Zopistad 7.5 Stella medicine supports short -term treatment of insomnia (1 blister x 10 tablets)

Dosage form Box of 1 blister x 10 tablets
Specifications ZopiClone

Ingredient

Composition information	Content
ZopiClone	7.5mg

Uses

indications

Zopistad 7.5 drugs are indicated in the following cases:

Short -term treatment of insomnia, including difficulty sleeping, waking up at night and waking up early, transient insomnia, temporary or chronic insomnia and secondary insomnia due to mental disorders, in cases where insomnia makes patients depressed or exhausted seriously.

Pharmacokology

Zopiclone belongs to the cyclopoprolon group that has the same characteristics as the derivatives of benzodiazepin: sedation, anxiety, muscle relaxation, forgetting and anti -convulsions. The drug has an indirect effect that increases the activity of gamma acid - aminobutyric (GABA) in the brain. ZopiClone is attached to the benzodiazepin receptor of the GABA receptor complex but in a different position than the benzodiazepin derivatives. The drug has a short impact time. The sleeping drug starts fast but does not reduce the total time of fast eye movement (REM) and maintains normal slow sleep. In general, the drug is considered as effective as a sleeping pills similar to the derivatives of benzodiazepin.

Pharmacokinetics

absorption

Zopiclone is quickly absorbed and widely distributed after drinking.

Distribution

The drug has a half -life after 3.5 - 6.5 hours and about 45 - 80% of the drug is connected to plasma proteins.

Metabolism

Zopiclone is metabolized in the liver. Two main metabolites, Zopiclone N - Oxyd is less active and N - Desmethyl - Zopiclone is not active, excreted mainly through urine.

Elimination

About 50% of the dose is converted due to carboxyl reduction into non -activity metabolites that are partially eliminated through the lungs in the form of carbon dioxyd. Only about 5% of the undet sheets appear in the urine and about 16% in the feces. ZopiClone is also excreted through saliva due to the bitter taste. The drug is also distributed into breast milk.

Before taking Zopistad 7.5 Stella medicine supports short -term treatment of insomnia (1 blister x 10 tablets)

How to use

Should use the lowest dose effectively in each treatment.

Should drink Zopistad 7.5 before going to bed, in a standing position.

Dosage

Adults

Common dose: 7.5 mg.

Elderly

Should start treatment at a dose of 3.75 mg.

Patients with renal failure or mild to moderate liver failure

Should start treatment with zopiClone at the dose of 3.75 mg.

Treatment time: temporary insomnia: 2 - 5 days. Short -term insomnia: 2 - 3 weeks. A therapy should not last more than 4 weeks including the dose reduction time.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose? However, death is also recorded after overdose zopiClone.

Treatment: Overdose treatment is mainly supportive. Adults take over 150 mg of zopiClone or children who take 1.5 mg/kg within 1 hour may order activated carbon. In addition, gastric lavage is also considered for adults within 1 hour after an overdose risk threatening life. Flumazenil is used in the case of serious central neurological inhibition. Consciousness will quickly recover after Flumazenil intravenous intravenous injection for Zopiclone overdose.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.

Side Effects

When using Zopistad 7.5, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Digestive: The mouth has a slightly bitter taste or a metal taste.

Uncommon, 1/1000

Digestive: mild digestive disorders, including nausea and vomiting, dizziness, headache, dozing off and dry mouth.

Rare, 1/10000

Mental: Mental disorders and behavior, such as irritability, aggression, confusion, depression, forgetting later, the head is lightheaded and the ability to coordinate, sleepwalking, hallucinations and nightmares, more common in the elderly.

Skin and subcutaneous tissue: allergies and similar symptoms (such as urticaria or rash), edema.

immune system: Anaphylactic reaction.

Metabolism: Increased transaminase and/or alkalin phosphatase in mild to moderate serum.

Symptoms of quitting smoking include insomnia, anxiety, tremor, sweating, agitation, confusion, headache, brushing chest drum, fast heartbeat, delirious, nightmares, hallucinations, panic, muscle/cramps, digestive disorders and irritability. The seizure may occur but very rare.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Zopistad drug 7.5 Contraindications in the following cases:

Hypersensitivity to zopiClone or any excipients.

Severe myasthenia gravis, respiratory failure, serious sleep apnea, serious liver failure.

Children.

Be cautious when using

The risk of drug dependence

Clinical experience so far with Zopiclone shows that the risk of drug dependence is very small when the therapeutic time does not exceed 4 weeks. The risk of drug dependence increases by dosage and therapeutic time; Higher increase in patients with a history of alcohol and/or drug abuse, or patients with significant personality disorders. The decision to use sleeping pills for these patients is only clear. If physical dependence progresses, sudden stop treatment will be accompanied by symptoms of cessation.

Quit drug

The stop treatment with zopiClone is uncertain related to the symptoms of quitting when the treatment process is limited to 4 weeks. Patients may benefit from reducing the dose gradually before stopping.

Depression

Do not specify zopiClone to treat depression. Any basic cause of insomnia should be determined before treating symptoms to avoid treating serious potential symptoms of depression.

Medicine tolerance

There is no Zopiclone tolerance with treatment time up to 4 weeks.

Insomnia again

Due to the risk of quitting or insomnia may increase when the treatment time is prolonged, or sudden treatment stops, the decrease of the dose of each step may be useful.

sleepwalking and related behaviors

Forgoting the events that have been done as sleeping and other related behaviors including "sleeping when driving", when cooking and eating or calling for recorded in patients who have used Zopiclone without waking up completely. The stopping of ZopiClone should be carefully considered for the patients with the above behavior.

Forgot

Rarely forgotten but may occur later, especially when sleep is interrupted or going to sleep is postponed after taking the drug. Therefore, patients should only take medicine when sure to sleep and may have a night sleep.

Zopistad 7.5 contains lactose. This drug should not be used for patients with rare genetic problems galactose intolerance, total lactase enzyme deficiency or glucose - galactose.

The ability to drive and operate machinery

Although unwanted effects are rare and often negligible, patients should not drive or operate machinery after treatment until determining the performance of these jobs. The risk will increase when used simultaneously with alcohol.

Pregnancy

Experience about the use of zopiClone during pregnancy is still limited although there are no disadvantages on animals. Therefore, zopiClone should not be appointed during pregnancy.

Breastfeeding period

Should avoid using Zopiclone for women who are breastfeeding because of breast milk.

Interactive drug

alcohol

Do not use it simultaneously with alcohol because alcohol increases the sedative effect of zopiClone. Especially this will affect the ability to drive or operate machinery.

Central neurological inhibitors

Combined with central neurological inhibitors can increase the neurological inhibition effect, carefully consider the benefits of therapeutic in combination with anti -dysplasia drugs (neuroleptics), sleeping pills, anxiety/sedatives, antidepressants, addictive painkillers, anti -epileptic drugs, anesthetic and anti -histamine drugs have sedative effects. Simultaneous use of benzodiazepin or benzodiazepin medications with addictive painkillers can increase the feeling of excitement that leads to mental increases. Inhibitors inhibit some liver enzymes (especially cytochrom P450) may increase the effects of benzodiazepine and benzodiazepine medications.

CYP3A4 inhibitors (erythromycin, clarithromycin, ketoconazole, iTraconazole and ritonavir)

Because Zopiclone is metabolized by Cytochrom P450 (CYP) 3A4 Isoenzym, the zopiclone level in plasma can increase when used simultaneously with CYP3A4 inhibitors. Zopicione dose should be reduced when used simultaneously with CYP3A4 inhibitors.

CYP3A4 induction drugs (Rifampicin, Carbamazepin, Phenobarbital, Phenytoin and St. John's Wort)

Zopiclone concentration in plasma decreases when used simultaneously with CYP3A4 induction drugs. ZopiClone should be increased when used simultaneously with CYP3A4 induction drugs.

Storage

Store in closed packaging, dry place, avoid light. The temperature does not exceed 30 ° C.

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