibiting symptoms of depression. Suicidal tendencies may be present. Due to the possibility of intentional overdose by the patient, the lowest amount of medicinal product that is feasible should be supplied to these patients. Unacknowledged existing depression may be exacerbated by the use of benzodiazepines and benzodiazepine-like agents. Benzodiazepines and benzodiazepine-like agents
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