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IMOVANE (ZOPICLONE): PRECAUTIONS

Prolonged use of hypnotics is not recommended especially in the elderly.

Dependence

Zopiclone (Imovane) tablets should be prescribed for short periods only (2-4 weeks). Continuous long term use is not recommended. Use of sedative-hypnotic agents like zopiclone may lead to the development of physical and psychological dependence or abuse. It is therefore recommended that after prolonged use the dose should be decreased gradually and the patient advised about such a possibility.

Risks of dependence or abuse increase with:

  • Dose and duration of treatment.
  • History of alcohol and/or drug abuse.
  • Use with alcohol or other psychotropics.

    Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms.

    Rebound Insomnia

    A transient syndrome whereby the symptoms that led to treatment with sedative-hypnotic agents recur in an enhanced form, may occur on withdrawal of hypnotic treatment. Since the risk of such phenomena is greater after abrupt discontinuation of zopiclone, especially after prolonged treatment, it is, therefore, recommended to decrease the dosage gradually and to advise the patient accordingly.

    Amnesia

    Anterograde amnesia may occur, specially when sleep is interrupted or when retiring to bed is delayed after the intake of the tablet.

    To reduce the possibility of anterograde amnesia, patients should ensure that:

  • they take the tablet strictly when retiring for the night,
  • they are able to have a full night sleep.

    Other Psychiatric and Paradoxical Reactions

    Other psychiatric and paradoxical reactions have been reported, like agitation, restlessness, irritability, delusion, aggression, anger, nightmares, inappropriate behaviour, hallucinations, and other adverse behavioural effects are known to occur when using sedative/hypnotic agents like zopiclone. Should this occur, use of zopiclone should be discontinued. These reactions are more likely to occur in the elderly.

    Somnambulism and Associated Behaviours

    Sleep walking and other associated behaviours such as "sleep driving", preparing and eating food, or making phone calls, with amnesia for the event, have been reported in patients who have taken zopiclone and were not fully awake. The use of alcohol and other CNS-depressants with zopiclone appears to increase the risk of such behaviours, as does the use of Zopiclone (Imovane) at doses exceeding the maximum recommended dose. Discontinuation of Imovane (Zopiclone) tablets would be strongly considered for patients who report such behaviours.

    Depression, Psychosis and Schizophrenia

    As with other hypnotics, zopiclone does not constitute a treatment of depression and may even mask its symptoms. Caution should be exercised if zopiclone is prescribed to depressed patients, including those with latent depression, particularly when suicidal tendencies may be present and protective measures may be required.

    Epilepsy

    Patients with a history of seizures should not be abruptly withdrawn from any CNS depressant drug, including zopiclone.

    Severe Anaphylactic and Anaphylactoid Reactions

    Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zopiclone. Some patients have had additional symptoms such as dyspnoea, throat closing, or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with zopiclone should not be rechallenged with the drug.

    Hepatic Insufficiency

    In patients with severe hepatic insufficiency (serum albumin less than 30 g/l or presence of gross oedema), the elimination of zopiclone may be significantly reduced. Treatment should be initiated on a dose of 3.75 mg and if necessary, may be increased to 7.5 mg.

    Renal Insufficiency

    Zopiclone (Imovane) tablets are removed by dialysis.

    Respiratory Insufficiency

    Caution should be exercised in treating patients with chronic respiratory insufficiency. Treatment should be initiated on a dose of 3.75 mg and if necessary, should be carried out at 7.5 mg.

    Hormonal Systems

    Treatment of rats with zopiclone increases hepatic thyroid hormone metabolism of T4, resulting in increases in TSH and T3 levels, and decreases in T4 levels. It is suggested that zopiclone not be administered to individuals with impaired thyroid hormone homeostatic mechanisms or with conditions linked to hormonal imbalances.

    Effects on Ability to Drive and use Machinery

    As with all patients taking CNS depressant medications, patients receiving zopiclone should be warned not to operate dangerous machinery or motor vehicles until it is known that they do not become drowsy after zopiclone therapy. Abilities may be impaired on the day following use. It has been reported that the risk that zopiclone adversely affects driving ability is increased by concomitant intake of alcohol. Therefore, driving is not recommended after the concomitant intake of zopiclone and alcohol.

    Abuse

    Caution must be exercised in administering Imovane (Zopiclone) to individuals known to be addiction prone or those whose history suggests they may increase the dosage on their own initiative.

    Geriatric or Debilitated Patients

    Such patients may be particularly susceptible to the sedative effects of zopiclone and associated giddiness, ataxia and confusion, which may increase the possibility of a fall.

    Use in Children

    The safe and effective dose of Zopiclone (Imovane) in children and adolescents under 18 years of age has not been established.

    Effects on Fertility

    Imovane (Zopiclone) tablets has been shown to severely reduce fertility in male rats treated with 50 mg / kg per day or greater. The significance of this finding for humans is not known.

    Use in Pregnancy

    Pregnancy Category C

    Insufficient data are available on Zopiclone (Imovane) tablets to assess its safety during human pregnancy and lactation, therefore the use of zopiclone during pregnancy is not recommended. Studies in animals have not shown evidence of an increased occurrence of foetal damage. However, zopiclone has been shown to cross the placenta, and increase postnatal mortality in rats given 10 mg / kg per day and above. Although the significance of this for humans is not known, it is likely that zopiclone may be harmful to the neonate.

    Treatment should be as short as possible and should not exceed four weeks including the period of tapering off. Moreover, infants born to mothers who took sedative/hypnotics agents 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.

    If Imovane (Zopiclone) is prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding discontinuation of the product if she intends to become or suspects she is pregnant.

    Moreover, if zopiclone is used during the last three months of pregnancy or during labour, due to the pharmacological action of the product, effects on the neonate, such as hypothermia, hypotonia and respiratory depression can be expected.

    Use in Lactation

    Zopiclone (Imovane) and/or its metabolites are excreted in breast milk so therefore use in nursing mothers is not recommended.

    Carcinogenicity

    Treatment with zopiclone by dietary administration for 2 years increased the incidence of thyroid carcinomas in male rats dosed with 100 mg / kg per day, and increased the incidence of mammary carcinoma in female rats dosed with 100 mg / kg per day, probably due to interference with thyroid hormone and 17beta-estradiol metabolism. Studies with mice treated with zopiclone at dietary doses up to 100 mg / kg per day showed no evidence of drug-related carcinogenicity.

    Genotoxicity

    Genotoxicity studies, using a standard battery of tests, showed no evidence of gene mutations or chromosomal damage.

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