Patients should be advised not to drive or operate machinery the day after treatment until it is established that their performance is unimpaired.
It has been reported that the risk that Alcherae adversely affects driving ability is increased by the concomitant intake of alcohol.
Therefore, it is recommended not to drive while taking Alcherae and alcohol concomitantly. This may also affect the patient's ability to drive and use machinery the following morning. Confusional state, numbed emotions, irritability, aggressiveness, hallucinations, psychoses, libido disorder. Dependency, restlessness, delusion, anger, depressed mood, somnambulism and other abnormal behaviour possibly associated with amnesia. See below under 'Depression', 'Psychiatric and paradoxical reactions', 'withdrawal syndrome', 'Somnambulism and associated behaviours' and 'Dependency'.
Ataxia predominantly at the start of therapy and usually disappears with repeated administration , paraesthesia, cognitive disorders such as memory impairment. Diplopia predominantly at the start of therapy and usually disappears with repeated administration. Withdrawal syndrome has been reported upon discontinuation of Alcherae. 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.
In very rare cases, seizures may occur. Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages. Amnesiac effects may be associated with inappropriate behaviour.
Pre-existing depression may be unmasked during use of benzodiazepines or benzodiazepine-like agents. Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines or benzodiazepine-like products.
They are more likely to occur in the elderly. There is an increased risk of sleepwalking and other associated behaviours with amnesia for the event in patients who have taken Alcherae and were not fully awake. It appears that there is an increased risk of such behaviour with the concomitant use of alcohol, other CNS depressants and the use of Alcherae at doses exceeding the maximum recommended dose. Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card scheme at: www. Symptoms of central nervous system depression, which can range from drowsiness to coma according to the quantity ingested.
In mild cases, symptoms include drowsiness, confusion and lethargy; in more severe cases, symptoms may include ataxia, hypotonia, hypotension, methaemoglobinaemia, respiratory depression and coma. The effects of overdose may be magnified if combined with alcohol or any other CNS depressants and in severe cases may be life-threatening.
Other risk factors, such as the presence of concomitant illness and the debilitated state of the patient may contribute to the severity of symptoms and very rarely can result in fatal outcome. Treatment of overdose should be symptomatic and supportive paying particular attention to respiratory and cardiac functions. Consider activated charcoal if an adult has ingested more than mg or a child more than 1.
Alternatively, consider gastric lavage in adults within one hour of a potentially life-threatening overdose. If CNS depression is severe consider the use of flumazenil. It has a short half-life about an hour.
Haemodialysis does not have any therapeutic effect in cases of Alcherae overdose. For current practice, refer to local poison centre or equivalent information sources regarding management of overdose.
Alcherae is a hypnotic agent belonging to the cyclopyrrolone class of psychotherapeutic agents. Although structurally unrelated to the benzodiazepines, Alcherae binds with high affinity and specificity to the GABA A -benzodiazepine chloride channel macromolecular receptor complex. Alcherae binds to a site different to the benzodiazepines and induces different conformational changes to the receptor complex thus modifying the activity of the chloride ion channel. Pharmacological properties are: anxiolysis, sedation, hypnosis, anticonvulsion and muscle relaxation.
Alcherae is swiftly absorbed. Absorption is the same in men and women and is not affected by simultaneous ingestion of food or repetition of doses. Alcherae is swiftly distributed from the vascular compartment. The most important metabolites are the N-oxide derivative pharmacologically active in animals and the N-desmethyl metabolite pharmacologically inactive in animals. Their apparent half-life times are approximately 4. No significant accumulation of the compound as seen following repeat dosing.
In animals, no enzyme induction has been observed even at high doses. The low renal clearance of Alcherae on average 8. In various trials with elderly patients, no accumulation of Alcherae was observed in the plasma after repeated doses, in spite of a slight reduction in the hepatic function and extension of the eliminated half-life to approximately 7 hours. In renal insufficiency, no accumulation of Alcherae or its metabolites have been detected after prolonged administration.
Alcherae crosses the dialysing membrane. For this reason the dosage should be adjusted for these patients. Hepatotoxic effects were observed in repeat dose toxicity studies conducted in rats and dogs. In dogs anaemia was observed in some studies. Increased incidence of mammary carcinomas in female rats at high multiples of the maximum plasma concentration from therapeutic doses in humans has been attributed to increased beta-estradiol serum levels.
Increased incidence of thyroid tumours in rats has been associated with increased TSH serum levels. In humans Alcherae has no effects on thyroid hormones. Foetal developmental retardations and foetotoxic effects in rats and rabbits were observed only at doses well above the maximum human dosage.
There was no evidence of a teratogenic potential. Alchera Print. Name of the medicinal product Qualitative and quantitative composition Therapeutic indications Dosage Posology and method of administration Contraindications Special warnings and precautions for use Effects on ability to drive and use machines Undesirable effects Overdose Pharmacodynamic properties Pharmacokinetic properties Pharmacotherapeutic group Preclinical safety data Incompatibilities Special precautions for disposal and other handling.
Components: Zopiclone. Method of action: Hypnotic. Treatment option: Insomnia. Name of the medicinal product. The information provided in Name of the medicinal product of Alchera is based on data of another medicine with exactly the same composition as the Alchera. Be careful and be sure to specify the information on the section Name of the medicinal product in the instructions to the drug Alchera directly from the package or from the pharmacist at the pharmacy.
Qualitative and quantitative composition. The information provided in Qualitative and quantitative composition of Alchera is based on data of another medicine with exactly the same composition as the Alchera. Be careful and be sure to specify the information on the section Qualitative and quantitative composition in the instructions to the drug Alchera directly from the package or from the pharmacist at the pharmacy.
Therapeutic indications. The information provided in Therapeutic indications of Alchera is based on data of another medicine with exactly the same composition as the Alchera. Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Alchera directly from the package or from the pharmacist at the pharmacy.
Alcherae is indicated for the short-term treatment of insomnia in adults. Dosage Posology and method of administration. The information provided in Dosage Posology and method of administration of Alchera is based on data of another medicine with exactly the same composition as the Alchera. If it is close to the time of your next dose, skip the missed dose and resume your dosing schedule. Do not use extra dose to make up for a missed dose.
If you are regularly missing doses, consider setting an alarm or asking a family member to remind you. Please consult your doctor to discuss changes in your dosing schedule or a new schedule to make up for missed doses, if you have missed too many doses recently.
Overdosage of Alchera Tablet Do not use more than prescribed dose. Taking more medication will not improve your symptoms; rather they may cause poisoning or serious side-effects.
If you suspect that you or anyone else who may have overdosed of Alchera Tablet , please go to the emergency department of the closest hospital or nursing home. Bring a medicine box, container, or label with you to help doctors with necessary information. Do not give your medicines to other people even if you know that they have the same condition or it seems that they may have similar condition s. This may lead to overdosage. Please consult your physician or pharmacist or product package for more information.
Storage of Alchera Tablet Store medicines at room temperature, away from heat and direct light. Do not freeze medicines unless required by package insert.
Keep medicines away from children and pets. Do not flush medications down the toilet or pour them into drainage unless instructed to do so. Medication discarded in this manner may contaminate the environment. Please consult your pharmacist or doctor for more details on how to safely discard Alchera Tablet.
Expired Alchera Tablet Taking a single dose of expired Alchera Tablet is unlikely to produce an adverse event. However, please discuss with your primary health provider or pharmacist for proper advice or if you feel unwell or sick. Expired drug may become ineffective in treating your prescribed conditions. To be on the safe side, it is important not to use expired drugs. If you have a chronic illness that requires taking medicine constantly such as heart condition, seizures, and life-threatening allergies, you are much safer keeping in touch with your primary health care provider so that you can have a fresh supply of unexpired medications.
Dosage Information Please consult your physician or pharmacist or refer to the product package. Cite this page Page URL. Accessed July 27, More about Alchera Tablet Uses Reviews. What are the uses of Alchera Tablet? What are the side-effects of Alchera Tablet? What other medicines does Alchera Tablet interact with? When should you not use Alchera Tablet? What precautions should you take while using Alchera Tablet? This page provides information for Alchera Tablet Product in English.
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