Zopiclon 7.5 mg. 30 tablets

WHAT IS ZOPICLON AND WHAT IT IS USED FOR

Pharmacotherapeutic group:

Sleep agent is a fast-acting and short-acting sleeping agent (a sleeping agent) with a chemical structure different from that of the sleeping agents used so far (a class of cycloprololones). As well as causing sleep and alleviating anxiety, zopiclone also has an anticonvulsant effect and relieves tension in the muscles.

Therapeutic indications:

Zopiclon is used for the short-term treatment of sleep disorders, including sleeping difficulties, often waking up at night, and early morning wake when insomnia is severe and disrupts day-to-day activities.

Unless otherwise prescribed by the physician, the medicinal product should not be administered for more than 28 days,
including the days for gradual dose reduction.

Zopiclon is for use in adults over 18 years of age.

2. BEFORE YOU STARTED USING ZOPICLON

Do not take Zopiclon

• If you are allergic (hypersensitive) to zopiclone (the active substance in the medicine) or to any of the other ingredients of Zopiclone-Nicomed

• If you are pregnant or breast-feeding

• If you suffer from:

♦ muscular weakness due to myasthenia gravis

♦ severe respiratory failure

♦ severe hepatic impairment

♦ rhythm disturbances of breathing during sleep (sleep apnea)

Zopiclon should not be used in children and adolescents under 18 years of age.

If any of the above conditions occur during treatment with the medicinal product, you should contact your doctor.

Be especially careful with Zopiclon

If you use this medicine, there is a risk of developing drug dependence on ziphixone (this risk however is minimal when the duration of treatment is up to 4 weeks). The risk of developing addiction increases with the dose and duration of treatment; this risk is also higher in alcohol-abusive patients and medicinal products (also in the past).

In the development of dependence, sudden discontinuation of treatment is accompanied by withdrawal symptoms such as headache, muscle weakness, tension, anxiety, confusion and irritability.

Anterograde amnesia (no memory of what happened after taking the tablet) may develop when taking Zopiclon if sleep is interrupted or a longer time has elapsed between taking the medicine and sleeping.

The onset of anterograde amnesia can be prevented by following the following rules:

• the medicine should be taken immediately before bedtime;

• the medicine should be used only if it is possible to ensure continuous sleep throughout the night.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

The action of Zopiclon and other medicinal products used at the same time may interfere with each other. Therefore, your doctor should be informed of all the medicines you are taking at the moment or you are going to start taking, whether on prescription or free of charge. You should consult your doctor before taking any of the free medicines at the same time as Zopiclon-Nicomed. The relaxing action of zopiclone may be enhanced by concomitant use of neuroleptics (medicines to treat mental illness), hypnotics (sleeping agents), sedatives, anxiolytics (anxiolytic medicines), antidepressants (medicines to relieve the symptoms of depression), narcotic drugs (some potent painkillers, addictive drugs, etc.), antiepileptic agents (for the treatment of epilepsy) and antihistamines (mainly antiallergic agents tba).

Zopiclon can be potentiated when taken concomitantly with erythromycin, clarithromycin, ketoconazole, itraconazole and ritonavir, and a dose reduction of Zopiclon may be necessary.

Conversely, it may be necessary to increase the dose of Zopiclone-Nicomed while on concomitant use with rifampicin, carbamazepine, fetobarbital, phenytoin and St. John's wort.
Taking Zopiclon with food and liquids

The tablets should be taken with a small amount of liquid.

Pregnancy and breastfeeding

The medicinal product should not be taken during pregnancy and lactation. Please tell your doctor or pharmacist before taking any medicine.

Driving and using machines

The medicinal product may adversely affect activities requiring caution, motor coordination and rapid decision-making, eg. driving, working with machines or at heights. These activities can only be done with the consent of a doctor!

Important information about some of the ingredients of ZOPICLON

This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before you start using this medicine. Zopiclon contains wheat starch and is suitable for people with gluten enteropathy. Patients with wheat allergy (other than gluten enteropathy) are not recommended to take this medicine.

3. HOW TO USE ZOPICLON

Take Zopiclon-Nicomed as your doctor has told you. Ask your doctor or pharmacist if you are not sure.

The exact dosage and duration of treatment is always determined by a doctor.

The usual adult dose is 1 tablet immediately before bedtime. This dose should not be increased without prescription.

• In elderly patients, in the presence of hepatic impairment and chronic respiratory insufficiency, treatment should be started with 1/2 tablet (3.75 mg) of Zopiclone-Nikomed at bedtime; if necessary, this dose may be increased to 1 tablet before bedtime. In patients with severe renal impairment, the recommended dose is 1/2 tablet (3.75 mg) of Zopiclon

Application method

The tablets should be taken with a small amount of liquid.
Taking the medicine should be done immediately before sleep.

If you take more Zopiclon than you need:

Symptoms of zidovudine overdose are manifested by varying degrees of central nervous system depression - from sleepiness to consciousness, depending on the dose. Overdose of this medicinal product is usually not life threatening unless it is combined with other sedative medicinal products that affect the central nervous system (see other medicines), including alcohol.

Treatment of overdosage

Seek immediate medical attention if you experience the above symptoms! If the patient is conscious, try to cause vomiting. If the patient is not conscious, put him or her in a lying position on one side and follow the basic vital functions (breathing, pulse) carefully.

If you forget to take Zopiclon

Do not take a double dose to make up for the missed dose.

If you stop taking Zopiclon

After a sudden discontinuation of treatment, insomnia may recur. It is recommended that treatment be discontinued by gradual dose reduction under careful medical supervision.

4. POSSIBLE SIDE EFFECTS

Like any medicine, Zopiclon can cause side effects that do not occur in any patient.

The drug is usually well tolerated, but the following reactions may occur: dry mouth, metallic taste, headache, nausea, daytime drowsiness and dizziness. Psychiatric disorders and behavioral changes (increased irritability, confusion, hallucinations, aggressiveness) may occasionally occur, in some cases it is possible to experience depression after awakening or allergic skin reactions. If any side effects or other unusual reactions occur, you should consult your doctor about further use of the medicine. If any of these effects get worse or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
HOW TO STORE ZOPICLON

• Keep out of the reach and sight of children.

• Do not use Zopiclon  after the expiry date which is stated on the carton
box / blister. The expiration date expires on the last day of the month.

• Store below 25 ° C. Keep away from moisture and light.

• Medicines should not be disposed of with household waste or household waste.

• Ask your pharmacist how to destroy the medicine you no longer need.
These measures help to protect the environment.

6. ADDITIONAL INFORMATION

What Zopiclon contains

• The drug is Zopiclon 7.5 mg in each film-coated tablet.

• Excipients:

Core: lactose monohydrate, magnesium stearate, wheat starch, calcium dihydrogenphosphate, sodium carboxymethyl starch.

Coat: hypromellose, titanium dioxide.

What Zopiclon is and what it contains

Zopiclon are white circular biconvex film-coated tablets scored

Contents of 1 pack: 10 or 30 film-coated tablets

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