Zopiclone 7.5 mg film-coated tablets

Zopiclone 7.5 mg Film-coated Tablets (Arrow) - Summary of Product

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Zopiclone 7.5 mg Film-coated Tablets (Arrow) - Summary of Product

Zopiclone 7.5 mg Film-coated Tablets. 2. Qualitative and quantitative composition. Each tablet contains Zopiclone 7.5 mg. For excipients, see.

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Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK.

Last Updated on eMC 26-Jun-2013 View changes| Actavis UK Ltd Contact details.

The effect of erythromycin on the pharmacokinetics of zopiclone has been studied in 10 healthy subjects. Marketing authorisation number(s) PL 18909/0159 9. Metabolism: The main metabolites are the n-oxide derivative (pharmacologically active in animals) and the n-desmethyl metabolite (pharmacologically inactive in animals). At doses between 3.75-15 mg, plasma clearance does not depend on dose. 5.3 Preclinical safety data Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction. Any underlying cause of the insomnia should also be addressed before symptomatic treatment to avoid under- treating potentially serious effects of depression. The decision to use a hypnotic in such patients should be taken only with this clearly in mind. Each tablet should be swallowed whole without sucking, chewing or breaking. Rare cases of abuse have been reported. High density polyethylene tablet containers with a polypropylene screw cap fitted with a pressure sensitive innerseal. However with zopiclone there is an absence of any marked tolerance during treatment periods of up to 4 weeks. Use of benzodiazepines and benzodiazepine-like agents (even at therapeutic doses) may lead to the development of physical and psychological dependence upon these products. These are related to its high affinity and specific agonist action at central receptors belonging to the 'GABA macromolecular receptor complex modulating the opening of the chloride ion channel. It rapidly initiates and sustains sleep without reduction of total REM sleep and with preservation of slow wave sleep. 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, hypnotic and respiratory depression can be expected. In particular this could affect the patient's ability to drive or use machines. Its pharmacological properties include hypnotic, sedative, anxiolytic, anti convulsant and muscle-relaxant actions. 4.7 Effects on ability to drive and use machines Although residual effects are rare and generally of minor significance patients should be advised not to drive or operate machinery the day after treatment until it is established that their performance is unimpaired. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Patients with myasthenia gravis, respiratory failure, severe sleep apnoea syndrome and severe hepatic insufficiency. Negligible residual effects are seen the following morning. The product is eliminated by the urinary route (approximay 80%) in the form of free metabolites (n-oxide and n-desmethyl derivatives) and in the faeces (approximay 16%). The volume of distribution is 91.8-104.6 litres. Oral. Symptomatic and supportive treatment in an adequate clinical environment is recommended, attention should be paid to respiratory and cardiovascular functions. Since the risk of withdrawal/ rebound phenomena may be increased after prolonged treatment, or abrupt discontinuation of therapy, decreasing the dosage in a stepwise fashion may be helpful. Rebound insomnia is a transient syndrome where the symptoms which led to treatment with a benzodiazepine or benzodiazepine-like agent recur in an enhanced form on discontinuation of therapy. As with all hypnotics zopiclone should not be used in children. Pharmaceutical particulars 6.1 List of excipients Calcium Hydrogen Phosphate Potato Starch Silicon Dioxide Sodium Starch Glycollate Magnesium Stearate Coating: Opadry II 33G28707 White, which contains- Hypromellose Titanium Dioxide (E 171) Lactose monohydrate Macrogol Glycerol triacetate 6.2 Incompatibilities Not applicable. The elimination half life is approximay 5 hours. 6.5 Nature and contents of container PVC / PVdC / aluminium blister packs. Angiodema and/or anaphylactic reactions have been reported very rarely. Store in the original package HDPE/ PP Containers: Do not store above 25°C. Absorption is not modified by gender, food or repetition of doses. 4.5 Interaction with other medicinal products and other forms of interaction The sedative effect of zopiclone may be enhanced when used in combination with alcohol, concomitant use is therefore not recommended. Lactose: This medication contains lactose. Therefore, patients should ensure that they take the tablet when certain of retiring for the night and they are able to have a full night's sleep. If the product is prescribed to a woman of child bearing potential, she should be advised to contact her physician about stopping the product if she intends to become pregnant, or suspects that she is pregnant. Driving: It has been reported that the risk of zopiclone adversely affecting driving ability is increased by the concomitant intake of alcohol. 6. 6.4 Special precautions for storage Blister packs: Do not store above 25°C. Haemodialysis is of no value due to the large volume of distribution of zopiclone. 4.6 Pregnancy and lactation Use during pregnancy : Experience of use of zopiclone during pregnancy in humans is limited although there have been no adverse findings in animals. After repeated administration, there is no accumulation, and inter-individual variations appear to be very small. 7. Peak concentrations are reached within 1.5-2 hours and they are approximay 30 ng/ml and 60 ng/ml after administration of 3.75 mg and 7.5 mg respectively. In cirrhotic patients, the plasma clearance of Zopiclone is clearly reduced by the slowing of the desmethylation process: dosage will therefore have to be modified in these patients. In combination with CNS depressants an enhancement of the central depressive effect may occur. 4.8 Undesirable effects A mild bitter or metallic after-taste is the most frequently reported adverse effect. 6.6 Special precautions for disposal and other handling No special requirements. 6.3 Shelf life 2 years. Compounds which inhibit certain hepatic enzymes (particularly cytochrome P450) may enhance the activity of benzodiazepines and benzodiazepine-like agents. Use in renal insufficiency : A reduced dosage is recommended, see posology. Special patient groups: In elderly patients, not withstanding a slight decrease in hepatic metabolism and a lengthening of elimination half-life to approximay 7 hours, various studies have shown no plasma accumulation of drug substance on repeated dosing. 4.9 Overdose Overdose is usually manifested by varying degrees of central nervous system depression ranging from drowsiness to coma according to the quantity ingested. These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. Tolerance : Some loss of efficacy to the hypnotic effect of benzodiazepines and benzodiazepine-like agents may develop after repeated use for a few weeks. Pack sizes 30, 1000 tablets. A course of treatment should employ the lowest effective dose for the minimum length of time necessary for effective treatment. Pharmacological properties 5.1 Pharmacodynamic properties Benzodiazepine related drugs. Excretion: The low renal clearance value of unchanged zopiclone (mean 8.4 ml/min) compared with the plasma clearance (232 ml/min) indicates that Zopiclone clearance is mainly metabolic. Less commonly, mild gastrointestinal disturbances, including nausea and vomiting, dizziness, headache, drowsiness and dry mouth have occurred. Keep the container tightly closed. In animals, no enzyme induction has been observed even at high doses. Distribution: The product is rapidly distributed from the vascular compartment. Marketing authorisation holder Arrow Generics Limited Unit 2, Eastman Way Stevenage Herts SG1 4SZ 8. Risk of dependence : Clinical experience to date with zopiclone suggests that the risk of dependence is minimal when the duration of treatment is limited to not more than 4 weeks. As a consequence, the hypnotic effect of zopiclone may be enhanced. The therapeutic benefit of co-administration with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, anti-epileptic drugs, anaesthetics and sedative antihistamines should therefore be carefully weighed. Overdose should not be life-threatening unless combined with other CNS depressants (including alcohol). If physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms (see warnings and precautions). Infants born to mothers who took benzodiazepines or benzodiazepine-like agents chronically during the latter stages of pregnancy may have developed physical dependence and may be at some risk of developing withdrawal symptoms in the postnatal period. A course of treatment should not continue for longer than 4 weeks including any tapering off. Therefore, it is recommended not to drive while taking zopiclone and alcohol concomitantly. The risk of dependence increases with dose and duration of treatment; it is also greater in patients with a history of alcohol and or drug abuse, or those who have marked personality disorders. Flumazenil may be a useful antidote. In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures. No significant accumulation is seen on repeated dosing (15 mg) for 14 days. Gastric lavage is only useful when performed soon after ingestion. Zopiclone crosses dialysis membranes. It may be accompanied by other reactions including mood changes, anxiety and restlessness. Date of first authorisation/renewal of the authorisation 2nd February, 2007 10. The AUC of zopiclone is increased by 80% in presence of erythromycin which indicates that erythromycin can inhibit the metabolism of drugs metabolised by CYP 3A4. Date of revision of the text Company contact details Actavis UK Ltd www.actavis.co.uk. Their apparent half-lives (evaluated from the urinary data) are approximay 4.5 hours and 1.5 hours respectively. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients. However, it has been shown that zopiclone and other cyclopyrrolones act on a different site to those of benzodiazepines inducing different conformational changes in the receptor complex. Pack sizes 20, 28, 30, 50, 56, 60, 84, and 100 tablets. Patients may benefit from tapering of the dose before discontinuation. Rarely these reactions may be severe and may be more likely to occur in the elderly. ATC code: N05 CF01 Zopiclone is a hypnotic agent, and a member of the cyclopyrrolone group of compounds. Concomitant use of benzodiazepine or benzodiazepine-like agents with narcotic analgesics may enhance their euphoric effect and could lead to an increase in psychic dependence. 5. Withdrawal: The termination of treatment with zopiclone is unlikely to be associated with withdrawal effects when duration of treatment is limited to 4 weeks. The risk is increased by concomitant intake of alcohol (see section “4.4 Special warnings and special precautions for use”). Not all pack sizes may be marketed. 5.2 Pharmacokinetic properties Absorption: Zopiclone is absorbed rapidly. Amnesia : Amnesia is rare, but anterograde amnesia may occur, especially when sleep is interrupted or when retiring to bed is delayed after taking the tablet. Use in pregnancy is therefore not recommended. In renal insufficiency, no accumulation of Zopiclone or of its metabolites has been detected after prolonged administration. Use during lactation: Zopiclone is excreted in breast milk and use in nursing mothers must be avoided. There is very little risk of drug interactions due to protein bindings. Psychological and behavioural disturbances, such as irritability, aggressiveness, confusion, depressed mood, anterograde amnesia, hallucinations and nightmares have been reported. Mild to moderate increases in serum transaminases and/or alkaline phosphatase have been reported very rarely. See posology for guidance on possible treatment regimen. Depression: Zopiclone does not constitute a treatment for depression. 4.4 Special warnings and precautions for use Use in hepatic insufficiency : A reduced dosage is recommended, see posology. Rarely allergic and allied manifestations such as urticaria or rashes have been observed and, more rarely, light headedness and incoordination. Plasma protein binding is weak (approximay 45%) and non saturable.

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Zopiclone 3.75 mg & 7.5mg Film-coated Tablets (Arrow) (PIL).

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Short term insomnia: 2-3 weeks. A single course of treatment should not continue for longer than 4 weeks including any tapering off. Transient insomnia: 2-5 days. Route of Administration.

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Qualitative and quantitative composition Each tablet contains Zopiclone 7.5 mg For excipients, see 6.1. Adults : The recommended dose is 7.5 mg zopiclone shortly before retiring. Depending on effectiveness and acceptability, the dosage subsequently may be increased if clinically necessary. Zopiclone 7.5 mg Film-coated Tablets 2. Treatment Duration. Pharmaceutical form Film-coated tablet. Approximay 10 mm x 5 mm 4. Renal insufficiency : Accumulation of zopiclone or its metabolites has not been seen during treatment of insomnia in patients with renal insufficiency. 3. Elderly : A lower dose of 3.75 mg zopiclone should be employed to start treatment in the elderly. A course of treatment should employ the lowest effective dose. White, oblong, film-coated tablet with Arrow logo on one side, “Z / 7.5” on the reverse. 4.2 Posology and method of administration Long term continuous use is not recommended. The standard dose of 7.5 mg zopiclone may be used with caution in some cases, depending on effectiveness and acceptability. Patients with hepatic insufficiency: As elimination of zopiclone may be reduced in patients with hepatic dysfunction, a lower dose of 3.75 mg zopiclone nightly is recommended. Clinical particulars 4.1 Therapeutic indications Short term treatment of insomnia, including difficulties in falling asleep, nocturnal awakening and early awakening, transient, situational or chronic insomnia, and insomnia secondary to psychiatric disturbances, in situations where the insomnia is debilitating or is causing severe distress for the patient. However it is recommended that patients with impaired renal function should start treatment with 3.75 mg.

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