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ZOPICLONE GRINDEKS is a brand name for Zopiclone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Zopiclone is indicated for the short-term treatment of insomnia in adults. Benzodiazepines and benzodiazepine-like substances are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress.
Verbatim from this product's MHRA label. Tap a section to expand.
4). Treatment should be given for the shortest possible duration. The lowest effective dose should be used. The usual initial dose is 5 mg as a single dose at bedtime and should not be re- taken during the same night. 5 mg. 5 mg per day.
Treatment duration The treatment time should be as short as possible (a few days to 2 weeks) and no longer than 4 weeks, including the tapering off. 4). 75 mg for elderly. 5 mg. 75 mg. 75 mg. 5 mg. Paediatric population Zopiclone Grindeks should not be administered in children and adolescents aged less than 18 years.
The safety and efficacy of zopiclone in this age group have not been established. Method of administration • For oral use. • The tablet should be taken before bedtime at night. • The tablets should be taken in an upright position as the absorption might be delayed in the lying position.
). Treatment with sleeping pills should be temporary or intermittent to reduce the risk of withdrawal problems. 2) but not longer than 4 weeks including the tapering off process. This period should only be exceeded after re-evaluation of the patient’s status.
It may be of benefit to inform the patient at the beginning of treatment that the treatment will be of short duration, and to explain precisely how to reduce the dose gradually. It is also important to draw attention to the possibility of a rebound effect, so the patient does not worry unduly about these symptoms during the treatment withdrawal.
Psychomotor impairment Like any other sedative/hypnotic medicine, zopiclone has CNS-depressant effects. Alterations in psychomotor functions are likely to appear within hours of administration. 5). , operating machinery or driving) after taking zopiclone, and especially during the first 12 hours after administration.
Anterograde amnesia Anterograde amnesia may occur, especially if sleep is interrupted or if bedtime is delayed after taking Zopiclone Grindeks. Anterograde amnesia could appear within hours of administration. To reduce the risk of anterograde amnesia, the patient should be advised to: - take the tablet immediately before bedtime or when already in bed, - create the most favourable conditions for a full night's sleep (7-8 hours).
Somnambulism and associated behaviours Sleepwalking and other associated complex sleep behaviours such as ‘sleep driving’, cooking and eating, having sex or making phone calls in sleep, with amnesia for the event, have been reported in patients who have taken the first or any subsequent dose of zopiclone and have not been awaken enough.
Patients usually do not remember these events. Patients can be seriously injured or injure others during complex sleep behaviors. Such injuries may result in a fatal outcome. The use of alcohol and other CNS depressants with zopiclone may increase the risk of such behaviour or when the maximum recommended dose is exceeded.
Before starting treatment with zopiclone any underlying cause of insomnia should be addressed carefully. Zopiclone Grindeks should also be used with caution in patients with a history of alcohol or drug abuse. Concomitant alcohol consumption should be avoided.
Dependence, tolerance and potential for abuse Drug addiction comprises behavioural, cognitive and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use and possible tolerance or physical dependence.
Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, which manifests as withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.
Addiction and dependence are related but distinct presentations and in discussing these themes, terminology that apportion blame to the individual should be avoided. For all patients, prolonged use of this product may lead to drug dependence and addiction but can occur with short-term use at recommended therapeutic doses.
, major depression). Additional support and monitoring may be necessary when prescribing for patients at risk of drug misuse. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on- line, and past and present medical and psychiatric conditions.
Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of symptom control as initially experienced. Patients may also supplement their treatment with additional medications to achieve the same effect.
These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else.
1. 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5). Other psychiatric and paradoxical reactions Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychosis, inappropriate behavior and other behavioral disturbances may occur during treatment with benzodiazepines and benzodiazepine-like agents.
In this case, the medicinal product must be discontinued. These reactions occur more often in the elderly. Suicide / Depression / Major depressive episode Some epidemiological studies show an increased incidence of suicidal ideation, suicide attempts and suicides in patients with or without depression, and treated with benzodiazepines and other hypnotics, including zopiclone.
However, a causal relationship has not been established. As with other hypnotics, zopiclone does not constitute a treatment for depression and may even mask its symptoms (suicide may be precipitated in such patients).
In persons with major depressive episode:
Benzodiazepines and benzodiazepine-like medicinal products should not be prescribed as monotherapy as this may allow the underlying depression to evolve and become persistent, leading to an increased risk of suicide. Because of the suicidal risk in these patients, the lowest possible dose of zopiclone should be used to these patients to avoid the possibility of intentional overdose.
Risks of concomitant use of opioids Concomitant use of Zopiclone Grindeks and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs such as Zopiclone Grindeks with opioids should be reserved for patients for whom alternative treatment options are not possible.
2). The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). 2. 3). Respiratory impairment A lower dose is recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression.
2). 2). There is a risk of fall, particularly in the elderly when they get up during the night due to the muscle relaxing effect of zopiclone. Paediatric population Zopiclone Grindeks should not be administered in children and adolescents under 18 years of age.
The safety and efficacy of zopiclone in this group have not been established. , is essentially 'sodium-free'. 5 mg film-coated tablet contains Cochineal red A […]
Patients should be closely monitored for signs of misuse, abuse, or addiction. The clinical need for treatment with zopiclone should be reviewed regularly, with frequent assessments of patients being undertaken during the course of their treatment.
Drug withdrawal syndrome Prior to starting treatment with zopiclone, a discussion should be held with patients to explain the risk of dependence, addiction, and drug withdrawal syndrome. A withdrawal strategy for ending treatment with zopiclone should also be put in place with the patient before starting treatment (there may be exceptions to this in specific clinical situations such as symptom management in end of life palliative care).
Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take in excess of weeks or months.
Patients should be informed of this when the medication is first prescribed. The reduction schedule for a patient should be tailored to the individual and should be modified to allow intolerable withdrawal symptoms to improve before making the next reduction.
If using a published withdrawal schedule, apply it flexibly to accommodate the person’s preferences, changes to their circumstances and the response to dose reductions. Suggest a slow stepwise rate of reduction proportionate to the existing dose, so that decrements become smaller as the dose is lowered, unless clinical risk is such that rapid withdrawal is needed.
If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome.
Rebound insomnia A transient syndrome where the symptoms that led to treatment with sedative/hypnotic agents recur in an enhanced form on discontinuation of therapy. The risk of these symptoms occurring is greater with an abrupt discontinuation, especially after prolonged treatment with sleeping pills.
8 Undesirable effects). Treatment with sleeping pills should be temporary or intermittent to reduce the risk of withdrawal problems. 2) but not longer than 4 weeks including the tapering off process. This period should only be exceeded after re-evaluation of the patient’s status.
It may be of benefit to inform the patient at the beginning of treatment that the treatment will be of short duration, and to explain precisely how to reduce the dose gradually. It is also important to draw attention to the possibility of a rebound effect, so the patient does not worry unduly about these symptoms during the treatment withdrawal.
Psychomotor impairment Like any other sedative/hypnotic medicine, zopiclone has CNS-depressant effects. Alterations in psychomotor functions are likely to appear within hours of administration. 5). , operating machinery or driving) after taking […]